# L7 Informatics > L7 Informatics: Synchronized Solutions for Science + Health ## Posts ### Best MES for Life Sciences in 2025 Best MES for Life Sciences in 2025@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPiBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Manufacturing Execution Systems (MES) have evolved from basic production tracking tools into sophisticated platforms essential for pharmaceutical and biotechnology manufacturing operations. According to BioPhorum’s MES of the Future Manifesto and its 2025 progress report, the life sciences industry is pushing MES suppliers toward greater modularity, seamless integration, and AI-readiness, which are essential capabilities for meeting the complex demands of modern pharmaceutical and biotechnology manufacturing. This guide compares the best MES for pharma and biotech, including cloud MES, low-code MES, and AI-powered MES solutions for 2025. Here are the top MES vendors empowering life sciences organizations in 2025: 1. L7 Informatics — L7|ESP® L7|ESP revolutionizes pharmaceutical manufacturing by delivering a comprehensive Manufacturing Execution System that seamlessly integrates with LIMS, inventory management, and workflow orchestration within a unified platform. Unlike traditional point solution MES systems that create data silos, L7 MES operates within the L7|ESP ecosystem, enabling manufacturers to rapidly configure Master Batch Records, manage Electronic Batch Records (EBR), and orchestrate complex manufacturing processes with full visibility. In advanced modalities like cell and gene therapy, L7|ESP automates Chain of Identity (CoI) and Chain of Custody (CoC) tracking from material receipt through batch release. Integrated LIMS/MES capabilities enable near real-time disposition with automated quality review, while bi-directional integration with SAP, process equipment, and QC instrumentation reduces lead times and minimizes operational risk. The platform’s low-code/no-code framework supports rapid recipe changes (even personalized recipes per patient) and scales to hundreds of concurrent batches with real-time status alerts. 2. Tulip MES Tulip offers a no-code, cloud-based MES aimed at rapid deployment and process digitization, giving teams the flexibility to build and adapt workflows without heavy IT support. This makes it attractive for organizations seeking quick implementation and frontline configurability. However, in regulated life sciences manufacturing (especially in cell and gene therapy), Tulip faces significant limitations. It cannot currently automate CoC, perform two-way SAP integration, or integrate with CAR-T process equipment. These gaps often result in manual workarounds for chain-of-identity tracking and material management, impacting compliance and scalability. While suitable for certain MES-lite use cases, Tulip often requires complementary systems to achieve full GMP manufacturing orchestration. 3. Körber — PAS-X MES (formerly Werum PAS-X) Körber’s PAS-X remains one of the most recognized MES platforms in pharmaceutical manufacturing, offering deep industry specialization, robust integration with SAP, and extensive EBR capabilities. It supports large-scale, validated manufacturing with standard integrations to process equipment and strong compliance features. Its traditional enterprise architecture, however, often leads to long deployment cycles, heavy customization requirements, and reliance on vendor-specific resources for changes. While powerful for standardized production environments, PAS-X can be less agile for emerging modalities like personalized therapies that require rapid recipe adjustments. 4. Rockwell Automation — FactoryTalk PharmaSuite FactoryTalk PharmaSuite delivers MES functionality designed for regulated pharmaceutical manufacturing, with strong integration to Rockwell’s automation portfolio. It provides comprehensive batch execution, quality management, and regulatory compliance capabilities, making it a logical choice for organizations already standardized on Rockwell automation. That said, achieving flexible, modality-agnostic workflows can require significant customization. Its architecture is well-suited to traditional batch manufacturing but may be less adaptable for fast-changing, small-batch, or personalized production models. 5. MasterControl — Manufacturing Excellence MasterControl’s Manufacturing Excellence module connects quality management and MES functionality to deliver compliant batch execution and streamlined deviation handling. The platform’s ability to link production and quality data natively is a key strength for GMP-regulated operations. As a point solution, however, it requires integration with other manufacturing and laboratory systems for complete operational visibility. This can result in fragmented data and manual processes, perpetuating the same silos manufacturers aim to eliminate. 6. Apprentice — Tempo Manufacturing Cloud Apprentice brings a modern, cloud-native approach to MES with a focus on user-friendly design and rapid deployment. Its clean interface and flexible recipe tools appeal to teams seeking a lighter-weight alternative to legacy MES platforms. Yet in large-scale, regulated contexts, challenges with enterprise-scale validation, recipe composability, and API maturity can limit its role as a primary MES without additional integration and governance investment. 7. Emerson — Syncade/DeltaV MES Emerson’s Syncade is a well-established MES with strong compliance credentials and deep integration with the DeltaV automation system. It offers solid quality review, document management, and regulatory alignment. However, its monolithic architecture and “paper-under-glass” approach often result in unstructured data and limited reusability across processes. Implementations are resource-intensive, and changes typically require significant IT and vendor effort. 8. AVEVA — AVEVA MES (formerly Wonderware) AVEVA MES combines MES functionality with process control heritage, especially when paired with PI System data historians. It offers foundational capabilities for production tracking and quality management, particularly in SCADA-rich environments. Its fragmented architecture, shaped by multiple acquisitions, can complicate integration and limit unified visibility across manufacturing operations. Organizations may encounter inefficiencies in data extraction and process monitoring in fast-paced life sciences manufacturing. Also in the Market Several other global players remain in the MES landscape for life sciences, including Honeywell (POMSnet), SAP (Digital Manufacturing Cloud), and Dassault Systèmes (DELMIA Apriso). While these platforms offer robust manufacturing capabilities for broader industries, life sciences organizations often encounter significant limitations around regulatory compliance, workflow flexibility, and integration with specialized laboratory systems. IDBS, known primarily for ELN/LIMS solutions, offers workflow execution features that can support MES-adjacent needs in specific contexts. For most pharma and biotech manufacturers, the vendors reviewed above remain the primary options in 2025. How to Choose Selecting the right MES requires careful evaluation of your organization's manufacturing complexity, regulatory environment, and digital transformation timeline. Consider the platform's ability to handle both current production needs and future manufacturing modalities like cell and gene therapy, which require flexible processes and real-time adaptability. Evaluate implementation speed and user adoption curves, as lengthy deployment cycles can significantly impact manufacturing operations and time-to-market for critical therapies. Assess the vendor's track record with similar manufacturing environments and their ability to provide ongoing support for evolving regulatory requirements and process improvements. The Future of Manufacturing Execution Industry analysis from BioPhorum’s MES of the Future Manifesto and its 2025 progress report points to a decisive shift toward modular, cloud-enabled, low-code MES platforms with AI-powered automation. The next generation of MES will not only digitize batch records but also enable predictive quality, real-time analytics, and seamless data flow from research to production. This evolution reflects the pharmaceutical industry's growing need for agile, scalable solutions that can adapt to personalized medicine demands and complex supply chain requirements. Traditional point solution MES systems are increasingly inadequate for organizations requiring seamless integration across research, development, and manufacturing operations. In this rapidly evolving manufacturing landscape, the question isn't just which MES can track your batch records today, but which platform can orchestrate your entire manufacturing enterprise while enabling AI-driven insights and real-time adaptability. Most MES systems promise digital transformation, but only unified platforms like L7|ESP deliver the orchestration, adaptability, and data foundation required for AI-enabled life sciences manufacturing; no one else has what L7 has. ________ Sources: BioPhorum MES of the future manifesto - 26 January 2022 BioPhorum Advancing MES solutions for biomanufacturing: Manifesto progress report 2025 - 30 May 2025 ### Turning Data Into an Engine for Innovation: Why Contextualization and Orchestration Matter More Than Ever in Life Sciences L7 | CHATS thought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFZhc3UgUmFuZ2FkYXNzLCBQaC5ELiBhbmQgQWxmcmVkbyBDb3ZpZWxsbyB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@Walk into any biopharma or diagnostics organization today, and you will find data generated at nearly every step of the process: from sequencers and bioreactors to chromatography systems, laboratory notebooks, LIMS, MES, ERP, and QMS. This data arrives in many forms: from instruments, chemometrics, bioinformatics, scientific calculations, spreadsheets, PDFs, and manual entries. For scientists, engineers, and manufacturing leads, the challenge is not the lack of data, but the complexity of turning scattered records into useful information that supports decisions, ensures compliance, and advances science. This gap is now widely recognized. According to Gartner’s “2025 Hype Cycle for Artificial Intelligence¹,” 57 percent of organizations say their data is not “AI-ready.” The most common reasons are fragmented sources and missing context. Gartner warns that without a strong foundation for data quality, integration, and contextualization, organizations risk missing both operational targets and strategic goals. A New Playbook: Orchestrate, Contextualize, and Make Data Work “At L7, we focus on connecting every point where data is produced and used,” says Vasu Rangadass, Ph.D., Founder and Chief Strategy Officer at L7 Informatics. “This is not just a technology issue; it is a business necessity.” For most organizations, data contextualization across these point sources of truth is still a daily pain. Teams pull CSV files from instruments, copy values from paper forms, and try to reconcile sample IDs across disconnected systems. L7 takes a different approach. L7’s scientific orchestration capability starts by capturing data at the source, whether from a bioreactor’s digital output, a scientist’s electronic notebook entry, or an automated workflow. The next step is to harmonize and validate this information so that it matches consistent ontologies, formats, and business rules, with automated checks for integrity. Finally, the orchestration engine links each data point to its process, experiment, or business outcome, so that everything from sample genealogy to experimental and process outcomes can be contextualised at the source into knowledge graphs, traced and understood. This approach changes the daily work of research, development, manufacturing, and compliance teams: Instead of exporting and merging files by hand, teams receive unified datasets ready for reporting. Each result is tied to its experimental conditions, process stage, and operator, providing traceability and context. AI and analytics tools can then use this harmonized information to detect patterns, surface trends, and generate recommendations. GenAI applications can leverage contextualized knowledge graph data to enhance LLM performance. The ROI: Measurable Gains Across Operations The value of orchestrated, contextualized data is now being measured across the industry. According to a recent McKinsey publication², organizations using GenAI and automation in life sciences operations are seeing tangible improvements: “After implementing a gen AI copilot tool for maintenance support, one biopharma manufacturing team achieved 5 percent reductions in breakdown time, speed losses, and minor stoppages and a 30 percent reduction in execution time.” “It also experienced a 40 to 50 percent workload reduction for corrective maintenance.” “In pilots, companies have achieved reductions of up to 90 percent in manual effort for particular tasks (for example, medical coding or data review).” L7 customers have observed similar progress. For example, a research institute cut time spent preparing submission documents by over 80 percent using the L7|ESP platform. A biomanufacturing customer improved operational efficiency by 50 percent and made faster, more informed decisions across its production workflows. Beyond efficiency, organizations are using better data to strengthen experimental insights, process development, improve product quality, and demonstrate compliance. Continuous process verification, robust trend analysis, and predictive insights are becoming standard practice, not just aspirations. L7|INTELLIGENCE® as the Business Intelligence Layer L7|INTELLIGENCE is the business intelligence layer within L7|ESP. It works by regularly creating a query-optimized view of all operational records, such as experimental data, batch release data, QC results data, stability analysis data, and analytical data. L7|INTELLIGENCE transforms the raw transactional tables into structured, domain-specific views and data products. For example, a join between batch production data with QC sample results and operator annotations produces a comprehensive report for each batch run, so that Quality can use integrated views of information for regulatory compliance and submissions. To make reporting scalable and reliable, L7|INTELLIGENCE uses workflows that move and structure data between the L7|ESP operational database and the reporting layer. For teams using cloud data warehouses like Snowflake, L7|INTELLIGENCE provides direct integration, allowing users to run advanced queries or analytics without manual data exports or duplication. Because the data is harmonized at source and available in near real-time, customer teams can produce data products and reports for many use cases, such as: Process Development: Analyzing experimental results and scaling up processes with automated statistical summaries. Analytical Method Development: Monitoring method validation and performance over time. Stability Management: Aggregating and trending stability study outcomes for shelf-life determination and compliance. Continuous Process Verification (CPV): Detecting trends in critical process parameters and providing early warnings for deviations. Clinical and Commercial Manufacturing: Combining batch records and equipment data for analysis and investigation. Environmental and Method Lifecycle Monitoring: Centralizing monitoring data for quality and clinical operations. This harmonized layer also acts as the gateway to AI enablement of the business, including the application of large language models (LLMs) and Machine Learning models to support both operational reporting and predictive modeling of chemical and biological processes. Reports generated by L7|INTELLIGENCE help scientists, engineers, and quality teams focus on high-impact questions, such as: How to optimize the chemical reactions? How to increase the cell count in the bioreactor expansion process? Which batches show early signs of process drift? How does stability compare across production sites? Where can manual review be replaced with automation? As Alfredo Coviello, Director of Product at L7 Informatics, explains: “With L7|INTELLIGENCE, our goal is to make high-quality analytics available in near real-time to every business function that needs it. By combining the powerful scientific orchestration and data contextualization into knowledge graphs and integration with Snowflake (or custom data warehouses), we deliver contextualized data and insight at the speed business teams require for rapid decision-making and continuous process improvement.”The Bottom Line: Orchestration and Contextualization are the Foundation for AI in Life Sciences AI (and all the business value and ROI) will only be as strong as the data foundation underneath. Without orchestrated and contextualized information and analytics, AI models cannot deliver their full promise.As Vasu Rangadass puts it: “The organizations that succeed in the next era of life sciences will treat their data as a strategic asset, making sure it is automatically contextualized at the source of data creation, and ready to drive decisions and AI models. It is time to put manual contextualization using aging toolsets behind us so we can get true ROI from all the AI IT expenditures.” _______ Sources: ¹ Gartner: “The 2025 Hype Cycle for Artificial Intelligence Goes Beyond GenAI,” Haritha Khandabattu - July 8, 2025 ² McKinsey: “Gen AI: A game changer for biopharma operations,” Boyd Spencer, Parag Patel, and Vivek Arora, with Krithiknath Tirupapuliyur and Raj Rajendran - January 28, 2025 ABOUT THE AUTHORSVasu Rangadass, Founder and Strategy Officer Vasu Rangadass, Ph.D., is the Founder and Strategy Officer at L7 Informatics, Inc., a leader in life sciences workflow and data management. Previously, Dr. Rangadass was the Chief Strategy Officer at NantHealth, following its acquisition of Net.Orange, the company he founded, to provide an enterprise-wide platform to simplify and optimize care delivery processes in health systems. Before Net.Orange, Vasu was the first employee of i2 Technologies (currently Blue Yonder), which later grew to be a global company that revolutionized the supply chain market through innovative approaches based on the principles of Six-Sigma, operations research, and process optimization.Alfredo Coviello, Director of Product Alfredo Coviello is a seasoned technology product leader with a strong emphasis on data-driven AI and ML solutions. Bringing extensive experience across various industries, including Life Sciences, since joining L7, he has led a cross-functional team to design, build, and deliver L7|ESP’s leading-edge functionalities. He has a track record of successfully delivering business-critical applications and is passionate about driving the creation of pioneering solutions at the forefront of technological innovation. ### Best ELN for Life Sciences in 2025 Best ELN for Life Sciences in 2025@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPiBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Electronic Lab Notebooks (ELNs) have evolved from simple digital replacements for paper notebooks into sophisticated platforms essential for modern research operations. As organizations increasingly prioritize digital transformation and regulatory compliance, the demand for intelligent, integrated ELN solutions continues to accelerate across life sciences organizations. Here are the top ELN vendors empowering life sciences organizations in 2025: 1. L7 Informatics — L7|ESP® L7|ESP revolutionizes laboratory documentation by seamlessly integrating structured and unstructured data capture within a truly unified platform. Unlike traditional point solution ELNs that operate in isolation, L7 Notebooks, as part of L7|ESP, dynamically links with LIMS, inventory data, scheduling tools, and workflow orchestration systems in a single database. This enables researchers to document sample collection in L7 Notebooks and automatically trigger analytical procedures in L7 LIMS, with results flowing back for interpretation—eliminating the data silos and manual handoffs that plague conventional approaches. With template-driven experiments, streamlined protocol transfer from research to production, and role-based security, L7|ESP delivers the unified data contextualization essential for modern life sciences operations. 2. Benchling — Benchling ELN Benchling remains a popular ELN choice among biotechnology and pharmaceutical companies, offering molecular biology tools and real-time collaboration features. While well-established in early research environments, Benchling's point solution architecture creates significant limitations for enterprise operations. Users frequently report data lock-in challenges, with migration difficulties once committed to the platform. The pricing model combined with limited workflow orchestration capabilities and predominantly single-threaded workflows, restricts scalability for complex, multi-departmental organizations requiring sophisticated integration. 3. IDBS — E-WorkBook IDBS E-WorkBook, now part of Danaher, represents one of the most established enterprise ELN platforms, serving over 50,000 researchers across 25 countries. While offering comprehensive data management capabilities and regulatory compliance features, E-WorkBook suffers from the typical limitations of legacy enterprise software. The platform requires extensive IT resources for implementation and customization, often resulting in lengthy deployment cycles that can frustrate organizations seeking rapid digital transformation. 4. LabWare — LabWare ELN LabWare ELN leverages the company's established LIMS expertise to provide integrated electronic notebook functionality within its Enterprise Laboratory Platform. While offering seamless integration with LabWare LIMS and strong instrument connectivity, the platform inherits the complexity and rigidity associated with traditional LIMS architectures. Users often struggle with the system's inflexibility for research-focused workflows, as it primarily serves compliance-driven environments rather than innovative research operations that require agile, configurable processes. 5. SciNote — SciNote ELN SciNote positions itself as a biologist-friendly platform with protocol management and inventory tracking capabilities. While praised for its intuitive interface and collaborative features, SciNote suffers from rigidity in workflow customization and performance issues with larger projects. The platform's limited instrument integration and lack of advanced data contextualization capabilities restrict its effectiveness for complex research operations that require seamless data flow across multiple systems and analytical processes. 6. Revvity (formerly PerkinElmer) — Signals Notebook Signals Notebook offers strong chemistry support and regulatory compliance features, appealing to established pharmaceutical organizations with substantial IT budgets. However, the platform requires extensive implementation time and training resources, while maintaining an outdated interface that many users find difficult to navigate. The high cost and complex setup process make it less accessible for organizations seeking agile, modern solutions that can be rapidly deployed and easily adopted across research teams. 7. Labguru — Labguru ELN Labguru markets itself as an all-in-one ELN solution with inventory management and basic workflow automation. While offering some collaborative features, users consistently report navigation difficulties and steep learning curves that require significant onboarding investments. The platform lacks real-time instrument integration capabilities essential for modern high-throughput laboratories, and its limited workflow customization restricts organizations requiring tailored research processes. 8. Sapio Sciences — Sapio ELN Sapio offers a configurable ELN platform with claimed AI integration through their "ELaiN" system. While providing some flexibility for research applications, the platform's general-purpose architecture lacks the life sciences-specific optimization required for complex experimental workflows. Users note insufficient training materials and limited standard content, requiring extensive customization efforts that can delay implementation and increase the total cost of ownership. 9. Dotmatics — Dotmatics ELN Dotmatics ELN results from multiple acquisitions, creating a piecemeal product architecture with integration challenges across its various components. Although the Dotmatics solution offers some specialized tools, its fragmented nature makes data extraction difficult and limits operational efficiency. The predominantly small-to-medium organization focus may not provide the enterprise-scale capabilities required for comprehensive digital transformation initiatives. How to Choose Selecting the right ELN requires careful evaluation of your organization's specific research workflows, regulatory requirements, and scalability needs. Key factors to consider include ease of implementation and user adoption, as lengthy deployment cycles can significantly impact research productivity. Assess the platform's ability to integrate with existing laboratory instruments and systems, as seamless data flow is essential for modern research operations. Evaluate the vendor's track record with organizations similar to yours in size and regulatory environment, particularly their support capabilities and long-term product roadmap. Consider the total cost of ownership beyond initial licensing, including customization, training, and ongoing maintenance requirements that can vary dramatically between vendors. The Future of Laboratory Documentation It should be noted that although this represents a point solution comparison, industry analysts indicate a clear movement away from standalone ELN systems toward unified, composable platforms that span the entire research and development lifecycle. This architectural evolution breaks down traditional barriers between documentation, sample management, and process execution, enabling advanced analytics and AI capabilities that transform how scientific insights are captured and leveraged. In this rapidly evolving landscape, the question isn't just which ELN can capture your experimental data today, but which platform can orchestrate your entire research enterprise while seamlessly connecting every aspect of your scientific workflow. When it comes to truly integrated platforms that unify ELN capabilities with LIMS, scheduling, inventory management, and advanced workflow orchestration—all while maintaining enterprise-grade security and enabling AI-driven insights, no one else has what L7 has. ### Best LIMS for Life Sciences in 2025 Best LIMS for Life Sciences in 2025@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPiBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Laboratory Information Management Systems (LIMS) are foundational for digital labs, enabling secure sample tracking, compliance, and workflow automation. With a market value of approximately $2.4 billion in 2025 and projected to reach $3.8 billion by 2029, the landscape is rapidly evolving toward more intelligent and integrated solutions. Here are the top LIMS vendors empowering life sciences organizations in 2025: 1. L7 Informatics: L7|ESP® L7|ESP is more than just a LIMS; it's a unified data orchestration platform purpose-built to accelerate digital transformation in life sciences and healthcare. Unlike traditional point solutions that require costly integrations, L7|ESP natively combines LIMS, ELN, MES, Scheduling, and advanced orchestration capabilities within a single, configurable platform. Designed for both research and manufacturing, L7|ESP delivers comprehensive sample management, data contextualization, and regulatory compliance while eliminating the data silos that plague legacy systems. With hundreds of pre-built connectors and AI-ready architecture, organizations choose L7|ESP to future-proof their operations and unlock insights impossible with fragmented approaches. 2. LabWare: LabWare LIMS LabWare remains a stalwart in the industry, widely adopted by pharmaceutical and biopharma labs across 14,000 laboratories in 125 countries. Their Enterprise Laboratory Platform (ELP) combines LIMS functionality with integrated ELN capabilities, offering strong sample tracking and regulatory support. However, LabWare's monolithic architecture can create significant implementation complexity and customization challenges, particularly for organizations seeking agility in fast-changing digital environments. Many users report lengthy deployment cycles and heavy reliance on vendor-specific expertise for modifications. 3. QBench: QBench LIMS QBench is a modern, cloud-based LIMS that has gained recognition among smaller laboratories for its user-friendly interface and no-code workflow capabilities. While QBench excels in ease of use and quick implementation for straightforward laboratory operations, its architecture lacks the enterprise-scale orchestration and advanced analytics capabilities required for complex, multi-site organizations. The platform works well for labs with basic sample tracking needs but may require significant workarounds for sophisticated manufacturing or research workflows. 4. Thermo Fisher Scientific: SampleManager LIMS SampleManager is a comprehensive LIMS platform favored by large enterprises with established IT infrastructure. While offering deep sample and test management capabilities with strong compliance features, Thermo's fragmented approach requires extensive integration work to connect disparate systems. The modular architecture, which spans Core LIMS for R&D and SampleManager for enterprise needs, often results in data silos and complex maintenance requirements that can hinder organizational agility and increase the total cost of ownership. 5. LabVantage Solutions: LabVantage LIMS LabVantage provides a scalable LIMS with broad instrument support and a relatively modern interface. However, the platform's core architecture remains rooted in traditional LIMS thinking, requiring significant add-ons and custom development for advanced manufacturing execution or AI/ML capabilities. Organizations often find themselves managing multiple disparate systems rather than benefiting from a truly integrated approach, leading to increased complexity and higher long-term costs. 6. Starlims (Abbott Informatics): STARLIMS STARLIMS offers broad industry deployment with particular strength in manufacturing and clinical diagnostics applications. While highly configurable, the platform suffers from performance challenges and data management complexity that can frustrate users. The system's flexibility comes at the cost of longer deployment cycles and steep learning curves, often requiring extensive training and vendor dependency that can limit organizational autonomy and increase operational risk. 7. Sapio Sciences: Sapio LIMS Sapio offers a cloud-based LIMS with configurable workflows and strong support for genomics applications. While well-regarded for ease of use in research settings, the platform's limited orchestration capabilities and narrow manufacturing integration restrict its utility for comprehensive digital transformation initiatives. Organizations often find Sapio suitable for specific use cases but insufficient for enterprise-wide laboratory operations that require seamless data flow across research, development, and production environments. 8. Zontal: Zontal Digital Platform Zontal offers a FAIR data platform that augments traditional LIMS environments by enabling data continuity, contextualization, and compliance. While not a standalone LIMS, Zontal is valued for bridging the gaps between legacy systems and modern digital initiatives in the life sciences, serving as a data integration and harmonization layer that complements existing laboratory informatics infrastructures. How to Choose The right LIMS depends on your organization's scale, compliance needs, and digital transformation ambitions. Traditional point solutions may address immediate sample tracking requirements, but often create long-term technical debt and integration challenges. The market is experiencing a decisive shift toward unified platforms that eliminate the costly complexity of managing multiple disconnected systems. While legacy vendors offer familiarity, forward-thinking organizations are choosing platforms like L7|ESP that provide comprehensive orchestration capabilities and AI-ready architecture from day one. The Future of Laboratory Informatics It should be noted that although this represents a point solution comparison, Gartner's latest Market Guide for LIMS indicates a clear movement away from legacy solutions toward unified, composable platforms that can span research, development, and manufacturing. This architectural shift breaks down organizational silos, enabling advanced AI capabilities that transform how laboratories operate and innovate. In this evolving landscape, the question isn't just which LIMS can manage your samples today, but which platform can orchestrate your entire scientific enterprise tomorrow. When it comes to truly unified, AI-ready platforms that seamlessly integrate LIMS, ELN, MES, and advanced orchestration capabilities while eliminating data silos across the entire value chain, no one else has what L7 has. ### Top 5 Considerations for Lab Digital Transformation: What Gartner's Market Convergence Means for Your Data Migration Strategy L7 | CHATS thought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFRlb2RvciBMZWFodSB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@Here's a question that keeps CIOs awake at night: "We have 15 years of critical laboratory data across seven different systems. How do we modernize without losing everything we've built?" It's not just about the data itself. It's about the context, the relationships, the workflows that make that data meaningful. And increasingly, it's about preparing for a future where laboratory informatics and business systems don't just coexist; they converge into unified digital platforms. Gartner's latest Market Guide for Laboratory Information Management Systems reveals a fundamental shift happening in our industry. The research shows that laboratory informatics vendors and business system vendors are on what they call a "collision course," with unified platforms emerging as the new standard for enterprise-scale operations. However, here's what the high-level strategic guidance doesn't fully address: how do you transition from fragmented legacy systems to a unified future without disrupting what's already working? The answer lies in understanding that data migration isn't just a technical challenge; it's the foundation of your entire digital transformation strategy. The Convergence Challenge: Breaking Free from Vendor-Defined Constraints Gartner's research identifies nearly 240 LIMS vendors serving diverse market segments, each with "highly variable capabilities," creating a "complex, hard-to-navigate set of vendors." However, the complexity isn't in choosing between vendors. It's in understanding that the entire category is evolving while traditional best-of-breed approaches force you to adapt your science to vendor-defined constraints. The traditional approach has been to use "best-of-breed solutions," meaning selecting the best LIMS, ELN, and MES, and then attempting to integrate them. But when you select multiple point solutions, you're not just buying software. You're accepting that your comprehensive scientific processes will be artificially fragmented across systems that weren't designed to work together. Your analytical workflows get squeezed into LIMS configurations. Your manufacturing execution gets separated from quality decisions. As Gartner shows, we're moving toward "unified laboratory informatics platforms" that bridge the gap between lab operations and business systems. This convergence creates both opportunity and challenge for data migration. The opportunity: You can finally create that single source of truth across your entire operation. The challenge: Your migration strategy needs to account for not just where your data is today, but where the entire industry is heading. Most organizations approach data migration as a one-time event. Move from System A to System B, validate the transfer, and move on. But in the converged world that Gartner describes, migration becomes orchestration, creating dynamic connections between systems that reflect how your science actually works, not how vendors think it should work. Five Strategic Considerations for Laboratory Digital Transformation 1. Platform Composability: Can Your Migration Strategy Adapt as Technology Evolves? Gartner highlights a critical shift: "accelerated technological innovation has shifted the market toward composable platforming." Traditional migration moves data from one static system to another. Composable platforms orchestrate that data across an expanding ecosystem without requiring re-migration. How L7|ESP addresses this: The Enterprise Science Platform utilizes "flexible data modeling," a composable architecture that enables you to define relationships between data objects regardless of their source system. When you migrate CHO cell line data from your legacy LIMS, it doesn’t just land in a new database; it becomes part of a unified data model that simultaneously supports LIMS workflows, ELN documentation, MES batch records, and business system integrations. 2. Cross-System Orchestration: Beyond Integration to Workflow Unification Gartner notes that LIMS vendors are "advancing their interoperability and integration into other business systems, such as CRM for B2B interfacing, and ERP for supply chain cost modeling." But integration and orchestration are fundamentally different approaches. Integration connects systems at the data level. Orchestration connects them at the workflow level… and eliminates the biggest hidden cost in laboratory digital transformation: perpetual reconfiguration. Here's the reality most organizations face: "I've spent millions configuring my analytical workflows into LIMS Vendor A. How many years and millions will it take to repeat this process for LIMS Vendor B?" The traditional answer has been "forever," resulting in vendor lock-in due to the sheer investment in configuration. How L7|ESP addresses this: Our unified platform approach breaks this cycle. Your workflows live in L7|ESP as executable processes that orchestrate across all your systems. Instead of rebuilding configurations every time you switch vendors, you migrate once into a platform designed for your long-term operational evolution. 3. AI-Ready Data Architecture: Is Your Migration Strategy Preparing for Intelligent Operations? Gartner emphasizes that LIMS vendors are offering "novel technology differentiators, such as generative pretrained transformer (GPT) for searching for data such as reagents, research findings, and test results." But AI capabilities are only as good as the data architecture they're built on. The most important requirement is data context. When migrating laboratory data, you're moving scientific context, experimental conditions, equipment calibrations, and environmental factors that make those numbers meaningful. How L7|ESP addresses this: Our platform includes "contextual data capture," meaning every piece of migrated data retains its full scientific and operational context. When you migrate chromatography results, L7|ESP captures not just the peak areas and retention times, but the instrument conditions, method parameters, operator details, and sample preparation history. This contextualized data serves as the foundation for AI capabilities such as predictive analytics and automated anomaly detection. 4. Regulatory Compliance and Data Integrity: Beyond 21 CFR Part 11 to Comprehensive Audit Trails Gartner’s research states "validation and regulatory compliance" as a core LIMS capability, noting that "the pharmaceutical industry requires GxP compliance in manufacturing and 21 CFR Part 11 compliance in research." As laboratory informatics platforms converge with business systems, compliance requirements become more complex. Your migrated data needs to maintain audit trails across business system integrations. Traditional migration often breaks audit trails, losing the historical context of who created data, when it was modified, and why changes were made. How L7|ESP addresses this: Our platform maintains "continuous audit lineage" throughout migration and beyond. When we migrate your legacy data, every record retains its complete audit history. As that data moves through new workflows in L7|ESP, the audit trail continues seamlessly, ensuring regulatory compliance across your entire product lifecycle. And when a regulatory inspector asks about a three-year-old batch record, you can trace every decision across the entire product lifecycle. 5. Total Cost of Ownership: The Hidden Economics of Platform Convergence Gartner shows that life science organizations are moving toward "unified platforms" away from "individual siloed best-of-breed lab informatics integration programs." The economic implications extend far beyond the costs of software licensing. When you migrate from multiple legacy systems into a unified platform, you fundamentally change your operational economics. The value lies in operational efficiency gains from unified workflows. How L7|ESP addresses this: Our platform delivers what Gartner calls "enterprise enablement that maximizes total ROI." Our customers typically see 40% reductions in data management overhead and 30% improvements in process cycle times. One client reduced their batch record cycle time by six days simply by eliminating manual data transfers between their LIMS, ELN, and MES systems. The Strategic Imperative: Why Platform Convergence Can't Wait Gartner's research concludes: "Unified laboratory informatics platforms are on a collision course with business systems as the demand for end-to-end workflows emerges as a must-have capability." This convergence isn't a future possibility. It's happening now. The companies that will thrive are those that recognize data migration as the foundation of platform transformation. When you approach migration strategically, with composable architecture, cross-system orchestration, AI-ready data models, comprehensive compliance, and total economic impact in mind, you're not just solving today’s data challenges; you’re positioning your organization for the converged future that Gartner describes. From Migration to Orchestration: The L7|ESP Advantage L7|ESP represents exactly this convergence. We're not just a LIMS, ELN, or MES. We're a unified Enterprise Science Platform that orchestrates data and workflows across the entire spectrum of laboratory and business operations. When you migrate to L7|ESP, you're not just moving data; you're transforming how your organization operates. The question isn't whether your industry will embrace platform convergence. Gartner's research makes clear that it will. The question is whether your organization will lead that transformation or be forced to catch up. Your data migration strategy is your digital transformation strategy. Make sure it's designed for the converged future, not just the fragmented past. Contact us to start the conversation about your digital transformation journey. ___________ Source: Gartner Research: Michael Shanler, Reuben Harwood, Lynn Rice, Market Guide for Laboratory Information Management Systems (16 April 2025)ABOUT THE AUTHOR ### Case Study: Building a Digital Foundation for Scientific Innovation with a Unified Platform Everyday discoveries in pediatric genomics are creating new possibilities to understand and treat rare genetic diseases. This work requires robust computational strength in order to process, analyze, and manage large data sets. Please fill out the form to view the Rady Children's case study ### Top 5 Hidden Costs of Delaying Digital Transformation in Life Sciences L7 | CHATS thought leadership @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IE1hcmsgU3BlbmNlciB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@In my last post, I explored the “Build vs. Buy” dilemma and offered five key questions to help life sciences organizations evaluate their platform strategy. Today, I want to focus on what happens when organizations don’t take action, meaning when digital transformation projects are delayed, deprioritized, or put on hold. The costs of inaction are real, and in our industry, they can be the difference between leading and falling behind. Let me be clear: every day that life sciences organizations postpone digital transformation, they risk more than just missed deadlines. Delays erode competitive advantage, drain budgets, and, most importantly, slow the delivery of therapies and diagnostics to patients who need them. To make matters worse, the risks multiply with every month of delay. Here are the top five hidden costs every leader should consider: 1. Lost Productivity and Innovation When your teams are bogged down by manual processes, fragmented data, and outdated systems, they spend more time “keeping the lights on” than driving innovation. Deloitte’s 2025 Life Sciences Outlook¹ highlights that nearly 60% of industry executives are increasing investments in digital technologies and generative AI, moving beyond pilots to realize value at scale. Organizations that accelerate digital transformation are already seeing stronger productivity and innovation outcomes. In life sciences, speed to insight and discovery matters… and delaying digital transformation means leaving productivity and breakthrough potential on the table. 2. Rising Costs and Budget Bloat When digital transformation is delayed, inefficiencies and redundancies persist, and the financial consequences quickly add up. Manual, disconnected systems increase headcount requirements, lengthen project timelines, and lead to higher per-program spending. According to McKinsey², biopharma organizations that fail to streamline research and early development processes can face up to 40% longer cycle times than digital leaders, resulting in millions in extra costs for each asset. Over a full pipeline, these delays can add hundreds of millions in unnecessary expenses and drain resources that could be directed toward innovation. Every month spent relying on outdated systems compounds operational costs and inflates budgets, often with little to show for the extra spend. 3. Missed AI and Data Opportunities Generative AI is already transforming life sciences… but only for those who act. Gartner³ predicts that 30% of generative AI projects will have to be abandoned after proof of concept by the end of 2025, primarily due to the lack of data readiness or delayed infrastructure investment. Deloitte’s research¹ also shows that biopharma companies could generate up to 11% in value relative to revenue through AI investments, while medtech firms could achieve up to 12% in cost savings within two to three years. In other words, delaying digital transformation means missing out on the full potential of AI and advanced analytics. 4. Regulatory and Compliance Risk Compliance is non-negotiable in life sciences, and outdated systems only increase risk. Deloitte’s 2025 Life Science Regulatory Outlook⁴ emphasizes that digital transformation is essential for maintaining data integrity, streamlining audits, and ensuring timely, accurate regulatory submissions. Digital platforms provide the transparency, traceability, and automation required to stay ahead of evolving regulations. Delaying these upgrades means exposing your organization to unnecessary compliance risks and costly consequences. 5. Talent Drain and Turnover Overhead The competition for talent in life sciences is fierce, and top performers want to work with modern, data-driven organizations. Companies that are slow to modernize struggle with knowledge retention, onboarding, and audit readiness, especially as teams evolve. McKinsey’s research⁵ shows that organizations with strong digital cultures empower their people to make the most of new technologies and retain critical expertise. A modern digital platform fosters an engaging, efficient, and stable work environment that attracts and retains the talent you need for the future. The Bottom Line: Now is the Time to Act Industry research is clear: the cost of delaying digital transformation in life sciences is far greater than the investment required to move forward. Every month of inaction means lost productivity, higher costs, missed AI opportunities, increased compliance risk, and talent challenges. The best time to act is now. At L7 Informatics, we’re here to help you move faster. Whether you’re building, buying, or blending both. Our platform, L7|ESP®, is designed to unify your data, streamline your workflows, empower your teams, and accelerate your digital journey, all without disruptive rip-and-replace. If you’re ready to explore how to reduce the hidden costs of delay, let’s start a conversation. _______ Sources: ¹ Pete Lyons, Todd Konersmann, Leena Gupta, and Darshan Gosalia, Deloitte 2025 Life Sciences Outlook (December 10, 2024) ² Ahsan Saeed, Gaurav Agrawal, Guang Yang, and Stephan Wurzer, with Alana Horowitz, Daniel von Bornstädt, and Jan Günthner, McKinsey Report 'Operational excellence in biopharma research and early development' (January 9, 2025) ³ Gartner Predicts 30% of Generative AI Projects Will Be Abandoned After Proof of Concept By End of 2025 (July 29, 2024) ⁴ Paul Siver, Matin Shaikh, Shuba Balasubramanian, Clarissa Crain, and Jack Tanselle, “Deloitte 2025 Life Sciences Regulatory Outlook” (2025) ⁵ Hannah Mayer, Lareina Yee, Michael Chui, and Roger Roberts, ​​McKinsey Report 'Superagency in the workplace: Empowering people to unlock AI’s full potential' (January 28, 2025)ABOUT THE AUTHOR ### CGT Outsourcing: Trends, Challenges, and Future Growth ### Pharma's Simplification Imperative: From McKinsey's Vision to Implementation Reality L7 | CHATS thought leadership @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFRlb2RvciBMZWFodSB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@A recent McKinsey industry report, "Simplification for Success: Rewiring the Biopharma Operating Model," presents a compelling case for fundamental transformation in pharmaceutical companies. Their research reveals that 37 out of 50 global life sciences leaders expect to pursue simplification efforts within the next 12 months, with nearly half indicating they must "completely abandon their traditional business model" to stay competitive. But here's what caught my attention in the data: only three respondents believe they've solved what the report calls a "critical value-diminishing bottleneck," in other words, reducing manual workloads that prevent teams from focusing on high-value tasks. Three. Out of fifty. This data point suggests we're not just discussing organizational restructuring or process optimization. We're looking at a foundational data and technology challenge that most pharma companies have yet to address. The Challenge Behind Pharma Digital Transformation The report outlines four strategic actions for pharma simplification: first, identifying and building distinctive capabilities; second, simplifying organizational structures; third, streamlining burdensome processes; and fourth, rewiring with digital-first strategies. Each recommendation addresses real industry pain points that pharmaceutical companies face today. But dig deeper into their findings, and you'll see the common thread running through every challenge they outline: data fragmentation and operational inefficiency. Consider the key industry pressures the research identifies: portfolio diversification has led to increasingly crowded markets, with competitive entry times shrinking from fifteen years to just two. Regulatory changes like the Inflation Reduction Act are projected to reduce industry EBITDA by $50-70 billion through 2028. And AI integration, which could generate $60-110 billion in pharmaceutical industry value, requires companies to acquire new capabilities "at a pace faster than previous industry transformations." Every one of these challenges demands faster, better decision-making in pharmaceutical operations. But you can't make faster decisions when your data lives in silos. You can't streamline processes when your workflows are disconnected. And you certainly can't leverage AI when your information architecture is fragmented across dozens of legacy systems. The uncomfortable truth? Most pharmaceutical companies are trying to solve 2025 problems with 2005 technology infrastructure. Why Digital-First Strategy Enables Pharma Operational Excellence The fourth recommendation, rewiring with digital-first strategies, may be the most critical of the four strategic actions because it enables the other three. The research provides compelling examples, including a pharma company that deployed AI-driven procurement analytics and "uncovered $10 million in value within four weeks, just from analyzing 10 percent of its spending." But here's the implementation reality that these high-level recommendations don't fully address: that success didn't happen because of the AI alone. It happened because someone finally had access to clean, contextualized data that could actually be analyzed. I've seen this pattern repeatedly in pharmaceutical digital transformation projects. Companies invest millions in AI initiatives, only to spend 80% of their time on data preparation. They implement digital transformation programs that add complexity instead of reducing it. They consolidate systems without addressing the underlying orchestration challenge. The result? What McKinsey accurately describes as "initiatives that often stall at the proof-of-concept stage." From Pharma Simplification Theory to Implementation Reality Let me build on these strategic recommendations with specific implementation insights, because the framework, while directionally sound, leaves some room for tactical guidance on operations execution. Simplification starts with unifying data at the source. Not after it's been transformed, cleaned, and loaded into yet another system. At the point of generation, with full context and lineage intact. Process streamlining happens through orchestration, not consolidation. You don't need to rip and replace every system. You need to orchestrate workflows across systems so they behave as one unified platform. AI readiness in pharma operations requires structured, contextualized data from day one. Not data lakes filled with unstructured information that requires armies of data scientists to interpret. This is exactly what we built L7|ESP to address. While other solutions focus on data storage or analysis, we prioritize data orchestration and contextual workflow management. Our platform leverages advanced data modeling to standardize information from diverse sources, and seamless API integrations make it easy to connect legacy and next-gen systems (without disruptive rip-and-replace required). The result is a unified data layer, creating what the report calls a "single source of truth" across research, development, and manufacturing. What $7 Billion in Pharma Cost Savings Means for Digital Transformation The analysis of 100+ industry announcements reveals "widespread simplification efforts that could yield more than $7 billion in cost savings." But that number actually understates the opportunity for pharmaceutical companies implementing comprehensive digital transformation. When you eliminate data silos and orchestrate end-to-end pharmaceutical processes, you don't just reduce costs. You accelerate timelines. A major pharma company we work with cut their biosample management cycle time by 40% while improving data quality and regulatory compliance. That's not just operational efficiency. That's competitive advantage in a market where, as the research notes, the window to achieve 50% of lifetime sales has compressed by 18 months since 2000. The value isn't in the cost reduction. It's in the time acceleration and decision quality improvement that comes from having unified, AI-ready data across your entire pharmaceutical operation. The Path Forward: Orchestration Over Consolidation in Pharma Operations The report concludes with a call for "bold commitment to simplification." I agree. But let me be more specific about what that commitment should look like for pharmaceutical companies pursuing digital transformation. First, recognize that pharmaceutical simplification isn't about fewer systems; it's about better orchestration across systems. Most pharma companies will continue to operate in hybrid environments with both legacy and next-generation technologies. The question isn't whether to replace everything, but how to make everything work together seamlessly. Second, prioritize data contextualization over data consolidation in pharmaceutical operations. Raw data without context is just noise. Contextualized data, captured at the source with full lineage and meaning, becomes the foundation for everything the research recommends: faster decision-making, AI readiness, and streamlined operations. Third, think in terms of platform capabilities, not point solutions for pharmaceutical digital transformation. The companies that will thrive in this vision of simplified pharma operations are those that can orchestrate complex workflows across multiple systems, business units, and external partners. That requires a platform approach, not a patchwork of individual tools. The Window Is Closing for Pharma Digital Transformation The research is right about the urgency facing pharmaceutical companies. With asset lifecycles compressing and competitive pressures intensifying, pharma companies don't have the luxury of gradual transformation. But they also can't afford to get digital transformation wrong. The good news? The technology to enable pharmaceutical simplification already exists. Platforms like L7|ESP are already helping leading pharma companies orchestrate complex workflows, eliminate data silos, and create the AI-ready infrastructure that industry experts describe. The question isn't whether the pharmaceutical industry will embrace simplification. The data makes clear that it will. The question is whether your organization will lead that transformation or be forced to catch up.ABOUT THE AUTHOR ### When Complexity Creeps In: Why Life Sciences Need to Rethink Their Digital Foundation L7 | CHATS thought leadership @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFdpbGwgR3JheSB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@It’s a pattern I’ve seen again and again in life sciences organizations: a large and growing patchwork of point solutions, each chosen and implemented for a specific purpose, yet required to be integrated together to enable end-to-end processes. An ELN to support scientists at the bench, LIMS for the lab, MES for manufacturing, Inventory Management, Freezer Management, and on and on. Spreadsheets fill some gaps here and there. Suddenly, what was supposed to streamline operations is doing exactly the opposite. Not only that, but critical and valuable data is sitting in multiple silos thus limiting the ability to use it, learn from it, and drive continuous improvement. This isn’t the result of poor planning. It’s the inevitable outcome of addressing one problem after another as technology and software improve, all the while creating tech debt by layering complexity on top of complexity. There is a better way. A Familiar Pain Point… and a Way Forward In my experience working with global pharma, biotech companies, and even with other industries like F&B and chemicals, the common challenge isn’t a shortage of digital tools. It’s the lack of orchestration between them. When systems aren’t aligned, and data lacks context, it becomes difficult to move at the speed that science and business now demand. Valuable time and resources are spent chasing answers across multiple systems where data needs to be aligned instead of acting on them to drive the science and the business. No matter how many “best-in-class” tools you add, there will still be gaps between the data silos. That’s why I believe the next phase of digital transformation won’t come from another point solution. It will come from starting with the data model and process model first and establishing a solid foundation upon which to build the processes that drive your science and your business. Where Orchestration Meets Intelligence At L7 Informatics, we’ve built Enterprise Science Platform (L7|ESP®) around this very idea of a configurable, unified platform that orchestrates your processes and contextualizes your data within your existing ecosystem. Once you deploy L7|ESP as a central orchestration node in this new architecture, you’ve established that solid foundation with your data model and your process model, not ours. While L7|ESP’s own business apps (L7 Notebooks (ELN), L7 MES, and L7 LIMS) can be used, application replacement is not always feasible or even realistic, especially in large organizations. The beauty of this approach is that you can swap applications as needed at implementation and in the future, but the overall architecture does not change. This is where L7|ESP stands apart. Most solutions treat data as something to move or store. We treat it as part of the scientific process: modeled, contextualized, and orchestrated. That includes experimental data, QC results, manufacturing steps, and instrument outputs, all captured within your own process logic. L7|ESP gives you full control over your data model with versioned, composable building blocks (entities, protocols, workflows, and workflow chains) that reflect how your organization actually works. And because the platform preserves context even when integrating external systems, you maintain full traceability and alignment. It’s a flexible, future-proof foundation that supports both operational scale and AI-readiness, without locking you into rigid tools or vendor-defined workflows. And as demands for cost reduction, speed to market, and AI adoption continue to rise, that kind of architectural agility becomes a real competitive advantage. This isn’t hypothetical; it’s actually already been deployed at multiple companies we serve. And I’ve seen firsthand how orchestrated platforms can reduce tech transfer timelines, simplify validation, and enable seamless handoffs across functions, whether in a research lab or a GMP environment. Here’s what that looks like in practice: Every step, sample, and action is captured, contextualized, and linked within a Knowledge Graph structure. You’ll need this for Generative AI and Agentic AI Batch records, QC results, Inventory, Stability Testing, Environmental Monitoring Data, User Qualification; it all ties together. And because it’s modeled from the ground up using FAIR principles, the data is actually usable, not just stored. It’s a foundation that enables cross-functional alignment, accelerates implementation timelines, and drastically reduces the cost of change. Why This Matters for AI… and for the Bottom Line I’ll put it bluntly: if your data isn’t contextualized, your AI won’t work. No algorithm can compensate for missing metadata, misaligned timelines, or siloed context. I’ve seen companies throw enormous budgets at AI initiatives, only to realize that their data foundation was never ready. That’s why data contextualization is a prerequisite. And it’s also why orchestration platforms like L7|ESP, backed by normalized data models, a shared ontology, and orchestration logic, are becoming central to how life sciences companies prepare for the future. They enable the right foundation to drive faster decisions, better compliance, and scalable innovation, without requiring you to rebuild your tech stack from scratch. The Case for Change If your teams are still reconciling data manually…If your digital workflows depend on offline documents… If your tech transfer process still involves exporting and emailing files… If every new assay feels like a fire drill…If every new site rollout feels like a ground-up implementation… Then maybe it’s time to start rethinking the structure. The Life Sciences industry is at a turning point. The organizations I’ve seen succeed aren’t the ones with the most tools. They’re the ones with the clearest data foundation and have the agility to evolve with it. Those who move toward a unified, orchestrated approach will gain a competitive edge, not just in operations, but also in how fast they can innovate. Let’s talk about how that shift could work for you.ABOUT THE AUTHOR ### Pharma Matters Q&A: Building Smarter, Faster CDMOs: A Data-First Strategy for Advanced Therapies ### Case Study: Advancing DNA Sequencing Services in a Public Sector AgBio Research Facility Everyday discoveries in pediatric genomics are creating new possibilities to understand and treat rare genetic diseases. This work requires robust computational strength in order to process, analyze, and manage large data sets. Please fill out the form to view the Rady Children's case study ### Case Study: Modernizing Agricultural Trait Development with a Configurable Digital Platform Everyday discoveries in pediatric genomics are creating new possibilities to understand and treat rare genetic diseases. This work requires robust computational strength in order to process, analyze, and manage large data sets. Please fill out the form to view the Rady Children's case study ### Top 5 Questions to Ask When Choosing Lab Digitalization Solutions L7 | CHATS thought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IE9hbmEgTHVuZ3UsIFBoLkQuIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@Digital transformation in life sciences isn’t just about eliminating paper or moving to the cloud; it’s about unlocking the full potential of your data. When done right, digitalization streamlines operations, ensures regulatory compliance, accelerates discovery, and improves decision-making across the organization. A well-designed digital lab captures clean, contextualized, and interoperable data, which sets the stage for AI readiness through machine learning, predictive analytics, and real-time optimization. This means faster cycle times, higher quality outputs, and smarter R&D and manufacturing decisions. Here are the five questions that matter most when selecting a solution for laboratory digitalization and preparing you for AI, and how L7|ESP® answers them. 1. Does the solution advance our vision of digitalization and prepare us for AI? AI is the next competitive edge in life sciences. But AI can’t function without clean, contextualized, and connected data. True digitalization means transforming fragmented, siloed information into structured, FAIR (Findable, Accessible, Interoperable, Reusable) data that’s ready for automation, prediction, and optimization. To stay ahead of future trends and maximize efficiency, labs need a platform built with AI readiness at its core. L7|ESP is exactly that. It is a platform that acts as a digital backbone for AI readiness, breaking down silos, streamlining fragmented data, and organizing information. With powerful models for data contextualization, L7|ESP turns raw lab outputs into AI-ready assets to fuel faster decision-making. 2. How can we integrate our systems and instruments? A digitalization solution is only as powerful as its ability to connect with your existing ecosystem. If it can’t easily integrate with critical instruments, software, and data sources, it will introduce friction instead of value. Seamless integration is essential for speed, consistency, and long-term scalability. L7|ESP is built with integration in mind. The platform includes robust, extensible APIs and a growing library of pre-built connectors, at no additional cost. Unlike many vendors who charge extra for interfaces or treat connectivity as an add-on, L7 delivers integration as a core capability. We also support industry standards like HL7 and others, allowing your systems to communicate freely and reliably. This inclusive approach accelerates deployment and dramatically reduces integration overhead over time, making L7|ESP a smarter, more scalable investment. 3. Is the solution built for quality and compliance? In life sciences, quality and compliance are mission-critical. But manual processes and disconnected systems make it hard to consistently meet regulatory standards or catch issues before they become problems. That’s where digitalization makes a major impact. By embedding compliance directly into lab workflows, digital tools can enforce quality and compliance in real time. The right solution should support FDA 21 CFR Part 11, provide complete audit trails, and enable secure electronic signatures out of the box. But more importantly, it should turn quality into a proactive, automated part of every process. L7|ESP is built from the ground up for regulated environments. It helps labs integrate quality and compliance into daily operations with precision and traceability. Customers like Cellipont Bioservices have used it to strengthen quality, reduce manual errors, and streamline regulated processes. When compliance is built into the system, it becomes second nature. 4. Will the solution flex with our lab processes? Flexibility is a necessity, as scientific priorities and processes shift, new instruments are introduced, and regulatory demands evolve. Your lab can’t afford to be locked into rigid systems that slow down change or require expensive rework every time a process updates. The right digital platform should adapt as fast as your science does by allowing you to modify workflows, add new data types, and adjust protocols without major IT overhead. That kind of agility saves time, reduces costs, and keeps your lab competitive. The value of L7|ESP lies in its flexibility. Whether you're running a GMP manufacturing facility, a clinical diagnostics lab, or an R&D operation, L7|ESP can model your unique workflows, instruments, and data structures. And when those processes need to change, the platform’s low-code tools and modular design let you adjust workflows, add new instruments, and update data models. That means less disruption, more flexibility, and faster go-lives. 5. What are the true maintenance costs? The initial investment, such as licensing, setup, and onboarding, is only the beginning. What often goes unseen is the ongoing cost contributing to total cost of ownership (TCO), which includes: maintaining disparate systems, integrating new tools, updating workflows, and scaling to meet evolving business needs. For organizations relying on a patchwork of point solutions, these hidden costs escalate quickly, each change requiring custom integrations, vendor coordination, and separate support agreements. At L7, we understand how taxing that can be, financially and operationally. Our enablement strategy is designed to reduce complexity and empower your teams. With L7|ESP, you gain more than just software; you gain a unified, extensible platform that evolves with your team. Our approach enables collaborative onboarding, agile change management, and streamlined support, leading to significantly lower total cost of ownership over time. Bottom line: The right lab digitalization platform should deliver measurable ROI, in cost savings as well as speed, quality, compliance, and strategic insight. With L7|ESP, you get a unified, AI-ready solution designed to track and drive performance across every layer of your operations. Its low-code flexibility, built-in configurability, and comprehensive enablement strategy allow your team to adapt and scale without constant vendor support, reducing total cost of ownership. From day one, L7 partners with you to define clear KPIs, align on business goals, and configure the platform to deliver lasting, visible impact. ABOUT THE AUTHOR ### Build vs. Buy: The Merits of Each, Plus 5 Questions to Help Evaluate L7 | CHATS thought leadership @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IE1hcmsgU3BlbmNlcnwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@In life sciences, deciding to build or buy a platform isn’t easy and shouldn’t be. Both paths come with tradeoffs. Building gives you control and customization, while buying gives you speed, support, and scalability. What matters most is choosing the approach that aligns with your team’s goals, capacity, and vision for the future. At L7, we don’t see this as a binary choice. In fact, many of the organizations we work with are navigating a hybrid reality, where some systems are homegrown, some are commercial, and all need to work together. We’re not here to convince you to switch sides. We’re here to be a trusted partner, no matter where you are on your journey. Whether you’re evaluating platforms for the first time or revisiting a prior build decision, here are five questions to help guide your thinking. 1. What’s your timeline to deliver measurable value? Building internally gives you control, but it often comes with longer timelines. Every integration, validation, and update becomes your responsibility. If you have the time and resources, that may be worth it. But if speed matters (whether for an audit, a tech transfer, or an AI initiative), it’s worth asking: How quickly can we show impact? With a commercial platform like L7|ESP®, many customers are up and running in months, not years. That can make the difference between staying ahead and falling behind. ▶ If time-to-value is critical, buying may accelerate your roadmap. 2. How much internal capacity do you have for long-term maintenance? Custom platforms come with ownership. That’s a good thing… until it’s not. When teams change, priorities shift, or compliance requirements evolve, that ownership can become a burden. Internal builds require ongoing attention: bug fixes, documentation, user support, security, and audit readiness. If your IT team is stretched thin, that overhead can quickly limit their ability to focus on innovation. Buying doesn’t eliminate responsibility, but it shares it. Vendors like L7 offer ongoing updates, built-in validation, and expert support, so your team can spend more time on science and less on infrastructure. ▶ If your team is at capacity, buying can ease the load and reduce long-term risk. 3. Will your platform need to scale across functions, geographies, or partners? What starts as a local lab solution often expands across departments, regions, or external collaborators. That’s where architecture matters. Building gives you the freedom to tailor every detail, but scaling that architecture adds complexity. New integrations, new user types, new compliance needs, all of it has to be managed and validated. Commercial platforms like L7|ESP® are built for scale from the start. APIs, data models, and compliance frameworks are already in place. And because they're modular, you can configure them to your needs without starting over every time you expand. ▶ If scale is on the horizon, make sure your platform can grow with you. 4. Where do you want your internal teams focused? Your team has deep expertise. The question is: how are they best used? If your IT team wants to innovate on analytics, AI, or scientific modeling, it needs time and focus. But if it’s consumed with patching systems or troubleshooting data flow, those priorities take a backseat. That’s where buying can be an enabler. L7|ESP provides a proven, configurable backbone that frees internal teams to build value on top, rather than spending time keeping the lights on. ▶ If innovation is your north star, buying may give your team the headroom to chase it. 5. What happens when priorities shift or key people leave? Every organization faces turnover and change. When platform knowledge lives with a handful of developers, sustainability becomes a risk. Documentation gaps, tribal knowledge, and bespoke workflows can make continuity difficult, and audits even harder. With a commercial partner, you gain more than software. You gain stability. At L7, we provide ongoing validation packages, regulatory support, and platform continuity, so you’re never left scrambling when internal change happens. ▶ If continuity and compliance are key, a commercial partner can offer peace of mind. Still Building? We're Still With You. We’re not here to tell you that building is wrong. In many cases, it’s the right move, especially for organizations with very specific needs, strong internal capacity, or a strategic preference for custom infrastructure. What we want to do is help, wherever we can. If you’ve already built, L7|ESP can help fill in the gaps. If you're in the middle of a build, we can support integrations or bring validation structure. And if you’re re-evaluating your approach, we’re here to talk openly about what’s worked (and what hasn’t) for organizations like yours. We’re not just a vendor. We’re a platform partner obsessed with orchestration. We’re here to make you look good, run smoother, and go faster, on your terms. Final Word: Build Smart. Buy Smart. But Don’t Go It Alone. Choosing between building and buying isn’t about ideology. It’s about focus. What do you want your teams working on? What do you want to maintain? What will set you up to scale, adapt, and lead? Whether you build, buy, or blend both, we’re here to support you. Because success in life sciences isn’t just about infrastructure. It’s about outcomes. To learn more about L7|ESP, explore L7Informatics.com or contact us to start the conversation.ABOUT THE AUTHOR ### Top 5 Reasons Tech Transfer Keeps Breaking… And What We Can Do About It L7 | CHATS thought leadership @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFRlb2RvciBMZWFodSB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@In biologics, tech transfer isn’t a one-time event. It’s a recurring challenge across scales, sites, and often entire organizations. A single product might go through three or four transfers across its lifecycle: from process development to validation, then to clinical production, and eventually into commercial manufacturing. These transitions are essential. But more often than not, they’re also painful. Despite decades of innovation, tech transfer remains one of the slowest, most failure-prone stages in the product lifecycle. We keep trying to fix it with more documentation, more SOPs, more alignment meetings. But the problem isn’t effort. It’s architecture. Most life sciences teams still treat tech transfer as a handoff, when what we really need is co-authorship. Why Internal Transfers Aren’t as Simple as They Seem There’s a persistent belief that internal tech transfers—between departments or sites within the same organization—are simpler. Shared systems. Aligned teams. One big happy enterprise. But here’s the reality: if the knowledge doesn’t flow, it doesn’t matter who owns the building. I’ve worked on internal transfers where process development was on the first floor, and manufacturing was on the third. Still, we were out of sync. I’ve also worked on transfers across continents, and in many ways, the disconnects were the same. Imagine the scenario - midway through a tech transfer to pilot scale for a clinical material campaign, your chromatography yield is below specification. The root cause: process development (PD) updated the UV collection values without informing manufacturing. The update to PD documentation never propagated. A simple misalignment that results in months of delay while compromising your ability to demonstrate manufacturing consistency. Now, consider the same failure, specifically on the second of three consecutive validation batches. How does one data transfer oversight impact your regulatory timeline and commercial launch? It’s not about location. It’s about alignment. And alignment is hard to achieve when your process knowledge is fragmented, your communication is linear, and your collaboration lives in static documents. The Hidden Pitfalls of Tech Transfer (and What They Really Look Like) Many of the biggest breakdowns in tech transfer stem from familiar issues, but most organizations don’t see the full picture until something goes wrong. Below are the core pitfalls I’ve seen again and again… and why they persist. 1. Dispersed Knowledge Let’s say your process development team has generated a series of reports, each with critical insights. One outlines unit operations, another defines setpoints, and a third details intermediate sampling. Individually, each is valuable. But none of them, on their own, tells the whole story. In practice, that means the team receiving the tech transfer has to reverse-engineer the logic behind the process. Stitch together PDFs. Cross-reference slides. Hope nothing gets lost in translation. And something always does. We talk a lot about “process knowledge,” but too often that knowledge is scattered and nowhere near ready for handoff. 2. Incomplete Documentation Even when the science is solid, the documentation often falls short. Why? Because process understanding doesn’t always get formalized. It stays in people’s heads or in unstructured formats spread across departments. I’ve seen cases where critical parameters or sampling steps weren’t explicitly documented because someone assumed, “Well, everyone knows that.” But when that assumption crosses continents (or even just departments), it fails. And then, a deviation. Process definition and control strategy are rarely documented as one unified object. But they should be. Because in practice, they represent two halves of the same thing: process knowledge. If you don't know what you're measuring, when, and why, you're not ready to scale. 3. One-Way Communication Traditional tech transfer assumes a unidirectional flow: development pushes, manufacturing receives. That model breaks down quickly in real life. When you’re scaling from small-scale development to CGMP manufacturing, adjustments are inevitable. Pumps, probes, mixing dynamics—all differ at large scale. But if feedback from the recipient never reaches the donor, the process is treated as locked. That’s a problem. For example: I’ve seen a spec for a pH sensor set at ±0.05, only to find out that the inline sensor at commercial scale had a tolerance of ±0.1. That’s not a trivial mismatch. That’s a baked-in deviation. Process development brings the science. Manufacturing brings the engineering. If those voices don’t meet early(and by early, I mean before specs are finalized), you’re setting yourself up for iterative failure. 4. Engineering Misalignment Sometimes, a spec defined at development scale isn’t feasible at manufacturing scale. But instead of raising a red flag, the manufacturing team quietly adjusts it. Maybe they round up a flow rate. Swap a pump. Modify a hold time. All of it well-intentioned, but all of it potentially process-breaking. The development team never knows. Until they get a call about a failed lot. This is where the idea of “first-time-right” tech transfer dies. Not because of poor science, but because the process was never calibrated for the real-world constraints of production. The fix? Collaboration before execution. Not after failure. 5. Static, Siloed Formats Most tech transfers are still run on PDFs, Word docs, Excel files, and disconnected systems. That means every stakeholder, from development to QC to the CDMO, gets a slightly different version of the truth. I once worked on a tech transfer where the process development team shared a schematic of the filtration step. It made sense to them, but not to my technicians. We had to redraw the entire diagram, down to the valve instructions, just to make it operational. And that’s assuming the documentation even includes material details. In one transfer, we couldn’t figure out why buffer conductivity was off until we discovered we were sourcing salt from different vendors. Nowhere in the master batch record did it mention the supplier name or catalog number. Just “NaCl.” Bridging Science and Engineering with Shared Process Knowledge At its core, successful tech transfer isn’t about documentation. It’s about shared understanding. Process development contributes scientific knowledge on how and why a process works. Manufacturing contributes engineering knowledge, in other words, what’s actually feasible on real equipment. Too often, those knowledge sets don’t meet until it’s too late. But when they do, and when they converge in a shared digital space, something powerful happens: you stop handing off documents, and you start co-authoring process execution. That’s where orchestration comes in. Orchestration: Turning Process Knowledge into a Shared Asset Let me put it this way: if you give me the Mona Lisa and tell me to replicate it on a seven-meter-tall building, I can try. But unless you also give me the brushstrokes, the coordinates, and the color palette, I’m going to fail. Tech transfer works the same way. A PDF can’t give you execution logic. A version-controlled Word doc can’t notify you when the pH spec gets updated. A schematic in someone’s slide deck doesn’t tell you how it behaves in MES. But a dynamic, executable workflow can. When you orchestrate tech transfer through a shared, versioned workflow: Process definition and control strategy become one object. Scientific assumptions are visible and reviewable by engineering. Equipment constraints are flagged before deviations happen. And both sides—donor and recipient—co-own the outcome. You stop running after deviations. You start designing for success. Conclusion – What’s at Stake When tech transfer fails, it’s not just a process problem; it’s a business problem. Delayed lots cost months. Missed specs cost credibility. And in competitive markets, even a small delay can mean losing first-mover advantage. But it doesn’t have to be that way. When process development and manufacturing teams align early, scientific logic on one side, engineering realities on the other, you create the conditions for first-time-right execution. And when that shared understanding lives in a unified digital workflow, it becomes repeatable, scalable, and future-proof. You don’t need more documents. You need orchestration. To learn more about our orchestration platform, L7|ESP®, visit the L7 website or contact us to start the conversation.ABOUT THE AUTHOR ### Beyond Consolidation: Why Orchestration is the Real ROI Multiplier in Life Sciences L7 | CHATS thought leadership @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFZhc3UgUmFuZ2FkYXNzLCBQaC5ELiB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@McKinsey recently published a compelling insight¹: biopharma companies that consolidate software and migrate to modern cloud-based architectures can free up as much as 30% of their R&D IT spend; resources that can then be redirected to fuel innovation, automation, and AI. It’s a powerful number. But what if I told you it’s just the beginning? Having worked with life sciences organizations across research, development, and manufacturing for decades, I’ve seen the challenges and complexities of systems consolidation, especially when trying to keep the business running simultaneously. This is where orchestration platforms come in. Data orchestration platforms bridge departments, integrate with instruments, decouple systems, and contextualize data at the source of creation of scientific data. Think of orchestration as laying the groundwork for creating a roadmap for consolidation. The greater the number of fragmented systems you have in a business, the slower and more expensive it is to run that business. So, while systems consolidation and portfolio optimization accelerate performance and unlock enterprise-level ROI, the data orchestration layer allows you to keep running your business as you gradually consolidate your portfolio of applications. The added bonus? The data is contextualized and made AI-ready at the source of data creation as opposed to downstream data lakes. But, more on this later. The Hidden Cost of Fragmentation Let’s step back for a moment and look at how we got here. Over time, the life sciences software landscape has been flooded with specialized point solutions, each narrowly focusing on a single task or problem. Vendors weren’t tasked with worrying about the broader ecosystem, the long-term implications, or the fact that these point solutions don’t work together. The result? Data silos, process silos, complex and expensive regulatory compliance, a lot of Excel spreadsheets (orphan data), version control nightmares, brittle integrations, and a constantly growing burden of technical debt and shadow IT, making true automation and AI feel out of reach. In other words, data and application fragmentation have become the silent ROI killer in life sciences. That’s why McKinsey’s estimate—that consolidating and migrating to cloud-based architectures could reduce R&D IT spend by up to 30%—is so important. But in my experience, that’s just the beginning, because it reflects the cost of inefficiencies that most companies have accepted as the norm. Consolidation surely helps cut costs, but data orchestration platforms help you create a roadmap for consolidation and real-value generation. Why Data Orchestration Delivers More Than Simple Consolidation The short answer is that while consolidation focuses on simplifying what you already have, data orchestration is about enabling the speed, agility, and scalability needed to thrive in a fast-changing environment. The combination is a win-win for life-sciences companies. An orchestration layer isn’t just about connecting systems. It’s about coordinating how data flows, how decisions are made, and how people collaborate across the entire product lifecycle, from research to development to manufacturing. It decouples data from applications and workflows from specific tools, creating a foundation that’s far more agile, scalable, and intelligent. This decoupling is what gives life sciences organizations the ability to evolve without rebuilding from scratch every time a business restructures, the business climate changes, or a new scientific modality comes along. It’s also what makes your organization future-ready, positioned not just to integrate AI but to actually benefit from it without a lot of investment in time and money. Rethinking ROI in the Age of Data Orchestration And that brings us to ROI. For years, digital transformation in life sciences has been framed around cost reduction. Consolidate your systems. Reduce IT spend. Retire legacy infrastructure. And while those savings are real, (and necessary!), they only tell part of the story. Orchestration changes the equation. It’s more than reducing what you spend. It’s about unlocking an entirely new value. Here’s what I mean: Portfolio Optimization: Orchestration brings structure to sprawling IT ecosystems, enabling organizations to reduce complexity without disrupting operations. It supports phased transitions from legacy systems to next-gen tools, allowing teams to scale, adapt, and innovate without rebuilding from scratch. AI-Ready Data: Orchestration contextualizes data at the point of execution, making it instantly usable across teams, systems, and AI models. No more manual stitching together of data. No more cleaning after the fact. Faster Tech Transfers: By harmonizing processes across internal teams and external partners, orchestration minimizes handoff delays, reduces rework, and accelerates internal and external tech transfer timelines, whether it’s within your own departments, sites, or with CDMO partners. Compliance by Design: With audit trails, traceability, and version control built into the process, orchestration helps ensure compliance is met without adding extra overhead or manual work. You extract your business process from within your point solutions and externalize it, thus making it easier to make business process improvements without much disruption. Mergers and Acquisitions: Portfolio optimization and systems consolidation are never one-and-done activities. They are ongoing housekeeping efforts that must keep pace as the business undergoes continuous evolution, including mergers, acquisitions, and divestitures, all of which are commonplace in life sciences. A Digital Backbone for Scalable Innovation and Real ROI L7|ESP® is a unifying platform purpose-built for life sciences. Designed as a composable platform, it contextualizes data at the source, automates end-to-end processes, and standardizes workflows across research, development, and manufacturing. In short, it’s the digital backbone of your organization, with modular components that power AI-ready data, seamless orchestration, and cross-functional collaboration. Unlike traditional systems that require costly, disruptive rip-and-replace efforts, L7|ESP seamlessly layers over your existing stack, connecting and coordinating tools without halting operations, while extending the value of your prior investments. L7|ESP is also GenAI-, Agentic AI-, and ML/AI-ready, thereby accelerating your journey to integrate these technologies with the contextualized data rapidly. It’s not about replacing what works. It’s about orchestrating what’s next, and delivering the ROI that moves the needle. L7|ESP also has best-in-class native applications built on the platform, such as L7 Notebooks, L7 LIMS, L7 MES/EBR, L7 Scheduling, L7 Environmental Monitoring, L7 Stability Monitoring, L7 Asset Management, and L7 Inventory Management. The Real ROI Multiplier If the last decade was about digitalizing the lab, the current one is about orchestrating the entire scientific enterprise. It’s no longer enough to consolidate applications or migrate to the cloud. To drive real ROI (measured in speed, scale, and scientific impact), life sciences organizations need a new kind of data and process foundation. One that unifies and accelerates departmental workflows, contextualizes data, removes inter-departmental bottlenecks, integrates with systems and scientific instruments, and empowers teams to move faster without having to re-architect your business every few years. That’s what data orchestration unlocks. And that’s what L7|ESP was built to deliver. Organizations that embrace this shift won’t just achieve higher returns—they’ll outpace the competition in agility, scalability, and innovation, because the real cost isn’t in modernizing your stack. It’s in staying complacent. If you're ready to explore how orchestration can support your digital transformation, visit www.l7informatics.com or contact our team. ______________ ¹ Jeffrey Lewis, Joachim Bleys, and Ralf Raschke with Moritz Wolf, “Boosting biopharma R&D performance with a next-generation technology stack” (January 9, 2025)ABOUT THE AUTHOR ### Gartner’s 2025 Vision for LIMS is Clear… and L7 has Been Building it Since 2012 L7 | CHATS thought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFJvYmVydCBaZWlnbGVyLCBQaC5ELiB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@When I joined L7 Informatics at the beginning of 2018, I joined not just a company but a vision for what the future of life science informatics could be. The systems of the day were fragmented into niches, with an abundance of letters: LIMS, LIS, LES, SPDM, and more. But the vision at L7 was for something different - a single, unified platform capable of spanning the entire scientific endeavor, enabling scientific IT organizations to move at the pace of science. It was a bold, ambitious vision, and exactly what life sciences needed to connect disparate data. Fast forward seven years later to Gartner’s Market Guide for Laboratory Information Management Systems. In it, Gartner lays out the realities of modern scientific organizations: many separate systems with a rat's nest of integrations across them to attempt to connect data. But, as we noted in a previous blog post, integrating disparate systems doesn’t scale and won’t provide the framework necessary to support modern AI endeavors. Instead, the report points to the systems of the future: digital unified platforms. By bringing together multiple capabilities into one platform, the data model is unified, the number of separate systems to support is reduced, and the web of integrations is streamlined. But more importantly, a unified platform provides the ability to truly break down silos and to contextualize the data being captured: to connect the dots from patients to insights, from research to development, from development to manufacturing. The best part is that you don’t have to wait for the next generation of systems to arrive because the future is now. While other companies scramble to bolt together different solutions to try to present a unified platform, at L7, we’ve been building L7|ESP® as a composable, data-centric, unified orchestration platform from the ground up for years. It’s a single system capable of capturing complex data and processes across the entire life sciences domain, bringing together all your science and your business in one place. If you’re leading digital transformation in a life sciences organization—whether in research, manufacturing, or IT—Gartner’s report should serve as both a roadmap and a warning. Roadmap, because the future is now clearly defined: a unified platform that eliminates silos and accelerates innovation through orchestration and contextualized data. A warning, because the cost of waiting just went up. The days of managing separate systems for lab workflows, sample tracking, batch records, and compliance are numbered. Organizations that continue down that road will find it increasingly difficult to scale, enable AI, and move fast when new opportunities arise. Don’t wait for the rest of the industry to catch up. You can leap ahead today, starting with a platform that’s already built for Gartner’s 2025 vision and beyond. Visit www.L7informatics.com to explore how L7|ESP can support your transformation—or contact our team to start the conversation.ABOUT THE AUTHOR ### Q&A with Marcia Blackmoore | Building Smarter, Faster CDMOs: A Data-First Strategy for Advanced Therapies L7 | CHATS thought leadership @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IE1hcmNpYSBCbGFja21vb3JlLCBNLlNjLiB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@Originally published in Contract Pharma's Pharma Matters Q&A with L7 Informatics. QUESTION 1: L7 Informatics emphasizes a “data-first” approach to cell and gene therapy manufacturing. What does that mean in practice, and why is it particularly important for CDMOs working in this complex space?Marcia Blackmoore: When we say “data-first,” we mean building your processes with the requisite data model in mind from the very beginning. This approach is more efficient than the rework involved in trying to stitch it together later. In cell and gene therapy, the work is too complex and high-stakes to rely on manual documentation, siloed systems, or after-the-fact reconciliation. For CDMOs, this becomes even more critical. You're working across multiple clients, products, and modalities—often with inconsistent source systems and tight timelines. If data is not reliable, contextualized, and accessible at every step, it slows down everything: tech transfer, batch release, investigations, quality review, you name it. At L7, we help CDMOs design digital workflows with structured, contextualized data baked in from the start. Our platform, L7|ESP®, gives teams the tools to standardize manufacturing and QC/QA processes, automate process execution (including data capture from instruments, equipment, and distributed control systems such as DeltaV), and keep everything traceable and audit-ready, thereby enabling on-time batch release. It’s about creating a foundation that scales, supports flexibility, and enables teams to make faster and better decisions. That’s what a data-first approach should look like. — — — QUESTION 2: CDMOs often face the challenge of bridging gaps between R&D, clinical, and commercial stages. How does L7’s unified platform help streamline these transitions in a highly regulated environment? Marcia Blackmoore: The handoff between R&D, clinical, and commercial is where many organizations stumble—especially in cell and gene therapy, where every stage is tightly interconnected but often managed in disparate systems by different organizations. L7|ESP offers a unified platform that can work across these boundaries. Instead of reinventing the wheel at every phase or translating from paper and transferring between systems at each phase of the drug development lifecycle or at each touchpoint, a single digital process can be defined and carried forward, while preserving context, standards, and controls. This is invaluable in regulated environments, where traceability can be lost or errors can be introduced at each transition point. In addition, this approach can dramatically reduce the duration of the tech transfer and ultimately, time to market. With L7, the data isn’t just there—it’s structured, version-controlled, and compliant by design. — — — QUESTION 3: In your collaboration with Cellipont, what were some of the key pain points they faced around data integration and scalability—and how did L7 help address them? Marcia Blackmoore: Cellipont was a greenfield site that embraced the digital-first mindset with an integrated data platform. When we started working with Cellipont, they were preparing to scale quickly and needed a digital backbone that could grow with them. We utilized L7’s pre-built, cell therapy-focused manufacturing processes. These composable digital workflows can adapt to different client needs while maintaining consistency in core processes and data models. Using this approach, we were able to deliver an EBR and inventory management system that is both flexible and scalable within a few months. — — — QUESTION 4: Real-time data orchestration and contextualization are core capabilities of your platform. How do these features directly impact product quality, regulatory compliance, and manufacturing efficiency for CDMOs? Marcia Blackmoore: Real-time orchestration and contextualization are the foundation of L7|ESP, which is precisely what enables CDMOs to transition from a reactive to a proactive approach. When systems are connected and your data carries full context—who did what, when, and under what conditions—CDMOs can track material usage, environmental monitoring trends, QC results, manufacturing progress, and batch status in real-time. From a product quality and compliance perspective, this means you can (pro)actively detect and respond to potential issues rather than discovering them days or weeks later during a paper-based review. In addition, L7|ESP’s ability to organize data into one knowledge graph can enable far more efficient deviation investigations. In terms of manufacturing efficiency, orchestration eliminates the need for manual handoffs and status checks. The system drives the process, automates the routine, and flags the exceptions. That level of visibility and control helps CDMOs deliver more consistent outcomes, accelerate timelines, and build confidence with both clients and regulators. — — — QUESTION 5: What are the most common data and digital infrastructure challenges you see among CDMOs, especially those entering or expanding in the cell and gene therapy market? Marcia Blackmoore: One of the biggest challenges I see—especially with CDMOs entering or expanding in cell and gene therapy—are the siloed systems and the reliance on paper-based processes, even while the technology itself is on the cutting edge of innovation. Organizations attempt to scale without a digital foundation that can keep up. Many are still relying on paper, Excel, or disconnected point solutions to run highly complex and variable processes. Another issue is fragmented infrastructure. There might be an MES system, a LIMS system, and perhaps a QMS, but none of which talk to each other. Teams, therefore, reconcile data manually, which slows down tech transfers, delays batch release, and introduces risk. L7|ESP can be layered on top of existing systems to orchestrate workflows, unify data, and bring structure without the need to replace legacy systems. L7|ESP is able to integrate these siloed systems or fully replace existing systems. — — — QUESTION 6: From your perspective, how can digital platforms like L7|ESP contribute to shortening time-to-market for advanced therapies without compromising on quality or traceability? Marcia Blackmoore: One of the major bottlenecks in the product development lifecycle is the tech transfer process. L7|ESP enables digitalization and transfer from a library of pre-built recipes, unit operations, and methods. Those pre-built units can be dragged and dropped from L7|HUB® and configured for new customers or products, thereby decreasing tech transfer execution times and, by extension, time-to-market vs. paper-based tech transfers. Tech transfer times can be further accelerated if both the customer (sending party) and the CDMO (receiving party) utilize L7|ESP. — — — QUESTION 7: Looking ahead, how is L7 evolving its solutions to support the next wave of CDMO innovation—whether that’s personalized medicine, decentralized manufacturing, or AI-driven optimization? Marcia Blackmoore: L7|HUB®, Reusable Content, Knowledge Graph (L7|INTELLIGENCE®), AI. The next wave of CDMO innovation—personalized medicine, decentralized manufacturing, and AI-driven optimization—requires a solid data foundation and the ability to be nimble to be successful. Using L7|HUB and the pre-built content library, we can enable accelerated scale-up and tech transfers. L7|ESP orchestrates workflows and captures data at every step—with structure, context, and traceability built in. That means CDMOs can create AI-ready data that can be utilized for everything from predictive modeling to real-time quality control. We’re also expanding our knowledge graph and data product capabilities, enabling customers to move beyond manual reviews and static reports toward systems that can reason, adapt, and help teams make smarter decisions more quickly. The promise of this next era isn’t just speed or automation—it’s intelligence. And that comes from treating data as a strategic asset from day one. ABOUT THE AUTHOR ### Top 7 Must-Haves for AI Readiness in Biopharmaceutical Laboratories L7 | CHATS AI in life sciences@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IE9hbmEgTHVuZ3UsIFBoLkQuIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@AI is transforming biotech and pharmaceutical research, development, and manufacturing by speeding up discovery, unlocking insights, and automating tedious work. However, having AI tools isn’t enough; AI readiness requires clean, contextualized data, along with a clear understanding of how it can be integrated into business processes to surface real insights and drive meaningful outcomes. AI readiness needs a coherent strategy in order to strengthen your business efficiency, scalability, and ability to stay competitive in a rapidly evolving market. The path to AI readiness begins with understanding your current state, including how your data is captured and structured, its relationships, how it scales, how it's shared, and whether it’s sufficiently contextualized for AI tools to interpret and act upon. The more fragmented your systems are, the harder it will be for AI to access clean, contextualized data. Here are the seven must-haves to ensure your lab is ready to scale with AI: 1. Know Your Business and Your Systems To start your AI readiness journey, it is crucial to understand your current workflows and the tools that support them. Start by asking the following questions: What are all of your critical laboratory processes? What instruments and platforms are in use? Are your systems integrated, or working in silos? ▹ Quick check:How many systems does your laboratory rely on to manage data, workflows, and operations?A. 1-2 fully integrated systemsB. 3-5 systems, some partially integratedC. 5+ siloed systems with lots of manual effort 2. Understand Your Throughput and Scale Your ability to capture data and derive meaningful insights through the power of AI must scale with your business and processes. Track your lab’s throughput across different workflows, teams, and sites. Understand the trends that drive your laboratory’s business: changes in processes and how often they occur, expanding teams, or changes in demand. Can the systems that capture the data driving AI keep up with the changes in your business? The more fragmented your systems are, the harder it will be for AI to access clean, contextualized data. ▹ Self-Assessment:How confident are you in your systems and their ability to scale across new teams, sites, or use cases?A. Very confident—it’s built to growB. Somewhat—we’re hitting limitationsC. Not confident—it’s already a patchwork 3. Align with Your Team No strategy works without people: AI readiness must align people and their roles in your organization with the critical data they are responsible for. Map out how key roles in your organization, such as scientists, technicians, and data analysts, interact with data and the systems that structure it. Systems in your organization and the AI-generated insights they enable should support your team—not slow them down. ▹ Team Alignment Check:How long does it take for a new team member to learn your systems?A. Days—it’s intuitiveB. Weeks—with trainingC. Months—everyone learns it differently 4. Evaluate Your Data Practices Take a baseline for how your data is captured, shared, and contextualized today. Is it still trapped in paper records, scattered spreadsheets, or siloed systems? If so, AI tools will struggle to piece together the data and deliver value. For AI to be effective, your data must follow FAIR principles—it must be Findable, Accessible, Interoperable, and Reusable, with rich context, so that AI can interpret it accurately and act upon it. ▹ Data Practices Check: Data handoff issues often reveal the cracks—how often do you lose time to broken pipelines, inconsistent formats, or missing information?A. RarelyB. OccasionallyC. All the time 5. Consider Regulatory Requirements Ensure your strategy is built around the appropriate regulatory requirements for data integrity, security, and reporting. Key considerations include: making sure your systems are built for traceability, audit-readiness, and privacy considerations for sensitive data, as well as understanding the specific compliance frameworks that apply to your business: GxP, 21 CFR Part 11, ISO, etc. ▹ Regulatory Compliance Check:How does regulatory compliance factor into your current laboratory system(s) for data capture?A. Critical—we require cloud-agnostic, compliance-ready solutionsB. Important—it’s a factor, but not a deal-breakerC. Not a major concern—we adapt our processes around the tools 6. Identify The Pain Points AI is a tool to help get the most out of your laboratory data by automating tasks, overcoming pain points, and unlocking key insights that are difficult for humans to discern. Whether it’s inefficient workflows, tedious tasks, or challenging data analysis, AI should plug into those gaps to help move science forward. But first, you need to know where those gaps are. That means having a clear, structured, and documented view of your lab’s processes, data flows, and blind spots. Many labs are trying to leverage AI but have yet to align its use with their actual process challenges. Understanding where AI tools can relieve pressure is critical to effectively harnessing their power, rather than just adding another layer of complexity. ▹ AI Assessment:What’s your current approach to enabling AI and ML across your research or operations?A. We have a solid pipeline in productionB. We’re experimenting, but integration is toughC. We’re struggling to even get clean, contextual data 7. Prioritize AI-Ready Data Throughout this process, you’re likely to identify a range of pain points and opportunities for improvement, and prioritization will be key. Focus on what will have the highest impact on your lab’s performance and its ability to realize the full potential of AI. And nothing is more foundational, or more powerful, than making sure your data is AI-ready. Data is the lifeblood of your lab. If it’s fragmented, inconsistent, or lacks context, AI can’t deliver meaningful insights. That’s where the L7|ESP platform comes in. It helps ensure your data is not only clean and connected but contextualized so that AI can actually understand and act on it. With flexible applications and built-in process orchestration, L7|ESP brings together your systems, data, and workflows, and people into a platform designed to scale with your needs. If you want to make real progress with AI, start by making your data ready for it. Final Thought Getting AI-ready is about aligning your systems, people, and data to build a strategy that maximizes the value to your business. Start by understanding your current state, and use these seven areas to guide your roadmap. As you answer the AI-readiness assessment questions provided in each section, consider what the results indicate about your laboratory’s AI readiness. Results: ▹ Mostly A’s: You’re ahead of the curve.Still, L7|ESP might help consolidate your gains and future-proof your AI investment. Worth a peek? ▹ Mostly B’s: You’re halfway there—but friction is building.A unified platform like L7|ESP can reduce complexity and accelerate your roadmap. ▹ Mostly C’s: It's time.You're dealing with fragmentation that’s stalling progress. Let’s talk about how L7|ESP can change that. I thoroughly enjoyed crafting this piece to share insights from my experience with laboratory digitalization and strategic initiatives such as AI readiness. These are areas I’m passionate about, especially when it comes to helping organizations turn their data and processes into real business value. Please don't hesitate to reach out if you'd like to discuss further or explore how I can assist you.ABOUT THE AUTHOR ### Why Orchestration—Not Integration—Is the Future of Digital Life Sciences L7 | CHATS thought leadership @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFRlb2RvciBMZWFodSB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@Despite years of digital transformation, many life sciences organizations are still held back by an invisible force: the technical debt of integration Every new tool, every system upgrade, or every workflow tweak introduces friction. What began as a best-of-breed architecture has become a brittle web of point-to-point connections. Integrations break. Projects stall. Innovation slows to a crawl. But let me tell you: it’s not a software problem—it’s an architecture problem. And solving it requires a strategic shift—from connecting systems to orchestrating business processes. Most digital roadmaps in life sciences were built with good intentions: deploy the best IT system for every job. But as systems and scientific modalities grew, so did the complexity of the IT landscape. Each system required dedicated integrations. Each change demanded careful coordination. And as the ecosystem expanded, the cost of change skyrocketed. Because every system evolves on its own timeline—driven by independent release cycles and departmental tweaks—maintaining point-to-point connections becomes increasingly fragile and unsustainable. This is the trap of traditional integration. And it's why many organizations find themselves slowing down just when they need to move faster. Now imagine a different approach—one where systems don’t talk directly to each other but instead communicate through a shared orchestration layer. This layer doesn't just relay data—it understands processes. To be precise, it decouples the underlying systems, allowing each to evolve independently, and more importantly, it manages the HOW of your scientific operations—standardizing, routing, and contextualizing tasks across your ecosystem. In short, orchestration isn’t a technical fix. It’s a strategic foundation. It becomes a control system for the ecosystem.Systems don’t talk directly to each other but instead communicate through a shared orchestration layer. At the most basic level, the orchestration system eliminates the need for 1,000 brittle connections. Each system connects once—to the orchestration layer—and that’s it. You need to replace your ELN? Just update the single connector. You want to scale out your QC tools across regions? Go for it; there won’t be any ripple effects. The same logic applies to integrating instruments and equipment in the ecosystem into software systems. The result is a more agile, resilient IT landscape—one that doesn’t crumble with every change or modification.If technical decoupling gives you flexibility, data decoupling gives you control and an onramp to AI. But the benefits go further. If technical decoupling gives you flexibility, data decoupling gives you control and an onramp to AI. In most vendor-led ecosystems, the data model is fixed. You inherit someone else’s schema, someone else’s assumptions about how your science works. This applies to your data orchestration system as much as it does to your individual point solutions (LIMS, ELN, MES etc). That rigidity doesn’t just force costly mappings—it holds your hostage to the vendor data model. Let me clarify this point for you: if your scientific data has been configured around the data model of System A, switching to System B becomes nearly impossible. If replacing one ELN is painful because of the need to replicate hundreds of point-to-point connections, replacing your orchestration system with its off-the-shelf data model becomes impossible. We need to flip that dynamic. You start with your science—your terminology, your scientific modalities, your scientific processes—and build a system-agnostic semantic data model. This model becomes the single source of truth, independent of both the orchestration system and the systems (and instruments) surrounding it. And because that data model is yours, it stays consistent—even when your instruments and software systems change. As your science and modalities evolve, the semantic data model adapts because YOU control it, not the vendor.The data model is yours, it stays consistent—even when your instruments and software systems change.This architectural shift has immediate practical implications. Take something as seemingly simple as sample registration. Today, the process is often hardwired not just to a specific system—but to multiple systems. For example, ELISA samples might need to be registered in Vendor ELN-1, while HPLC data has to go through Vendor LIMS-1. Scientists are left navigating a fragmented landscape: they must remember which test maps to which system and follow a different registration process each time. It’s not uncommon to register samples five or ten different ways in a single week. With the orchestration layer, that complexity disappears. The scientist simply says, “Register this sample.” The orchestration layer routes the instruction to the appropriate system, formats the data accordingly, and ensures it’s logged in the correct place. The underlying vendor systems and instruments do not matter. The process stays the same. That’s business agility—built right into the architecture. This is precisely the philosophy behind L7|ESP. We didn’t build another integration platform. We built a composable, regulatory-compliant, low-code orchestration system where your organization defines the data model (using the L7 Reference Data Model), the workflows, and the business logic. Before you can do anything in L7|ESP, you start by modeling your science—your way. Then, you layer in the systems, the instruments, and the automation. L7|ESP becomes the digital brain, routing tasks, contextualizing data, and preserving scientific meaning from start to finish. It’s not just a platform. It’s a new way to think about digitalizing and automating your scientific operations. It also scales seamlessly as you enter the world of GenAI and Agentic AI by contextualizing your data and generating knowledge graphs by semantically linking disparate pieces of data.True digital transformation in life sciences means building an architecture that’s flexible, sustainable, and ready for what’s next. This isn’t just theory. According to a recent McKinsey & Company article, life sciences organizations that consolidate software and migrate to cloud-based architectures can free up as much as 30% of R&D IT spending—resources that can then be reinvested into innovation, advanced automation, and AI.¹ Orchestration is what makes this level of efficiency possible. It reduces the burden of legacy integration, unlocks agility, and creates the architectural runway for scalable digital transformation. If you're still operating on a patchwork of fragile integrations, you're spending more time maintaining than innovating. And in a field where speed and time to market matters—whether you're discovering new therapies or scaling production—that's a risk you can’t afford. True digital transformation in life sciences means building an architecture that’s flexible, sustainable, and ready for what’s next. Because the systems will change. Science will evolve. The questions (e.g. Root Cause Analysis) that need answering will get more complex. And when they do, you’ll want an IT foundation that’s ready—and not reactive. Orchestration is that silver bullet. To learn more about L7|ESP, please contact us or explore our website at L7Informatics.com. _______ (1) Jeffrey Lewis, Joachim Bleys, and Ralf Raschke with Moritz Wolf, “Boosting biopharma R&D performance with a next-generation technology stack” (January 9, 2025)ABOUT THE AUTHOR ### Recap of Bio-IT World 2025: Why AI-Readiness Demands a Unified Approach Through a Digital Backbone L7 | CHATS AI in life sciences@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IE9hbmEgTHVuZ3UgfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Bio-IT World 2025 brought together the best minds in life sciences and tech. From pharma to clinical research to healthcare, the message was clear: AI is reshaping biomedical research at a breathtaking pace. Yet, despite the promise, one stubborn roadblock kept coming up: siloed systems leading to data fragmentation. Bluntly stated: grappling with too many systems! That sentiment echoed throughout the conference. Organizations are still wrestling with siloed systems that limit their ability to fully capitalize on AI. Some have patched together a web of point solutions. Others are building custom pipelines from scratch. Vendors, meanwhile, showcased everything from ultra-specialized tools to full-stack platforms promising to unify the ecosystem. One consistent thread: no one has it totally figured out. There’s a clear hesitation around relying too heavily on a single vendor or system, but the drawbacks of scattered tools are just as real. Here’s a hot take: your AI-readiness strategy needs a digital backbone—a unified orchestration platform that connects instruments, people, and processes, and contextualizes data from end to end. The payoff? A consolidated solution that cuts training time, simplifies maintenance, reduces costs, and delivers unified, AI-ready data. Yes, there’s risk in vendor lock-in. But that risk is manageable with the right choice: a platform that’s infrastructure-agnostic, so your data stays under your control—whether it’s deployed on your own servers or in the cloud; with extensible APIs; and that enables data models built around your workflows and scientific context. That combination gives you long-term flexibility and ownership, while still delivering the cohesion your AI strategy demands. That’s where L7|ESP stands out. It’s an orchestration platform designed to give you the best of both worlds: the structure to scale AI across your operations and the openness to avoid getting boxed in. In a world of too many systems, L7|ESP is the backbone life sciences organizations need to go from fragmented to future-ready.ABOUT THE AUTHOR ### Beyond the Limits of LIMS: Why Life Sciences Needs a Unifying Platform Approach L7 | CHATS thought leadership @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFdpbGwgR3JheSB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@For decades, life sciences organizations have relied on an expanding array of point solutions to manage laboratory operations. Nowhere is this more evident than in the LIMS (Laboratory Information Management System) market, where vendors continue to multiply, each promising better data management, workflow automation, and regulatory compliance. With the global LIMS market projected to grow from $2.4 billion in 2025 to $4.6 billion by 2032, the demand for these solutions remains strong. Yet, despite this rapid expansion, life sciences organizations still grapple with fundamental challenges: data silos, disconnected workflows, and an increasingly complex IT landscape. The question is no longer whether LIMS is necessary but whether traditional LIMS solutions alone can meet the evolving needs of modern research, development, and manufacturing. The answer? They can’t. The future lies in a unifying platform approach—one that goes beyond LIMS to orchestrate processes, contextualize data, and ensure seamless integration across the entire enterprise. The Pitfalls of Legacy LIMS: Myths vs. Reality LIMS has long been viewed as the cornerstone of lab operations, but traditional solutions have inherent limitations that hinder their ability to support enterprise-wide digital transformation. ▶ Myth #1: LIMS is a comprehensive solution for lab data management Reality: LIMS was originally designed for one primary function—managing assay results for quality control and sample testing. Over time, vendors have bolted on additional features like lab execution modules (LES) and lightweight electronic lab notebooks (ELN), but these additions remain rigid and fail to support end-to-end workflow execution. ▶ Myth #2: LIMS scales effortlessly with an organization’s needs Reality: Legacy LIMS are often static, built on outdated architectures that don’t scale with evolving workflows. Many organizations find themselves managing multiple LIMS across different sites and departments, leading to a fragmented system landscape rather than a scalable solution. ▶ Myth #3: LIMS integrates seamlessly with other lab systems Reality: The integration of LIMS with ELN, MES (Manufacturing Execution Systems), and material management systems is complex, costly, and often unreliable. Many legacy LIMS struggle to communicate with laboratory instruments, requiring manual data transfers that increase errors and compliance risks. The Harsh Reality of Integrating Point Solutions Recognizing the limitations of standalone LIMS, many organizations have attempted to patch together multiple-point solutions. In theory, this should create a more comprehensive lab ecosystem. In practice, it introduces a host of new challenges: Complex Integrations: Each new system added increases IT complexity, making system maintenance and upgrades a nightmare. High Maintenance Costs: Integrating multiple systems requires constant updates, troubleshooting, and expensive middleware solutions. Data Fragmentation: Data is scattered across multiple systems, making it difficult to achieve a single source of truth. Compliance Risks: When critical data is spread across disparate systems, tracking contamination events, ensuring regulatory adherence, and maintaining audit trails become significantly more challenging. One life sciences executive recently shared how their organization believed they had achieved end-to-end automation—only to later realize they had 30 different labs operating in complete isolation. This illusion of connectivity is common among companies relying on disparate systems that don’t truly communicate with each other. A New Path Forward: The Unifying Platform Approach Rather than continuing to stack disconnected solutions on top of each other, forward-thinking organizations are adopting a unifying platform approach. A true unifying platform does more than act as a LIMS—it orchestrates workflows, contextualizes data, and integrates seamlessly with existing systems to eliminate silos. This is where L7|ESP® fits in.L7|ESP is not just another LIMS—it is an enterprise-wide orchestration platform that: Provides an integrated ecosystem with native applications (LIMS, ELN, LES, etc.) while allowing organizations to keep third-party solutions in place if desired. Orchestrates workflows and contextualizes data across R&D, clinical development, and manufacturing for a true end-to-end approach. Enhances regulatory compliance by ensuring standardized processes, audit trails, and real-time tracking of critical data. Offers unmatched scalability and flexibility, allowing organizations to expand and adapt their digital landscape without the risk of vendor lock-in. A major biotech organization recently leveraged L7|ESP to consolidate multiple disconnected systems, dramatically improving data accuracy and workflow efficiency. Another customer in the contract development and manufacturing space (CDMO) reduced time-to-market by up to 40% by shifting from a fragmented system landscape to an orchestrated platform approach.The Bottom Line: LIMS Alone Won’t Drive Digital Transformation Legacy LIMS solutions were never designed to handle the scale and complexity of today’s life sciences operations. The industry is rapidly moving toward AI-driven insights, automated workflows, and enterprise-wide digital transformation—initiatives that cannot succeed without a data-first approach. Only organizations that embrace a unifying approach—one that seamlessly connects research, development, and manufacturing—will be truly AI-ready. Without this level of contextualized data and orchestration, companies risk falling behind in the race toward smarter, faster, and more efficient life sciences operations. The days of relying on standalone LIMS are over. The future belongs to platforms that unify, orchestrate, and transform the way science is done. Contact us if you’re ready to explore L7|ESP, or visit our website at L7 Informatics.ABOUT THE AUTHOR ### Stop Feeding AI Junk Data: The Role of Data Contextualization in Smarter Manufacturing L7 | CHATS thought leadership @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEtldmluIE1jTWFob24gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Manufacturing Execution Systems (MES) have long been the backbone of modern life sciences manufacturing. They help organizations manage operations, track production, and ensure compliance in highly regulated industries like pharma and cell & gene therapy (CGT). However, as AI adoption accelerates across the industry, MES faces a new challenge that many organizations are unprepared for. AI thrives on data, but not just any data. Without structured, contextualized information, AI turns out to be an expensive experiment rather than a transformative tool. Why Traditional MES is Holding Back AI Innovation Traditional MES solutions, designed primarily for documentation and process control, often lack the agility and interoperability required to support AI-driven initiatives. As a result, manufacturers struggle to extract meaningful intelligence from their systems, leaving them with disconnected data silos instead of a unified, AI-ready foundation. Here are the two major limitations they suffer from: Rigid and slow to adapt – Traditional MES solutions are monolithic and complex to change. Any updates to processes or workflows require specialized SMEs or external vendors, causing long delays and high costs. Disconnected data silos – Many MES platforms don’t seamlessly integrate with LIMS, QMS, or other solutions, making it challenging to cross reference batches, verify status, directly from primary source systems, and achieve real-time operational insights that allow prevention rather than reaction. For AI to succeed in manufacturing, MES can’t just be a passive system of record—it needs to be part of a broader orchestration strategy that ensures data is structured, contextualized, easily accessed, and AI-ready. Orchestration Platforms: The Missing Link Between MES and AI Readiness This is where orchestration platforms like L7|ESP show the way. AI can only be as effective as the data it is built and trained upon, and that requires an ecosystem that doesn’t just collect data but actively structures and contextualizes it in real time. L7|ESP is designed to unify disparate systems—MES, LIMS, QMS, ERP, DCS, and more—by ensuring data flows seamlessly end-to-end. Whether integrating with legacy systems or leveraging its built-in applications, such as L7 MES, the L7|ESP platform enables real-time process execution, data integrity, and regulatory compliance. This flexibility allows organizations to modernize their operations without completely overhauling existing infrastructure while ensuring that AI has a solid, structured data foundation to thrive. L7 Knowledge Graph and L7|INTELLIGENCE: Turning Data into Actionable Intelligence Built within the platform, the L7 Knowledge Graph enhances data visibility by offering a dynamic visualization of relationships between data points across manufacturing processes. This powerful tool allows organizations to easily trace batch records, equipment status, sample tracking, and compliance data, providing a clearer understanding of how key data points relate to one another. While L7|ESP structures and contextualizes data at the source and the L7 Knowledge Graph provides a visual representation of these connections, L7|INTELLIGENCE takes this structured data to the next level. With L7|INTELLIGENCE, organizations can quickly identify trends, dependencies, and potential bottlenecks—transforming data into actionable insights that drive smarter decision-making and greater operational efficiency. By orchestrating and contextualizing their data in real-time, organizations can finally break free from silos and lay the foundation for true AI readiness. With seamless integration across systems, they can ensure that automation, compliance, and intelligence work together—unlocking new efficiencies and driving innovation.What Life Sciences Organizations Need to Do Now From my experience working with MES and AI readiness, one thing is clear: organizations don’t need more data—they need smarter data. That starts with having a well-defined data model and the right data infrastructure in place. Companies that fail to establish structured, contextualized data will continue to struggle with disconnected information and missed opportunities. By adopting a digital orchestration and data contextualization platform like L7|ESP, life sciences organizations will achieve the following: Connect all their data sources into a single, structured model. Automate data integration across manufacturing, quality, and research domains. Power AI-driven insights that drive efficiency, compliance, and innovation. Contact us to learn more about how L7|ESP can help you create an AI-ready data infrastructure, or explore our website at L7Informatics.com.ABOUT THE AUTHOR ### Fixing AI's Blind Spot: The Role of Knowledge Graphs in Life Sciences L7 | CHATS thought leadership @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFZhc3UgUmFuZ2FkYXNzLCBQaC5ELiB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@The promise of AI in life sciences is undeniable: It can accelerate drug discovery, optimize manufacturing, and personalize patient care. Yet, despite all the advancements, I often hear the same frustration from executives, data scientists, and IT leaders: “We’ve invested in AI, but we’re not seeing the impact we expected.” The problem isn’t AI itself—it’s data. Or rather, data silos. AI models, particularly Large Language Models (LLMs), are only as good as the data they’re built on. And yet, life sciences data is fragmented, unstructured, and locked in silos across R&D, manufacturing, and clinical operations. AI that lacks context and governance doesn’t just produce inefficiencies—it creates risk. I’ve seen firsthand how organizations struggle to extract real intelligence from their data. Without a foundation of structured, explainable, and trusted data, even the most advanced AI will fail to deliver reliable results. The key to unlocking AI's potential lies in knowledge graphs and unified data platforms—technologies designed to bring order, context, and meaning to life sciences data. AI Without Context is Just Guesswork At its core, AI thrives on patterns—but it can only recognize valuable patterns if the underlying data is structured and meaningful. LLMs promise to unlock vast amounts of data but suffer from a critical flaw: lack of trust. A recent ScienceDirect article, Knowledge Graphs as a Source of Trust for LLM-Powered Enterprise Question-Answering, highlights this challenge. LLMs, while powerful, have a hallucination problem—they can fabricate answers with no clear provenance. They lack the ability to verify, validate, or explain their responses. This is a non-starter in life sciences—where regulatory compliance, patient safety, and scientific integrity are paramount. AI that cannot be trusted is worse than no AI at all. The Role of Knowledge Graphs: Structure, Trust, and Explainability Knowledge graphs address these challenges by imposing structure and context onto data, enabling AI to generate accurate, explainable, and governable insights. The solution isn’t just more data—it’s more smart data. Here's why Knowledge Graphs matter: Accuracy: AI models trained on disconnected data are prone to errors. Knowledge graphs connect the dots, reducing hallucinations and increasing precision. Explainability: AI can’t be a black box in life sciences. Knowledge graphs provide a traceable lineage of information, showing how AI concluded. Governance: Compliance is non-negotiable. Knowledge graphs ensure AI-driven insights are sourced from approved, authoritative data. BUT KNOWLEDGE GRAPHS ARE HARD TO CREATE FROM A LOT OF SILOS.Unifying Data and Workflow Orchestrations: The Missing Piece But Knowledge Graphs alone aren't enough. To drive real impact, they must be operationalized within a unifying data and workflow orchestration platform. AI doesn't just need structured data—it needs orchestrated and contextualized-at-the-time-of-execution data that seamlessly flows across scientific, operational, and business systems.Generating Knowledge Graphs from siloed applications is expensive and difficult... and traditional methods don't scaleThis is where proper orchestration platforms like L7|ESP® come into play. By unifying workflow automation, data contextualization, and Knowledge Graph generation (AI readiness), organizations can finally move from AI potential to AI execution.Automatic data contextualization: the contextualized data layer enables the data model required for analytics and ML/AI toolsAI Without Data Contextualization is a Risky Bet Organizations that fail to address data fragmentation and governance will remain stuck in expensive data harmonization and contextualization projects, fragmented insights, and compliance risks. The way forward is clear: AI must be built on a foundation of data orchestration engines that generate contextualized, structured, and explainable data.Orchestration platforms can automate and contextualize dataThe technology exists. The strategy is clear. The only question is: How long can life sciences organizations afford to wait? If you're ready to dive deeper, check out our recent blog post "Bridging The AI Chasm in Life Sciences: Why Orchestration Platforms are the Key to Intelligence," or explore our website at L7Informatics.com. ABOUT THE AUTHOR ### L7 Informatics and Waters Corporation Partner to Seamlessly Connect Waters’ Informatics Solutions with L7|ESP® L7 | CHATS partnership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEw3IEluZm9ybWF0aWNzfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@At L7 Informatics, we help biopharma customers digitally transform and automate their R&D, Tech Transfer, Clinical, and Commercial Manufacturing workflows. We deliver real-time insights and analytics by contextualizing operational data and enabling end-to-end process orchestration. This approach unlocks AI-ready data, empowering customers to integrate Gen AI and Agentic AI into daily operations. Due to this commitment, L7 Informatics has partnered with Waters Corporation to achieve seamless data connectivity with the Waters instrument lines and drive our industry forward with real-time analytics and control at the manufacturing line, thereby adopting the ever-sought-after continuous manufacturing (CM) capabilities our industry is moving towards. Waters provides state-of-the-art chromatography, mass spectrometry, and analytical instruments widely used worldwide by pharmaceutical and life sciences organizations. By enabling a seamless connection between Waters' informatics solutions and L7|ESP, we will allow scientists to automate workflows further, eliminate manual data transfers, and ensure complete traceability across their analytical processes. "One of our key objectives is to deliver seamless data connectivity to our customers to enable AI-driven method workflow optimization studies via integrated process and analytical development workflows. Scientists continue to struggle to centralize, report, and analyze datasets for their scale-up and tech transfer studies and resort to spreadsheets and paper-based forms; our mission is to simplify the workflow via process orchestration." — Mark L. Spencer, President & CEO, L7 Informatics This partnership is just the beginning. As lab environments grow more complex and the demand for AI-ready data increases, seamless interoperability isn't a luxury—it's a necessity. We're committed to building solutions that improve lab operations today while laying the foundation for smarter, more data-driven science in the future. To learn more about how L7 and Waters can help transform your lab operations, contact us at info@l7informatics.com. ### Bridging the AI Chasm in Life Sciences: Why Orchestration Platforms Are the Key to Intelligence L7 | CHATS thought leadership @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFZhc3UgUmFuZ2FkYXNzLCBQaC5ELiB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@The life sciences industry stands at the edge of an AI revolution. We hear about Generative AI (Gen AI) and Agentic AI every turn we make. But despite the hype, the hard truth is that most organizations are not ready for AI—at least not in a way that delivers real, tangible value. I’ve seen firsthand how companies that invest heavily in AI, but struggle with the same fundamental problem: data fragmentation. Scientific and operational data remain trapped in disconnected systems—ELNs, LIMS, MES, scheduling tools, bioreactors, testing instruments—the list goes on. Without addressing this foundational issue, AI initiatives will remain expensive, ineffective, and riddled with unreliable outputs. So, the real question isn’t just how to use AI. It’s how to get AI-ready data in the first place. And that’s where orchestration comes in. Knowledge vs. Intelligence: The Missing Link A fundamental distinction often gets overlooked in AI conversations: knowledge vs. intelligence. Intelligence requires structured, contextualized knowledge—but many life sciences organizations don’t have that. Instead, they often have scattered and siloed databases, spreadsheets, and paper-based records. When data is isolated like this, there’s no efficient way to extract meaning, let alone train AI models without the risk of hallucinations (a problem many organizations are starting to experience firsthand). For AI to be truly intelligent, we must first create a structured representation of enterprise knowledge. The best way to do that is through semantic networks—specifically, Knowledge Graphs that dynamically organize relationships between key data points (samples, experiments, manufacturing processes, test results, etc.). This structured approach eliminates ambiguity and ensures AI models operate with clean, contextualized data—not just raw, disconnected inputs. The Orchestration Approach: Automating Knowledge Creation Many organizations have tried to solve this challenge by spending more money on data lakes, warehouses, or integration projects. But those approaches are static, expensive, and difficult to maintain. Every time a system changes, the entire data pipeline risks breaking down, forcing teams into an endless cycle of fixes and patches. There’s a smarter way. Instead of attempting to force fragmented systems into alignment manually, we can use orchestration platforms to dynamically structure and contextualize data as workflows are executed. This changes the game. With workflow orchestration, every process—whether in research, manufacturing, or diagnostics—is automated in real time. As these processes run, they generate a Knowledge Graph on the fly. This means that, rather than scrambling to harmonize siloed data after the fact, we capture and structure knowledge at the moment of execution. Real-World Applications: How Orchestration is Changing the Game At L7, we’re already seeing orchestration transform operations in real-world settings. Here are a few examples: At a biomedical research institution and NCI-designated Cancer Center, we’ve automated proteomics workflows, seamlessly integrating instruments, data pipelines, and analytical processes. At a multinational molecular diagnostics solutions company, orchestration now manages highly complex companion diagnostics workflows, ensuring precision across sequencing, bioinformatics, and regulatory requirements. What do all these examples have in common? They eliminate data fragmentation at the source—so AI isn’t operating in a vacuum. Agentic AI: The Next Evolution Most of today’s AI models, including Gen AI, generate insights based on pre-trained data. But Agentic AI is where things get interesting. Agentic AI is dynamic, continuously learning, and capable of autonomous decision-making. In a manufacturing setting, for example, an Agentic AI system could detect deviations in a bioreactor’s pH levels and automatically suggest (or even execute) corrective actions—without human intervention. But here’s the catch: Agentic AI can only function with real-time, structured, and reliable data. That’s exactly why orchestration platforms are so critical—they ensure AI models aren’t guessing based on incomplete or outdated information. The Future of AI in Life Sciences: A Call to Action AI will not deliver on its promise in life sciences until organizations fix their data problem. It’s that simple. Rather than continuing to invest in costly, unreliable data pipelines, the future belongs to companies that embrace orchestration platforms as the foundation for AI. These platforms do more than connect systems—they unify, automate, and contextualize data in a way that makes AI genuinely actionable. The companies that get this right today will have a massive advantage tomorrow. The ones that don’t? They’ll find themselves stuck in an endless cycle of expensive AI experiments with little to show. The choice is clear: Without orchestration, AI is just a costly experiment. With orchestration, AI becomes a strategic advantage. To learn more, contact us at info@l7informatics.com.ABOUT THE AUTHOR ### Building the Future of Cell Therapy: How Cellipont Bioservices Transformed Manufacturing Through Enhanced Quality and Operational Efficiency with a Unifying Platform L7 | CHATS customer story@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IE9hbmEgSS4gTHVuZ3UgfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Paper-based processes and disconnected workflows create bottlenecks in cell therapy manufacturing, slowing progress and increasing risks. Manual inefficiencies aren’t just an operational burden; they threaten quality, compliance, and scalability. How do you move beyond these barriers to a fully digitalized, future-ready manufacturing ecosystem? For Cellipont Bioservices (Cellipont), a leader in cell therapy CDMO services, the answer was clear: embrace a robust and flexible unifying platform. When launching its state-of-the-art manufacturing facility in The Woodlands, TX, Cellipont seized the opportunity to digitally transform its operations with L7|ESP, including its Manufacturing Execution System (MES). By leveraging workflow orchestration and data contextualization, Cellipont didn’t just optimize processes, it set a new standard for efficiency, compliance, and innovation. “The unifying L7|ESP platform is the ideal solution for us to digitalize, modernize, and improve our internal Excel spreadsheet- and paper-based processes to formalize our manufacturing processes and data and to optimize quality review and inventory management,” said Mike O’Mara, Chief Operating Officer at Cellipont Bioservices. The impact was transformative across the business: Streamlined digital workflows replaced paper-based batch records, increasing efficiency and accuracy. Efficient QA processes accelerated quality reviews while keeping manufacturing activities aligned. Automated sample tracking reduced errors and freed up valuable time. Optimized inventory and equipment management improved reliability and operational readiness. By implementing L7|ESP, Cellipont moved beyond regulatory compliance to pioneer a smarter, more adaptable approach to manufacturing, designed for the next era of cell therapy. Want to see how Cellipont made the leap into fully digitalized manufacturing? Download the case study here.ABOUT THE AUTHOR ### Unleashing the Power of Gen AI: It's All About the Data L7 | CHATS ‘everything data’ series@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEFsZnJlZG8gQ292aWVsbG8gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@The transformative potential of Generative AI (Gen AI) in life sciences is undeniable. Its applications range from accelerating drug discovery to revolutionizing diagnostics. However, Gen AI's true power lies in its foundation: high-quality data. In this insightful piece, I delve into the critical role of data in Gen AI, exploring how data quality, advanced data models, and contextualized information can significantly enhance the performance and accuracy of Gen AI applications. With their robust data management and integration capabilities, I will also showcase how platforms like L7|ESP® can empower life sciences organizations to harness Gen AI's full potential. Here are a few key learnings: The Data Difference: Understand why data quality, contextualization, and intelligent data models are the cornerstones of Gen AI's success. The L7|ESP Advantage: Discover how L7|ESP leverages knowledge graphs, normalized schemas, ontology integration, and dimensional models to optimize Gen AI applications in the life sciences. Gen AI in Action: Explore real-world examples of how Gen AI is transforming the life sciences landscape. Agentic AI: Learn how the L7|ESP workflow engine will enable the next generation of Gen AI applications in your company. The fusion of Gen AI and robust data management is not just a possibility—it's the future of life sciences. By understanding the pivotal role of data and leveraging innovative platforms like L7|ESP, organizations can unlock the true potential of Gen AI, driving innovation and accelerating discoveries. Don't miss out on this transformative opportunity. Download the full article to learn more about how unifying platforms such as L7|ESP can empower your Gen AI initiatives. ABOUT THE AUTHOR ### Enhance Gen AI Performance with Unifying Platforms Gen AI is transforming life sciences, but its success depends on more than just algorithms—it requires structured, high-quality, and contextualized data. Without the right data foundation, AI-driven insights can be incomplete, unreliable, or even misleading. In this in-depth article, Alfredo Coviello, Director of Product at L7 Informatics, explores the critical role of data models, knowledge graphs, workflow orchestration, and ontology integration in optimizing AI performance. Discover how a unifying platform approach can help organizations break down data silos, enhance AI-driven decision-making, and lay the groundwork for Agentic AI. ### Breaking Down Data Silos in Life Sciences for Smarter AI L7 | CHATS thought leadership @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFZhc3UgUmFuZ2FkYXNzLCBQaC5ELiB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@Work smarter, not harder The life sciences industry is at a unique juncture. On one hand, we have incredible scientific breakthroughs and unprecedented advancements in AI and machine learning. On the other hand, we face the growing complexity of siloed systems and disconnected workflows that threaten innovation. Data flows through a maze of siloed systems—LIMS, ELN, MES, and more—from research labs to manufacturing floors. Each system operates in isolation, creating inefficiencies that slow discovery, inflate costs, and jeopardize quality. "Existing architectures hinder the velocity of innovation. Moving experimental data from one silo to another is cumbersome, and contextualizing this data is even more challenging. This manual process is unsustainable and error-prone, especially as organizations aim to leverage AI and machine learning." At L7 Informatics, we've long believed that the key to overcoming these challenges lies in a unifying execution platform. Our L7|ESP® (Enterprise Science Platform) was built with this goal in mind. Grounded in principles outlined by Gartner in 2018, L7|ESP integrates data and processes across research, development, and manufacturing into one seamless ecosystem. Here's how it works: Ontology Management: To ensure consistency, L7|ESP normalizes vocabularies across instruments, systems, and equipment. Process Orchestration: Workflows are automated while remaining compatible with legacy systems, preserving prior investments. Data Contextualization: L7|ESP transforms raw data into a smart, contextualized knowledge graph, eliminating the need for fragile, manual ETL processes. The result? The data is clean, connected, and ready to fuel AI-driven insights and make important business decisions in real-time. Let me share an example. One of the world's largest pharmaceutical companies faced a problem many in the industry can relate to. Over the years, they had invested heavily in LIMS and ELN systems, and replacing these tools altogether wasn't feasible. However, these legacy systems, while functional, weren't designed to support modern AI applications or FAIR principles, leaving their data fragmented and their workflows inefficient. They turned to L7|ESP to bridge the gap. With our platform, they were able to unify their data, automate workflows, and build a FAIR data foundation. This resulted in streamlined operations, faster time-to-market, and smarter AI integration—all without overhauling their existing infrastructure. They also created a smart, contextualized knowledge graph that enabled real-time insights and continuous improvement. "The ability to contextualize data and maintain it across systems is not just a technical feat—it's a business imperative." When organizations break down silos, they unlock more than just operational efficiencies—they unlock the full potential of AI. When data is contextualized, organizations can perform root cause analysis, conduct rapid audits, and uncover actionable insights in real time. Processes flow seamlessly, whether for tech transfer between development and manufacturing or for gaining transparency across R&D operations. And the results speak for themselves: faster time-to-market, reduced costs, and improved throughput. As the industry looks toward an AI-driven future, standardization has become essential. Every process must be based on a common language—spanning ontologies, vocabularies, and processes. This is where L7|ESP excels. It doesn't just orchestrate workflows; it establishes the FAIR data foundation that AI needs to thrive. The era of fragmented systems is over. By adopting a unifying platform approach, life sciences organizations can accelerate innovation, reduce costs, improve quality, and foster collaboration across teams and departments. Or, as I like to say, "It's about transforming chaos into clarity—enabling life sciences to work smarter, not harder." Ready to dive deeper? Click below and watch the video recording. ABOUT THE AUTHOR ### Why Disruptive Technology is the Key to Transforming Life Sciences L7 | CHATS thought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEw3IEluZm9ybWF0aWNzIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@Key Takeaways from L7 Informatics and Zaether Leaders L7 Informatics and Zaether recently announced a strategic partnership to accelerate digital transformation in life sciences. To mark this milestone, Mark Spencer, President of L7 Informatics, and Jenn Azar, CEO of Stellix, Zaether’s parent company, sat down at Zaether's Customer Excellence Center in Foxborough, MA. Together, they discussed the industry's challenges and how their collaboration aims to drive meaningful change. Their conversation was both candid and forward-looking, touching on critical issues such as breaking down silos, contextualizing data, and enabling the systemic shift required to unlock the industry’s full potential. Here are some of the most compelling insights from their discussion: The Unmet Need: Breaking the Cycle of Fragmentation "As an industry, we've been talking for years about digitalizing processes, but the focus has stayed too narrow," Azar explained. "Instead of connecting the entire ecosystem, efforts remain siloed—incrementally improving one area while ignoring the bigger picture." Spencer echoed this thought, emphasizing the need for a real paradigm shift. "A definition of disruptive technology is where you take an existing process, break it down, and invent a new one." The life sciences industry faces a fundamental challenge: moving away from fragmented silos toward end-to-end systems and mindset that accelerate everything—from research to manufacturing and ultimately to the patient. Without this unifying approach, opportunities for future innovation will be delayed and even lost to the nature and speed of the industry. As Spencer and Azar pointed out, while breaking silos and rethinking processes is imperative for digital transformation, we must also lay the groundwork for future technologies such as AI. Why Contextualized Data Matters More Than Ever As Spencer puts it, "AI will not work unless the data is contextualized." Without proper context, data remains an untapped resource—useful for specific tasks such as a retrospective analysis but incapable of driving predictive and prescriptive insights. Azar expands on this idea: "You have to think about contextualizing the data as you work; it's a complete shift in how we work. We really need to get after it to change the way the industry operates." This shift from fragmented data systems to dynamic, contextualized data enables organizations to streamline operations and unlock AI's full potential. Instead of forcing disparate datasets to align after the fact, a unifying platform like L7|ESP embeds native context into data from the start, ensuring it’s AI-ready, actionable, and inherently valuable across the entire lifecycle. However, while contextualized data forms the backbone of transformation, another critical and daunting challenge—tech transfer—continues to bottleneck the industry at every stage, from research to patient delivery. The Tech Transfer Problem: Solving What No One Wants To Own Tech transfer—the process of moving scientific discoveries from research to development to manufacturing—remains one of the industry's most persistent challenges. Yet, it's too often treated as a local problem for individual teams to solve rather than a systemic issue requiring a holistic solution.. "Everyone is trying to solve their piece of the puzzle within their silo, but no one is stepping back to address the system as a whole,” Azar pointed out. “To truly speed up the pipeline from discovery to patient, we need an end-to-end approach." L7|ESP delivers precisely that: an orchestration platform that connects workflows and contextualizes data in real time. The platform enables seamless tech transfer by bridging research, development, and manufacturing, ensuring therapies reach patients faster without compromising quality. Still, addressing tech transfer challenges requires more than technology; collaboration and a connected ecosystem are also necessary to drive systemic change. Beyond Digital Transformation: A Collaborative Ecosystem While digital transformation remains an industry buzzword with reason, its impact often falls short when implemented via point solutions. Azar highlights why: "The industry is fragmenting digital transformation into organizational silos instead of focusing on holistic outcomes." The partnership between L7 Informatics and Zaether addresses this challenge and complements each other by combining technology and their joint industry expertise: L7|ESP provides a powerful end-to-end platform to unify data and workflows. Zaether provides consulting and change management expertise to drive adoption. Together, they empower life sciences organizations to operate as integrated and connected ecosystems, delivering measurable real-world results instead of incremental fixes. This approach sets the stage for a more resilient, forward-thinking future. Looking Ahead: A Call to Action for the Industry The conversation ends with an explicit call for systemic change. Azar urges the industry to rethink its approach, "Imagine the response we could have to the next global pandemic if we orchestrated these processes the right way. We know what has to be done; now, we need to be ready to execute smarter and faster." Spencer reinforced the forward-looking approach at the heart of L7's mission, "We're not building systems for yesterday; we're building systems for tomorrow. It's about creating an adaptable open environment where innovation can thrive." The message is clear: the life science industry has reached a tipping point. Incremental improvements are no longer enough to keep pace with the speed of science and the demands of patients. To unlock their full potential, life sciences organizations must move beyond point solutions to embrace disruptive technology and collaboration. Unifying platforms like L7|ESP and partnerships like the one between L7 and Zaether offer a path forward—one that enables and accelerates innovation, streamlines processes, and keeps patient outcomes as the ultimate focus. To learn more, visit L7informatics.com or contact us at info@l7informatics.com ### Scaling Biomanufacturing for the Future: Why Data as an Asset is Non-Negotiable L7 | CHATS thought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFN0ZXZlbiBCYXJhc2ggfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@When I think about the future of biomanufacturing, especially with the incredible breakthroughs in cell and gene therapies, I can't help but feel a sense of urgency. These therapies have the potential to change lives, yet the industry is barely scratching the surface when it comes to scaling. Right now, even the best-equipped facilities struggle to produce a few hundred batches yearly. But what happens when the demand grows to tens of thousands of doses? Let me be candid: I'm concerned. If organizations don't rethink how they approach manufacturing—if they don't invest in digital systems and, most importantly, start treating data as an asset—they will find themselves stuck. Data is the real game-changer; data connects everything and flows seamlessly between systems, and that’s why data needs to be treated with the same care and strategic intent as the therapies themselves. The Hidden Challenge in Biomanufacturing Here's what I've observed across the industry: life science companies focus so heavily on optimizing their processes or enhancing their products that they miss the bigger picture. Processes and products don't exist in a vacuum—they're tied together by data. And if that data isn't contextualized, standardized, and accessible, no amount of process optimization will help. Think of it this way: data is not a byproduct of manufacturing; it's the foundation of everything scientific organizations do. Without that foundation, the industry risks more than inefficiencies—it risks the future of these therapies. The Time to Act is Now I wish my concerns were theoretical, but I hear them from colleagues, partners, and customers daily. The question is no longer whether digital transformation is necessary but how quickly life science companies will act. Because those who treat data as an afterthought are, unfortunately, already behind. Investing in digital infrastructure is necessary for long-term survival. Organizations that establish robust data strategies today—by adopting unifying platforms like L7|ESP®—are the ones that will lead tomorrow. These platforms don't just manage workflows; they ensure that every piece of data is contextualized and leveraged to its full potential. That's what enables scalability, real-time decision-making, and the integration of cutting-edge tools like robotics and machine learning. The Path Forward Scaling biomanufacturing means meeting today's demand and building confidence in tomorrow's possibilities. Patients, prescribers, and healthcare systems must trust that our industry can deliver these life-changing therapies reliably and at scale. That trust starts with the choices organizations make today about their digital infrastructure and data strategy. By treating data as a strategic asset—investing in its contextualization, flow, and accessibility—life science companies position themselves to meet the challenges of scale and redefine what's possible in biomanufacturing. With the right foundation, the leap from hundreds of doses to tens of thousands isn't daunting; it's bound to happen. The tools are here, and the stakes couldn't be higher. If you're ready to have that conversation, I'd love to connect. Let's talk about what it means to put data first and how platforms like L7|ESP can help you scale your operations while future-proofing your business.ABOUT THE AUTHOR ### BMWS Panel: Digital Change for Future-Proof Biomanufacturing: How Biopharmas and CDMOs Redefine Operations Participants: Steven BarashVice President of Strategy & Product ManagementL7 Informatics Steven Barash is a dynamic manufacturing information systems thought leader spearheading digital manufacturing initiatives at L7 Informatics. Steven holds an established software implementation portfolio of regulated technology solutions in the cell and gene therapy manufacturing industry. Steven is committed to end-to-end automation of complex cell gene manufacturing operations to deliver personalized treatments to patients. He is focused on delivering unified enterprise data solutions to ease operational complexities, improve product quality, and digitally scale GMP commercial operations. Before L7 Informatics, Steven held various leadership and engineering roles at Charles River Labs, Cognate BioServices, TRC, Juno Therapeutics, Regeneron Pharmaceuticals, and AxoGen. Steven has a B.S. in Chemical Engineering from the University of Florida where he focused on translational research in immunomodulatory drug efficacy in preclinical animal models. Brad LambertPresident, MILRAE; former VP of Global IT AGC BiologicsFormer AGC Biologics Brad Lambert is a seasoned IT leader with over 20 years of experience in the biotechnology industry. He has driven innovation and IT strategies across various functions, including Manufacturing, QC, QA, PMO, Supply Chain, HR, Safety, Security, Facilities, Engineering, and Process Sciences. Brad excels in budgeting, procurement, organizational restructuring, and global resourcing. He has successfully led complex IT programs, developed strategic roadmaps, and managed global strategies to advance business digitization and deliver application effectiveness, reliability, and cybersecurity control. Mike CodyDirector of Digital Life ScienceZaether Mike Cody is the Director of Digital Life Science at ZAETHER, where he works with digital leaders and executives at global life science companies to reimagine process development and manufacturing while building a digitally enabled enterprise. Mike orchestrates his team of industry experts, consultants, and analysts to support visioning, designing, and execution of novel digital and IT/OT solutions to meet the evolving needs of life sciences clients. Information: Key takeaways of the panel discussion: Data Ecosystem for the Future: We’ll look at how AI and data-centric architectures are setting the stage for future innovations and predictive capabilities Scale Out and Up Across Manufacturing Networks: We’ll discuss strategies for standardizing and integrating digital processes across multi-site and decentralized networks Accelerate Technology Transfers and New Product Introductions: We’ll examine how digital solutions are transforming tech transfer and expediting the launch of new products, including how global contract development manufacturing organizations (CDMOs), are accelerating knowledge transfer and reducing time-to-market by up to 40% Enable Composable Architectures: We will discuss how composable architecture addresses the limitations of monolithic systems, ensuring flexibility, scalability, and better data-driven decision-making ### Bioprocess Online: Keep An Eye On These Analytical And Monitoring Trends in 2025 ### Outsourced Pharma: Keep An Eye On These Analytical And Monitoring Trends in 2025 ### Biosimilar Development: Keep An Eye On These Analytical And Monitoring Trends in 2025 ### The State of Biomanufacturing Today: Why Digital Change Can't Wait L7 | CHATS thought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFN0ZXZlbiBCYXJhc2ggfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@I've been there. Leading IT and technical operations for CDMOs and collaborating with biotech companies, I witnessed firsthand what happens when the CDMO digital infrastructure doesn't keep up with the pace of innovation and customer demands and expectations. Biotechs are innovating faster than ever, pushing groundbreaking therapies through development to the clinical, and rightfully so, expect tech transfers to accelerate. However, their success relies on how quickly CDMOs can deliver and share manufacturing milestones, process and CMC analytics, and disposition timelines delivered in paper forms, emails, and Excel sheets, and relying on CDMOs to enter data manually across disconnected systems. I've worked with many teams (material handling, QC, manufacturing groups, etc...) and witnessed them, more than once, entering the same information—by hand—into LIMS, MES, Excel spreadsheets, and sometimes paper logs to meet customer expectations. This redundancy doesn't just slow teams down; it creates frustration among teams, delays tasks, and adds unnecessary risk of manual errors. And yet, the CDMO still needs to provide this data back to the biotech—data for regulatory submissions, CMC process analytics, and regulatory decisions. Without integrated systems, delivering that data becomes an enormous challenge. And for biotechs, this lack of transparency means delayed decisions and stalled progress. "How can we release this product if we can't see our data?" is a question I've heard far too often. The urgency becomes even greater when we consider the growing demand of Advanced Therapy Medicinal Products (ATMPs) in the clinic, thereby relying on tight collaboration between the CDMO and its Biotech customers to accelerate technology transfers and initiate clinical manufacturing campaigns. Removing tech transfer delays from the equation has never been more important. If CDMOs want to meet the demands of their biotech partners, they need to mature their processes and manufacturing platforms by embracing digital tools and technologies and investing in modernizing its digital infrastructure to establish systems that eliminate redundancies, integrate workflows, and prioritize collaboration and transparency. If you think the status quo is an option and relying on paper-based and disparate systems to manage your operations, I have to tell you that the cost of doing nothing is far greater. Beyond impacting the patient experience, each delay in a tech transfer and manufacturing presents missed opportunities, stalled growth, and increased operational costs, holding your organization back while competitors invest in native digital platforms to accelerate their operations. Don't let it be this way–options exist, such as a unifying platform to initiate digital transformation without a rip-and-replace approach. It's time to accept digital transformation is required to streamline your operations, maintain operational expenditures, strengthen your partnerships, and position yourself as a trusted leader in the industry. Let's stop living with these challenges. Let's fix them—together—by driving a customer-centric experience through data sharing. Please contact me or an L7 team member if you would like to learn more about our unique approach and how we can help enable a faster and more efficient tech transfer. info@l7informatics.com Subject: tech-transfer ABOUT THE AUTHOR ### Take a Look Inside the Latest Version of L7|ESP®, Version 3.4 L7 | CHATS product release@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyaWdpdHRlIEdhbnRlciwgUGguRC4gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@This latest L7|ESP version delivers significant enhancements to L7|MASTER®, L7 Notebooks, and L7 MES, empowering diverse teams—from research to therapeutics production—to maximize their ROI. The unified platform L7|ESP tackles laboratory and business management challenges with industry-leading advancements that improve business, accelerate operations, boost intelligence, and reduce costs for professionals in research, therapeutics, and diagnostics.Boost your efficiency and ROI with L7|ESP v3.4.Specifically, L7|ESP v3.4 includes new capabilities and enhancements to the low code/no-code data model builder L7|MASTER® and the lab management and manufacturing business applications L7 Notebooks and L7 MES, in addition to enhancements to L7 Scheduling and the collaboration and deployment resource L7|HUB®. Here are some release highlights that may be of interest to you. They include, but are not limited to: Adapt your workflows on the fly in L7|MASTER, L7 LIMS, and L7 MES with the addition of General and BOM Dynamic Execution Plans (DEPs) for greater control and responsiveness. Transfer these plans seamlessly between systems via L7|HUB. Loop and repeat batch sections in L7 MES to automate repetitive tasks and optimize production. Take advantage of enhanced Vector Field Types in L7 MES for more versatile data management. Enjoy extended widget features, better visualization, and asynchronous signature support for smoother, more insightful analyses in L7 Notebooks. Want to streamline your lab and business operations for a boost in productivity? Reach out to Sean Smith, L7's Director of Account Management, to learn about our latest release and how it can transform your processes. Our Product Owners have created an insightful demo showcasing these powerful new capabilities.ABOUT THE AUTHOR ### Case Study: Supporting Cellipont Bioservices in Their Mission to Advance Cell Therapy Development and Manufacturing Everyday discoveries in pediatric genomics are creating new possibilities to understand and treat rare genetic diseases. This work requires robust computational strength in order to process, analyze, and manage large data sets. Please fill out the form to view the Rady Children's case study ### Life Sciences’ Need for AI-Ready Data and Unifying Platform Places L7 Informatics on the Deloitte Technology Fast 500™ List for 4th Year Running Growth Attributed to Need for a Unifying Platform with Process Orchestration and Data Contextualization that Enables the Power of AI AUSTIN, Nov. 21, 2024 /PRNewswire/ -- L7 Informatics today announced it ranked for the fourth time in a row on the Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America. Now in its 30th year, the ranking includes the fastest-growing companies in the following categories: media, telecommunications, life sciences, fintech, and energy tech. L7 Informatics' chief executive officer, Vasu Rangadass, Ph.D., credits the increasing awareness for the need for a unifying platform like L7|ESP® that integrates data across various departments (R&D, clinical, manufacturing, etc.) while seamlessly providing process orchestration and data contextualization. Adding, "It's imperative that we break down these digital silos produced by legacy point solutions by adding a platform that unifies data into knowledge graphs, offers holistic control of the scientific workflow orchestration (including instrument integration), and applies data contextualization so these companies can now unlock the power of AI without human intervention." "For 30 years, we've been celebrating companies that are actively driving innovation. The software industry continues to be a beacon of growth, and the fintech industry made a strong showing on this year's list, surpassing life sciences for the first time," said Steve Fineberg, vice chair, U.S. technology sector leader at Deloitte. "Significantly, we also saw a breakthrough in the performance of private companies, with the highest number of private companies named to the list in our program's history. This year's winners have shown they have the vision and expertise to continue to perform at a high level, and that deserves to be celebrated." "Innovation, transformation, and disruption of the status quo are at the forefront for this year's Technology Fast 500 list, and there's no better way to celebrate 30 years of program history," said Christie Simons, partner, Deloitte & Touche LLP and industry leader for technology, media and telecommunications within Deloitte's Audit & Assurance practice. "This year's winning companies have demonstrated a continuous commitment to growth and remarkable consistency in driving forward progress. We extend our congratulations to all of this year's winners — it's an incredible time for innovation." --- About the 2024 Deloitte Technology Fast 500 Now in its 30th year, the Deloitte Technology Fast 500 provides a ranking of the fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies — both public and private — in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2020 to 2023. In order to be eligible for Technology Fast 500 recognition, companies must own proprietary intellectual property or technology that is sold to customers in products that contribute to a majority of the company’s operating revenues. Companies must have base-year operating revenues of at least US$50,000, and current-year operating revenues of at least US$5 million. Additionally, companies must be in business for a minimum of four years and be headquartered within North America. About L7 Informatics, Inc. L7 Informatics, Inc. is a leading provider of integrated scientific data and analytics solutions. The company offers a comprehensive platform that enables seamless data integration, advanced analytics, and collaborative workflows, empowering scientists and researchers to accelerate discoveries, improve operational efficiencies, and drive innovation. L7’s mission is to revolutionize how scientific data is managed, analyzed, and utilized, facilitating breakthroughs in research, drug discovery, development, and manufacturing. Please visit L7informatics.com to learn more. About Deloitte Deloitte provides industry-leading audit, consulting, tax and advisory services to many of the world’s most admired brands, including nearly 90% of the Fortune 500® and more than 8,500 U.S.-based private companies. At Deloitte, we strive to live our purpose of making an impact that matters by creating trust and confidence in a more equitable society. We leverage our unique blend of business acumen, command of technology, and strategic technology alliances to advise our clients across industries as they build their future. Deloitte is proud to be part of the largest global professional services network serving our clients in the markets that are most important to them. Bringing more than 175 years of service, our network of member firms spans more than 150 countries and territories. Learn how Deloitte’s approximately 460,000 people worldwide connect for impact at www.deloitte.com. # # # Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms. ### To read the original press release, click here. ### L7 Informatics Partners with ZAETHER to Accelerate Digital Transformation in Life Sciences Strategic Alliance Combines L7's Unifying Platform with ZAETHER's Consulting Expertise to Drive Innovation and Operational Excellence AUSTIN, Texas, Nov. 19, 2024 /PRNewswire/ -- L7 Informatics, the provider of the leading unifying platform for integrated data and workflow solutions in the life sciences industry, is pleased to announce a strategic partnership with ZAETHER, a renowned enterprise business transformation consultant and industry outcomes provider. This collaboration is set to deliver comprehensive software, transformation roadmaps, and support solutions that will empower life sciences leaders to drive transformative change with greater flexibility, adaptability, and speed to market. Under this partnership, L7 Informatics will provide its extensive life sciences software portfolio, anchored by the L7 Enterprise Science Platform (L7|ESP®), while ZAETHER will complement L7 Informatics with its operations expertise and managed services solutions. Together, we will offer life sciences leaders the tools and expertise needed to maximize the value of their software investments and enhance the digital maturity of their operations. "Our partnership with ZAETHER represents a significant step forward in our mission to support life sciences organizations in their digital transformation journeys. By combining L7's cutting-edge platform with ZAETHER's deep industry expertise, we are enabling our customers to achieve unprecedented levels of operational excellence and innovation," said Steven Barash, VP of Strategy and Product Management at L7 Informatics. The combined offering of L7 Informatics and ZAETHER will give life sciences organizations the agility to adapt to the rapidly changing industry landscape. By streamlining processes, enhancing data integration, and fostering collaboration, this partnership aims to accelerate time-to-market for life-saving therapies and products. "At ZAETHER, we are committed to helping organizations achieve their business objectives by leveraging digital technologies to transform how they operate and ensuring their people and processes are adapted to the new ways of working. Partnering with L7 Informatics allows us to extend our capabilities and deliver even greater value to our clients in the life sciences sector," said John Seffernick, Managing Director of ZAETHER. --- For media inquiries, please contact: info@l7informatics.com --- About L7 Informatics L7 Informatics, Inc. is a leading provider of integrated scientific data and analytics solutions. The company offers a comprehensive platform that enables seamless data integration, advanced analytics, and collaborative workflows, empowering scientists and researchers to accelerate discoveries, improve operational efficiencies, and drive innovation. L7's mission is to revolutionize how scientific data is managed, analyzed, and utilized, facilitating breakthroughs in research, drug discovery, development, and manufacturing. To learn more, visit www.l7informatics.com. About ZAETHER ZAETHER (zaether.com) is a digital consultant and outcomes provider for life science companies seeking scale, speed, and competitive advantage to get products to the world faster. ZAETHER is working with digital leaders and executives at global life science companies to reimagine operations and manufacturing by building a digitally enabled enterprise. Parties interested in working with or for ZAETHER should go to www.ZAETHER.com to send a message of interest. ### To read the original press release, click here. ### Saying “No” to the Status Quo: How The Jackson Laboratory is Unlocking Research Excellence L7 | CHATS case study@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFN0ZXZlbiBCYXJhc2ggfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@The Jackson Laboratory (JAX), known for pioneering genomics research and scientific leadership, needed to digitally enable their scientists to streamline their research operations and invest in the FAIRification of their scientific and operational data, where FAIRification ensures data is Findable, Accessible, Interoperable, and Reusable. JAX, like many other prominent life science organizations, faced a common industry challenge: fragmented systems bred data silos across the organization's multiple laboratories, slowing down scientists' discovery. Fragmented systems, paper-based manual tracking, and disparate homegrown applications impeded scientific day-to-day research operations—solvable dilemmas no organization at the forefront of biomedical innovation should ignore. As JAX planned to scale its operations and scientific expertise, it required an optimal solution that didn't just band-aid the problem but transformed how it managed its research processes and data by implementing a platform purpose-built for end-to-end scientific operations. That's where L7|ESP® came in—a unifying digital platform that enabled JAX to orchestrate and execute their scientific workflows, thereby contextualizing their data to unlock its full value. L7|ESP didn't just organize JAX's operations—it streamlined research operation inefficiencies, surfaced contextualized data, and resulted in significant savings and efficiencies, including: 80% reduction in time spent on manual processes that were draining resources Seamless integration across research teams, breaking down the silos that hindered collaboration Alignment with FAIR principles, turning fragmented data into a cohesive, accessible research ecosystem Consolidation of outdated applications, reducing the clutter and complexity The Jackson Laboratory's decision to move away from the status quo wasn't just a technical upgrade—it was a strategic leap forward that reshaped its entire approach to research. Curious to learn more and understand how they made the leap? Download the case study here and discover how L7|ESP helped JAX turn inefficiency into innovation. ABOUT THE AUTHOR ### Case Study: Supporting The Jackson Laboratory’s Need to Increase Connectivity and Communication Across Research Groups via a Centralized Data Solution That Follows FAIR Data Principles Everyday discoveries in pediatric genomics are creating new possibilities to understand and treat rare genetic diseases. This work requires robust computational strength in order to process, analyze, and manage large data sets. Please fill out the form to view the Rady Children's case study ### L7|INTELLIGENCE® Datasheet Download @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9leGNlcnB0Iiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiIiwiYWZ0ZXIiOiIiLCJ3b3JkcyI6IiIsInJlYWRfbW9yZV9sYWJlbCI6IiJ9fQ==@ ### SciBite + L7: Foundations for Effective AI Implementation Participants: Vasu Rangadass, Ph.D., Chief Executing Officer, L7 Informatics Sam Shelton, Director of Alliances, SciBite Zahra Hosseini, Senior Data Scientist, SciBite Alfredo Coviello, Director of Product Development and Engineering, L7 Informatics Information: Life science processes, be it in research, drug discovery, development, manufacturing, or diagnostic test development and execution, have grown in complexity and scale, not the least because the industry is facing ongoing pressures such as ROI challenges. This rapid growth has resulted in disconnected and suboptimal laboratory process management systems and the lack of a unified data strategy that would provide the necessary laboratory and business process insights with the potential to shorten the overall product life cycle. In parallel, the industry is heavily investing in modernizing data infrastructures and, more recently, in artificial intelligence (AI) capabilities to derive insights from the rapidly growing volumes of data generated. While the promise of AI is huge, what is often overlooked when implementing generative AI and predictive AI models is the foundation of data on which AI is based and used. To derive high-value insights from an AI data model requires removing data silos and applying an enterprise-wide data standard. The L7 Informatics and SciBite partnership offers the solution to these requirements. As contextualized data is collected during process orchestration within the Unified L7|ESP platform, the integration with SciBite’s CENtree platform facilitates the alignment of the data collected to enterprise data standards and public ontologies. This webinar will outline the synergies between L7 Informatics and SciBite and how an integration of our respective platforms, support our mutual customers in preparing their data to fully exploit the power of AI. ### L7 Informatics Wins Gold in Learning and Development at the 2024 Brandon Hall Group HCM Excellence Awards™ Austin, TX, August 26, 2024 – The 2024 Brandon Hall Group™ HCM Excellence Awards® recognizes best practices for initiatives in Learning and Development, Talent Management, Leadership Development, Talent Acquisition, Human Resources, Sales Performance, Diversity, Equity & Inclusion, and the Future of Work. L7 Informatics, a provider of scientific software solutions for research, development, manufacturing, and quality control operations, is proud to announce that it has won the coveted Gold award in the Learning and Development category for Best Training Team at the 2024 Brandon Hall Group HCM Excellence Awards™. This prestigious award, received on August 22, 2024, marks a significant achievement for L7 Informatics and underscores the commitment L7 makes to its customer and partner learning journeys. You can view the complete list of winners here: https://excellenceawards.brandonhall.com/winners/. "As the footprint of our L7|ESP platform continues to expand globally and across verticals, it's critical for adoption and retention that we provide a tiered, multi-channel educational ecosystem that equally supports on-demand self-service and deep skill training and certification. As we continue to build out our learning strategy and digital properties, we are seeing - and will continue to seek - measurable gains that tell us our customers and partners can efficiently onboard with our L7|ESP platform and ultimately achieve a high degree of autonomy and evangelism," said J.P. Brown, Director, Product Training and Education at L7 Informatics. “Excellence Award recipients have consistently demonstrated their commitment to employee growth and well-being through innovative human capital strategies. These organizations have implemented HCM programs that drive outstanding business results and create a positive and empowering work environment. Our rigorous evaluation process has confirmed these programs as industry-leading in their effectiveness and impact on employee satisfaction,” said Brandon Hall Group Chief Operating Officer Rachel Cooke™, HCM Excellence Awards® program leader. Entries were evaluated by a panel of veteran, independent senior industry experts, Brandon Hall Group analysts, and executives based on these criteria: Alignment to their business need and environment. Program design, functionality, and delivery. Adoption, integration, user experience, innovation, and creativity. Overall effectiveness, impact, and measurable benefits. Excellence Award winners will continue to be honored at Brandon Hall Group’s HCM Excellence Conference, January 28-30, 2025, at the Hilton West Palm Beach, Florida. Select winners will also serve as presenters in breakout sessions, sharing their leading practices during the conference. “Our award recipients demonstrate an unwavering commitment to excellence in human capital management,” said Brandon Hall Group™ Chief Executive Officer Mike Cooke. “This year, we’ve witnessed some of the most groundbreaking applications of HCM strategies in our organization’s history. Many of these innovations leverage cutting-edge technologies and foster unprecedented levels of cross-functional collaboration, resulting in remarkable improvements in operational efficiency and employee engagement.” — — About L7 Informatics L7 Informatics, Inc. provides integrated scientific data and analytics solutions through its comprehensive platform, enabling seamless data integration, advanced analytics, and collaborative workflows. L7's mission is to revolutionize how scientific data is managed, analyzed, and utilized, facilitating breakthroughs in research, drug discovery, development, and manufacturing. The L7 Enterprise Science Platform (L7|ESP®) is a unified platform that contextualizes data and eliminates business silos via process orchestration, optimizing workflow orchestration, data management, and task automation in life sciences organizations. About Brandon Hall Group™ Brandon Hall Group™ is the only professional development company that offers data, research, insights, and certification to Learning and Talent executives and organizations. The best minds in Human Capital Management (HCM) choose Brandon Hall Group™ to help them create future-proof employee development plans for the new era. For over 30 years, we have empowered, recognized, and certified excellence in organizations worldwide, influencing the development of over 10 million employees and executives. Our HCM Excellence Awards® program was the first to recognize organizations for learning and talent and is the gold standard, known as the “Academy Awards of Human Capital Management.” The awards recognize the best organizations that have successfully developed and deployed programs, strategies, modalities, processes, systems, and tools that have achieved measurable results. We are honored to receive applications from organizations worldwide ranging from small, medium, large, and global enterprises to government, not-for-profits, and associations. ### L7|MASTER®, A Digital No Code / Low Code Authoring Tool to Digitalize Science Across Research, Therapeutics, and Diagnostics L7 | CHATS product update@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFJvYmVydCBaZWlnbGVyLCBQaC5ELiB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@Today, science is still predominantly planned and documented using paper-based or simple computer-assisted approaches (e.g., Excel), with limited to no standard representations. While we have accepted standards for documents (e.g., Word and PDF) and music files (e.g., MP3), this is not the case when it comes to research, development, diagnostics, and manufacturing processes. Instead, the authoring, collaboration, and distribution of scientific processes and procedures (i.e., protocols) via Word and PDF documents remain the norm, directly hindering digital transformation within the life sciences business. A Digital Standard to Represent Science Scientific collaborations across global teams, sites, and organizations, along with the added complexities due to version and revision management, data integrity and regulatory controls, and audit trails, require a digital standard to represent science. This digital standard must be standardized, versioned, qualified, executed, shared, and easily converted to a human-readable format (e.g., PDF). The sharing of a scientific process should be analogous to sharing a song. One does not want to share the sheet music; one rather wants to share and receive the MP3 file that can immediately be played. Establishing the digital standard of science is the only path forward to achieve true digital transformation within the life sciences industry.L7|MASTER®, a foundational application of the L7 Enterprise Science Platform (L7|ESP®), is a low code/no code authoring tool that enables the creation of any scientific data and process model as a single digital standard, like the MP3 file for music.THE SOLUTION IS L7|MASTER® The intuitive user interface provides simplified drag-and-drop features for non-technical users to configure process and data models, thereby reducing the time to define research, development, manufacturing, and diagnostic processes with inherent FAIRification capabilities. Furthermore, the L7|MASTER application provides users with a simplified library of reusable, composable process and data models when creating processes, further achieving data standardization and harmonization across global and interdepartmental organizations.Key Capabilities of the L7|MASTER Authoring Tool Creates and manages building blocks for all types of scientific digital processes and process sequences with innate audit-trailed version control. Manages all business object types (i.e., master data) and entities (e.g., samples, documents, instruments, and equipment) as they move through workflows regardless of complexity (e.g., feed-forward and feed-back loops). Supports integration to ontology management systems and terminology servers to enable better business intelligence, AI/LLM, and predictive modeling. Provides a drag-and-drop, low code/no code authoring tool that can be extended via customized HTML code and enables graphical representation of data and process models. Offers out-of-the-box data models via an intuitive UI for all traditional aspects of science (e.g., user representation of reagents, freezers, plates, and plate layouts). Supports collaborative data and process modeling across scientific teams. Supports connectivity to external instruments, equipment, and software systems. Generates human-readable PDF documents such as Master Batch Records (MBRs) to enable companies to adopt a digital first framework for modeling science while preserving the ability to distribute procedures as PDF documents. L7|MASTER IS PART OF THE UNIFIED PLATFORM L7|ESP The L7|MASTER is a key element of the Unified Platform L7|ESP, with its Workflow Orchestration and Data Contextualization, where L7 Notebooks, L7 LIMS, L7 MES, L7 Scheduling, and other scientific data and process management applications reside.Benefits of the L7|MASTER Authoring Tool Accelerate new product introductions (NPIs) at lower cost with the library of ready-to-use standard data and process models to jumpstart the digitalization journey. Streamline technology transfers between organizations through DigitalFirst™ collaboration, sharing, and distribution of data within experiments, test methods, master batch records (MBRs), or diagnostic assays. Reduce disruption associated with change management, where scientific users can configure and version up scientific processes without dependence on centralized IT teams. Reduce the overhead for adoption and training of employees on L7|ESP as digital versions of scientific processes available in L7|MASTER can be directly executed in L7|ESP applications, including L7 LIMS, L7 Notebooks, L7 MES, and L7 Scheduling. Reduce TCO (total cost of ownership) as fewer scientists and citizen developers are required to manage a large library of scientific processes. Leverage complete audit trails, rapid approvals, version control, and a GMP/GCP/GLP-compliant database to enable risk-based validation. L7|MASTER is DESIGNED for: Research scientists, process engineers, technical writers, Tech-Ops, assay developers, pipeline and process developers, and IT infrastructure and laboratory managers across drug research, development, manufacturing, and clinical diagnostics that use, develop, optimize, and share digitalized scientific data models and protocols. Therapeutics research, development, manufacturing, and diagnostics lab managers who need to control the deployment of new digitalized scientific protocols and SOPs. CROs and CDMOs who need to streamline technology transfers from one site to another or with their clients and collaborators. L7|MASTER Got Even Better with Our Latest L7|ESP v3.3 Release Updates to the L7|MASTER were numerous and included: UI/UX enhancements: To strive for optimal user experience, increased UI/UX alignment with design language was considered, of which the result is a builder experience that ensures a consistent editing experience across all the builder L7|MASTER. Support of Protocol Pinning and Explicit Protocol Versioning in Workflows: To avoid the introduction of unintentional changes when creating and updating Workflows, Protocols versions can now be given an explicit version name and associated to workflows using that version name, which aids in Change Control compliance and optimizes the maintenance of user Workflows and Workflow Chains. Improvements to Configuration and Version Control Management: To ensure compliance with the latest set of Standard Operating Procedures (SOPs), workflow version management has been improved to allow users to retire and reactivate WFCs as needed. Simplified way to “schedule” entities: Resource availability can be maintained and updated as required, including defining which types of resources can be associated with a scheduled task. This is of particular interest to process/pipeline developers, application platform owners, configuration scientists, lab directors, and project/program managers as it allows them to reserve equipment and other types of resources for use in workflows and monitor available capacity and utilization of those resources. There are many more exciting L7|ESP 3.3 release updates, which can be found in the L7 Resource Center, and which include: Product updates to L7 MES: MES, The Comprehensive Manufacturing Execution System for the Precision Therapeutics Workflow Official Release of L7 Scheduling: L7 Scheduling Builds on Embedded Workflows to Maximize Production Capacity and Operational Efficiency Product updates to L7 Notebooks: L7 Notebooks Takes ELNs to the Next Level with Embedded Workflows and Dynamic Linking of All Entities Contact us or visit the L7|ESP landing page to learn more about the L7|ESP platform, with its Workflow Orchestration and Data Contextualization, and how it could help you with your laboratory and business processes.ABOUT THE AUTHOR ### L7|MASTER® Datasheet Download @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9leGNlcnB0Iiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiIiwiYWZ0ZXIiOiIiLCJ3b3JkcyI6IiIsInJlYWRfbW9yZV9sYWJlbCI6IiJ9fQ==@ ### L7 MES, The Comprehensive Manufacturing Execution System for the Precision Therapeutics Workflow L7 | CHATS product update@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEthcnJpIFVucnVoIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@Manufacturing of pharmaceutical products is complex and time-consuming, often resulting in delays, deviations, and unplanned, increased costs. Traditional processes frequently operated with complex, paper-based ecosystems, rigid manufacturing electronic systems, and non-compliant spreadsheets can bottleneck operations, resulting in delayed product dispositions.Consider a fully flexible, digital, and process-oriented solution designed to overcome traditional pharmaceutical manufacturing bottlenecks to improve ROI across your value chain!L7 Informatics has built the digital solution L7 MES to streamline entire productions in the pharmaceutical industry while enabling review-by-exception manufacturing and ensuring 21 CFR Part 11 compliance for the production of small molecules, biologics, and CGT products.Importantly, L7 MES is part of the Unified Platform L7|ESP® where manufacturing execution system data resides in the same database as LIMS and inventory data. It uses existing L7|ESP workflow chain configurations to represent the manufacturing process and registers samples during the manufacturing process to send to LIMS. I am excited to share with you what’s new in the L7|ESP v.3.3 release of L7 MES. More Intuitive Quality Review Operations review via the Reviewer Portal has been improved for manufacturing reviewers. This improvement helps reviewers to easily navigate to fields with flagged exceptions (Figure 1).Figure 1: Intuitive quality review portal includes a list of flagged, highlighted exceptions for each field. Exception Triage and Assessment L7 MES now allows quality reviewers to triage exceptions by assigning a Risk Level and an Exception Type, such as CAPA, deviations, or other assessment classifications. If configured, Risk Levels and Exception Types can also be pushed into a QMS, training, or other third-party system with a simple click, saving the additional step of entering the information again. Signature Flow Enhancements The signature flow experience has been enhanced to enable users to sign asynchronously or enforce user uniqueness as depicted in Figure 2. With signature flows that have been configured to “Allow Asynchronous”, there is no forced order of signing by the respective individuals, which simplifies the signature process if multiple individuals must sign. With signature flows that have been configured to “Enforce Uniqueness”, the system requires that each signer can only enter their credentials once within the signature flow. The end users that benefit the most from the improved signature flow experience are lab directors, manufacturing heads, program/project managers, material handlers, and quality reviewers (e.g., QA/QC associates and regulatory specialists). In other words, individuals who need to ensure that each department or role is represented by a different person or who have to wrangle multiple signers who want to sign when they are ready without waiting for earlier signatures to be entered. Figure 2: Asynchronous and Unique Signature Flow in L7 MES. The system allows users to sign in any order and can also enforce that a user may only sign once. Report Labeling/Theme Support A form of white labeling has been added to the already existing universal theme labeling provided within L7|ESP. This new, extended theme support capability allows L7|ESP customers to label L7 MES standard reports with the logo of their own customers before sharing the reports with them. Logos of image file format JPEG and PNG are supported (see Figure 3). This is of interest when sharing manufacturing results with customers (i.e., a CDMO is sharing the Final Batch Report with a pharmaceutical, biotechnology, or medical device client), as shown in Figure 4.Figure 3: Add customer logo to reports. As customer information (e.g., contact information, customer history) is populated in L7|ESP, the customer logo can also be attached to the customer file.Figure 4: L7 MES report labeling with customer logo. All reports generated for a specific customer that has a customer logo associated with its customer file (i.e., customer information) will have automatically a logo placed on the generated reports. Adding Watermarks on Reports for Failed Batches and Non-Executed Sections To ensure that any reviewer understands why there is no data recorded for some sections or when there are no executed sections, an added watermark “Not executed” is added to the final report (not shown). This is particularly important for batch processes, as they sometimes contain optional activities. Furthermore, reports generated for failed batches now indicate that the batch failed with the annotation “Failed Batch” across all pages of the final report. Please connect with us to learn more about L7 MES and the L7|ESP platform, with its Workflow Orchestration and Data Contextualization, and how these solutions can help you with your laboratory and business processes. I am certain you will not be disappointed.ABOUT THE AUTHOR ### L7 Scheduling Builds on Embedded Workflows to Maximize Production Capacity and Operational Efficiency L7 | CHATS product update@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IElzYWFjIFJvZHJpZ3VleiB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@Non-optimized production and planning schedules of highly regulated and complex processes are often still the norm across many laboratories and therapeutic manufacturing sites today. Examples of such complex processes include supply chain bioprocesses for cell and gene therapy (CGT) production and patient treatment management/oversight, clinical research activities, diagnostic test development and optimization, and clinical trial management. Common to all these scenarios is that time is of the essence, and any loss of efficiency negatively affects business return on investment (ROI) due to higher production costs and subsequent reduced revenues.Consider now for a moment a fully integrated, highly flexible, secure, and collaborative scheduling solution designed to overcome your traditional research, diagnostics test development, and therapeutics manufacturing bottlenecks!I am excited to share with you the details of the newly developed L7 Scheduling application, which is fully embedded in the Unified Platform L7|ESP® with its Workflow Orchestration and Data Contextualization – a solution that is critically helpful to laboratories and therapeutic manufacturing units. And do not just think of scheduling personnel resources; no, you can also schedule workgroups, locations, equipment, and custom resources. L7 Scheduling manages the schedules of all these resources and dynamically and automatically links to entries and schedulable data sources. L7 Scheduling allows defining resource schedules, planning and reviewing resource capacity, scheduling tasks and assigning resources, reviewing task progress in real-time, and monitoring resource utilization across tasks. Since L7 Scheduling is fully integrated within the L7|ESP Unified Platform with its Workflow Orchestration system, resources are dynamically and automatically linked to entries and schedulable data sources. L7 Scheduling enables optimized resource allocation, which results in diagnostics and therapies that benefit the entire organization, providing metrics that are most relevant to laboratory and manufacturing directors and C-level individuals (e.g., CFO, CEO, COO, CSO, CMO, CTO). L7 Scheduling highlights include: Resource scheduling based on priority, expected completion date, and task duration. Optimizes resource utilization with automatic combinations of instrument and equipment run times, staff schedules, and planned workflows. Optimizes instrument/equipment usage and longevity, minimizes downtime, and preemptively plans new instrument investments. Schedules Tasks and assigns resources. Schedules Entities that are marked as “Schedulable.” Assesses and plans resource capacity and adjusts schedules accordingly. Integrates assignee information with workgroup, location, and selected equipment into the scheduling process. Provides an intuitive Calendar View with all necessary details to view all tasks, whether scheduled or already completed, pending (i.e., scheduled in the future), and Tasks currently undergoing Entity processing via L7 LIMS. Completed Tasks show the total number of passed versus failed Entities. Synchronizes automatically with L7 LIMS. Supports real-world process supply chain complexities and their scheduling. Monitors Task progress in real-time. Ensures that laboratories and manufacturing plants run at capacity 24/7/365. Supports the creation and maintenance of manual and auto-generated Tasks. Schedules Workflows (WFs) and Workflow Chains (WFCs) and associates Tasks with a WFC. L7 Scheduling is a must-have for all laboratory directors, manufacturing site heads, and projects/program managers. Assess, Plan, Maintain, and Update Resource Availability The end-users who benefit the most from L7 Scheduling are the lab directors, manufacturing site heads, and program/project managers, but of course, also the lab technicians and bench researchers who must execute experiments and keep track of the progress. Basically, anyone who must assign and manage schedules and experiments, or anyone who must follow a strict laboratory and manufacturing processing throughput plan. For the lab director, manufacturing site head, and program/project manager: L7 Scheduling allows these individuals to view the availability of different resources (e.g., an individual team member or a specific piece of equipment) on a daily, weekly, and monthly basis, define a new schedule for a given resource, view and manage existing schedule details, or discontinue/disable the availability of a resource. Furthermore, the manager can also assign resources to all tasks and modify resource assignments as a schedule is planned. This helps with reducing and resolving scheduling conflicts across the entire process. An intuitive, one view user interface, the Calendar View, provides the capability to see resource availability and to request, schedule, monitor, and discontinue resources. Specific tasks of individual team members (e.g., bench researchers or lab technicians) are assigned in the Task Bucket in the Task Review Panel (see Figure 1). For the lab technician and bench researcher: L7 Scheduling allows those executing a specific process to see on a daily, weekly, and monthly basis what tasks need to be performed, what the expected task start and end dates are, and what equipment and instruments they will need to use to conduct the work (i.e., are associated with a specific task). Plan and Review Resource Capacity Optimal resource utilization requires understanding the over- and under-capacity of the various resources at hand. As shown in Figure 1, L7 Scheduling provides an intuitive and easy way to view assigned/unassigned resources and over- and under-capacity of any given resource (e.g., personnel). Resource capacity can be viewed on a daily, weekly, or even monthly basis. This allows managers to knowledgeably assign resources to specific tasks based on availability, capacity, and task durations.Figure 1: Over- and undercapacity and task hours for a given staff member are color-coded, with blue being at capacity or undercapacity and red being overcapacity. Schedule Tasks and Assign Resources Viewing scheduled, pending, and completed tasks is important for both lab members (e.g., lab technician and bench researcher) and the manager (e.g., lab director, manufacturing site head, program/project manager) overseeing all activities and their progress. As shown in Figure 2, the Calendar View provides all necessary details to view all Tasks, whether scheduled or already completed, pending (scheduled in the future), or currently undergoing entity processing via L7 LIMS. Completed tasks show the total number of passed versus failed entities, workgroup, and equipment), and time and date. Tasks can be edited right from within the Task’s details view within the Calendar. Tasks and Schedules can also be archived and filtered in the Calendar view, which helps reduce Calendar clutter and quickly find relevant Tasks. The Calendar view also shows Unscheduled Tasks in the right-hand panel (Figure 2) and supports dragging unscheduled Tasks into the Calendar by the manager. The Calendar view also allows scheduling resources and color/texture coding them to differentiate the newly added Tasks from other existing Tasks. Figure 2: Calendar View of scheduled and completed tasks. Monitor Task Progress Another way to Monitor Tasks and their progress is via a list accompanied by a Gantt chart (not shown), which shows Tasks progress in real time. This is of particular interest to anybody who needs to monitor the progress of a Task, e.g., the lab director or program/project manager. Selecting a specific Task opens the Inspector panel providing Task information such as WFC Name, Start and End Time, Due Date, Experiment Description, assigned Personnel and Equipment, and more. Lastly, a Task manager can review the Baseline for Task Monitoring to compare the start and end times of a scheduled Task versus a completed Task and filter Tasks to focus on the Tasks of interest. The Baseline can be used to extrapolate data when comparing the real Task progression in L7 LIMS versus the projected Task as scheduled in the Calendar. Schedule Entities Marked as “Schedulable” L7|ESP offers four out-of-the-box resource types that can be scheduled in addition to custom resource types. Out-of-the-box resource types include personnel, workgroups, equipment, and locations. Custom resource types, which can be added in L7|MASTER® by creating an Entity Class, can also be scheduled, simply by turning the “Schedulability” flag on. Entity Types that are created from Entity Classes with the “Schedulability” flag on are schedulable in L7 Scheduling. Therefore, Entities marked as “Schedulable” can then be scheduled based on priority, expected completion date, task duration, and assignee information. This is particularly useful for lab managers/directors assigning entities to be processed by the lab personnel. Create and Maintain Manual and Auto-Generated Tasks Also controlled within the L7 Scheduling application are manual and auto-generated Tasks. This includes: Auto-generated Tasks created from WFs and WFCs and that have been submitted as “Schedulable” Tasks. Events, meetings, and out-of-office days that affect an individual’s schedule and capacity can be monitored via the L7 Scheduling application as Tasks. Starting a worksheet in L7 LIMS and having the associated unscheduled Task auto-scheduled based on the start and end time. Scheduling WFs and WFCs and Associate Tasks to a WFC L7 Scheduling also supports scheduling WFs and WFCs, including non-linear WFCs. Additional scheduling actions associated with WFs and WFCs include scheduling/submitting WFs and WFCs, including non-linear WFCs, which will be displayed on the Calendar View and can be reviewed in the Monitor section; selecting a start node and have only downstream nodes that can accept samples displayed in the scheduling Calendar; filtering WFs and WFCs by resource type; scheduling a planned action within a WFC that is already in progress to account for major delays; selecting a WF or WFC on the Calendar view to display all WF details; scheduling non-linear WFCs which will return an approximation of when the WFC will be complete; editing and updating the scheduled date, assigned priority, and assigned due date of any WF and WFC; and scheduling Tasks, assign Tasks to a WF, and define WFC Task pattern to visually distinguish WFs within the same WFC. L7 Scheduling is certainly a solution that you may want to look into. Connect with us to learn more about L7 Scheduling and the L7|ESP platform, with its Workflow Orchestration and Data Contextualization, and how these could help you with your laboratory and business processes.ABOUT THE AUTHOR ### L7|HUB®, a One-Stop Shop for Standard Digitalized Methods, Much Like an App Library on Your Phone L7 | CHATS product update@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyYW5kb24gVmFyZWxhLCBNU2MuIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@Burdensome scientific methods, experiments, and recipes governance, in PDF and Word document formats or via SharePoint or Box.net document management solutions, creates a considerable time sink, extra cost, and hinders efficient tech transfer. The growing volume, complexity, and the many versions of scientific content created in the context of research, development, manufacturing of therapeutics, and diagnostic test development is an extra burden and results in unnecessary inefficient and slowed processes. It is now that you should consider streamlining digitalization to improve ROI across your value chain! As I pointed out in my prior blog post “Streamlining Digitalization Across the Value Chain & Entire Organizations”, L7|HUB is a key component of the Unified Platform L7|ESP® and is designed to facilitate scientific protocol management, streamline collaborations, and accelerate the deployment of standard methods and protocols via a “one-stop shop” in support of digitalizing scientific operations in research and regulated scientific organizations. L7|HUB stores the digitalized content and enables the transfer of these components from one environment to another. As such L7|HUB serves as a no-code/low code collaboration and deployment resource and a repository of robust and growing configurable scientific digital content (i.e., scientific data and process models, workflows, applications, and instrument and equipment pipelines). The L7|HUB plays an important role in an efficient L7|ESP deployment at multiple global sites, when teams and entire departments need to transfer technology (i.e., to share standardized digitalized file(s) that represent a data or process model) to another department or across sites. L7|HUB, with its intuitive interface and streamlined digitalization process, reduces the time to achieve research, development, and manufacturing goals and enables the FAIRification of scientific assets of an enterprise organization. I am excited to share with you what is new in the L7|ESP v3.3 L7|HUB release. Comparison of Scientific Methods/Protocols to Make Informed Digital Protocol Usage Decisions To simplify the process of finding the right digitalized method and to maximize the collaboration value, L7|HUB now allows side-by-side comparison of scientific content. Specifically, L7|HUB supports collaborators, be it a process/pipeline developer or a research scientist that needs to navigate through a compendium of rich content to quickly identify scientific methods/protocols (i.e. Bundles) of interest. They are now able can now compare different data models, YAML code, and the Bundle history (e.g., version history, date created) of scientific content (e.g., Protocols, Workflows, and Workflow Chains) as depicted in Figure 1. Furthermore, an intuitive user interface displays different Bundle versions via stacked cards (i.e., single right drawer), which is of interest when collaborators want to share scientific content while still optimizing a digitalized data or process model or if they simply want to share their newly developed model. Figure 1: Side-by-side comparison of Bundles. Note that all data models supported by L7|HUB can be compared leveraging this feature. User-friendly Bundle Creation and Bundle Upload Via the UI To make Bundle creation and Bundle upload intuitive and user-friendly a couple of user-guided wizards have been implemented as shown in Figure 2 for Bundle creation, and in Figure 3 for Bundle upload. The biggest beneficiaries of the Bundle creation and Bundle upload wizards are any type of collaborator (e.g., pipeline/process developers, bioinformaticians, and regulatory specialist) that need to create and share a Bundle, need to enrich Bundles by attaching relevant files (e.g., images, supporting documents), or need to leverage L7|HUB facilities even when direct HUB|HUB connections are not possible. 5-step “Bundle Creation Wizard” Step 1: Check Dependencies Step 2: Input Details Step 3: Attach Files Step 4: View Details Step 5: Plan Review Figure 2: 5-step Bundle Creation Wizard. 3-step “Bundle Upload Wizard” Step 1: Upload .zip File Step 2: Attach Files Step 3: View Details Figure 3: 3-step Upload Bundle Wizard. Export Bundle Review History From within L7|HUB the end user can access and export branded PDF Bundle Review History reports with Bundle details (e.g., Universally Unique Identifier (UUID), Created by, Created date) and Bundle Contents (e.g., Sample and Entity Type). This is important for pipeline/process developers, bioinformaticians, and regulatory specialists that need to download and share Bundle details with their coworkers and collaborators. For example, a regulatory specialist may need to export the Bundle Review History to upload it into their internal QMS system, or to streamline solution verification and the validation process. This implemented capability supports this activity. I hope you are as excited about this latest L7|HUB release as I am. Connect with us to learn more about L7|HUB and the L7|ESP platform, with its Workflow Orchestration and Data Contextualization, and how these solutions can help you with your laboratory and business processes. ABOUT THE AUTHOR ### Supporting Alpine Bio in Their Mission to Transform Plants into the World’s Most Regenerative Ingredient Factories L7 | CHATS case study @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyaWdpdHRlIEdhbnRlciwgUGguRC4gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Alpine Bio is taking plant genetics to the next level by using plants as highly efficient protein production factories. They have developed an end-to-end biomanufacturing platform, currently validated with the proof-of-concept protein, bovine milk protein casein. The approach they are taking is using genetics to insert the gene of interest (e.g., the casein gene) into the plant’s genome (e.g., the soybean plant) to overexpress the protein within the plant and harvest the product for cheese production. The overall goal is to create an animal-free cheese using the plant expressed protein that provides dairy products with their nutritional and functional properties. This includes the characteristics of a traditional dairy cheese product, with its stretch and melt features, while also tasting great, of course. This requires tracking the success of molecular modifications to screen and identify optimal promotor-casein constructs that deliver the best expression yields and cheese-like characteristics. Figure 1: High-level description of Alpine Bio’s approach to using plants as highly efficient protein production factories. Implementing an efficient, sustainable, and scalable process that supports the tracking of thousands of plants during their growth stages, as well as tracking associated seeds, extracted material, and molecular constructs, is of critical importance. Even more so when 25 people, split across five different teams and two sites are involved in collecting, summarizing, and researching all the data. While the data volume is not necessarily the challenge, maintaining the complex connectivity between the data points is. The Unified Platform L7|ESP®, with its Workflow Orchestration and Data Contextualization, was chosen as the central data platform to accommodate the data collection and connectivity requirements. L7|ESP provides real-time updates with all the results being linked back to the source plants so that team members know in “real time” which lineage to retain or discard for future experiments to deliver an optimized product. Lastly, L7|ESP provides calculations to set up molecular and protein analysis experiments.L7|ESP Helps Achieve Research Goals and Addresses Data Tracking and Linking Challenges Challenges L7|ESP Provides the Solution Cumbersome large Google sheets to track and aggregate data, complicating syncing data across all Master Data sheets ● Collects, tracks, manages, and stores all samples, plants, lineages, experiments, data, and meta information across the entire organization within one platform o Removes the requirement of manual sample tracking o Streamlines data access for anyone at the organization ● Tracks sample location via the fully integrated Container application ● Creates transparency across research groups which results in enhanced, company-wide research efficiency ● Enforces consistency for the lab users ● Tracks the well-being of a plant Non-standardized data entry with data being stored in too many different places ● Receives data once and links all entities to experiment information, location data, user (i.e., researcher) information, and more ● Simplifies the data ingestion process ● Updates information in real-time ● Provides consistent data formats ● Prevents individuals from accidentally changing column headers and introducing typos/errors ● Allows users to extend and design their own data collection applets and reports Manual sample tracking and loss of samples ● Automates sample registration, tracking, and information gathering o Prevents sample loss o Standardizes data entry which in turn reduces errors through consistent naming schemas ● Integrates with label printing tools o Matches read information across the entire database and populates fields accordingly o Custom workflow includes buttons for QR code generation, barcode printing, and for sample/process tracking o Removes manual label writing and reduces time and errors ● Supports easy upload of sample data and their information and dragging them into worksheets ● Applies logic to evaluate plants and understand when plants are ready for the next set of experiment(s) ● Ensures traceability and sample/data provenance ● Provides an audit trail for each entity, whether a seed, a plant, or a lineage, including their specific locations o Tracks experimental details, who performed the experiment, and when Tracking and collecting all samples at scale ● Flexible and fully featured LIMS software that captures all process information o Associates all sample information with the workflow which is associated with the plant meta data or tags o Tracks seed entities, seed pods, seed/plant location, and seed/plant harvest status ● Takes advantage of integrated Inventory and Location applet o Improves coordination between teams, sample tracking, and sample hand-off ● Simplifies internal workflows ● Informs all teams of plant status and sampling Value Add: L7|ESP brings consistency and efficiency to the Alpine Bio research processes – a 50% increase in sample throughput compared to legacy manual tracking and sample management processes. Facilitating, standardizing, and centralizing experiments, samples (i.e., seed, plant, and plant lineages), and data (e.g., sample location, sample processing details such as researcher and date/time), as well as preventing sample loss and ensuring traceability and sample/data provenance. The system not only offers the potential for accelerated development times, but also allows for better connectivity and communication between various research groups and team members. At Alpine Bio, embracing innovation is essential for our journey. L7 Informatics’ highly flexible Unified Platform L7|ESP revolutionizes how we track plants, samples, and lineages, empowering our R&D endeavors with a consistent process that has already resulted in a 50% increase in efficiency. We're excited to continue our partnership, leveraging L7 Informatics to modernize our digital infrastructure and shape the future of our industry. ABOUT THE AUTHOR ### Case Study: Supporting Alpine Bio in Their Mission to Transform Plants into the World’s Most Regenerative Ingredient Factories Everyday discoveries in pediatric genomics are creating new possibilities to understand and treat rare genetic diseases. This work requires robust computational strength in order to process, analyze, and manage large data sets. Please fill out the form to view the Rady Children's case study ### Streamlining Digitalization Across the Value Chain and Entire Organizations with L7|HUB® L7 | CHATS product update@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyYW5kb24gVmFyZWxhLCBNU2MuIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@Current scientific methods, experiments, and recipes are often still stored and exchanged in PDF and Word document formats within document management solutions such as SharePoint and Box.net. With the rapid pace of digitalization, these approaches of methods management face many challenges, not the least because of the growing volume, complexity, and the many versions of scientific content created in the context of research, development, manufacturing of therapeutics, and diagnostic test development. This is more pronounced as multiple teams are actively collaborating and exchanging methods, recipes, and analytical methods across different departments and even organizations. Effective collaboration and tech transfer across these global, diverse teams, requires managing digitalized scientific protocols, their versioning, multi-step approval processes, and secure deployment of scientific content from development through validation into production. Embrace the Future of Scientific Collaboration Often, multiple teams need to collaborate on projects, whether it's developing a new diagnostic test or transferring manufacturing protocols between departments or organizations. The key to success lies in effective collaboration, secure deployment, and precise management of digitalized scientific methods and protocols. L7|HUB: Your Solution to Digitalization Challenges L7|HUB is revolutionizing scientific protocol management with its comprehensive, no-code, and intuitive collaboration and deployment tool. As an integral part of the Unified Platform L7|ESP®, L7|HUB streamlines collaborations, accelerates the deployment of standard methods and protocols, and supports the digitalization of scientific operations across research, diagnostics, and manufacturing sectors. L7|HUB is a "one-stop shop" that serves as a robust repository of configurable scientific digital content, including data models, workflows, applications, and instrument pipelines, making it an essential resource for regulated scientific organizations. L7|HUB, with its intuitive interface and streamlined digitalization process, reduces the time to achieve research, development, and manufacturing goals and enables the FAIRification** of scientific assets of an enterprise organization. Key Features of L7|HUB Centralized Repository: Organize all scientific methods, data and process models, and instrument and equipment connectors in one place. Allows individuals and entire organizations to centralize and streamline internal protocols and methods (e.g., SOPs) sharing, including scientific methods, recipes, data models, and instrument and equipment pipelines. Rich Digital Content: Access a vast compendium of ready-to-use digital scientific protocols and methods. Provides access to a growing repertoire of configurable standard workflows provided by L7 Informatics. Efficient Sharing: Centralize and streamline the sharing of internal protocols and methods (e.g., SOPs) across teams and entire organizations. Content Mobility: Easily move and share content between L7|ESP instances. Content Comparison: Compare scientific methods and protocols - compare changes and approve prior to publishing for validation and production. Benefits of L7|HUB Organized Methods: Keep all scientific methods in one, access-controlled location. Integrated Search: Discover relevant protocols quickly with integrated search and filter capabilities. Informed Decisions: Compare scientific methods and protocols to make informed decisions, installing only those that most closely align with the operation of choice. Time Efficiency: Reduce the time spent finding and deploying methods and protocols. Seamless Collaboration: Share methods and protocols effortlessly with collaborators across teams and departments, and across the entire organization. User-Friendly: Easily collaborate and deploy digital methods and protocols without the need for advanced technical skills (i.e., reduces the need for technical expertise or to host code). Tech Transfer: Efficiently share and move data model definitions between L7|ESP servers and reduce the time it takes to digitalize scientific operations. Streamlined SDLC: Accelerate tech transfer, increase collaboration, and improve reusability of science. Optimize all steps of the solution development SDLC, from exploring and accessing standard digital scientific protocols, to collaborating to make revisions and develop new digital scientific methods, and to securely promoting approved digital scientific protocols. Who Can Benefit from L7|HUB? Research scientists, pipeline and process developers, and IT infrastructure and laboratory managers across drug research, development, manufacturing, and clinical diagnostics that use, develop, optimize, and share digitalized scientific protocols. Therapeutics research, development, manufacturing, and diagnostics lab managers that need to control the deployment of new digitalized scientific protocols and SOPs. CROs and CDMOs that need to efficiently transfer/exchange methods and technology from one site to another or with clients and collaborators. Part of the Unified Platform L7|ESP L7|HUB is a key component of the Unified Platform L7|ESP, which includes Workflow Orchestration and Data Contextualization Systems, where L7 Notebooks, L7 LIMS, L7 MES, and a myriad of other scientific data and process management applications reside.Embrace the future of scientific collaboration with L7|HUB - streamline your operations, enhance collaboration, and accelerate your research and development goals with ease.ABOUT THE AUTHOR ### L7|HUB® Datasheet Download @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9leGNlcnB0Iiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiIiwiYWZ0ZXIiOiIiLCJ3b3JkcyI6IiIsInJlYWRfbW9yZV9sYWJlbCI6IiJ9fQ==@ ### L7 Informatics at Cell and Gene on the Med 2024 Participant: Kevin McMahon, Ph.D., Solutions Consulting, Therapeutics Lead at L7 Informatics Information: In this short recording, Kevin McMahon, Ph.D., Solutions Consulting, Therapeutics Lead at L7 Informatics, gives an overview of L7 and what we stand for. ### The L7 and SciBite Partnership Enables AI Implementation Through Ontology-backed Data Unification and Harmonization L7 | CHATS ‘everything data’ series@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyaWdpdHRlIEdhbnRlciwgUGguRC4gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@This is the second installment of our series of blog entries that will focus on “everything data.” Laboratory and manufacturing processing data can comprise numerous structured or unstructured data sets which are often not aligned to any standard terminology and therefore heterogeneous. Reusing laboratory and manufacturing processing data for secondary process insight generation has gained importance and is seen as the only way to understand process bottlenecks, identify cost sinks, and detect process inefficiencies. Collecting these data can be a nightmare, especially if not all are in the same structure or in the same system, a common challenge across the therapeutics industry. This is where L7 Informatics with its Unified Platform L7|ESP®, comes into play. As summarized in our last AI post, Building the Foundation for Artificial Intelligence Applications, the L7|ESP platform, with its Workflow Orchestration and Data Contextualization, is built with an architecture for digitalization. L7|ESP not only integrates all common data information management systems, including L7 LIMS, L7 Notebooks, and L7 MES together with other process-oriented applications, but is also open and flexible to integrate with existing management systems and even works with legacy systems, providing a unified view of all laboratory and business processes across the value chain, thereby increasing transparency of the product life cycle and its information flow, while ensuring operational efficiency.L7|ESP harmonizes and structures data at the point of capture and can also be extended with data trending and charting tools for real-time operational and scientific insight. Download the L7|ESP data sheet to learn more about L7|ESP.Ontologies Are Key to Extracting Maximal Value from Laboratory and Manufacturing Process Data and Laying the Foundation for AI To date, many process data analytics projects fail or do not deliver the expected outcome, mostly due to impaired access to all the relevant data or low-quality, unstructured data. Ideally, data would be aggregated into a single system and structured and aligned to common standards. The industry is not at that point, and unstructured data and siloed systems are the norm. For process data analytics projects to be successful, the data feeding these analytics needs to be well structured and use standardized terminology. A data-centric approach, ensuring data is fit for purpose and aligned to standard terminology, is required. The only effective way of achieving this is via an ontology-backed approach. Ontologies support the development and management of a consensus view of knowledge in a domain, including hierarchical relationships between entities and the mapping of synonyms. Aligning data to ontologies ensures consistency of terminology and interoperability of data, supporting robust analytics and efficient extraction of insights. Data aggregation and alignment to ontologies make information more transparent to both internal (e.g., data consumers) and external stakeholders (e.g., audiences such as regulators) and are crucial to achieving business efficiency. Ontologies, which are networks of human-generated, machine-readable descriptions of knowledge, are a critical tool for making data FAIR (Findable, Accessible, Interoperable, and Reusable), and as such, reusable for business applications.A semantic model (i.e., an ontology) is required to organize data that shows the basic meaning of data items and the relationships between them. This can help with knowledge sharing, reasoning, and understanding of concepts.Ontologies Solve the Pharmaceutical Industry’s Massive Issue of Information Transparency and Interoperability by Making Data FAIR Rich public ontologies are addressing the life sciences’ unique challenge in relation to the heterogeneity and complexity of language and terminology. They organize and represent concepts, properties, and their relationships. Public ontologies are a structured representation of knowledge agreed upon by experts and represent a consensus view of a particular field, e.g., genes, drugs, or assays. Each concept within a public ontology contains a unique identifier and by adopting these public identifiers, data becomes interoperable within the organization and between different organizations. These individual identifiers are persistent and remain unchanged, even if the preferred term or synonyms associated with them change. This provides a future-proof solution to data interoperability. Ontologies classify and explain entities Ontologies classify and explain entities (i.e., things or classes) via a common vocabulary. In other words, they formally conceptualize the content of a specific domain, e.g., “rare disease” or “laboratory and manufacturing” domains in the therapeutics industry. In the world of laboratory processes, this means a “DNA sequencer” is a type of “equipment,” with subtypes being a “benchtop sequencer” or “production-scale sequencer.” The classes may have contextual definitions that a human can use to understand what the class contains, as well as synonyms and relationships to other classes. For example, there are classes of sequencers of type “Illumina sequencer” for “short-read sequencing,” or in other words, they are “short-read sequencer,” while sequencers of type “PacBio sequencer” are for “long-read sequencing”, hence they are “long-read sequencer” (Side note: Illumina also now offers a complete long-read technology and PacBio a short-read sequencer). Following this classification, not every sequencer is a “short-read sequencer” but a “sequencer.” Ontologies help define the relationships between them. ​An ontology-backed approach is important when it comes to laboratory and manufacturing processes and extracting insights from the data collected to improve laboratory and business processes. This is further demonstrated when it comes to downstream processing of sequence data. Accurate mapping of sequencing reads to a reference genome or transcriptome relies on the use of high-quality alignment and mapping tools. Since the products generated using one of those “sequencer” (i.e., “short-read sequencer” versus “long-read sequencer”) are mapped and processed differently, read length-specific software, or in other words, “sequence mapping software,” is required. To map the product generated by a “short-read sequencer,” a “short-read sequence mapping tool” is required. One popular “short-read sequence mapping tool” is the BWA package, which includes three options of algorithms: BWA-backtrack, BWA-SW, and BWA-MEM. Whereas for long-read sequences, a “long-read sequence mapping tool” is required, of which examples are Minimap2 and LRA. To complicate matters, Minimap2 can also be used to map short-read sequences. Which brings me to my point: all these details are important to refine and optimize the process, and therefore, these details need to be tracked and aligned to a structured ontology. L7 Informatics and SciBite Partnership for Effective AI Implementation Through Ontology-backed Data Harmonization Understanding the value that ontologies provide for data unification and interoperability, L7 Informatics has partnered with SciBite to support the use of SciBite’s CENtree ontology management platform with L7|ESP. CENtree simplifies the implementation of public ontologies and standards and allows its users to seamlessly merge public ontologies with proprietary terminology, facilitating the development, management, and use of ontologies in data models within the L7|ESP platform.Thus, data can be aligned to public standards at the point of capture in L7|ESP, using ontology-backed picklists, and following FAIR data principles.Furthermore, existing CENtree users can bring their enterprise ontologies from CENtree into L7|ESP through the integration between these tools (i.e., the integration with L7|MASTER) as depicted in Figure 1, aligning terminology across their business and serving as the single source of truth for terminology. Non-CENtree users are also able to benefit via an embedded version of CENtree available as a module within L7|ESP (not shown).Figure 1: L7|ESP integration with CENtree.Figure 2: Prospective capture workflow using ontology-backed pick lists using the SciBite platform of applications.The L7 Informatics / SciBite partner integration enables customers of both companies to leverage L7|ESP data models, public ontologies, or internal data models and ontologies managed in CENtree.About SciBite’s CENtree and TERMite Ontology-backed picklists allow prospective capture of structured data in alignment with enterprise-wide terminology. The prospective capture of data via ontology-backed pick lists and the retrospective alignment of legacy and unstructured data to ontologies using TERMite is shown in Figure 2. Through alignment with public ontologies, data is aligned more broadly with agreed upon terminology within the scientific community. However, legacy data and unstructured data are often captured in the form of free-text experimental write-ups and attached documents, such as Word, PowerPoint, or PDF documents attached to experiments. This type of data is not amenable to a picklist that has already been captured, and this presents a challenge. Specifically, the data captured is, in many instances, not using common terminology and lacks structure which limits its usage. Using a process called Named Entity Recognition (NER), these same ontologies developed and managed in CENtree can also be used to standardize and structure legacy data. Ontologies can be exported from CENtree in a format that is compatible with SciBite’s TERMite NER tool. TERMite processes this unstructured text, identifying concepts within the text and assigning public identifiers and additional metadata to the legacy data. The enriched data can then be presented in a unified format in L7|ESP, enabling its usage for AI applications. SciBite also offers over 100 VOCabs covering a broad range of concepts in the life sciences that are based on public ontologies but are optimized for NER and for extracting entities from unstructured data. This optimization is done by SciBite’s ontology team and includes automated and manual synonym expansion as well as creating rules that allow the context in which an entity occurs in the text to be considered, improving the accuracy of entity recognition. CENtree is SciBite’s enterprise ontology management platform (Ontology Manager), which supports the development and deployment of ontologies at enterprise scale and the integration into downstream applications via an API-first architecture. TERMite is SciBite’s named entity recognition tool (a Text Analysis Engine), allowing legacy and unstructured data to be retrospectively aligned to ontologies. VOCabs are SciBite’s Named Entity Recognition optimized vocabularies based on public ontologies (Premade Expert Ontologies). In conjunction with TERMite they can support the harmonization and structuring of unstructured or semi-structured data in alignment to public ontologies. Key Benefits of the L7 Informatics-SciBite Partnership Existing CENtree users can connect their respective platforms to bring ontologies and the terminology managed in CENtree to L7|ESP. Non-CENtree users can take advantage of SciBite’s ontology management CENtree module within L7|ESP. Merge public ontologies and standards with your internal terminology via application ontologies, which then can be pushed to L7|ESP as data models. Streamline the development and ongoing management of ontologies in L7|ESP. Prospectively align data to ontologies at the point of capture in L7|ESP. Retrospectively align legacy and unstructured data to ontologies via SciBite’s TERMite NER tool. Take advantage of AI-ready, harmonized data aligned to standards. Combining L7|ESP with SciBite’s CENtree ontology management solution provides L7|ESP users with a robust, ontology-backed data capture and unification tool that supports complex life science workflows and product supply chains. Not only can it be implemented quickly, but it also provides a powerful data management tool aligned with FAIR data principles.ABOUT THE AUTHOR ### L7 Notebooks Takes ELNs to the Next Level with Embedded Workflows and Dynamic Linking of all Entities L7 | CHATS product release@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEFuc2h1IE1hbGluaSB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@Cumbersome data recording, disconnected ELN and LIMS systems, with limited data exchange, collaboration, and communication are among the key challenges that most laboratories encounter with their current laboratory management and ELN systems. Situations like this result in data loss, loss of efficiency, and disconnected laboratories and teams within a single organization, all with the high likelihood of affecting business performance and stakeholder engagement.Switch now to a fully integrated solution that is poised to immediately benefit your processes!Think of the L7 Notebooks Entry page like a word document on steroids, as it not only allows you to add text and images just like you are used to when writing a document, but also lets you: Add content via different widgets that support data entry, data visualization, and data summarization. Take advantage of an intuitive spreadsheet widget providing Excel-like functionality. Use features such as merging cells, functions, and download content in CSV file format. Make use of source widgets to graph your data in worksheets. Employ a wide variety of different graph types, including line, bar, and column charts and scatter plots. Print graphs in PDF format. Navigate through the different elements within an L7 Notebooks Entry via a set of navigation widgets. Print your Entry in PDF format, print wide tables, and see the overall print history. Print Notebooks Entry details, including audit information with time stamp. Customize data width (e.g., print wide tables/worksheets). Share PDF report with collaborators, partners, and stakeholders. Share Notebook Entries with your collaborators using access controls and permission levels. Grant and revoke access as needed. Collaborate by commenting inline. Modify ownership of Entries if needed. View, edit, and annotate plasmids and manage plasmid versions using the Plasmid Editor and Viewer. For more information about the Plasmid Editor see also our recent blog “The L7|ESP® Plasmid Editor Streamlines Plasmid Information Management Across a Unified Platform” Manage plasmid versions, including parent-child relationships. Easily track and find plasmid information. View, edit, and annotate plasmids in various formats within L7 Notebooks. Use easy filtering, browsing, and querying of plasmid data. View plasmid features, including gene details, cut sites, open reading frames, and translation information. But most importantly(and this is the biggest differentiator compared to any other ELN offering currently on the market): L7 Notebooks is fully integrated into the L7|ESP® Unified Platform with Workflow Orchestration and Data Contextualization, and therefore uses existing L7|ESP workflow configurations to automate task orchestration. This results in expedited notebook entries and supports the execution of Protocols and Workflows from within L7 Notebooks thereby reducing errors by making re-entering data for each step obsolete. Take advantage of a fully integrated L7 Notebooks App within L7|ESP with embedded Workflows. Dynamically link all entities and streamline your process(es). Add samples to L7 Notebooks as you record your experiments. Execute Protocols and Workflows from within L7 Notebooks. Enhance your visibility into experiments, protocols, and samples. Here what is new in the L7|ESP v3.3 L7 Notebooks release ▶ It’s all in the Navigation and Usability Widget Details Widgets for Entry Page Creation and Management, Spreadsheet-like Experience, Table Generation, and Data Visualization To make data entry into L7 Notebooks easy and intuitive several navigation widgets have been added, including a re-order widget (i.e., move up/down widget) and a widget to navigate through long entries by jumping from one section to the next without having to scroll long entry pages. The Excel-like spreadsheet widget enhances the data entry and overall spreadsheet user experience. This includes support for merging cells, sorting and filtering data, exporting data to a CSV file, selecting a formula from an existing list of formulas provided to perform basic and advanced calculations, and dragging/copying text and formulas across cells within the spreadsheet widget. Using the table generation widget supports selecting the desired number of rows and columns while adding a new table, basic text formatting options (e.g., automatic text wrapping based on the default or set column width), exporting data to a CSV file, and entering text in the table widget and performing basic text formatting functions for the specified cell(s). Lastly, to support the visualization of L7 Notebook entry data a graph widget has been added. Process data collected can now be charted using line (Figure 1), bar, and columns charts, or scatter plots. This widget allows a user (e.g., a lab technician) to analyze and visualize the data processed on a given day for any given project.Figure 1: L7 Notebooks entry graph widgets – line chart example is shown. ▶ PDF Preview and Export of L7 Notebooks Entries, including Wide Tables Best practice printing capabilities have been added, allowing users to print L7 Notebooks Entries to be shared with collaborators, customers, and other stakeholders. PDF printing in L7 Notebooks supports print preview generation with default settings before the PDF file is exported (Figure 2), getting access to PDF version history, and adjusting print parameters for wide tables.Figure 2: Setting adjustable print parameters for wide table printing in L7 Notebooks. ▶ Lastly, and Perhaps Most Importantly, Embedding Workflows and Dynamic Linking of All Entities in L7 Notebooks Entries Embedding Workflows in L7 Notebooks Entries makes re-entering data for each step obsolete. This results in a huge benefit to all users (e.g., lab technicians, bench researchers), as well as to the overall business performance, as it does not only reduce potential re-entry errors, it also reduces the time to set up experiments as users are now able to add existing or new samples to an embedded Workflow within an L7 Notebooks Entry to be executed from within the L7 Notebooks Entry (Figure 3).Figure 3: Embed Workflows and add samples to Workflows in L7 Notebooks Entry. And wait! This is not all! It is even getting better with the upcoming fall 3.4 release of L7|ESP, which will add a wealth of additional new features and enhancements. ▶ L7 Notebooks Gets Even Better with the L7|ESP v3.4 Release While we have just released v3.3, we are already feverishly working on our next product update, L7|ESP v3.4. Take a sneak peek of what v3.4 has in stock for L7 Notebooks. Flexible/asynchronous and secure signature flow which removes the need to wait for other signers when approving/rejecting notebook entries. This feature includes locking an entry once the signature flow has been initiated to prevent unwanted edits. Flexible widget naming, including autogenerated container and table widget naming for easy identification. Easy duplication of tables (i.e., a specified table widget) within a notebook entry which includes copying of all the underlying data and data formats. This added capability reduces notebook entry time. Useful “collapse files” (i.e., file/image widgets) via an accordion capability within a notebook entry to hide File Preview when in need to reduce long editing sections. Word-like support of nested numbering/bulleting which enhances the overall notebook entry navigation experience, combining structured content to the reviewer, helping with storytelling elements, and improving the overall writing process. Support of zip file export of a notebook entry in PDF format and its attachments for easy content sharing. Autosave capability, if enabled, which guards notebook entries against loss in unforeseen events. Connect with us to learn more about L7 Notebooks and the L7|ESP platform, with its Workflow Orchestration and Data Contextualization, and how these could help you with your laboratory and business processes. ABOUT THE AUTHOR ### We Are Excited To Share Our New Product Release - See What’s Inside L7|ESP v3.3 L7 | CHATS product release@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyaWdpdHRlIEdhbnRlciwgUGguRC4gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@We're thrilled to launch L7|ESP® v3.3 with significant enhancements and additions across the entire core platform, empowering researchers, therapeutics development and manufacturing staff, diagnostic testing labs, and entire organizations to maximize the return on investment with its Workflow Orchestration and Data Contextualization capabilities. L7|ESP v3.3 does not only include major updates and enhancements to the low code/no-code data model builder L7|MASTER®, the collaboration and deployment portal L7|HUB®, the various lab management and manufacturing applications L7 Notebooks, L7 LIMS, and L7 MES, it also includes adherence to UX/UI best practices guidelines, the release of a set of normalized tables (i.e., Intelligence Table Definitions – ITDs) with support access to entity and process data via L7|INTELLIGENCE®, and the official launch of the fully integrated L7 Scheduling application. As initially stated, L7|ESP v3.3 is a pretty darn good product release you should be eyeing. The L7|ESP platform v3.3 - with its innovative approach to address laboratory and business management challenges – provides a host of industry-leading advancements that together enable improved business intelligence, comprehensive business velocity, and reduced cost for laboratory and data management professionals and business executives in research, therapeutics, and diagnostics. As such, this new L7|ESP 3.3 version includes a wide range of new capabilities that address the various needs of different end users across those sectors: Official launch of L7 Scheduling which benefits individuals who need to schedule resources in the lab, be it personnel, workgroups, location, equipment, or custom resources. The lab managers/directors and program/project managers usually benefit the most from the L7 Scheduling application as they manage and optimize the schedules and utilization of those resources. L7 Scheduling allows defining resource schedules, planning and reviewing of resource capacity, scheduling tasks and assigning resources, reviewing task progress in real-time, and reviewing resource utilization across tasks. Since L7 Scheduling is fully integrated within the L7|ESP Unified Platform with its Workflow Orchestration system, resources are dynamically and automatically linked to entries and schedulable data sources. The outcomes or which are optimized resources and overall cost reduction due to higher laboratory efficiency and cost-effective production of therapies that benefit the entire organization and are most relevant to C-level individuals (e.g., CFO, CEO, COO, CSO, CMO, CTO). Some of the L7 Scheduling highlights include: Enables resource scheduling based on priority, expected completion date, and task duration. Integrates assignee information with workgroup, location, and selected equipment into the scheduling process. The Calendar View provides all necessary details to view all tasks, whether scheduled or already completed, pending (i.e., scheduled in the future), and Tasks currently undergoing Entity processing via L7 LIMS. Completed Tasks show the total number of passed versus failed Entities. Automatically synchronizes with the L7 LIMS application. Supports real-world process supply chain complexities and their scheduling. Monitors Tasks progress in real time. Figure 1: Calendar View of scheduled and completed Tasks. New features and enhancements to L7|HUB® - L7|HUB is a one-stop-shop for streamlining scientific collaborations, providing a rich library of standard and pre-built scientific content (i.e., methods and scientific protocols | e.g., configurable L7 LIMS Workflows), much like an App library on your phone. The 3.3 L7|HUB updates are particularly important if one team or department needs to transfer technology (i.e., to share standardized digitalized file(s) representing a data or process model) with another department or across sites. To maximize the collaboration value, L7|HUB now allows side-by-side comparison (e.g., data model, YAML code, and Bundle history comparison of scientific content (e.g., Protocols, Workflows, and Workflow Chains)), provides a capability to export Bundle review history, and adding images and supporting files to a Bundle while creating or uploading a Bundle. UI Visibility to Intelligence ITDs via L7|INTELLIGENCE® – L7|INTELLIGENCE extensions unlock process and operational insights which allow organizations to harness the power of process data made available via Intelligence ITDs to translate process insights into improved resource utilization, increased business velocity, reduced operational costs, and reduced variability in cycle times. Specifically, with the 3.3 release, a set of normalized tables (i.e., Intelligence Table Definitions ), that will provide access to entity and process data, will be made available. This is of particular interest to data and computational scientists that need to extract insight from the data collected during the orchestration of lab and therapeutic manufacturing processes. The data in ITDs can be accessed via API calls or SQL queries or can be used externally to L7|ESP in a data warehouse. Data accessible via ITDs can be browsed and downloaded. New features and enhancements to L7 LIMS – The support for Dynamic Execution Plans (DEPs) is paving the way for future support of DOE (Design of Experiment). Support within L7 LIMS allows more unit op-centric procedures that can be tuned for a particular therapeutic test or a site (i.e., production site). In addition, a multi-select picklist is available in the Workflow Chain configuration, which allows builders to set a specific type of DEP, ensuring users must specify an Execution Plan before proceeding when creating an L7 MES batch or an L7 LIMS experiment. New features and enhancements to L7 Notebooks - L7 Notebooks uses existing L7|ESP WFC configurations to automate task orchestration, resulting in expedited notebook entries and supporting the execution of Protocols and Workflows from within L7 Notebooks. The plentiful L7 Notebooks additions include a series of different data visualization widgets (e.g., line, bar, and column charts, and scatter plot), intuitive table and navigation widgets, embedded workflows and dynamic linking of all entities, an added Plasmid Editor and Viewer supporting editing, viewing, and annotating of plasmids in various formats, and L7 Notebooks Entry sharing capability which includes inline commenting. The fact that L7 Notebooks is a fully integrated application within L7|ESP provides the capability of embedding workflows within L7 Notebooks Entries, allowing users to use an existing Workflow and embed it, making re-entering data for each step obsolete. This results in a huge benefit to all users (e.g., lab technicians, bench researchers), as it does not only reduce potential re-entry errors, it also reduces the time to set up experiments as users are now able to add existing or new samples to an embedded workflow within an L7 Notebooks Entry to be executed from within the L7 Notebooks Entry (see Figure 2). Figure 2: Embed Workflows and add samples to Workflows in L7 Notebooks Entry. New features and enhancements to L7 MES – The flexible, digital process-oriented L7 MES, which uses existing L7|ESP WFC configurations to automate task orchestration, is designed to overcome traditional pharmaceutical manufacturing bottlenecks by streamlining entire productions while enabling review-by-exception manufacturing. Besides a signature flow enhancement that enables users to sign asynchronously or enforces user uniqueness, a key 3.3 L7 MES update includes customer report branding/labeling with customer logos which is particularly of interest for CDMOs when sharing the Final Batch Report with a pharmaceutical, biotechnology, or medical device clients. UI/UX enhancements – To constantly strive for optimal user experience across the entire L7|ESP platform, increased UI/UX alignment with design language was considered; global search was improved with Boolean operators to expedite finding records of interest and deep search through L7 Notebooks Entries, recognizing results in embedded worksheets; improved, granular error messaging and service status visibility was added; improved intuitive L7 Notebooks Entry and navigation was implemented; and added intuitive table generation and spreadsheet widgets are now supported in L7 Notebooks. Contact us to learn more about the latest L7|ESP release, or visit the L7|ESP webpage to learn more about the L7|ESP platform, with its Workflow Orchestration and Data Contextualization capabilities, and how it could help you with your laboratory and business processes. ABOUT THE AUTHOR ### Embracing Pharma 4.0: How L7|ESP® is Transforming Data Contextualization and Workflow Management for CDMOs L7 | CHATS thought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFN0ZXZlbiBCYXJhc2ggfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@In the dynamic pharmaceutical industry landscape, Contract Development and Manufacturing Organizations (CDMOs) are increasingly adopting Pharma 4.0 principles to enhance their operations and deliver greater value to their customers. A recent article in Contract Pharma highlights the imperative for CDMOs to digitalize their processes, emphasizing the crucial role of advanced data management and workflow automation. At L7 Informatics, we are at the forefront of this digital transformation with our innovative L7|ESP® platform, designed to revolutionize data contextualization and workflow management. The Challenge: Navigating Complex Data Environments As CDMOs strive to meet the growing demands of the biopharmaceutical market, they face the challenges of increased timelines for successful tech transfer, paper-based operations, increased batch disposition timelines, insufficient data integrity controls, and resource demand for manual-based operations. Their customers, in turn, expect reduced fees based on increased capacity among their competitors. We need to address these challenges now, especially as traditional data management systems lack the necessary integration and context, leading to inefficiencies and potential compliance risks. L7|ESP: A Unified Digital Platform with a Suite of Business Apps L7 Informatics has developed the L7|ESP platform to address the critical challenges faced by CDMOs, particularly those relying on paper-based operations for manufacturing and testing. These manual processes delay batch disposition timelines and ultimately impact the bottom line. L7|ESP offers an integrated solution that combines Manufacturing Execution Systems (L7 MES), Laboratory Information Management Systems (L7 LIMS), and the L7 Scheduling applications. This unified approach automates workflows, reduces human error, and integrates seamlessly with instruments, significantly mitigating data integrity risks. By transitioning to this digital platform, CDMOs can streamline operations, enhance product quality, and accelerate revenue recognition, transforming their manufacturing and testing processes for better efficiency and reliability. Streamlining Workflows with Automation In addition to data contextualization, L7|ESP offers robust workflow management capabilities. The platform enables CDMOs to automate development, manufacturing, and testing workflows, reducing manual intervention and minimizing the risk of human error. This automation extends across various processes, including sample management, quality control, and batch disposition. By automating these workflows, L7|ESP enhances the overall operational efficiency. CDMOs can achieve greater consistency and quality in their manufacturing processes, ultimately delivering better outcomes for their customers. Enhancing Customer Value Through Digitalization CDMOs' digitalization journey is not just about technology adoption; it's about transforming their entire approach to drug development and manufacturing. L7|ESP plays a pivotal role in this transformation by providing a scalable and flexible platform that adapts to CDMOs' evolving needs. With L7|ESP, CDMOs can leverage advanced analytics and machine learning to gain deeper insights into their operations. These insights enable proactive decision-making, predictive maintenance, and continuous improvement, driving operational excellence and enhancing customer value. Real-World Impact: Success Stories Several leading CDMOs have already realized the benefits of implementing L7|ESP. For example, a prominent CDMO leveraged the platform to streamline its data management processes, resulting in a 30% reduction in data handling time and a significant improvement in data accuracy. Another CDMO used L7| ESP's workflow automation capabilities to enhance batch record management, achieving a 25% increase in production efficiency. Looking Ahead: The Future of Pharma 4.0 As the pharmaceutical industry continues to evolve, adopting Pharma 4.0 principles will become increasingly critical for CDMOs. L7 Informatics is committed to supporting this evolution with our cutting-edge L7|ESP platform. By providing advanced data contextualization and workflow management solutions, we are helping CDMOs navigate the complexities of the digital age and deliver superior value to their customers. In conclusion, the digital transformation of CDMOs is a journey that requires innovative solutions and a forward-thinking approach. L7|ESP is not just a tool; it's a catalyst for change, empowering CDMOs to achieve their digitalization goals and thrive in the competitive pharmaceutical landscape.ABOUT THE AUTHOR ### DMark + L7: Empowering Canada's Biomanufacturing and Life Sciences Strategy Participants: Jeffrey Seitz, Vice President at DMark Biosciences Vasu Rangadass, Ph.D., CEO at L7 Informatics Information: In this webinar, Vasu Rangadass, Ph.D., CEO at L7 Informatics, explores how the L7|ESP unified platform can support the Hub Club to accelerate vaccine and therapeutics production. L7 Informatics provides a unified platform (L7|ESP®) for managing life science data contextualization and process orchestration. Built on a modern cloud platform, it offers apps like ELN, LIMS, MES, and SCHEDULING on a single data backbone. This single source of truth for scientific data and process management across the entire life sciences product lifecycle—from research to manufacturing—ensures more efficient operations, scientific and operational data transparency, and optimal business performance (lower costs and higher velocity), ultimately accelerating the time to market for drugs from research to commercialization. L7 has spent the past decade partnering with leading global pharmaceutical companies, CDMOs, and world-renowned academic centers to drive digital transformation through our unified platform. In this webinar, learn how L7|ESP helps to transform academic insights into powerful business engines by seamlessly integrating academic research with commercial operations. ### Creating an Efficient and Transparent Laboratory and Data Management Process to Expedite the Formalization of Internal R&D Standard Operating Procedures (SOPs) L7 | CHATS case study@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyaWdpdHRlIEdhbnRlciwgUGguRC4gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Developing new medicines for traditionally difficult protein targets requires new approaches that can easily be compared to building an airplane from scratch and learning to fly it. Think Bioscience is exactly at this stage. They are utilizing synthetic biology to both identify new natural products that can act as starting points for new therapeutic development and also help screen through those newly identified natural products in an efficient way. Think Bioscience’s approach is unique, in that they are optimizing their entire laboratory and data management processes (see Figure 1) while also formalizing their internal R&D Standard Operating Procedure (SOP). In other words, they are trying to fly the plane while still building it.Figure 1: High-level description of Think Bioscience’s approach to optimizing their entire laboratory and data management processes. To scale and standardize their proof-of-concept (PoC) processes and ensure all data collected follows a rigorously established SOP, all disparate data points (including metadata) are tracked and linked back to each specific experiment available within a centralized database. Think Bioscience needed to modernize, adapt, and improve their internal Excel spreadsheet-based processes to accommodate their need to manage all entities and data in one single source of truth. The Unified Platform L7|ESP®, with its Workflow Orchestration system, was identified as the perfect solution to bring organization, efficiency, and scalability to this process while formalizing the internal SOP process. Furthermore, to identify new protein targets using plasmid libraries and ensure efficient screening and identification of sequences of interest, and to be able to search through existing libraries in bulk, Think Bioscience took advantage of the plasmid editor (see Figure 2), data ingest app, and search capabilities available as open-source components in the L7|HUB to create an efficient and transparent process.Figure2: Plasmid editor available as an open-source component in the L7|HUB.L7|ESP Is the Solution to Overcome their Challenges CHALLENGES L7|ESP PROVIDES THE SOLUTION Tracking and collecting large disparate data at scale Flexible and fully featured LIMS software that captures all process information Integrates sample-specific information to inform all business processes Collects, tracks, manages, and stores all disparate data types across all experiments within one platform Stores large sequence data files, chemical structure data, in vitro assay data, including metadata Links disparate data collected to central experiment Handles any data size, including gigabytes of data Removes the requirement for manual tracking Tracks all processes, instruments, and samples, including location Uploads scale-level modifications via the ingest app Formalizing SOPs While Still Developing the Experimental Details Quickly reflects SOP rewrites Collects, tracks, and stores disparate data types across all experiments Provides the plasmid editor to generate and track plasmids with DNA variants to be used for screening purposes Streamlines library screening and data generation Executes experiments Provides bulk method of creating plasmids and libraries with metadata Understanding Process Efficiencies and Inefficiencies Functions as an organizational data hub that supports easy data retrieval Supports querying and mining large data to inform process details Saves downstream analytics time Organizes all NGS data metrics associated with in vitro data Managing Data Integrity Risk Removes the need to work with many different tools Centralizes library generation, data collection and tracking, and data querying Registers all libraries, samples, and experimental details Functions as the single source of truth Improves data reporting and transparency Organizes data and makes them accessible, following FAIR data principles Maintaining all Plasmid Data Stores high-throughput plasmid data Integrates plasmid database (DB) Removes the requirement for manual plasmid data tracking Efficiently Creating and Managing the Many Relationships Between DNA and Chemical Products Creates a seamless integration and experience to relate plasmid design, modification, and creation to LIMS features and business processes Provides plasmid editor for bulk plasmid creation Uses the plasmid as the most pivotal entity and assigns children and sibling relationships to designated plasmid libraries Shows the parent/child relationship at an entity level Queries every single data point and cross-examines it with any data point Creates plasmid samples and libraries, assigns the plasmid to a library, and associates it with all metadata Manages all NGS data associated with in vitro data Scales and expands to accommodate plasmid data throughput process needs Scaling the PoC Integrates and manages all laboratory instruments/equipment, robotics, supplies, and other resources Removes the requirement for manual instrument/equipment tracking Ensuring Adherence to Data Provenance Ensures highest standards of compliance, traceability, and sample/data provenance Provides an audit trail for each entity from sample to screening Controls all field changes L7|ESP Value-Add The Unified Platform, L7|ESP, with its Workflow Orchestration system, brings organization, efficiency, and transparency to Think Bioscience’s R&D SOP implementation process, facilitating disparate data collection, tracking, and storing. L7|ESP also streamlines library screening and data generation, integration of a plasmid editor, plasmid libraries with associated metadata, and efficient data mining and retrieval of its organizational data hub. The system not only allows for better data tracking, but also enables scalability, transparency, and connectivity between team members involved in rewriting SOPs to formalize internal processes. In other words, L7|ESP is helping Think Bioscience fly faster.The Unified L7|ESP Platform, with its Workflow Orchestration system, is the ideal solution for us to modernize, adapt, and improve our internal excel spreadsheet-based processes to formalize our SOPs and to manage all entities and data in one single source of truth. ABOUT THE AUTHOR ### Building the Foundation for Artificial Intelligence Applications L7 | CHATS 'everything data' series@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyaWdpdHRlIEdhbnRlciwgUGguRC4gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@This post is the beginning of a series of blog entries that will focus on "everything data," including how L7|ESP is well positioned to support complex laboratory and business process data applications, thus allowing organizations to make the best-informed business decisions in real time. We will cover new L7 Informatics data product launches and updates on critical partnerships L7 Informatics is engaging in (e.g., SciBite) for the benefit of our customers so they can overcome the challenges the life science industry is facing concerning the heterogeneity and complexity of language, terminology, and data sources. Realizing The Potential of AI/ML with the Right Data Access to artificial intelligence (AI) and machine learning (ML) technologies has broadened people's visions and ambitions across many life sciences sectors. Certainly, AI increases the potential of data-driven insights delivery and, with that, carries the promise of process optimizations, especially for large, complex data. Furthermore, AI is lowering the barriers to entry for many, allowing users to extract insights from complex data without the need to write code or complex queries but rather take advantage of an AI interpretation layer (e.g., natural-language-based interpretation). A comparison can be drawn to the availability of CPU- and GPU-based computing, which resulted in a range of different computational developments that were not possible several years before. For example, before the cloud, large engineering teams were needed to support complex infrastructures, making it cost-prohibitive and inaccessible to all but a minority of large organizations. Cloud computing changed this, increasing compute accessibility and thus fueling new ambitions to utilize these capabilities with ever-evolving use cases. Similarly, applications of AI/ML technologies are limitless, given the pre-requisite data corpus for model development and evaluation. However, the quality of this data has a huge impact on the accuracy and effectiveness of the model. AI/ML data modeling can be applied throughout the pharmaceutical value chain, including biomarker development, clinical trial optimization, drug repurposing, competitive intelligence research, post-market surveillance, and certainly lab and business process optimization.The ability to apply any model to any type of data requires the data to be standardized, structured, organized, and readily accessible. Otherwise, the data is of no value to any data consumer.Well-managed, Structured, and Standardized Data Is Foundational for Successful AI Applications Siloed and fractured systems, complex data, and process architectures, coupled with the rapid expansion in unstructured data volume and complexity, have challenged the potential to implement AI and realize its true value. A unified data strategy covering alignment of terminologies, and flexible platform architectures is needed to extract laboratory and business process insights. These insights can then drive process optimization, shortening the overall product life cycle, and reducing costs. To derive valuable insights from these data, the data must be contextualized, properly managed, and organized while also being easily findable, accessible, interoperable, and reusable, or in other words, following FAIR data guiding principles. Only then can the value be realized, for example, via developing predictive AI models that can be translated into new and improved lab and business processes.FAIRification of data and processes within the L7|ESP Process Orchestration Platform via data integration and contextualization improves business intelligence, increases business velocity, and reduces costs.A Data-Centric Approach is the Path Forward to Create Value for the Data Consumer Data-centricity is also the solution to address the pharmaceutical industry’s ROI challenges. Losing exclusivity of key assets, spiraling R&D costs, and a continuing need to demonstrate return on investment (ROI) have resulted in the pharmaceutical industry facing escalating pressures. To overcome these pressures, the industry actively adopted innovative high-throughput technologies, heavily invested in modernizing data infrastructure, and – more recently – in AI capabilities to derive insights from the rapidly growing volumes of increasingly complex data across the entire value chain. However, to derive high-value insights from an AI model requires high-quality and contextualized data as an input; otherwise, the saying “garbage in, garbage out” holds true. This point is further demonstrated in the article by Sequeda and team (2023), which showed that Large Language Models (LLMs) require contextualized data - represented over a knowledge graph - to provide higher accuracy for LLM-powered question-answering systems (see Figure 1). Figure 1: Investing in Knowledge Graph provides higher accuracy for LLM-powered question-answering systems. Adding AI capabilities on top of uncontextualized, low-quality, and siloed data returns sub-optimal results, while data volumes and costs of storage are continuing to grow without an equivalent ROI expected from these new IT investments. Improved E2E (end-to-end) processes via optimized throughput, increased efficiency, with lower overall cost can only be achieved through a data-first approach. Well-structured and harmonized lab and process data and accompanying metadata needs must be captured at every stage and made accessible across the entire business. Only then can research and manufacturing bottlenecks be identified, and steps can be taken to optimize various process components or entire processes. Having access to these process insights allows pharma companies to achieve shortened product life cycles at an overall reduced cost.To derive high-value insights from an AI model requires high-quality and contextualized data as an input.L7|ESP Is an Automated and Unified Platform that Controls and Executes Regulated Laboratory and Business Workflows The Unified Platform L7|ESP, with its Workflow Orchestration and Data Contextualization and its architecture for digitalization, not only integrates all common data information management systems, including LIMS, Notebooks, and MES together with other process-oriented applications, it also is open and flexible to integrate with existing management systems and even works with legacy systems providing a unified view of all laboratory and business processes across the value chain, increasing transparency of the product life cycle and its information flow, ensuring operational efficiency. L7|ESP’s data and workflow orchestration not only automates, optimizes, and executes tasks, providing a holistic approach to scientific process and business management, it also harmonizes and structures data at the point of capture, which includes all master process data and contextualized meta data (see Figure 2 for the L7|ESP Knowledge Graph). As an additional benefit, it can also be extended with data trending and charting tools for real-time operational and scientific insight.Figure2: L7|ESP Knowledge Graph.A unified view of all laboratory and business processes across the value chain, as provided via L7|ESP, increases transparency of the product life cycle and its information flow, ensures operational efficiency, and reduces operational costs.References Sequeda et al., A Benchmark to Understand the Role of Knowledge Graphs on the Large Language Model’s Accuracy for Question Answering on Enterprise SQL Databases. (2023) arXiv:2311.07509 , Nov 13. ABOUT THE AUTHOR ### Powering the Life Sciences Digital Revolution with L7|ESP L7 | CHATS thought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyaWdpdHRlIEdhbnRlciwgUGguRC4gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@The Data + Process Orchestration + Intelligence PlatformLife science processes, be it in research, drug discovery, development, manufacturing, or diagnostic test development and execution, have grown in complexity and scale over the last decade, not the least because the industry is facing ongoing pressures such as ROI (return of investment) challenges and/or loss of exclusivity on key assets. This rapid growth has resulted in disconnected and sub-optimal laboratory process management systems and the lack of a unified data strategy that would provide the necessary laboratory and business process insights with the potential to shorten the overall product life cycle. To overcome these challenges, the industry quickly adopted innovative high-throughput technologies, heavily invested in modernizing data infrastructure, and – more recently – in Artificial Intelligence (AI) capabilities to derive insights from the rapidly growing volumes of data. To derive high-value insights from an AI data model requires contextualized data as input. Otherwise, the saying “garbage in, garbage out” holds true. Adding AI capabilities on top of uncontextualized and siloed data returns sub-optimal results, while data volumes and costs of storage are continuing to grow without an equivalent ROI expected from these new IT investments. Fractured Processes and Data Can Be a Threat to Achieving ROI Goals Siloed data systems across labs and factories not only result in high maintenance and integration IT costs but also a loss in process and business knowledge that could be translated into increased business velocity and shortened product life cycles (aka faster drugs to market). Fractured vendor and home-grown systems (i.e., different information management systems that manage the laboratory processes | ELN, LIMS, EBR, MES, QC LIMS) across different groups and departments in drug discovery and development, and manufacturing. Legacy systems are not able to handle the advances in data sciences. No foundational, company-wide data strategy to make data and processes findable, shareable, accessible, and reusable between labs and scientists within and across departments, organizations, and multiple sites. This results in a lack of visibility and transparency on research, laboratory, and business data across labs and onerous and expensive regulatory submissions. High IT costs to maintain the various laboratory information management systems and data infrastructure. The Solution is L7|ESP - Purpose Built for the Life Sciences Based on Industry 4.0 Principles The Unified Platform L7|ESP is built based on best practices of industry 4.0 principles (The Fourth Industrial Revolution, Klaus Schwab, 2017), which reinvented how life science businesses conduct their research and develop, manufacture, and distribute their products. Technologies, such as Industrial Internet of Things (IIoT), cloud connectivity, AI, and machine learning (ML), are nowadays becoming deeply woven into the drug discovery, development, and manufacturing processes. Taking advantage of this unified and integrated approach to bringing new drugs to market results in highly connected and informed people, products, factories, and assets. Combining accuracy and speed of 4.0 tools with the creativity and talent of people yields is a win/win situation for both the workforce and the bottom line of a company. Drug research, development, and manufacturing operations become more efficient and productive, with individual teams and team members being relieved of low-value and repetitive operational tasks, providing them with the opportunity to efficiently collaborate instead with smart technologies embedded in the evolving technological landscape and the AI-powered future of their work. Meet Today’s and Tomorrow’s Organizational Needs of Maximizing the Total Return on Information Technology Investment The L7 Informatics’ Unified Platform L7|ESP, with its Workflow Orchestration and Data Contextualization, meets today’s and tomorrow’s organizational needs of any life science organization aiming to digitalize their data and scientific processes to maximize the total return on information technology investment. The L7|ESP data and workflow orchestration system automates, optimizes, and executes tasks, provides a holistic approach to scientific process and business management, and can be extended with trending and charting tools for real-time operational and scientific insight.L7|ESP creates visibility into the product life cycle process across the entire organization, from research to development, scale-up, and manufacturing or diagnostics.An Architecture for Digitalization Resulting in Shortened Product Life Cycles The L7|ESP platform integrates all common data information management systems, including L7 Notebooks, L7 LIMS, L7 MES, and L7 Scheduling, but also other resources such as Instrument Connectors, Sample Registration, Location, Receipt Accessioning, Logistics, Inventory, Environment Monitoring, Stability Testing, Custody of Chain, and Data Analytics. Works with legacy systems, allowing businesses to layer in L7|ESP alongside while continuing to use legacy systems already invested in. Contextualizes data across disparate legacy systems and brings them under the umbrella of a unified platform and data layer. Replaces redundant systems and upgrades legacy technologies, allowing the gradual decommissioning of redundant systems, while also replacing existing LIMS and ELN systems that cannot handle the emerging scientific and technology advancements. Ensures efficient operations, allowing the optimization of enterprise-wide scientific data and process management systems which results in optimized end-to-end (E2E) data and processes. Creates visibility into the product life cycle process across the entire organization from research to development, scale-up, and manufacturing or diagnostics. Ensures high performance in terms of cost management and insights delivery, which results in increased quality and speed of process execution. Creates transparency, enabling scientific information sharing between labs and programs and across the organization. Provides visibility on product data across the product value chain within an organization. L7|ESP, A UNIFIED PLATFORM that contextualizes data and ELIMINATES business SILOS VIA process ORCHESTRATIONThe L7|ESP’s virtuous digitalization lifecycle of designing, publishing, executing, monitoring, mining, and optimizing results in improved and redesigned processes and operations with increased operational efficiency and overall reduced costs across research, development, manufacturing, and quality operations.L7|ESP addresses data and laboratory management needs and challenges in life sciences across the value chain, specifically in: Research (academia and pharma) and diagnostics: Research scientists, bioinformaticians / computational scientists, lab technicians, lab managers, and IT infrastructure managers. Pharma and CDMO - small and large molecules and advanced therapeutics: Process development engineers and analytical development scientists, bioinformatician/computational scientists, IT infrastructure managers, GxP experts and quality reviewers, QC/QA associates and head of QC/QA, and project/program managers Clinical sample management: Regulatory scientists, QC/QA associates, project/program manager FAIRification of process and data along with the L7|ESP Process Orchestration Platform improves business intelligence, via data integration and contextualization, increases business velocity, and reduces costs. learn more about L7|ESPABOUT THE AUTHOR ### L7|ESP Unified Platform Datasheet Download @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9leGNlcnB0Iiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiIiwiYWZ0ZXIiOiIiLCJ3b3JkcyI6IiIsInJlYWRfbW9yZV9sYWJlbCI6IiJ9fQ==@ ### It’s Time to Talk About the Minimal Valuable Product, and Not Just an MVP L7 | CHATS thought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyaWdpdHRlIEdhbnRlciwgUGguRC4gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@I had the great opportunity to attend the latest Smartlab Exchange conference, which took place April 8-9 in Fort Lauderdale, Florida, USA. The theme of the conference focused on lab process digitalization, effective change management, and emerging technologies. As the name of the conference implies, there was a constant exchange between industry delegates and commercial solution providers, and wow, was there lots of exchange! One key takeaway message I took home from all the discussions and presentations: An MVP is not enough anymore; we need to think Minimal Valuable Product! Discuss the Implementation Strategy Upfront! You get further! It was interesting to see the enthusiasm and demand for process digitalization is higher than ever while also accompanied by the challenges that need to be navigated and addressed. The challenges, as I heard them, were around ownership clarification of change management, people being afraid of failing fast and picking the wrong solution, not enough resources with the right training for automation and digital transformation, implementation fatigue, and last, but not least, providing and selling a solution that is built with the end user in mind and not just selling a system. Some great quotes I collected during the different talks and panel discussions: “People working in the lab take longer to generate the paperwork then actually working on an experiment – so we really have to think about it from an end user in the lab perspective.” “Unlearning is required to adopt change.” “Everything should be completely integrated, including LIMS, ELN, etc.” “All the data produced is going through submissions and needs to be good for AI applications.” “One of the most important things is understanding the data, what is required in terms of security and data privacy, and what can be achieved via partnerships or building the controls in-house.” “Data has to be data ready so it can be used for decision-making purposes, including single source of truth.” “The right people for the right technology, which includes skill set, and the right infrastructure in place, and we need the right dollar amount to support it.” “Collaboration is an important aspect: in the lab with our peers and across the company.” “KPI is important – do science more effectively which resolves around taking a science-centered approach.” “Lab of the future has to plan for me the whole lab, including inventory management, so I can focus on the science.” “Digital transformation means E2E.” “The architecture and how the structure of the data is going to be are so important – since it is a multi-year type investment and a lot of dollars, so everyone wants the benefits pretty quickly, and as such, the architectural foundation is very important.” “Patience is important.” “We have done a lot from paper to digital, but people need to understand what the benefits are to be able to get over the hump.” “To successfully achieve digital transformation means to assess the current pain points and build out from there.” “Compared to programming background 18 years ago, nobody had that particular training/background, but now this is a completely different story. Eventually, the same will happen with digital transformation, automation background etc. which we should expect in 5-10 years.” “Always look within the organization and see who is the biggest supporter within a department – for buy-in you need department specific support.” Some interesting live polling that happened during the conference The data was based on about 30-40 active delegates in the room during any of those polling sessions. What are you seeking to use AI for? N=35 Automated analysis – 77% Experiment design and optimization – 73% Predictive maintenance and optimization – 54% Real-time monitoring for safety/efficiency – 46% Robotic sample handling and analysis – 42% Smart inventory management – 33% What is your strategy for dealing with disconnected lab systems? N=34 Adopting standardized data formats and using data lakes/warehouses for centralized data storage – 76% Investing in integration platforms – 41% Implementing middleware for data integration – 32% Prioritizing system compatibility in procurement – 26% What is the best strategy for overcoming disconnected lab systems? N=37 A mixture of both – 89% Replacing systems – 8% Integrating systems – 3% At what stage are you in your generative AI journey? N=31 Thinking about implementation and establishing strategy – 52% Started implementing a few initiatives – 32% Actively implementing – 16% Not thinking about implementing – 0% How frequently does IT share their vision for digital journey with scientists? N=24 They never share anything with us – 58% Monthly – 21% Quarterly – 17% Annually – 4% It Is Important to Not Just Sell a System but Provide an Actual Solution The breakout panel discussion with Scott Lunk (Bayer Crop Sciences) and Robert Guenard (Pfizer) engaged with the entire audience of 70+ individuals in the room, focusing on Change Management with the big takeaway message: focus on the journey with shaping the path instead of just thinking about the outcome. Whereas the path requires having owners (and not just buy-in because buy-in means the decision is already done), tenacity, meeting people where they are (e.g., if you want to improve the lab, go to the lab to learn more), bringing in some training (which includes training of the leadership team), and implement hyper care post-implementation (provide additional system support for like three months plus and don’t let people and labs hang after implementation).Digital transformation is too close to an outcome – we need to think about the digital journey.Which brings me to the Minimal Valuable Product Considering all the information I gathered, the industry sector is clearly longing for a Minimal Valuable Product and not just an MVP. Besides providing a solution that digitalizes and manages all lab processes and data, for example, via a LIMS, ELN, or LES, such as a solution also must make data available in a ready-to-use format for decision-making purpose and prevent the data from going to the dark side - as was mentioned by someone at the conference. A Minimal Valuable Product needs to: Be flexible, in that other laboratory management solutions can be fully integrated. Be built with the end user in mind, and not just IT, but also the lab personnel. Support collaboration across different teams and programs. Be highly secure with access controls and support data privacy. Provide data in a ready-to-use format for decision-making purposes. Function as a single source of truth. Support a science-centered approach. Have an architectural foundation that includes accessible and fully structured data. Address the current pain points in the lab. Be patient-centered. Support routine lab tasks, such as inventory management and scheduling. Be built by vendor organizations that: Have a focused approach on delivering the right solution. Understand the data science component just as much as they have domain knowledge. Have alignment from top to bottom and have the forward-thinking culture to implement. Provide hyper care post-implementation. t was nice to see that L7 Informatics with its Unified Platform L7|ESP is nicely aligned with these Minimal Valuable Product requirements, as it is built with an architecture for digitalization in mind, which not only manages all lab and business processes via workflow orchestration, using a low code/no code authoring tool, it is also integrates numerous lab management applications such as L7 LIMS, L7 Notebooks, L7 MES, L7 Scheduling, Inventory Management, and many other applications. This the while collecting all the process data along the way as the data is produced. The data collected does not only include master process data, but also valuable meta data that contextualizes the data and adds meaning to any process data point. The other alignment L7|ESP provides is that it can also integrate with existing lab management systems, including legacy systems, which, therefore, does not require any organization to replace existing systems but rather means it can function as a single source of truth. Furthermore, L7|ESP has the potential to provide lab and business insights via the L7|Intelligence layer, which includes data models, such as a physical database schema, ITDs (a set of normalized tables providing access to entity and process data), and Star schema data products. A data scientist can then use all the standardized and structured process and business data and extract insights to translate them into faster, optimized, and cheaper lab and business processes by applying data models (both internally within the platform or by exporting the data to analyze and visualize in your tool of choice outside of L7|ESP), including AI capabilities.We believe what people are looking for is a smart, contextualized, and related unified data platform.ABOUT THE AUTHOR ### Challenges and Breakthroughs in Unified Digital Laboratory Systems in Diagnostics and Research Core Laboratories L7 | CHATS thought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IENhbGViIERhdmlzIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@INTRODUCTION Recent advances in scientific procedures and best practices have been matched with a proliferation of specialized software solutions. This leads to most diagnostics and research labs using multiple software systems that each only track, manage, or process a subset of the lab's overall operations - thus effectively siloing each team member, group, or process from the rest of the lab. These silos then result in decreased data flow through the lab, decreased visibility into sample and data status, and decreased sample processing throughput. Here we demonstrate breakthroughs in digitalizing laboratory processes in fully compliant systems from the point of sample collection through to data reporting. This leads to an increase in laboratory efficiency, increased data integrity, better decision-making due to better data visibility, and reduced costs for diagnostics laboratories and research cores. As a proof of principle, we highlight how two different academic research cores have implemented this new technology, L7|ESP, to reduce their laboratory silos. Laboratory 1 is a sequencing core at an academic institution and processes hundreds to thousands of samples per day. Utilization of L7|ESP provided them with the ability to send information and samples across various groups within their core and seamlessly output final reports to their customers. Laboratory 2 is a cutting-edge protein sciences group at a large nonprofit biomedical research institution. Their work utilizes multiple different instruments, sample types, and desired outputs and thus requires flexibility and adaptability without sacrificing throughput, data integrity, or user experience. Through modeling these processes in L7|ESP they are able to run specialized processes at scale while still running generalized processes to meet the changing needs of their clients. These case studies show that modern diagnostics and research core laboratories can leverage today’s latest breakthroughs in computer science and software to enable them to successfully scale and grow to tomorrow’s scientific needs. METHOD – L7|ESP PLATFORMFigure 1: L7|ESP encompasses multiple laboratory needs and seamlessly integrates with external instruments and systems. L7|ESP is an advanced data intelligence platform for modern life science labs. As shown in Figure 1, L7|ESP contains multiple apps to meet the diverse needs of scientists. These diverse functionalities provide the backbone for most of a lab’s process and data needs. Each app has been designed, developed, and refined to maximize functionality for even the most discerning of users. In addition to the L7 apps, scientists can model any scientific or even non-scientific process ranging from manufacturing of precision medicines to high-throughput genomic engineering assays in the L7|ESP platform. RESULTS Lab 1, a large academic genomics core lab, was using a self-developed LIMS system to manage NGS experiments from many different collaborators. This led to a lack of scalability and data transparency across teams. L7|ESP provides Lab 1 with a central, unified platform that can scale as throughput grows (Figure 2). This process allows for transfer of samples and data across teams with a full audit trail, and integration with diverse pieces of equipment.Figure 2: Process diagram of ”Lab 1” -- a core genomics lab of a large academic research institution. For Laboratory 2, the workflow process outlined in Figure 3 was developed which provides end-to-end functionality for an academic core lab’s proteomics process needs and allows them to: Work with multiple customers who submit Service Requests via iLab Ingest and translate this Service Request into an actionable experiment plan Execute the necessary experiments while incorporating data from multiple instruments Analyze the data using multiple analysis pipelines Cohesively parse, combine, and visualize this data into a customer-facing report Communicate with the customer of the experiment status at each step along the way Figure 3: Process diagram of ”Lab 2” -- a core proteomics lab of a large nonprofit biomedical research institution. CONCLUSION The Lab of the Future must grow beyond the four walls of the lab to break down data silos, virtualize, and digitalize rapid scientific discoveries across departmental and organization walls to help lead to better outcomes, improved reproducibility, and an increased rate of scientific discovery.By digitalizing, automating, and simplifying all laboratory processes on a single regulatory-compliant informatics platform with all the apps and instrument integrations, a unified platform for managing operational data and processes is created. L7 Informatics’ ESP is such a platform that can bring increased workflow efficiencies and throughput to support any research, industrial, or clinical lab. This work was presented by Caleb Davis, Ph.D., in the poster exhibit at ASHG 2023. Have questions and want to learn more? Meet with the L7 Team next week at Bio-IT World in Boston, booth #617. ABOUT THE AUTHOR ### The L7|ESP™ Plasmid Editor Streamlines Plasmid Information Management Across a Unified Platform L7 | CHATS product feature@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IE9hbmEgSS4gTHVuZ3UgfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Plasmids are a critical tool in molecular biology Scientists have taken advantage of plasmids to clone, transfer, and manipulate genes for decades. By inserting any DNA fragment or gene of interest, scientists can create recombinant plasmids. Applications include protein engineering, gene editing, and high-throughput screening of genes or genetic elements. Plasmids contain rich information and complex structures, including multiple cloning sites, resistance genes, promoters, and other functional elements. This information is collected, organized, and stored throughout the laboratory and is used to drive key decisions. Capturing plasmid information in a way that enables easy access, editing, and annotation within interconnected laboratory systems can be challenging but is critical in realizing the value of rich plasmid data in a seamless, unified manner. Maintaining plasmid information in laboratories poses challenges In all situations, it is critical to collect, organize, and keep track of the plasmid information. Challenges in organizing this information in the laboratory include: Ensuring complex plasmid information is presented in an easily searchable, accessible, and viewable manner for comprehensive browsing. Providing effective mechanisms for versioning plasmids as they are evolved or modified so that users can access both original and modified versions. Integrating plasmid metadata with experiment information from the systems that capture it, such as ELN, for seamless retrieval and annotation across the laboratory. L7|ESP Plasmid Editor applies FAIR data principles to easily access plasmid information The Plasmid Editor has been integrated into the L7|ESP Unified Platform to allow for plasmid information usage in a FAIR (Findable, Accessible, Interoperable, Reusable) manner, ensuring ease of searchability, accessibility, and viewing. Using the Open Source Vector Editor Component (1), L7|ESP’s Plasmid Editor tool encompasses an advanced suite of functionalities that are highly sought after in vector mapping and sequence editing software, including: Allows plasmid information to be easily findable and accessible within a unified platform through the application of FAIR data principles. Enables viewing, editing, and annotation of plasmids in various formats (e.g., FASTA file format or GenBank format) Provides custom views of plasmid information, which supports easy filtering, browsing, and querying of data. Includes viewing of plasmid features such as gene details, cut sites, open reading frames, and translation information. Offers the ability to perform simulated digestions and simulated PCR reactions. Includes robust primer design tools for critical parameters such as melting temperatures and GC content L7|ESP Plasmid Editor is part of the L7 Notebooks App. Download the datasheet to learn more. Figure 1: The Plasmid Editor within L7|ESP establishes relationships between plasmid versions, their metadata, experimental process data, and version features and edits. The fully integrated L7|ESP Plasmid Editor leverages data relationships for plasmid versioning By being fully integrated, the Plasmid Editor leverages the L7|ESP system to establish relationships for interconnected plasmid data. Users can edit plasmids, manage all the resulting metadata, and process information by creating parent-child relationships between the original and modified plasmids, enabling versioning as well as traceability of plasmids. Figure 1 depicts how L7|ESP provides data contextualization for plasmid information by managing all plasmid metadata, process information, and intricate relationships in one single source of truth as plasmids are versioned. Parent-child relationships are established as plasmids are edited to create new versions (Top Left). Information is linked to the appropriate version when it is captured in experiments as process data (Second to the Left). Plasmid metadata is also appropriately linked to the plasmid version (Second to the Right). Lastly, the plasmid custom view enables browsing of the versioned plasmid edits and features (Bottom Right). L7|ESP utilizes the power of a platform to seamlessly integrate plasmid metadata with experiment information Plasmid information is seamlessly connected across the L7|ESP unified platform with workflow orchestration. A built-in widget connects in L7|ESP’s Notebooks application to plasmid metadata information, allowing for unification of plasmid information directly from the moment of capture. Figure 2 depicts how users are able to create Notebook templates and associated entries to record a variety of experimental processes and their resulting information, such as instrument or protocol data, alongside viewing, editing, and annotation of plasmids. As experiment information about processes being performed using plasmids is captured in Notebook entries, the data are seamlessly synched to plasmid metadata, ensuring a holistic view of plasmid sequences, their annotations, and the experimental processes with which they have been associated.Figure 2. Notebook Entries allow for the consolidation of experimental process information with plasmid information seamlessly as the data is captured. Think Biosciences uses the Plasmid Editor to evolve their plasmid library for new natural product screening. Maintaining plasmid libraries can add an additional layer of complexity to laboratory processes, necessitating sifting through vast libraries of sequences and ensuring accurate data is tied to the correct variants. Access to the right tools enables streamlining of these procedures. The recently published Think Bioscience case study demonstrates the value of the integrated Plasmid Editor within the L7|ESP platform. For Think Bioscience, the plasmid is the pivotal component in their laboratory workflows and, as such, plays a critical role in their evolving internal R&D Standard Operating Procedure (SOP). Having the Plasmid Editor fully integrated into L7|ESP, with its Workflow Orchestration system, brings organization and efficiency to Think Bioscience’s R&D SOP implementation process. By streamlining library screening and data generation in one platform, the L7|ESP platform facilitates tracking, sorting, and storing all information in one single source of truth for Think Bioscience.The Plasmid Editor, as integrated into the L7|ESP Platform, offers key functionality for tackling the challenges of capturing plasmid sequence information in a way that enables easy access, editing, and annotation within interconnected laboratory systems.Source:(1). https://github.com/TeselaGen/tg-oss/tree/master/packages/ove(2). https://l7informatics.com/think-bioscience-creating-an-efficient-and-transparent-laboratory-and-data-management-process/ABOUT THE AUTHOR ### L7 Scheduling – A Comprehensive Scheduling Solution to Maximize Product Capacity & Meet Operational Efficiency L7 | CHATS product highlight @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyaWdpdHRlIEdhbnRlciB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@Manufacturing of pharmaceutical products and managing/monitoring patient treatment are highly regulated and complex processes. This is the more challenging as efficiency and cost factors come into play. The complex supply chain for cell and gene therapy (CGT) production and patient treatment management/oversight must be fast for the treatment to work. In addition, manufacturing processes of biologics (e.g., monoclonal antibodies) must also run at the lowest possible cost. As such, achieving maximum production capacity and improving operational agility is of the highest importance for any therapeutics manufacturing facility or laboratory. Efficient and cost-effective production of high-quality therapies requires overcoming one of the biggest hurdles the industry is facing, namely suboptimal production and planning schedules resulting in operational inefficiencies. An optimized production and planning schedule represents a key requirement to guarantee faster and lower-cost delivery of high-quality therapeutic products and entails optimizing the laboratory (and manufacturing) resources at hand, be it qualified staff, instruments, or equipment. Furthermore, adhering to regulatory standards and full compliance is an absolute must, and this without sacrificing operational efficiency. The L7|ESP Scheduling Application Offers the Solution to Overcome Production and Patient Treatment Challenges Pharmaceutical Manufacturing Departments and Organizations Face The L7|ESP Scheduling application is not a standalone offering, but rather is fully integrated into the flexible, secure, and collaborative digital and process-oriented L7|ESP platform designed to overcome traditional pharmaceutical manufacturing bottlenecks. The L7|ESP Scheduling application: Dynamically and automatically links entries to L7|ESP schedulable data sources. Enables resource scheduling based on priority, expected completion date, and task duration. Integrates assignee information with workgroup, location, and selected equipment into the scheduling process. Automatically synchronizes with MES and LIMS applications. Is part of the L7|ESP Unified Platform, seamlessly contextualizing data and orchestrating workflows throughout its analytical and manufacturing ecosystem. Supports real-world process supply chain complexities and their scheduling. Ensures 21 CFR Part 11 compliance for production of small molecules, biologics, and CGT products. The L7|ESP Scheduling Application Outperforms Traditional, Standalone Scheduling Solutions Recent advancements in digital technologies, like the L7|ESP Scheduling application, have started to shape the entire life sciences and healthcare value chains by streamlining and optimizing lab and business processes. The L7|ESP Scheduling application is part of the L7|ESP Unified Platform, with its Workflow Orchestration and Data Contextualization System, where manufacturing execution system (MES) data resides in the same database as LIMS, inventory data, and a myriad of other applications. The system uses existing L7|ESP workflow chain configurations to automate task orchestration and, therefore, provides a holistic approach to lab process management. L7|ESP can be extended with data trending and charting tools for single-batch and cross-batch trending and reporting. Specifically, with the L7|ESP Scheduling application you can now: Run laboratories and manufacturing plants at capacity 24/7/365. Assess and plan resource capacity and adjust schedules accordingly. Monitor task progress in real-time. Optimize resource utilization with automatic combinations of instrument/equipment run times, staff schedules, and planned workflows. Optimize instrument/equipment usage and longevity, minimize downtime, and preemptively plan new instrument investments. The L7|ESP Scheduling Application is for Laboratory and Project Managers L7|ESP Scheduling optimizes laboratory and business processes across therapeutics, drug manufacturing, and diagnostic testing. Laboratory and Project Managers across therapeutics, drug manufacturing, and diagnostic testing, including process development & analytical development. Research, Therapeutics, and Diagnostic Laboratory Managers who need to optimize their resources and their staff to be more efficient and cost-effective and want their staff to focus on science instead of low value activities. By utilizing the Scheduling application as part of the L7|ESP Unified Platform allows researchers to run their laboratories at capacity with optimized resource utilization and staff schedules. Automating the administrative burden with L7|ESP allows laboratory staff to focus on high value activities while optimizing production cost-effectiveness.ABOUT THE AUTHOR ### The Future of Pathogen Detection: A Genomic Breakthrough L7 | CHATS customer story@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEw3IEluZm9ybWF0aWNzIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@Imagine a world where identifying a pathogen in a clinical sample isn't a painstaking wait for cultures to grow and where we rely on something other than the limited view of DNA-based methods. Justin Wright, the Executive VP of Data Analytics at Contamination Source Identification, or CSI for short, walks us through a scientific marvel that promises to transform the landscape of clinical diagnostics. Welcome to the future of diagnostics, where RNA sequencing takes center stage. CSI's RNA Powerhouse: A Game Changer At the heart of the CSI revolution is a groundbreaking RNA-based approach. It's not just another diagnostic tool; it's a game-changer. This cutting-edge technology can simultaneously detect thousands of active pathogens, providing a dynamic window into what's happening inside a patient's body. Imagine this: with the help of state-of-the-art robotic liquid handlers, CSI speeds up sample processing, extracting, purifying, and enriching microbial RNA. This RNA sequence is like a unique identifier for transcriptionally active microbes, enabling precise, lightning-fast diagnoses that are changing the game of clinical diagnostics as we know it. It's not just about identifying pathogens; it's about understanding them in real time. Streamlining Data Management with L7|ESP™ We all know that data can be a monster to manage. But not for CSI. At the center of their data management lies the L7|ESP platform, seamlessly bridging the gap between the wet lab and dry lab phases: no more lost-in-translation moments or delays. With L7|ESP, data flows effortlessly while ensuring compliance in the highly regulated clinical diagnostics field. Orthopedic Advancements: CSI's Groundbreaking Approach to Pathogen Identification CSI’s initial proof of concept was initiated by a challenge from Dr. Javad Parvizi, a world-renowned thought leader for prosthetic joint infections. In addition to the precise reporting of pathogens in infected knees, CSI’s platform unearthed an existing microbiome in synovial fluid, contrarian to traditional teaching and mindset. Additional collaboration with Zimmer Biomet, a medical device company that works on restoring mobility, alleviating pain, and improving the quality of life for patients around the world, further challenged the data management system and the L7 platform. CSI tested their method on 320+ synovial fluid samples. The results weren't just promising; they're a potential game-changer for accurate and rapid diagnoses of prosthetic joint infections and a ray of hope, as traditional methods often struggle with high false positive and false negative rates, especially when dealing with challenging-to-culture pathogens. A Glimpse into the Future The possibilities offered by CSI extend beyond the realm of prosthetic joint infections. The future looks bright. The company is actively seeking collaborations with clinical institutions to explore the application of their technology in early sepsis detection and blood analysis, which is not only lifesaving but offers significant savings to the healthcare cost burden. They're also gearing up to tap into machine learning and predictive analytics, ready to squeeze every drop of knowledge from their data. In Conclusion CSI's hyper-focus on RNA-based sequencing and functional gene profiling, combined with their continued technique refinement and expanded collaborations, aims to make significant strides in clinical diagnostics. L7 is dedicated to its success, and L7|ESP offers a robust and flexible unified platform to enable the CSI team to make their mark on the world of pathogen detection. Please click below to watch the full recording. ### L7 Scheduling Datasheet Download @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9leGNlcnB0Iiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiIiwiYWZ0ZXIiOiIiLCJ3b3JkcyI6IiIsInJlYWRfbW9yZV9sYWJlbCI6IiJ9fQ==@ ### Testimonial of Mike O’Mara, COO of Cellipont Bioservices ### Cellipont Bioservices Selects L7 Informatics’ Manufacturing Platform ### Cellipont Bioservices Selects L7 Informatics For Its Flexible And Unified Platform, Enabling End-To-End Manufacturing Austin, TX, January 17th, 2024/ PRNewswire/ - L7 Informatics, the industry leader providing scientific software solutions for research, development, manufacturing, and quality control operations, is excited to announce a strategic partnership with Cellipont Bioservices, a distinguished CDMO specializing in cell therapy manufacturing. This collaboration marks a pivotal moment as Cellipont embraces L7 Informatics' L7|ESP™ unified platform and its integrated Manufacturing Execution System (MES) application to digitalize its cell therapy manufacturing recipes, streamline technology transfers, and digitally enable its customers. Unlike other MES solutions in the industry, L7|ESP MES offers advanced capabilities and flexibility to manage early and late-phase clinical to commercial programs with a unified process, data, and knowledge management platform to enable manufacturing, quality, and technology transfer operations end-to-end. "The decision to deploy L7|ESP reflects our commitment to staying at the forefront of innovation in this dynamic field. While we chose L7 to take advantage of its MES application, we will also leverage L7 Informatics' flexible platform to streamline our processes, enhance collaboration, and ultimately deliver even greater value to our clients and the broader scientific community," commented Cellipont COO, Mike O’Mara. The deployment of L7|ESP by Cellipont signifies a significant step towards optimizing cell therapy development and manufacturing processes. By integrating L7 Informatics' advanced platform, Cellipont Bioservices aims to elevate the quality and efficiency of its services, contributing to advancements in cell therapy development and manufacturing methods and technologies. "We are thrilled to collaborate with Cellipont as they deploy L7|ESP. They have built a state-of-the-art facility and assembled a well-experienced technical team for the development and manufacturing of cell therapies, and we designed our platform to empower organizations like Cellipont to create efficiencies and harness the full potential of their operations and data management. We are committed to providing transformative solutions that meet the evolving needs of cell therapy research, development, and manufacturing,” said L7 Informatics CEO Vasu Rangadass, Ph.D. Both companies will be exhibiting at Advanced Therapies Week in Miami this week and host case study chats in the L7 booth #352 at 2:00 pm on 1/17/24, and at the Cellipont booth #422 at 8:00 am on 1/18/24. The partners will also be hosting a webinar in Q1 diving into the customer-first, digital-first model—details to be shared via LinkedIn. Follow L7 Informatics for more information, or contact the team to learn more about L7|ESP capabilities. --- For media inquiries, please contact: info@l7informatics.com --- About L7 Informatics L7 Informatics, Inc. is a leading provider of integrated scientific data and analytics solutions. The company offers a comprehensive platform that enables seamless data integration, advanced analytics, and collaborative workflows, empowering scientists and researchers to accelerate discoveries, improve operational efficiencies, and drive innovation. L7’s mission is to revolutionize how scientific data is managed, analyzed, and utilized, facilitating breakthroughs in research, drug discovery, development, and manufacturing. To learn more, visit www.l7informatics.com. About Cellipont Cellipont Bioservices is a cell therapy CDMO with experience in the development and small-to-large batch manufacturing of cell therapies. Our leaders have played an instrumental role in shaping cell therapy development and manufacturing methods and technologies, and our technically strong team has been recognized by customers and technology partners for its ability to productively grow challenging cells. Cellipont Bioservices is driven to help our clients expand patient access to life-changing medicines through best-in-class development, analytical and manufacturing capabilities. To learn more, visit www.cellipont.com. ### To read the original press release, click here. ### Flexible and Fully Functional L7 LIMS, Integrated into the Unified Platform L7|ESP™ with Workflow Orchestration L7 | CHATS product highlight @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyaWdpdHRlIEdhbnRlciB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@CURRENT CHALLENGES Advances in equipment capabilities, such as high-throughput and high-frequency measurement technologies combined with innovative, new technological advancements and complex drug modalities in the therapeutics sector, have drastically changed the scale and complexity of laboratory experiments and study protocols. The paper and Excel paradigms are incompatible with the current reality of modern research and clinical laboratories. They simply cannot scale to keep up with today’s business and scientific demands, make it almost impossible to structure data for downstream process analysis, do not connect the broader lab environment, complicate collaborations, and make historical data retrieval problematic. The result is increased technical debt as the entire process lacks a clear view of the bigger picture, such as organizational strategy; digitizing documents; automating processes; addressing and controlling data and process explosion; securing information access; minimizing information silos; connecting and integrating older legacy systems, instruments, and equipment; managing resources; managing year-over-year cost; eliminating low-quality data; and data contextualization, reporting, and analytics (AI/ML). L7 LIMS Provides Endless Capabilities Using a Workflow Orchestration and Entity-Based Master Data Approach While the challenges are substantial, the L7 LIMS app provides an effective and clear solution to address the many challenges life sciences research organizations face by streamlining and optimizing laboratory operations, the result of which is a highly efficient and accurate process at a reduced cost. Key L7 LIMS benefits include: Track and manage samples from collection to disposal, including location, storage condition, and testing history, which results in reduced sample mix-ups, error-prone tracking, and increased traceability. Make data, results, protocols, and documentation available to all lab members, the entire organization, and collaborators via a centralized data repository that organizes all information, is fully searchable, and improves transparency. Automate and optimize workflows and tasks, which results in higher efficiency, accelerated processes, and fewer manual errors. Manage and optimize all your lab resources (e.g., consumables, equipment, and personnel), which results in better resource allocation and prevents shortages. Maintain data integrity with role-based user access controls, audit trails, and electronic signatures. L7 LIMS Capabilities Are Fully Integrated Within L7|ESP™ Is part of the L7|ESP Unified Platform with its Workflow Orchestration system and Data Contextualization. Dynamically and automatically links entries to L7|ESP data sources. Is a flexible, secure, and collaborative digital and process-oriented solution. Enforces standard operating procedures (SOPs) and regulatory guidelines. Generates customizable, white-label reports summarizing experimental outcomes, trends, and performance metrics. Follows and supports FAIR data principles. Is a low-code/no-code authoring tool for any scientific process. Easily scales and expands to any processing need. Is easy to navigate with a modern UI, which supports user-configured experiences. L7 LIMS Outperforms Traditional LIMS SystemsL7 LIMS is for Research Scientists and Managers The L7 LIMS App is for researchers and operational end users across research, therapeutics, diagnostics, and AgBio. Specifically, Research/R&D scientists and managers in drug discovery, process development, and analytical development. Operational end-users which include lab and R&D technicians, bench researchers, process development engineers and analytical development scientists, lab managers, project/program managers, and GxP expert/quality reviewers. By utilizing the flexible L7 LIMS as part of the L7|ESP Unified Platform, researchers benefit from a seamless integration of structured and unstructured data which is what most experimental paradigms require. Data is organized and accessible, follows FAIR data principles, with LIMS capabilities functioning on the operational side of the process which includes many different apps/modules. L7 LIMS Is Part of the L7|ESP Unified Platform The L7 LIMS app is part of the L7|ESP Unified Platform where samples are recorded, experiments are executed, inventory is tracked and where protocols and workflows reside in the same database as Notebooks, inventory data, scheduling tools, and a myriad of other applications. The system uses existing workflow chain configurations to automate task orchestration and therefore provides a holistic approach to lab process management.The L7 LIMS app offering, fully integrated into the Unified L7|ESP Platform with its Workflow Orchestration system, is the ideal solution for us to modernize, adapt, and improve our internal Excel spreadsheet-based processes to formalize our SOPs and to manage all entities and data in one single source of truth.ABOUT THE AUTHOR ### Transforming Cell Gene Therapy Operations: The Power of Integrated Scheduling and Resource Planning Systems L7 | CHATS partnership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEVkdWFyZCBIZXJnZW5yZWlkZXIgYW5kIFN0ZXZlbiBCYXJhc2ggfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Disclaimer: SAP Cell and Gene Therapy Orchestration (CGTO) is an industry cloud product of SAP with a quarterly release plan. In the below, when discussing specific functionality, I will include available functionality as well as capabilities that are part of the roadmap for CGTO and indicate future direction of the product. Collaboration with ecosystem partners has been a key pillar of the SAP strategy for many years and we are proud to have partners that help us on our mission to provide our customers with first in class solutions for their mission critical processes. We celebrate every addition to the SAP Ecosystem and I’m excited to welcome the most recent new member, L7 Informatics, Inc. as an official member of the SAP PartnerEdge open ecosystem! We are always looking for great complementary partner solutions that our SAP Industry Solutions for Life Sciences can be integrated with to empower our customers to thrive in the ever-evolving business landscape. While we were wrestling with the intricacies of scheduling, we identified L7’s L7|ESP™ (Enterprise Science Platform) as a complementary partner solution that supports our vision for our customers developing and manufacturing cell and gene therapy products. L7|ESP MES offers advanced capabilities and flexibility to manage early and late-phase clinical to commercial programs with a unified process, data, and knowledge management platform to enable manufacturing, quality, and technology transfer operations end-to-end. To outline how it fits into the picture for SAP CGTO, let’s review the complexity involved in scheduling individual treatments. In the dynamic world of cell and gene therapies (CGTs, also known as Advanced Therapy Medicinal Products, ATMPs), the orchestration of needle-to-needle operations embodies a complex symphony of processes. Healthcare providers, Biotech companies, and contract manufacturers are constantly navigating the intricacies of seamless scheduling (an interplay between the patient scheduling, treatment scheduling including logistics, and manufacturing scheduling), resource management, clinical operations, quality control, manufacturing, and batch release operations. The challenge is not just to manage these elements but to integrate them into a unified, efficient, and transparent system. This integration is crucial in an environment where constant changes, disruptions, and unplanned events are the norm rather than the exception. Our customers, the CGT/ATMP sponsors and manufacturers, as well as their customers, the healthcare providers and patients experience the impact of these challenges daily. The ability to manage, correct, and eventually predict these variations is vital for maintaining the integrity of the supply chain and ensuring the timely delivery of life-saving therapies. In this context, data becomes the linchpin of successful operations. Access to real-time, comprehensive data and advanced analytics is not merely an operational need; it forms the backbone of strategic decision-making. This data-driven approach enables our customers to gain critical insights into their production schedules, demand planning, capacity allocation, resource management, and consumption, and overall supply chain efficiency. Moreover, streamlined data access and transparency simplifies reporting for quality, regulatory, and project management teams, allowing for enhanced operations planning and execution while demonstrating regulatory compliance. The potential to visualize correlations between supply chain, material management, and manufacturing datasets opens new opportunities for optimization and innovation. In this blog, we will delve deeper into the complexities and solutions of orchestrating individual treatment schedules for cell therapies, we will explore how technologies like SAP Cell and Gene Therapy Orchestration (CGTO) integrated with unified process and data systems play a central role in transforming these challenges into opportunities for efficiency, quality, and patient care. The Complexity of Autologous Cell Therapy Scheduling We will use the model of an autologous cell therapy, as it represents one of the most complex examples of a personalized treatment and is a groundbreaking approach in personalized medicine, which demands an exceptional level of precision and coordination in its scheduling process . Today, this process more often than not, is based on a myriad of spreadsheets, emails, scanned forms, phone calls and disconnected portals. Once a patient is identified, enrolled, registered, and qualified for a certain therapy, the order is formally placed with the developer or manufacturer. Each patient’s treatment journey is unique, beginning with the collection of their cells (“apheresis” or “collection of starting material”) and culminating in the delivery of a tailored therapeutic product that must be administered only to the initial patient (hence, the regulatory demand for a “chain of identity” and “chain of custody” solution ). This journey encompasses a myriad of steps, each with its own set of complexities and dependencies. The Journey from Apheresis to Infusion Apheresis The process starts with scheduling the patient for apheresis, a critical step where the patient’s cells are collected. This step must be meticulously timed to ensure cell viability and optimal condition for subsequent processing and should not be imagined as a simple “blood donation”. Transportation and Logistics: Post-collection, these cells embark on a time-and temperature-sensitive journey. They are transported to the manufacturing facility, using specialized dewars to maintain optimal conditions for cell viability during transit. The transportation schedule must account for factors like distance, transit conditions, international trade regulations, and immediate availability at the manufacturing site. Manufacturing Process: Upon arrival at the manufacturing facility, the cells undergo a sophisticated manufacturing process. Scheduling at this stage must align with available manufacturing slots, resource allocation, availability of processing experts, availability of critical materials, and strict regulatory compliance requirements. Quality Control and Release: Before, during and post manufacturing, the transformed cellular material undergo rigorous quality control checks to ensure identity, viability, safety, and potency critical quality attributes (CQAs) before being approved for disposition to the clinical site for patient infusion. This stage requires careful timing to synchronize QC test result and batch release operations with patient treatment schedules. Return Journey and Infusion: Finally, the personalized therapy is transported back to the treatment center for infusion into the patient. This last leg of the journey requires as much precision as the first, ensuring the therapy arrives in time and in perfect condition for successful treatment. Navigating the Variables Manufacturing Capacity and Resource Availability: Understanding and predicting manufacturing capacity and resource availability including critical materials such as reagents, buffers, and media, qualified manufacturing and quality personnel, and require cell separation and processing system is pivotal. Delays or misalignments with capacity and resource availability can cause significant scheduling disruptions. Regulatory Compliance: Navigating the regulatory landscape is another layer of complexity. Compliance requirements can influence scheduling, often requiring additional time for documentation and approval processes. Just think about international shipments with customs operations. Patient Factors: Patient status and availability and clinical site readiness add another variable to the scheduling equation. Ensuring that treatment schedules align with patient needs and clinical timelines is crucial. The Ripple Effect of Delays or Changes A delay or disruption in any one of these steps can have a ripple effect, impacting the entire treatment schedule and can easily result in the loss of an available manufacturing capacity slot and hence the chance to treat one more patient. The precision required in scheduling (and rescheduling if necessary!) each step of the autologous cell therapy process underscores the complexity of this endeavor. In summary, orchestrating the scheduling for autologous cell therapy is akin to conducting a complex symphony, where timing, coordination, and precision are paramount. The next section will discuss how SAP Cell and Gene Therapy Orchestration (CGTO) addresses these challenges, providing an integrated solution to streamline, manage, and execute these multifaceted scheduling needs. The role of and need for an orchestration layer In the intricate world of autologous cell therapy, the SAP Cell and Gene Therapy Orchestration (CGTO) acts as an orchestration layer, as a platform of capabilities, addressing the multifaceted challenges of treatment scheduling. SAP CGTO is designed to bring coherence and efficiency to the scheduling process, transforming a complex web of tasks into a streamlined, manageable operation. Centralizing Treatment Scheduling Unified Platform: SAP CGTO serves as an overarching platform, integrating various aspects of the treatment schedule. From apheresis to the final infusion, each step is meticulously tracked and managed within this system in an interplay between the patient scheduling, courier scheduling, and manufacturing scheduling. Visibility and Coordination: It provides unparalleled visibility across the entire treatment pathway, ensuring that each phase of the cell therapy process is coordinated and aligned with the next. This visibility is crucial for timely decision-making and avoiding potential bottlenecks. Central Scheduling Service: SAP CGTO provides the central scheduling service. It can adapt to changes and variations in real-time, recalibrating the treatment schedule as needed. This adaptability is vital in a field where delays and unforeseen changes are common. Resource Optimization: The platform also plays a key role in resource optimization. It helps in identifying available manufacturing slots and manufacturing teams, allocate resources to patient product lots and manage consumption based on allocation rules, aligning them with transportation logistics, and ensuring that resources are utilized efficiently. Enhancing Compliance and Quality Control Regulatory Compliance: By integrating regulatory compliance into the orchestration process, SAP CGTO ensures an intact chain of identity and chain of custody. Quality Control LIMS Integration: The platform also integrates quality control checkpoints into the schedule, ensuring that each batch undergoes necessary testing and approvals without disrupting the overall timeline. Bridging Communication Gaps Inter-System Communication: SAP CGTO acts as a bridge between different systems, such as ERP and MES, facilitating seamless communication and data exchange based on an event-driven architecture approach (see this blog for details). This integration is critical for maintaining up-to-date information on resource availability, batch attributes and analytics, and manufacturing capacity. Real-Time Updates and Alerts: The platform offers real-time updates and alerts, enabling quick responses to scheduling changes or adjustments, further enhancing the efficiency of the treatment process. Exception is the Norm: Managing the Unexpected Effectively In the complex and highly individualized world of cell and gene therapy, exceptions in the supply chain are not just possibilities; they are expected occurrences. As one moves from concept to execution, especially given the make-to-order operating model of these therapies, navigating through these exceptions becomes a critical component of ensuring seamless delivery and maintaining the integrity of the treatment process. Anticipating and Addressing Supply Chain Exceptions Recognizing the Inevitability: Based on our conversations in the industry consortium for CGTO, experience in the industry highlighted that treatment orders are likely to encounter numerous issues. These can range from patients becoming unavailable for treatment to unforeseen logistical challenges, as well as quality exceptions based on out-of-specification results. Beyond Quality Exceptions: It’s important to distinguish supply chain exceptions from quality and manufacturing exceptions. While both are critical, supply chain exceptions pertain to the logistics and coordination aspects of the treatment process. The Digital Solution Current Challenges: A key observation from industry players is the lack of digital capability to manage these exceptions effectively. This gap often leads to manual, paper-based, or surrogate solutions, which are less efficient and prone to errors reliant on email, phone call, and messaging communications Exception Management in SAP CGTO: We have added the exception management and task management as core capabilities to SAP CGTO, and we plan to integrate an exception detection and management capability within the SAP CGTO platform to provide a “supply chain control tower”. This integration underlines that SAP CGTO is not just an order management system but a comprehensive solution capable of handling the dynamic nature of cell therapy supply chains. Rule Engine for Event Analysis: All events in the treatment process would pass through a rule engine within CGTO to determine if an exception has arisen. For example, if an order takes longer than expected to arrive at a certain milestone, the rule engine would flag this as an exception. Managing Exceptions with Pre-determined Workflows: Once an exception is confirmed, it would trigger pre-determined workflows to address and mitigate the exception, which could include re-scheduling of further milestones. This process ensures that deviations are handled swiftly and efficiently. After resolving the exception, the order would continue its journey without further disruptions. Communication Integration: Including communications in the process is vital to ensure proper awareness and coordination among all stakeholders involved in the exception management process. The Future of Treatment Scheduling in Cell and Gene Therapy As we look towards the future of cell and gene therapy, it becomes evident that these miraculous therapies will become more mainstream, and more and more patients will hopefully get access to these earlier in their treatment plan and with that, also the processes, including treatment scheduling, are poised for transformative changes. With advancements in technology and a deeper understanding of the complexities involved in these therapies, the potential to improve and “industrialize” the processes of individualized treatments is immense. Embracing Artificial Intelligence AI in Optimization: One of the most significant advancements in treatment scheduling is the incorporation of Artificial Intelligence (AI). AI can play a pivotal role in finding the optimal schedule for each patient’s treatment journey. By analyzing vast datasets, AI can support in scheduling the best times for each step of the process, from apheresis to infusion. AI in Re-scheduling: In situations where re-scheduling is necessary due to unforeseen circumstances, AI can quickly recalibrate the entire treatment plan. This capability will be particularly beneficial in managing the ‘exceptions’ that are commonplace in cell therapy, ensuring minimal disruption to the overall treatment process. Advanced Data Analytics Predictive Analytics: Beyond AI, advanced data analytics will provide deeper insights into scheduling efficiency. Predictive analytics can forecast potential bottlenecks and suggest preemptive actions to avoid delays. Real-Time Data Utilization: The future of treatment scheduling will also see a greater emphasis on real-time data utilization. This approach will allow for more dynamic and responsive scheduling, adapting to changes as they occur. Collaborative Ecosystems Interoperability Between Systems: The future will likely see enhanced interoperability between different healthcare, operations, and logistical systems, creating a more collaborative and efficient ecosystem. Partnerships and Collaborations: Partnerships between technology providers, healthcare institutions, and logistics companies will be crucial in developing comprehensive solutions that address all aspects of cell therapy delivery. Conclusion: Navigating the Future of Cell and Gene Therapy with Precision and Innovation As we conclude our exploration into the complex and evolving landscape of cell and gene therapy scheduling, it becomes clear that this field is at a pivotal crossroads. The challenges inherent in orchestrating individual treatment schedules are matched only by the innovative solutions emerging to address them. The role of technologies like SAP Cell and Gene Therapy Orchestration (CGTO) and the potential of AI and advanced data analytics in this space are not just facilitators; they are game-changers. Reflecting on the Journey Understanding the Complexities: We began by delving into the intricate nature of autologous cell therapy scheduling, highlighting the critical need for precision and coordination at every step of the treatment journey. The Role of SAP CGTO: We saw how SAP CGTO has risen as a central figure in streamlining these complex processes, bringing efficiency, compliance, and adaptability to the forefront of cell therapy operations. Embracing the Unexpected: We recognized that in this field, exception is the norm. The inclusion of exception management within CGTO and its evolution into a supply chain control tower underscore the need for agility and responsiveness in handling the unexpected. Looking Forward The Promise of Technological Advancements: The future of treatment scheduling in cell therapy is bright with the promise of AI, advanced analytics, and other technological innovations. These tools are set to transform the way we approach scheduling, making it more patient-centric, efficient, and adaptable. A Collaborative Ecosystem: The journey ahead also points towards greater collaboration and integration across various systems and stakeholders, from technology providers to healthcare systems, and many others. The path forward for cell and gene therapy is one of continuous learning and adaptation. As we embrace these new technologies and approaches, we not only improve the efficiency and effectiveness of treatment schedules but also enhance the overall patient experience and access. The advances in this field are a testament to the relentless pursuit of better, more effective industry-specific solutions. Join Us at Advanced Therapies Week As we navigate the intricate and evolving world of cell and gene therapy, the exchange of ideas and collaboration among industry leaders, innovators, and practitioners becomes more crucial than ever. To continue this vital conversation and explore these groundbreaking solutions in person, we extend an exclusive invitation to you, meet us at the Advanced Therapies Week in Miami from January 16-19th. This event presents a unique opportunity for you to dive deeper into the world of cell and gene therapy, engage with experts from SAP and our customers as well as our partners, and discuss the latest advancements and challenges in the field. You can meet the L7 Informatics team at their booth #352 and you are welcome to attend the SAP presentation on January 17th at 1pm in Theatre 4. Don’t hesitate to reach out to arrange a meeting with our team at a time that suits you for a meeting in the SAP Lounge! Read the original blog post here. ### L7 LIMS Datasheet Download @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9leGNlcnB0Iiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiIiwiYWZ0ZXIiOiIiLCJ3b3JkcyI6IiIsInJlYWRfbW9yZV9sYWJlbCI6IiJ9fQ==@ ### Reinventing Drug Discovery: The Power of Synthetic Biology and 'Informatics as a Service’ L7 | CHATS customer story@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEw3IEluZm9ybWF0aWNzIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@In the ever-evolving landscape of life sciences, staying at the forefront of innovation is not just an aspiration but a necessity. The quest for breakthroughs and the drive to optimize drug discovery processes have led to a groundbreaking collaboration that promises to reshape the industry. This is the story of Think Bioscience, Boulder BioConsulting, and L7 Informatics - a successful alliance that's streamlining, automating, and optimizing operations to accelerate biosynthetic drug discovery. The Bold Vision of Think Bioscience Think Bioscience isn't your typical biotech company. It's a trailblazer in biosynthetic drug discovery. Their mission? To develop small-molecule therapeutics against elusive targets. Joel Kralj, Director of Platform Innovation at Think Bioscience, explains their ingenious approach that fuses elements from classical pharmaceutical pipelines with the concept of natural selection. The result? The repurpose of synthetic biology by using living systems to guide the design and assembly of better medicines. Informatics as a Catalyst In this journey of innovation, Think Bioscience needed a partner that understood the intricate needs of a small and medium-sized pharma and biotech company. That's where Boulder BioConsulting comes into play. Dan Weaver, Founder and President at Boulder BioConsulting, brings the concept of "Informatics as a Service" to the table. The idea is simple yet game-changing: an integrated approach to informatics support. Boulder BioConsulting's collaboration with Think Bioscience has produced an informatics ecosystem that powers this engine of innovation. They've designed custom NGS pipelines to analyze the colossal amount of data generated by Think Bioscience's synthetic organisms. The result? A complete spectrum of support, including software tools, application assistance, data management, and data analysis. The L7 Informatics Connection One pivotal piece in the informatics puzzle is the L7 Informatics fully digitalized platform, L7|ESP™. Think Bioscience chose the L7|ESP LIMS App for their Laboratory Information Management System. It's an efficient, streamlined solution that plays a significant role in managing and processing data. Its seamless integration of software tools and informatics capabilities becomes the lifeblood that sustains this new era of drug discovery. The Future of Drug Discovery This successful partnership of Think Bioscience, Boulder BioConsulting, and L7 Informatics shines as a beacon of inspiration and a testament to what's possible when innovation, creative problem-solving, and collaboration converge. This collaboration promises to reshape the drug discovery landscape, making it more efficient, data-driven, and groundbreaking than ever before. We hope this story has inspired you, challenged you, and ignited your imagination. If you’d like to watch the full webinar, please follow this link.The keys to streamlining, automating, and optimizing your own operations may be closer than you think. If you're ready to explore the possibilities and witness the power of data analytics and informatics, we invite you to connect with us. For further insights and a product demo, contact us today and embark on your own journey of innovation. ### L7 Notebooks Is a Comprehensive Electronic Lab Notebook that Captures Unstructured and Structured Data for Research, Process, and Assay Development L7 | CHATS product highlight @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyaWdpdHRlIEdhbnRlciB8IHBvc3RlZCBvbiAiLCJhZnRlciI6IjwvaDM+IiwiZGF0ZV9mb3JtYXQiOiJjdXN0b20iLCJjdXN0b21fZGF0ZV9mb3JtYXQiOiJGIGQsIFkifX0=@Paper-based lab notebooks and spreadsheets present well-established logistical, scientific, and data challenges. Annotating experiments, aggregating results and findings, and diligent updates are laborious, time-consuming, and error-prone tasks. Moreover, advances in equipment capabilities such as high-throughput and high frequency measurement technologies have drastically changed the size and complexity of the data generated by study protocols and experimental paradigms in R&D. The current paradigms are incompatible with the current reality of modern R&D. Paper notebooks and spreadsheets simply can’t scale to keep up with today’s business and scientific demands. Paper-based notebooks provide no way to structure data for downstream process analysis, do not connect the broader lab, complicate collaborations, and make historical data retrieval problematic. While spreadsheets address some of the issues with paper notebooks, they come with additional data integrity, sharing, compliance, and intellectual property challenges. L7 Notebooks Addresses the Many Challenges Life Sciences Research Organizations Face L7 Notebooks offers a comprehensive solution to address many of the challenges life sciences research organizations face, especially those that need streamlined operations, flexibility, and the ability to react quickly to market changes. L7 Notebooks benefits include: Move protocols efficiently from research to production, resulting in reduced tech transfer time and improved data integrity and consistency for actionable data analysis. Generate reusable templates to standardize lab processes for improved productivity and precision. Ensure controlled and role-based user access during intra- and inter-lab/departmental collaboration and data security in an environment that meets modern security needs. Configure standardized processes, recipes, and experiments using the L7|ESP entities, such as protocols and workflow components. Quickly and easily query and report batch data to be presented to customers, managers, and other stakeholders. The L7 Notebooks Is Shaping the Entire Life Sciences and Healthcare Value Chains by Streamlining and Optimizing Lab and Business Processes Recent advancements in digital technologies, like the L7 Notebooks App, have started to shape the entire life sciences and healthcare value chains by streamlining and optimizing lab and business processes. Specifically, L7 Notebooks: Digitalizes laboratory processes in research, diagnostics, and therapeutics. Is part of the L7|ESP™ Unified Platform with its Workflow Orchestration system. Dynamically and automatically links entries to L7|ESP data sources. Is a flexible, secure, and collaborative digital and process-oriented solution. Supports the creation of notebook templates, libraries, and entries and enables the import and execution of protocols. Supports both structured and unstructured data. Supports seamless data harmonization and sharing across L7|ESP apps (e.g., point solutions for dedicated departments). L7 Notebooks Outperforms Traditional ELN Systems L7 Notebooks is for Research Scientists and Managers The L7 Notebooks App is for researchers and operational users across research, therapeutics, diagnostics, and AgBio. Specifically, Research/R&D scientists and managers in drug discovery, process development, and analytical development. Operational end users which include lab and R&D technicians, bench researchers, process development engineers and analytical development scientists, lab managers, project/program managers, and GxP expert/quality reviewers. By utilizing L7 Notebooks as part of an L7|ESP Unified Platform, researchers benefit from a seamless integration of structured and unstructured data which is what most experimental paradigms require. This ultimately leads to efficient tech transfer from research to production and streamlined research and production operations. L7 Notebooks is part of the L7|ESP Unified Platform L7 Notebooks is part of the L7|ESP Unified Platform where protocols and notebook library data reside in the same database as LIMS, inventory data, scheduling tools, and a myriad of other applications. It uses existing L7|ESP workflow chain configurations to automate task orchestration. For example, a benchtop researcher can document a sample collection in Notebooks which would automatically schedule the analytical procedure in L7 LIMS and subsequently query the result back into Notebooks for interpretation. ABOUT THE AUTHOR ### Think Bioscience: Creating an Efficient and Transparent Laboratory and Data Management Process Everyday discoveries in pediatric genomics are creating new possibilities to understand and treat rare genetic diseases. This work requires robust computational strength in order to process, analyze, and manage large data sets. Please fill out the form to view the Rady Children's case study ### L7 Notebooks Datasheet Download @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9leGNlcnB0Iiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiIiwiYWZ0ZXIiOiIiLCJ3b3JkcyI6IiIsInJlYWRfbW9yZV9sYWJlbCI6IiJ9fQ==@ ### QIAGEN's Path to Lab Digitalization with L7|ESP™ L7 | CHATS customer story@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEw3IEluZm9ybWF0aWNzIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@In a world where technological advancements are driving innovation across industries, the field of molecular biology and diagnostics is no exception. Helen Pye, a Manager within the Molecular Assay Development Department at QIAGEN in Manchester, UK, shares her journey of implementing L7|ESP, a fully digitalized platform that is changing the game for QIAGEN's laboratory operations. In this blog post, we'll dive into the fascinating digital transformation taking place at QIAGEN and explore the potential benefits of digitalization in the world of molecular biology and precision diagnostics. A Digital System to Improve Efficiency QIAGEN is a global leader in molecular diagnostics and life sciences. With a presence in more than 500,000 customers worldwide and a focus on enabling molecular insights for research and clinical healthcare, QIAGEN is committed to implementing a digital system that would eliminate the need for manual documentation of product development activities. The importance of this transformation becomes evident when considering the impact on patient's lives and the need for stringent documentation required in the development of medical devices. Through this digital transformation, QIAGEN will gain seamless access to data, improving efficiency and quality across their labs. The Power of Collaboration Implementing a digital system comes with its set of challenges. A unique challenge that QIAGEN faced was translating their technical requirements into functional features. QIAGEN's scientists had to communicate with software developers who had no particular background in molecular biology. To bridge this gap, they organized a workshop that allowed the developers to gain a deeper understanding of the lab's operations. This collaboration led to faster implementation of their design requirements, with developers even suggesting additional features that hadn't been considered. The Benefits of Digitalization The benefits of digitalization at QIAGEN are far-reaching. The L7|ESP platform has eliminated the time-consuming process of manual documentation and improved efficiency and quality. The QIAGEN Team can now scan samples, reagents, consumables, and equipment, enabling the system to recognize expired reagents or out-of-calibrated equipment, ultimately improving data integrity. The digital system also tracks and traces each step of experiments, providing clear evidence for reporting. What's Next for QIAGEN Having successfully implemented the digital system, QIAGEN plans to expand its usage across more projects in Manchester. We are also excited about QIAGEN utilizing the L7|ESP Notebooks app for a more fluid documentation process, particularly during the early stages of assay development. They aim to extend this digital revolution to other platforms, including next-generation sequencing and digital PCR, with a long-term plan for global adoption of the digital system. QIAGEN's journey towards digitalization is a testament to technology's positive impact on molecular biology and precision diagnostics. QIAGEN's commitment to innovation and collaboration has led to significant improvements in efficiency, quality, and, ultimately, the potential to make improvements in life through precision diagnostics. Watch the entire webinar for the full story:Don't hesitate to contact us if you have more questions or would like a demo of the L7|ESP platform. ### Implementing LIMS in a GMP Cellular Therapy Manufacturing Facility—Dana-Farber Cancer Institute's Experience with L7|ESP™ L7 | CHATS customer story@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEw3IEluZm9ybWF0aWNzIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@Over the past year, Dana-Farber Cancer Institute's Connell and O'Reilly Families Cell Manipulation Core Facility (DFCI CMCF) has been working to implement a LIMS (Laboratory Information Management System) for their GMP cellular therapy manufacturing facility. In this blog post, we'll take you through their challenges before implementation, their experience with L7|ESP, and the benefits they've realized. A Visionary Leap Dana-Farber Cancer Institute, renowned for pioneering cancer research and treatment work, embarked on a visionary quest to enhance its cellular therapy manufacturing facility. The objective was clear: to refine their operations, ensuring superior quality products for standard patient care and cutting-edge research. This facility operates as a Contract Development and Manufacturing Organization (CDMO), catering to various stakeholders, including Dana-Farber itself, Harvard Cancer Care, and external companies. To appreciate the magnitude of Dana-Farber's operations, one must look into the complexity of their organizational framework. The facility comprises various dedicated teams, each specializing in critical aspects of the manufacturing process. These include process development, a tissue bank, standard care, novel cell therapy production, testing labs, quality assurance, materials management, information management, and business direction. This comprehensive structure empowers them to efficiently handle consumable intake and the production of cellular therapy products. At the heart of their operations lies the clinical-based activity. Dana-Farber's facility is the epicenter for receiving, manufacturing, and banking products for research and clinical use, conducting quality control assessments, and delivering products to Dana-Farber/Harvard Cancer Center hospitals and other external institutions. Transitioning from Paper Records One of the significant challenges the facility faced was the extensive use of paper records for their manufacturing processes. Looking daily at their wall of binders filled with records, the team realized the urgency of embracing a digital solution. It was evident that a transition was necessary, one that would streamline operations, fortify traceability, and minimize paper usage. The implementation of L7|ESP was not just a small step; it was a major leap forward. Dana-Farber approached it with a phased strategy. Phase 1A marked a significant milestone, with the entire compendium being transferred to the new system. This phase was critical for discontinuing the use of legacy LIMS (Sunquest Enterprise) and gaining more control over their LIMS. L7|ESP: A Fully Validated System Dana-Farber's facility went live with a fully validated system during Phase 1B and remains committed to continuous validation for each subsequent phase. This dedication to GXP compliance underpins L7|ESP’s reliability and adherence to stringent regulatory standards. One of the highlights of their LIMS implementation was the creation of the ordering applet. This innovative feature simplifies the process of requesting tests, creating a user-friendly experience. Instead of sifting through standard operating procedures (SOPs) and work instructions, end-users can now effortlessly select tests based on the samples they are processing. This streamlined approach has markedly enhanced end-user satisfaction. Another popular feature among the L7|ESP users, who deal daily with intricate workflow chains, notably in the context of flow cytometry, is the "flex view" for result selection. This feature empowers users to view and choose data from different runs seamlessly, significantly enhancing operational efficiency. Realizing the Benefits and Looking Ahead The Dana-Farber Cancer Institute's Cell Manipulation Core Facility's journey to implement L7|ESP has been an inspiring endeavor. The transition from paper records to a digital LIMS system has brought numerous advantages, including reducing paper usage, improving end-user satisfaction, streamlining their testing and manufacturing processes, and improving their overall efficiency and traceability. The commitment to validation and future phases demonstrates their dedication to continually enhancing their operations. With this enhancement, DFCI CMCF is also receiving training to enable them to add their content moving forward. Additionally, the facility is now gearing up to implement the L7 Manufacturing Execution System (MES) app to offer a holistic approach to operations. To watch the entire webinar, please follow this link.If you're ready to embark on your digital transformation journey, we invite you to contact us. Discover the possibilities of L7’s fully digitalized and unified platform to accelerate discoveries, improve operational efficiencies, and drive innovation. For further insights or a product demo, contact us today! ### L7 UNIVERSE: LIMS in the Era of Gen AI - a Perspective by Quest Diagnostics Participant: Ray Veeraraghavan, Ph.D., Executive Director – Technology, Molecular Genomics & Oncology, Quest Diagnostics Information: In this webinar, Dr. Ray Veeraraghavan, the Executive Director for Technology and Molecular Genomics and Oncology at Quest Diagnostics, provides a comprehensive overview and insightful perspective on the current state and future possibilities of Generative AI in the Diagnostics space, offering valuable insights for professionals in the healthcare and technology sectors. ### For a 3rd Year Running, L7 Informatics Joins the Winner’s Circle Again, Making the 2023 Deloitte Technology Fast 500™ Attributes 2047% Revenue Growth to Companies Moving Away From Costly Data and Operation Silos Austin, TX, November 8th, 2023 — L7 Informatics today proudly announces its inclusion in the prestigious Deloitte Technology Fast 500™, for the third consecutive year. This accolade celebrates the company's extraordinary 2047% revenue growth, a testament to its groundbreaking approach and unwavering commitment to the life sciences sector. Under the visionary leadership of President & CEO Vasu Rangadass, Ph.D., L7 Informatics has become a vital partner for forward-thinking life science enterprises, propelling them beyond the confines of traditional data silos. Rangadass lauds innovative life science companies seeking to optimize data management and streamline their workflows to reduce costs and boost productivity for L7’s revenue growth. He said, "We offer a robust end-to-end solution with unparalleled flexibility that is unlike any other in the industry. Our customers understand that point solutions alone can create costly and inefficient data silos, while unified platforms such as L7|ESP™ now define the new standard of operating." “Each year, I look forward to reviewing the progress and innovations of our Technology Fast 500 winners as these companies truly demonstrate how important new ideas are to progressing our society and the world, especially during difficult times,” said Paul Silverglate, vice chair, Deloitte LLP and U.S. technology sector leader. “While software and services and life sciences continue to dominate the top 10, I’m encouraged to see other categories making their mark. Congratulations to all the winners who show us how creativity, hard work, and perseverance can lead to success.” “As a growing company, it’s always rewarding to be recognized for the ongoing commitment it takes to navigate obstacles, transform when necessary, and ultimately create a thriving business,” said Christie Simons, partner, Deloitte & Touche LLP and industry leader for technology, media and telecommunications within Deloitte’s audit and assurance practice. “Over the nearly 30 years we’ve been compiling the Technology Fast 500, we’ve seen new categories emerge, growth rates explode, and certain regional markets shine from the bright talent they attract. We are proud of all the winners for achieving this well-deserved honor.” In its third consecutive year on the Deloitte Technology Fast 500™, L7 Informatics celebrates its significant revenue growth of 2047%. This achievement underscores the company's innovative approach and dedication to delivering value to the life sciences sector. Led by CEO Dr. Vasu Rangadass, L7 Informatics has been instrumental in helping innovative life science organizations optimize their operations, transcending traditional data silos. The company's unified platform, L7|ESP™, offers unprecedented flexibility and has quickly become an industry standard, driving both cost efficiency and productivity. This recognition reflects not only past accomplishments but also the company's ongoing commitment to transformation, innovation, and a prosperous future. About the 2023 Deloitte Technology Fast 500 Now in its 29th year, the Deloitte Technology Fast 500 provides a ranking of the fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies — both public and private — in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2019 to 2022. About L7 Informatics L7 Informatics, Inc. is a leading provider of integrated scientific data and analytics solutions. The company offers a comprehensive platform that enables seamless data integration, advanced analytics, and collaborative workflows, empowering scientists and researchers to accelerate discoveries, improve operational efficiencies, and drive innovation. L7’s mission is to revolutionize how scientific data is managed, analyzed, and utilized, facilitating breakthroughs in research, drug discovery, development, and manufacturing. ### To read the original press release, click here. ### L7 UNIVERSE: Implementation of L7|ESP™ LIMS for a GMP Cellular Therapy Manufacturing Facility Participant: Joshua Geary, IT Manager, Cell Manipulation Core Facility, Dana-Farber Cancer Institute Information: Over the past year, an L7 implementation team has worked with the to implement LIMS for the Connell and O’Reilly Families Cell Manipulation Core Facility at the Dana-Farber Cancer Institute. The compendium of the facility has been implemented in L7|ESP, 1/3 of the assays going paperless, as well as key product traceability workflow. In future releases, additional workflows will become paperless, testing instruments will be integrated, and the product disposition workflow will be captured in L7|ESP, leading into the implementation of L7’s manufacturing execution system implementation for standard of care and IND manufacturing. ### L7 Informatics Manages and Supports the Entire Lab Workflow from Sample Processing to Data Analysis and Insight Generation Employing Workflow Orchestration The Result Is An Automated, Highly Efficient, and Cost Effective Lab Management Process This month’s “Company Spotlight” provides a closer look at L7 Informatics, the provider of a scientific process and data management (SPDM) solution to streamline and optimize lab processes and accelerate insights delivery for research, diagnostics, and therapeutics with the overall goal of better patient outcome. I spoke with Vasu Rangadass, CEO of L7 Informatics, about L7’s Unified Platform L7|ESP™ which facilitates workflow orchestration, ultimately leading to streamlined processes, increased efficiency, and reduced cost, all within a platform that supports collaboration and compliance. L7 Informatics is headquartered in Austin (TX), has about 180 employees, and has received ~$62.2M in total funding. Following is my interview with L7 Informatics’ President and CEO, Vasu Rangadass, Ph.D.. EB: Tell us more about L7 Informatics – what business and market needs are you addressing, and with what products and services? VR: L7 with its product and services is addressing the life sciences market, anything in the biology and sciences sector. To answer it more succinctly, while we initially focused on the research biology sector, we quickly realized that our platform could easily support any aspect of life science. The life sciences field is very broad; think basic research, drug development, diagnostic test development, clinical trials, or even aspects outside of classical life sciences, including agriculture. L7 with its platform supports all the needs individual contributors in those areas have throughout their journey of science, all the way from research to discovery to development of diagnostics or therapeutics, and beyond. For example, we also support the diagnostics and healthcare sector where those diagnostics and therapeutics are used to help physicians with treatment decisions, making for better patient outcomes. With our L7|ESP (Enterprise Science Platform) platform we support the entire value chain of science, including healthcare. This includes organizing, tracking, and quality controlling each and every entity from a sample all the way to results and insights and next steps such as the next experiment, a diagnostic test result, a drug candidate, or the final treatment decision. L7|ESP controls and streamlines the various workflows associated with these processes and increases the return on investment (ROI). Instead of looking at it with a siloed Laboratory Information Management System (LIMS), Electronic Laboratory Notebook (ELN), Manufacturing Execution System (MES), or Laboratory Execution System (LES), L7|ESP is looking at it from a holistic point of view and trying to address the scientific problem from both the technology and business sides. Specifically, L7|ESP: Improves scientific problems that need to be resolved, both from a technology side and an application side Addresses the challenges of sample and data management Addresses the challenges of workflow management Improves scientific problems related to efficiency Addresses the need to execute faster, better, and more economically The overall outcome is a higher return on investment. One of the domains that we are active in is the domain of genomics. We are talking advanced therapies like cell and gene therapies (CGT), RNA medicines, molecular diagnostics, or the development of new seeds with genomically modified better traits. In a broader sense, it’s all about the biological sciences of genomics and its implications (see the L7 Precision Medicine workflow as depicted in Figure 1). Figure 1: The L7 Precision Medicine workflow as supported with the L7|ESP platform. EB: You offer L7|ESP as a software solution – with L7|ESP standing for Enterprise Science Platform? What makes L7|ESP unique? VR: What makes L7|ESP unique is the way it was built from the start. It was designed from the ground up like an operating system or a platform for science. We did not go about solving a particular laboratory process problem, or a particular area in chemistry, biology, agriculture, diagnostics, or in pharma. Rather, we took a step back and realized that when looking at all these different segments, there are many LIMS offerings from hundreds of LIMS companies, and there are also hundreds of electronic lab notebooks (ELNs) offerings on the market. We said, let’s build one platform that solves any science workflow/process problem. “This is what makes L7|ESP unique; it is not designed to solve a particular type of science problem. It is designed to solve any science workflow problem.” And it does not matter whether it’s in biology, chemistry, diagnostics, research, or in manufacturing of drugs. Because, at the end of the day, these are all scientific processes or scientific workflows that need to be executed, monitored, controlled, and done so repeatedly. EB: When thinking of other players in the market, how is L7 positioned in that market and how do you differentiate yourself from them? Why should one consider L7 over some of them? Because of L7 Informatics with its L7|ESP platform and the multitude of Apps within, L7 is competing with many players in the market and this predominantly because we see that the future lies within a single data/process platform to run those workflows across all scientific processes – call it Industry 4.0 or fully digitally transformed businesses. Running research and clinical processes in multiple systems, or in other words, performing assay development or product development in one system, managing manufacturing in another system, and running tests with yet another system does not make any sense! Having to transfer the knowledge and insights gained and to be managed across the entire value chain from research to drug development to clinical trials, to manufacturing, and eventually to commercialization slows down and complicates the entire process if managed via individual freestanding solutions. The result of this is high drug development costs, which the industry is facing across the board. Not having an optimized, efficient, one platform process increases the cost and time at which we can bring new therapeutics and diagnostics to market. “The IT component, with its broken enterprise architecture, is a huge contributing factor to the sky-high average cost of developing a new drug which is approximately $2.3 billion. A fully integrated data platform will help speed up the development of diagnostics and therapeutics, in addition to reducing the overall development cost.” EB: What excites you about L7 Informatics, why did you join the company? What keeps you going every day? VR: My Ph.D. is in AI and machine learning, and still today, I struggle with the way enterprise organizations collect and manage data. To be able to use AI and machine learning successfully, lots of well-organized and structured data is required. I am a firm believer in bringing better health to this world, but at a faster pace and lower costs, and not the way it is done today. Today, everything is expensive and slow. To address both the cost and speed components, automation is required, in addition to predictive modeling and self-optimization systems. But again, to do that, you need clean data. And to get to clean data and a state where things work better, faster, and cheaper, one needs to put all the technologies together into one platform. “Current enterprise architectures are too siloed.” My vision and passion are to optimize the way we bring medicines, diagnostics, and overall better health to the larger population. That includes better medicines and more targeted treatments, and all at lower cost. It’s all around better health or more precise health and how we can help companies bring that to the market. While there is a lot of innovation happening, innovation can get killed if you are not economical and cost-effective. EB: The L7|ESP platform is populated with a large library of content, such as workflows, data models, and analytics, and includes a series of apps running on top of it. What is the flexibility for the end user to pick and choose a set of standard content and apps for their specific use? VR: With designing and building L7|ESP, we’ve taken a lot of concepts from how the smartphone industry evolved. All the content is stored in what we call the L7|HUB, which is like an app store. L7 customers have their own app store – or in other words, their repository of portable content, including workflows, data models, and analytics packages – that is connected to the L7 app store where we load all the content. Customers can pick and choose what content they want to download into their repository. Content includes equipment, connectors, protocols, their own scientific experiments. This allows for tailored and optimized product content because not everyone is performing the same science experiments. Our goal is to build a library of scientific protocols, instruments, equipment, reagents, connectors, again, to reduce the cost of implementation of software, but also to dramatically increase the productivity of each organization and their scientists. But more importantly also to make sure that all the workflow data is captured in a structured way. If the tools do not support easy capturing of structured data by directly talking to the instrument, processes cannot be efficient because scientists do not have the bandwidth to do this consistently across the entire experimental workflow. Hence, we enable through the content store/repository (i.e., L7|ESP Apps, L7|ESP Content, or L7|ESP Connectors) rapid creation of new experiments or new workflows without having the scientists to do the actual work of implementation or having IT personnel to create those workflows. We see this as a high-value content strategy. Another critical dimension is collaboration support among research scientists, but also individuals working in a diagnostics laboratory. Sharing scientific experiments, including protocols, data, results, and insights is an absolute must, but there are still limitations to do all this easily in today’s science environment. While researchers can share results or the data, there is no easy, standardized way to share methods/protocols that were used to run the experiments and create the data. Still today scientific protocols are predominately shared via sharing a word/PDF document, but that is not the approach one should have to take ever. Rather you want the protocol that immediately can be executed to produce the same type of result. The analogy is very similar to sharing a song. One does not want to share the sheet music; one rather wants to share and receive the MP3 file that one can immediately listen to. “The field of science is still quite backwards.” We have advanced in the science of instruments, and we can investigate cells at the subcellular and even molecular level, we can split and grow them, we can transform them and grow them into induced pluripotent stem cells (IPSCs) or organoids and do all kinds of cool experiments, but as scientists, we cannot easily share two scientific experiments among each other. The L7|ESP platform has an integrated scientific language that allows individuals to share experimental information, not just on paper, but in an executable format. Of course, you need to have L7|ESP on both sides to play the “music of science” just like you need an iPhone or a computer to play the music or open a media file. This is what L7|ESP is all about and what we are bringing to the market. EB: Let’s talk about the scientific content. Is your platform supporting, for example, the annotation of a gene panel analysis when reporting the results? Does L7|ESP include annotating some of the findings, or is that something that the end user can do by linking their internal data to it? VR: It depends on where you are on the scientific spectrum. For example, if you use an ELN, we allow users to do the experiment, get the data, and then annotate it. But if someone runs a high throughput setup with thousands of samples in a few hours, then people write business rules to make sure that they are annotating it electronically through business rules, all within L7|ESP, because you don’t have time to manually do it. A good example is a massive scale COVID testing that we did. To efficiently do that, you need to run a statistical analysis tool with the output providing with high confidence whether a patient has COVID or not. This cannot be performed manually. Rather, the solution is a backend analytics program linked to a 384-well plate reader and then annotating all the 384-well plate samples. This is all fully automated. It really depends on the specific experiment and what you are using it for. L7|ESP supports both low-scale, manual, and high-scale, automated workflows, so both approaches. What you can do in L7|ESP is to write execution pipelines that integrate instruments, equipment, ERP systems, or a knowledgebase like ClinVar that has variant to disease information. And that is the beauty of L7|ESP, it is not just supporting the wet lab experiment side of things, it’s going beyond that and includes the support of dry lab components of scientific experiments just as well. Therefore, L7|ESP can talk to any system from sample (wet lab) to data and insights (dry lab) following strict business rules. At the end of the day, automatic annotation means I need a physician or some scientist to say, this is how you need to annotate it and our technology supports that, but of course, someone needs to write the rules for specific use cases, such as for example, a diagnostics test pipeline. We provide a low-code/no-code environment that allows, what I call a citizen developer or a master scientist, to set up the rule set without having to depend on a computational researcher/programmer to do it. “L7|ESP can talk to any system from samples (wet lab) to data and insights (dry lab) following strict business rules.” EB: From an infrastructure perspective, what is required to run L7|ESP? Does it run exclusively in the cloud, or can it also be deployed behind the firewall or as a local install? VR: L7|ESP is cloud agnostic and therefore can be run on any cloud, e.g., Microsoft Azure, Google, or Amazon cloud. We also have L7|ESP running behind the firewall, on premise, or in the private customer cloud. The reason why we are cloud agnostic is because we work a lot in regulated environments, and in regulated environments you cannot easily upgrade the software, which also means, we can only upgrade when the customer wants to upgrade. Hence, it does not make sense to provide L7|ESP as a SaaS-managed system. We let the customer decide when they want an upgrade and not force them into an upgrade. Since lots of our customers use the cloud, we simply share our upgrade via Docker containers – operated via a Kubernetes system – into those various cloud environments. “L7|ESP is cloud agnostic and therefore can be run on any cloud.” EB: How does L7 Informatics prioritize product extensions/updates? Are they market-, business-, or customer-driven? How many product updates/releases do you have per year? VR: All of the above. We do learn a lot from our sales cycles and the feedback that we receive. In addition, of course, we always talk to existing and prospective customers which guide us in understanding what kind of product enhancements they would like to see implemented, or new applications they are developing to support new processes and businesses. Lastly, we also have an internal product strategy team that is actively looking into what research and business areas we need to invest in, what new features and capabilities we should be adding, and how we can make the product easier to use from creating new experiments to running them, to collecting data and to analyzing them. So, we are constantly working on making L7|ESP better for our customers. Product updates (i.e., point releases, like 3.1 to 3.2) happen twice a year, with major releases (i.e., whole number releases, like a change from 3.x to 4.x) only happening about every two to three years. EB: Who are some prominent L7 Informatics customers and how do they utilize L7|ESP for their internal purposes? How has your platform improved their overall processes? VR: One prominent customer that comes to mind in the molecular diagnostic sector and that has actively implemented the L7|ESP platform to support all their workflow needs is QIAGEN. They are active in the companion diagnostics IVD sector. They have been using paper-based records for capturing all the scientific data – we are talking large amounts of scientific data of 100 pages or more. Using L7|ESP we completely turned an extremely manual process into an electronic and fully automated one with individual workflow contributors pushing the pipeline forward when certain components are finished, and metrics are met. We achieved this by integrating all workflow components, including all instruments (e.g., sequencers), reagents, sample processing information, proprietary algorithms for data analysis, and insights capture. Another good example of how our customers use L7|ESP is Quest Diagnostics. They have highly automated laboratories and processes, and L7|ESP is fully integrated with their robotic systems and this in real time. The robots are moving samples from one station to another and this in a completely automated touchless fashion. As you can imagine, they are processing thousands of samples every month which results in the automatic generation of high-volume scientific data and reports. This is a highly complex process that we fully support. “L7|ESP can support both high volume, automated robotic processes or semi-automated and human quality-checked processes with a human allowing the process to move forward with the push of a button.” EB: We live in a time of data explosion, complex clinical processes with many stakeholders being the norm, clinical whole genome sequencing being established, multi-omics data applications soon requiring clinical support, and ChatGTP or other AI approaches in the near future or already being applied to EHR clinical decision-making. VR: My PhD is in AI and machine learning and people keep forgetting that the contextualization of the different pieces of data is the most important aspect when it comes to AI and data sciences. For AI applications to work one needs lots of contextualized and structured data. It is very difficult to contextualize data after the fact. Anytime you try to contextualize data after the fact, the result is an expensive, prone to failure approach. Automating the execution of any workflow is the cleanest way of contextualizing any data set. Without contextualization, machine learning algorithms will be trained with wrong or bad input data which results in a subpar algorithm which will provide bad predictions/answers. So, the feeder data to train an AI/machine algorithm or ChatGPT kind of tool – whether it’s generative AI or predictive AI – must be optimal. Hence, getting the most accurate and contextualized data is the most important aspect for these AI and machine learning algorithms to work. AI tools will always give you an answer, but you want an answer that is not far from the truth. This is where L7|ESP comes into play. L7|ESP helps contextualize all data from wet to dry lab, including which vendor reagents were used, what equipment/instruments were used, who are the scientists that performed what experimental step, whether the equipment was calibrated and when exactly, what were the quality metrics at certain workflow steps, and so on. All the data and metadata is collected from any system that is integrated with L7|ESP. Clearly, there is a lot that goes into making a successful scientific experiment and it can even get very complex in high-throughput clinical molecular diagnostics labs. And sometimes an experiment works and sometimes the experiment fails, or similarly high-throughput labs can be challenged by bad reagents or instrument challenges that will have an impact on the entire pipeline. To be and stay in control of the lab data generated, ideally all those various data points are collected in a contextual way, because only that way one can troubleshoot an issue quickly. Because L7|ESP runs those workflows, all the data generated is contextualized and is therefore ready for research and clinical applications, including test outcome predictions, assay comparisons, and process troubleshooting – if there is a need for that. That, of course, includes metadata. For example, if I run a PCR experiment and use a particular set of QIAGEN reagents with a Fluidigm instrument – this is contextualizing all the information. It is not just about the results of the experiment; it is also about how the experiment was performed. And then in some cases it failed because I am using a reagent from vendor X (e.g., lot B), but in other cases it was successful because I was using a reagent from vendor Y. Clearly, one can then go back and use this information to understand that lot B from vendor X was consistently bad, maybe contaminated. It is not just the science, the experiment, and the sample, there is so much that goes along with any experiment. It is important to feed an AI engine with all the contextualized data, not just the scientific data. EB: So, if you were to think about the whole ChatGTP and AI approach that is taking off right now, independent of L7|ESP, but still thinking about the entire process, what are some of the pros and cons resulting from that? VR: I think it is a little too early. I know ChatGPT is already out of the cage. It is running wild. You cannot ignore it for sure. There are lots of approaches that one can take and optimizations to help businesses. We are talking to a few customers that are providing us with examples of actual use cases where it will help the business. I want to make clear that I am not a big believer of using technology for the sake of technology. I am always a believer of saying technology needs to add value, either in terms of bringing a drug to the market faster or making it more efficient to save money. It must make some economic sense to use the system, not just, “Oh, it’s cool technology.” Certainly, we at L7 are also playing around with ChatGPT. From a generative AI perspective, it creates some interesting possibilities, and hopefully in the future one can say, “Hey ChatGPT, generate an experiment using the Illumina sequencer NovaSeq X, but for RNA extraction use the QIAGEN QIAcube HT platform in combination with reagents from this vendor A.” With L7|ESP you already do not have to manually create such a pipeline. It will learn from how you had previously done your experiments and hopefully come 99.9% close to creating that experiment. In L7|ESP, we have defined a meta language for representing experiments. So, we can teach ChatGPT, not just English, but other meta languages that are proprietary to L7 Informatics. And then we can teach it to rapidly create new experiments without having a scientist create them. Link to the original article. Brigitte Ganter, Ph.D. – enlightenbio Guest Blogger Brigitte Ganter, is currently Sr. Director of Product Marketing at L7 Informatics. Prior to her work at L7, Brigitte had founded enlightenbio LLC where she oversaw as General Manager all aspects of the company’s activities with particular focus on product management and product marketing services, including market research reports. Brigitte holds a PhD from the Swiss Federal Institute of Technology, Zurich (ETH Zurich) and conducted her post-doctoral work at Stanford University. Her broad industry experience includes positions of increasing responsibility predominantly in the role of Director of Product Management at several biotechnology/technology startups (Iconix Biosciences, Ingenuity System , DNAnexus). ### L7|ESP™ Manufacturing Execution System (MES) – Signature Flows: Configurable Electronic Signatures to suit your Operational Needs L7 | CHATSproduct update@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFthdXRob3J0aXRsZV0gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Introduction Following on from the L7 MES app introduction, let us have a deeper dive into the features that set the L7 MES app as the right choice for pharmaceutical manufacturing. In this blog, we explore electronic signatures and how L7|ESP and the L7 MES app approach and provide a unique and flexible solution. In Figure 1, have a quick look at how we represent electronic signatures in EBR. What is the importance of electronic signatures to an MES and EBR system?Figure 1: L7 MES Electronic signature locked Data in EBRElectronic Signatures as part of CFR Part 11 Compliance in an MES Electronic signatures are crucial to CFR 21 Part 11 compliance in a Manufacturing Execution System (MES) because they authenticate and secure electronic records, ensuring data integrity and authenticity. CFR 21 Part 11 is a regulation set by the FDA (Food and Drug Administration) that establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. In an MES system, electronic signatures provide a traceable record of who performed an action and when it was performed, which is essential for audit trails. This not only enhances accountability but also facilitates regulatory compliance, making electronic signatures a key component in maintaining the integrity of manufacturing processes and quality control within regulated industries. Authentication: Electronic signatures authenticate electronic records, ensuring that the data is coming from a verified source. Security: They provide a secure way to sign and approve electronic records, reducing the risk of data tampering. Data Integrity: Electronic signatures help maintain data integrity by providing a traceable record of who performed an action and when it was performed. Audit Trails: They are essential for creating audit trails, which are necessary for regulatory inspections. Accountability: Electronic signatures enhance accountability by clearly indicating who approved or performed a certain action. Regulatory Compliance: They facilitate compliance with regulatory requirements such as CFR 21 Part 11, which is crucial in regulated industries like pharmaceuticals and medical devices. Quality Control: In an MES system, electronic signatures play a key role in maintaining the integrity of manufacturing processes and quality control. How the L7 MES application adds industry knowledge to our solution. Signature Flows – A unique approach to electronic signatures that allows maximum flexibility on design and variable levels of control, specific to your process and the needs of your GXP documentation. Design different electronic signatures for your different departmental needs: Signature Flows can be configured for all your manufacturing and testing needs in L7|ESP applications. You can design the right signatures for MES, QC LIMS, and Notebooks. Use your GXP documentation’s terminology: Match L7|ESP Signature Flows to your GXP documentation terminology and regulatory meanings for signees, i.e., reviewer, approver, performer, verifier, witness, and any other format to suit your business process. IAM permissions tie directly into Signature Flows: Ensure you have only the right personnel signing for steps that are critical and of regulatory compliance importance. Create users who have roles and belong to workgroups, then assign who can sign with what role, or use workgroups to control users who can sign. Control progress at critical points in process: Place signature flows in any step to block progress until signed or simply use to lock data after steps are performed and verified in a parallel process. Note: Steps can be edited using quality review unlocking with QA permissions.Figure 2: Configuring Signature Flows in L7|Master is Simple and FlexibleObserve a task and nominate the performer: Allow people to continue work on steps where they are indisposed and cannot sign for every step performed. A manufacturing technician working in a Bio-safety cabinet or a laminar flow hood, performing multiple batch record steps while cleaned in can be observed and nominated for the activities they perform while all the data is captured contemporaneously by the observer. All steps captured and signed by observer can be signed at a later stage by nominated performer while still locking the captured data. See Figure 3 for an example of this approach.Figure 3: Observed by / Performed by with nomination – Variable signature flowBelow in Figure 4, we can see a library of signature flows created and ready to use in different scenarios within your manufacturing and testing processes. The signature flow assigned to steps in the master batch recipe applies the control and assurance you require while carrying out critical steps and capturing contemporaneous data in your process.Figure 4: A library of Signature Flow Definitions in L7|MASTER designed and created by you for your processes!Final Thoughts L7|MES application as part of the L7 Enterprise Science Platform (L7|ESP) provides a holistic manufacturing operations management experience. Signature Flows are just another way we try to cater for our customers’ needs for functionality, compliance, and MES flexibility. We are continually improving and adding additional applications to our unified platform to really tackle the needs of our customers and to provide the end-to-end infrastructure required to really accelerate and normalize biotech and C> businesses to their full potential. Standard functionality and features of L7|MES app for your CMC, Development, Tech transfer and CGMP needs:ABOUT THE AUTHOR ### L7 UNIVERSE: Metatransciptomic Sequencing for Pathogen Detection in Synovial Fluid and Beyond, empowered by the L7|ESP Platform Participant: Justin Wright, Co-Founder, Executive Vice President of Data Analytics, Contamination Source Identification (CSI-Dx) Information: Here we introduce the cutting-edge CSI-Dx® assay, a RNA-based sequencing technique designed for detecting pathogens in disease states such as Prosthetic Joint Infections (PJIs) and Sepsis. This presentation provides a concise overview of the CSI-Dx® test system and its potential applications. Discover the outcomes of a collaborative study with Zimmer Biomet involving over 320 synovial fluid samples, showcasing the clinical efficacy of CSI-Dx® and its transformative impact on pathogen detection. This collaboration highlights the assay’s role in providing crucial insights into pathogen detection and the downstream potential for better understanding functional gene expression. Integral to CSI-Dx® is the L7|ESP platform, functioning as a robust Laboratory Information Management System (LIMS) and platform solution. Join us to grasp the essence of CSI-Dx’s® innovation, its clinical significance through a substantial collaborative study, and the streamlined data management offered by the L7|ESP platform. ### L7 UNIVERSE: Think Bioscience & Boulder BioConsulting - Delivering a Unique Biosynthetic Platform on L7|ESP Through Informatics-as-a-Service Participants: Joel Kralj, Director, Platform Innovation, Think Bioscience Dan Weaver, President, Boulder BioConsulting Information: Think Biosciences utilizes an innovative biosynthetic platform to identify small molecule inhibitors against challenging protein targets. This synthetic platform presents unique informatics system requirements to support and accelerate their drug discovery projects. To rapidly overcome the informatics hurdles while maintaining cost-efficiency, Think partnered with Boulder BioConsulting (BBC). BBC is a life science informatics consulting company specializing in solutions and services for small- and mid-sized pharma and biotech enterprises. Through the “Informatics as a Service” approach, Think Biosciences and BBC jointly identified L7 Informatics as the ideal foundation to address Think’s use case. This talk will describe Think Bioscience’s novel platform, explore their successful collaboration with Boulder BioConsulting, and elaborate on the process used to identify L7 Informatics as the optimal solution. The presentation will showcase how this three-way partnership culminated in the swift and efficient delivery of Think Biosciences’ desired informatics solution. Attendees will also gain insights into the power of “Informatics as a Service” in catalyzing groundbreaking advancements within the biotech industry. ### L7 UNIVERSE: L7|ESP Has Enabled QIAGEN Laboratory Digitalization Participant: Helen Pye, Manager, QIAGEN Information: At the heart of QIAGEN’s business is a vision to make improvements in life possible. We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe. QIAGEN Manchester is a world leading centre for molecular diagnostic applications, expanding and enhancing the delivery of life-improving diagnostic systems for existing and emerging medical needs, with a focus on companion diagnostics and personalized healthcare in infectious disease and oncology. Working in a regulated environment comes with strict documentation practices. Transitioning from recording everything on paper to a digitalized system brings it’s challenges but also its rewards. This presentation will introduce how QIAGEN has been successful in using L7|ESP and customizing it to our needs to bring QIAGEN Manchester into the digitalization world. ### The Future of Precision Diagnostics: 10 Benefits of Enhanced Informatics and Digitalization L7 | CHATS thought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEpvbiBTdGFja3MgfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Enhanced informatics and digitalization offer numerous benefits to diagnostics, including improved speed, accuracy, personalization, and efficiency. The potential to revolutionize diagnostics in several key ways, in turn, leads to significant benefits for healthcare systems, patients, and medical professionals. Here are some of the key ways in which diagnostics will benefit from these advancements: Faster and more accurate diagnoses: Enhanced informatics and digitalization allow for the rapid processing of large volumes of medical data, such as electronic health records (EHRs), medical images, and genetic information. This can lead to quicker and more accurate diagnoses, helping healthcare professionals make informed decisions more efficiently. Predictive analytics: Advanced data analytics and machine learning algorithms can analyze patient data to identify patterns and trends that might not be apparent to human clinicians. This can help in predicting diseases, understanding disease progression, and assessing the risk of developing specific conditions. Personalized medicine: Digitalization allows for the creation of patient profiles that take into account individual genetic, lifestyle, and environmental factors. This information can be used to tailor treatment and diagnostic strategies for each patient, ensuring more effective and personalized care. Telemedicine and remote monitoring: Enhanced informatics and digitalization enable remote diagnostics and monitoring. Patients can have their health status assessed without visiting a physical clinic, which is especially beneficial for those in remote or underserved areas. Telemedicine can provide continuous monitoring for chronic conditions, improving early detection and management. AI-assisted diagnostics: Artificial intelligence (AI) and machine learning can assist healthcare professionals in making more accurate and consistent diagnoses. AI systems can analyze medical images, such as X-rays, MRIs, and CT scans, and help identify abnormalities or potential issues, reducing the risk of human error. Data sharing and collaboration: Digitalization facilitates the sharing of medical data among healthcare institutions and professionals, leading to better collaboration and a more comprehensive view of a patient's medical history. This can reduce redundant tests, improve care coordination, and enhance overall patient outcomes. Remote consultations and second opinions: Patients can consult with experts from around the world, reducing the need for travel and providing access to specialists in rare conditions. Digital platforms enable the sharing of medical records and images, making remote consultations and second opinions more accessible. Continuous monitoring and early detection: Wearable devices and IoT (Internet of Things) technologies can provide continuous monitoring of vital signs and health metrics. This allows for the early detection of health issues, helping individuals take proactive measures and seek medical attention when necessary. Quality improvement and research: Enhanced informatics and digitalization provide valuable data for quality improvement initiatives in healthcare. It also supports medical research by providing large datasets for studying diseases, treatment outcomes, and epidemiological trends. Cost reduction and resource optimization: By streamlining diagnostic processes, reducing the need for physical infrastructure, and avoiding unnecessary tests and treatments, enhanced informatics and digitalization can lead to cost savings in healthcare systems. These advancements have the potential to transform the way healthcare is delivered, making it more patient-centric, data-driven, and cost-effective.ABOUT THE AUTHOR ### L7 UNIVERSE Panel Discussion: Overcoming Challenges in the Digital Transformation of Research & Diagnostics Labs Panelists share their unique digital journeys in the transformation of their labs, their individual start and end points, the challenges along the way, and what the future holds for all of us in the lab. MODERATOR: Arvind Ramakrishnan, Vice President of Customer Solutions – Research & Diagnostics, L7 Informatics PANELISTS: Ray Veeraraghavan, Ph.D., Executive Director – Technology, Molecular Genomics & Oncology, Quest Diagnostics David Sexton, Vice President of Digital Lab Systems, Harbinger Health Brendan Arbuckle, Chief Information Officer, The Jackson Laboratory Mike Heinz, Assistant Director, Genome Technology Access Center at the McDonnell Genome Institute, Washington University in St Louis Kannan Jagamoorthy, Vice President and General Manager, Americas, Zifo ### L7 UNIVERSE Panel Discussion: Coming of Age - Cell & Gene Therapy Digitalization Panelists share approaches and challenges associated with digitalization of manufacturing, testing, release, and supply chain management of cell and gene therapies. MODERATOR: Marcia Blackmoore, Vice President of Customer Solutions – Therapeutics, L7 Informatics PANELISTS: Olive Sturtevant, MHP, Administrative Director, Dana-Farber Cancer Institute Dominic M Clarke, Ph.D., Chief Scientific Officer, Orange County Bio Lindsey Stinson, GMP, Application Systems Specialist, Vernal Biosciences Trent Carrier, Ph.D., MBA, Chief Operating Officer, L7 Informatics ### Translating Research Processes into Manufacturing Therapeutic Outcomes L7 | CHATS thought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEpvbiBTdGFja3MgfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Translating research processes into manufacturing therapeutics involves a complex and highly regulated journey from the laboratory to large-scale production. Informatics systems play a crucial role in managing and optimizing this transition. Here's a summary of how informatics systems lend a critical element in this process: Data Collection and Integration: Informatics systems facilitate the collection and integration of diverse data sources, including genomics, proteomics, and clinical trial data. This integrated data helps researchers make informed decisions during the development phase. Experimental Design: These systems assist in designing experiments, helping researchers plan and execute experiments more effectively. They can analyze historical data to optimize experimental parameters. Data Analysis and Interpretation: Informatics systems aid in analyzing experimental results, identifying patterns, and drawing meaningful conclusions. Machine learning algorithms can assist in identifying potential therapeutic candidates and predicting their efficacy. Regulatory Compliance: Manufacturing therapeutics involves complying with strict regulatory standards. Informatics systems help track and ensure compliance at every stage, from research to production, to meet the stringent quality and safety requirements of the pharmaceutical industry. Inventory Management: Managing reagents, chemicals, and other supplies is critical in research and manufacturing. Informatics systems can help maintain accurate inventory records, reducing the risk of delays and errors. Process Automation: These systems can automate repetitive tasks in manufacturing, reducing human error and ensuring consistency in product quality. Automation also helps scale up production to meet demand. Quality Control: Informatics systems enable real-time monitoring of quality parameters during the manufacturing process. They can flag any deviations from established standards, allowing for rapid corrective action. Supply Chain Management: Coordinating the supply chain is essential for the timely delivery of raw materials and the distribution of finished therapeutics. Informatics systems can optimize the supply chain, ensuring efficient and cost-effective operations. Data Security and Privacy: Protecting sensitive research and patient data is paramount. Informatics systems implement robust security measures to safeguard data from breaches or unauthorized access. Collaboration and Communication: Effective collaboration among researchers, manufacturing teams, and regulatory bodies is essential. Informatics systems facilitate communication and knowledge sharing, enhancing coordination across departments and organizations. Data Archiving and Retrieval: Storing and archiving research and manufacturing data is essential for long-term reference and regulatory compliance. Informatics systems ensure data is easily retrievable and securely stored. Continuous Improvement: These systems support the implementation of continuous improvement methodologies, such as Six Sigma or Lean Manufacturing, by providing data for process optimization. In summary, informatics systems serve as a critical bridge between research and manufacturing in the development of therapeutics. They enable efficient data management, process optimization, compliance with regulatory standards, and effective communication, ultimately speeding up the transition from the lab to large-scale production and improving the quality and safety of therapeutic products. ABOUT THE AUTHOR ### L7 UNIVERSE Keynote: Achieving Growth, the Lifeblood of Life Sciences and Diagnostics Companies, with L7|ESP™ Participant:Vasu Rangadass, CEO & President at L7 Informatics Information:Operational expenses are coming under scrutiny with value generation and return on investment taking center stage. Despite automation efforts, science product process design has remained a mostly manual, cognitively demanding task, making it time-consuming, labor-intensive, and error-prone. Not making it any easier, the life sciences product value chain is complex and very opaque. One of the reasons for this is the complex and disjointed IT infrastructure that has evolved over several decades. The fully digitalized novel platform L7|ESP will enable the much-needed growth of life science and diagnostics companies to accelerate science, by improving the speed to market products, simplifying IT infrastructure, and optimizing resource utilization across the entire product value chain. ### L7 MES Datasheet Download @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9leGNlcnB0Iiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiIiwiYWZ0ZXIiOiIiLCJ3b3JkcyI6IiIsInJlYWRfbW9yZV9sYWJlbCI6IiJ9fQ==@ ### L7|ESP™ 3.2 is Better, Faster, and Stronger! L7 | CHATS product release@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEw3IEluZm9ybWF0aWNzIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@First off, a big “Thank You” to all our customers for actively sharing their insights about L7|ESP - it’s our mission to continuously adapt and enhance product capabilities to help our evolving customers achieve their work goals. The Daft Punk song Harder, Better, Faster, Stronger nicely applies to our latest L7|ESP release, L7|ESP 3.2, where we focused on improving performance stability to ensure fast operations. Enhancements made to the platform now support faster, and stronger performance even when the database size increases. Additional release highlights include an improved Notebook UI for easier navigation, review and approval of Notebook entries, streamlined L7|HUB™ bundles into the creation and update process, and several updates to L7|MASTER™, formerly known as Builder, to support more LIMS and MES processes. Here are some release highlights. Notebooks Notebooks library creation and management The Notebooks app now has an improved UI where users can create a new notebook library that will be used to organize the entries created during experiments. The Notebooks tab also supports easy navigation through existing notebooks using search, filter, and manage functions. Signatures in Notebook Entries L7|ESP now allows assignment or modification of a signature flow after creating the notebook entry. This allows users to submit a notebook entry for review by selecting “Request for Review” after making changes to the entry. L7|HUB L7|HUB: Bundle Review - signed Bundle approval and retraction Added the ability to Plan a Bundle Review for new and existing bundles. Relevant stakeholders can approve or reject the developed content solution. Bundles planned for review can be modified or deleted as needed. Bundle Reviews can also be retracted. After a Bundle Review is created it can be monitored to determine how many signatures are needed easily and the flow of approvals. L7|MASTER™ (formerly Builders) Renamed the Builders app to L7|MASTER. Container Statuses to Support MES & LIMS Containers may now be assigned a status. Users can also specify that the status of a container changes after a selection is saved to the database. Super User Access to Protocols and Workflows Super users can now see workflows where a particular protocol is used or the workflow chains where a particular workflow is used so that they can access processes that may be impacted if changes to a workflow or protocol are made. Protocol Actions for Starting Downstream MES Workflows Added support for a Protocol Action that initiates a separate MES-based workflow chain, which allows users to create a downstream batch automatically while finishing the upstream batch. MES EBR, BOM, and Reports Added support for non-quantity items in the bill of materials (BOM) tab and report. Users can see consumables (non-quantity inventory items) on a separate table in the BOM report, allowing for tracking of items that have quantities more easily. MES Internationalization Added support for localization to MES. Performance LIMS processing performance enhancements Performance of LIMS operations has been improved in 3.2 relative to 3.1 with a focus on both faster operations as well as improved performance stability as database size increases. Impacted operations include: Experiment creation Sample sheet creation Sample sheet save Workflow chain transition processing Sample sheet data access in pipelines Ingest app ingest instance list load time Analysis app monitor list load time Container list load time Contact us today to learn more about L7|ESP 3.2! ### L7 Informatics Inc. Secures Silver in Prestigious Brandon Hall Group HCM Excellence Awards™ Austin, Texas – August 24th, 2023 – The 2023 Brandon Hall Group HCM Excellence Awards™ celebrate exemplary practices for initiatives in Learning and Development, Talent Management, Leadership Development, Talent Acquisition, Human Resources, Sales Performance, Diversity, Equity & Inclusion, and the Future of Work. L7 Informatics Inc., a leader in life sciences tools that unlock innovation at every stage of the clinical, research, and manufacturing value chains, won the coveted Brandon Hall Group Silver award for excellence in the Best Customer Training Program category. This remarkable achievement was marked on August 17, 2023, as L7 Informatics Inc.'s L7|ESP™ Super User MasterClass won the prestigious Silver award. For the comprehensive list of winners, please visit: https://excellenceawards.brandonhall.com/winners/ L7 successfully launched a 4-day MasterClass providing customers, partners, and L7 employees with deep knowledge and skills in data and process modeling within the L7|ESP software platform. Team-taught by scientists and platform engineers, customers experience an immersive, hands-on training that leverages case study, simulation, and team-based exercises to achieve modeling fluency which produce invaluable quantitative feedback to learners, instructors, and program designers. Evaluation data are gathered during and after program delivery, and results to date indicate the program is exceeding its goals for skill adoption and on-the-job success with the platform. JP Brown, Director of Product Training at L7 Informatics Inc., stated, "The L7|ESP platform accelerates how our customers conduct laboratory science while providing their labs with unprecedented intelligence into their own operations. Long-term success and self-sufficiency with L7|ESP require customer scientists and technicians to attain the skills and knowledge needed to translate, digitalize, and model their operations inside the platform. Our immersive MasterClasses are key to establishing those skills and preparing customers to successfully extend and expand their L7|ESP implementations to generate new efficiencies and insights." Brandon Hall Group Chief Operating Officer Rachel Cooke, HCM Excellence Awards program leader, affirmed, "Excellence Award winners are shown to be organizations that truly value their employees and invest in them through their human capital management programs. These HCM programs have been validated as best in class for business value and the impact on the employees themselves." Entries underwent rigorous assessment by a panel of seasoned independent senior industry experts, Brandon Hall Group analysts, and accomplished executives. The evaluation process encompassed the following criteria: alignment to their business need and environment; program design, functionality, and delivery; adoption, integration, user experience, innovation, and creativity; and overall effectiveness, impact, and measurable benefits. The exceptional Excellence Award winners will continue to be honored at Brandon Hall Group's HCM Excellence Conference, February 13-15, 2024, at the Hilton West Palm Beach, Florida. Moreover, select winners will take center stage as presenters during breakout sessions, sharing their outstanding practices and insights during the conference. "Our award winners are relentless in their pursuit of excellence," said Brandon Hall Group Chief Executive Officer Mike Cooke. "We have received some of the most innovative use of HCM strategy that we have seen in the last 30 years, and in most cases, technology and collaboration across departments have helped them achieve amazing business results." -- About L7 Informatics, Inc. L7 Informatics, Inc. is a leading provider of integrated scientific data and analytics solutions. The company offers a comprehensive platform that enables seamless data integration, advanced analytics, and collaborative workflows, empowering scientists and researchers to accelerate discoveries, improve operational efficiencies, and drive innovation. L7’s mission is to revolutionize how scientific data is managed, analyzed, and utilized, facilitating breakthroughs in research, drug discovery, development, and manufacturing. About Brandon Hall Group™ Brandon Hall Group is the only professional development company that offers data, research, insights, and certification to Learning and Talent executives and organizations. The best minds in Human Capital Management (HCM) choose Brandon Hall Group to help them create future-proof employee development plans for the new era. For over 30 years, we have empowered, recognized, and certified excellence in organizations worldwide, influencing the development of over 10 million employees and executives. Our HCM Excellence Awards program was the first to recognize organizations for learning and talent and is the gold standard, known as the "Academy Awards of Human Capital Management." The awards recognize the best organizations that have successfully developed and deployed programs, strategies, modalities, processes, systems, and tools that have achieved measurable results. We are honored to receive applications from organizations worldwide ranging from small, medium, large, and global enterprises to government, not-for-profits, and associations. ### L7|HUB - Unlocking the Power of L7|ESP™ Digital Scientific Content L7 | CHATS product update @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyYW5kb24gVmFyZWxhIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@At L7 Informatics Inc., we believe collaboration is the key to scientific progress. That's why we developed the L7|HUB, a cutting-edge app designed to revolutionize scientific collaboration in the biotechnology sector. Gone are the days of cumbersome paper-based processes and inefficient communication channels. L7|HUB empowers scientists to collaborate and share Digital Scientific Content (DSC) effortlessly. With L7|HUB and DSC, scientists can digitalize their operations faster and more seamlessly, paving the way for groundbreaking discoveries and advancements. Let's dive into the exciting world of L7|HUB and the power of DSC! L7|HUB Digital Scientific Content lies at the core of L7|ESP's transformative capabilities. These digital representations of scientific methods and operational processes provide scientists with a standardized framework for modeling, tracking, and reporting on scientific operations. Leveraging L7|HUB, researchers can easily access and utilize pre-defined content, saving time and ensuring consistency across experiments. Available Digital Scientific Content Bundles Each Bundle available within L7|HUB offers a documentation package, including a user guide to empower customers to understand how to leverage the available DSC best. Bundle Name Release Date Includes API Utility 09/09/2022 Applet Available Container Search 08/11/2022 Report, Rest API, Query Cell Counting (Automated) 11/11/2022 Entity Types, Entity Classes, Protocols, Workflows Cell Counting (Manual) 11/29/2022 Entity Types, Entity Classes, Protocols, Workflows Cell Counting Hematology 1/11/2023 Entity Types, Entity Classes, Protocols, Workflows, Workflow Chains Cell Sorting (Flow Cytometry) 12/16/2022 Entity Types, Entity Classes, Protocols, Workflows Compare Genealogies 05/02/2022 Report, Query, Extensions Digital PCR 05/31/2023 Protocols, Workflows, Workflow Chains, Configuration, Query, Extensions, Pipelines Endotoxin (Endosafe) 09/28/2022 Entity Types, Entity Classes, Protocols, Workflows Entity Location Search 08/11/2022 Report, Query Gram Stain 02/07/2023 Protocols, Workflows HPLC Quantification 03/01/2023 Protocols, Workflows, Configuration, Query, Extensions, Pipelines Inventory Details 05/12/2022 Report, Extensions L7|ESP SDK 05/05/2022 Extensions L7|HUB Config 08/04/2021 Doclet Mycoplasma 03/23/2023 Entity Types, Entity Classes, Container Types, Protocols, Workflows, Workflow Chains, Configuration, Query, Extensions, Pipelines Osmolality 09/28/2022 Entity Types, Entity Classes, Protocols, Workflows Outsourced Method 06/02/2023 Protocols, Workflows, Workflow Chains, Configuration, Query, Extensions, Pipelines pH 09/28/2022 Entity Types, Entity Classes, Protocols, Workflows Potency ELISA 05/22/2023 Protocols, Workflows, Configuration, Query, Extensions, Pipelines QC Appearance 01/21/2023 Entity Types, Entity Classes, Protocols, Workflows qPCR 05/08/2023 Protocols, Workflows, Workflow Chains, Configuration, Query, Extensions, Pipelines Residual DNA 05/15/2023 Protocols, Workflows, Workflow Chains, Configuration, Query, Extensions, Pipelines Residual HCP ELISA 03/13/2023 Entity Types, Entity Classes, Container Types, Protocols, Workflows, Configuration, Query, Extensions Residual HCP Method 06/23/2023 Protocols, Workflows, Configuration, Query, Extensions, Pipelines Sterility 02/12/2023 Entity Types, Entity Classes, Protocols, Workflows, Workflow Chains Sterility Direct Inoculation 01/23/2023 Entity Types, Entity Classes, Protocols, Workflows, Workflow Chains Targeted Amplicon Sequencing 06/19/2023 Protocols, Workflows, Configuration, Query, Extensions, Pipelines User Activity Summary 04/25/2023 Report, Query Empowering Scientific Advancement The biotechnology sector is witnessing an unprecedented wave of innovation, and L7 Informatics Inc. is at the forefront of this revolution. With L7|HUB, scientists can overcome the barriers of traditional collaboration and accelerate scientific advancements. By digitalizing their operations and harnessing the potential of L7|HUB Digital Scientific Content, researchers can unlock new frontiers and drive groundbreaking discoveries. At L7 Informatics Inc., we are committed to advancing science and empowering our customers with cutting-edge solutions. The L7|HUB is the epitome of our dedication to transforming scientific collaboration in the biotechnology sector. Embrace the power of L7|HUB and unlock a world of seamless digitalization, efficient communication, and unprecedented scientific advancement. Join us in shaping the future of scientific collaboration today! Additional Resources To learn more about the L7|HUB app, see Intro to L7|HUB. To learn more about scientific content, see What are L7|ESP Digital Scientific Content? ### L7 Informatics Expands European Operations to Strengthen Commitment to Pharmaceutical and Biotech Industries Austin, Texas – July 11th, 2023– L7 Informatics, Inc, the leading provider of scientific solutions for research, development, manufacturing, and quality control, is delighted to announce the expansion of its European operations, reinforcing its dedication to serving the pharmaceutical and biotech industries with advanced capabilities. This strategic move emphasizes L7's commitment to delivering unparalleled support and innovation to its European clientele and solidifies its position as a trusted partner. By leveraging its expertise in scientific data and process management platforms, L7 empowers organizations to unlock the full potential of their data and make informed decisions that drive scientific breakthroughs and operational excellence. L7 Informatics understands the critical role played by streamlined data management and efficient workflows. L7 equips scientists, researchers, and process engineers with the Apps (ELN, LIMS, MES, SCHEDULING, INVENTORY, LOCATION) needed to accelerate research, discovery, development and manufacturing, and testing of drug products and substances. These applications being on a single unified data platform also helps improve operational efficiencies and ensure regulatory compliance and seamlessly contextualize diverse departmental data and enhance company-wide decision-making and AI/ML capabilities. Vasu Rangadass, President & CEO of L7 Informatics, emphasized the importance of L7's capabilities within the pharmaceutical and biotech industries, stating, "At L7, we recognize the significant impact that streamlined operations and optimal data utilization have on the success of these organizations. Our solutions are designed to address the unique operational challenges faced by the industry, enabling organizations to drive efficiencies, improve outcomes, and ultimately make a positive impact on patient lives." The newly established operations will serve as pivotal hubs for L7's European commercial efforts. With this presence, L7 aims to provide localized support and tailored expertise to life science organizations across the region. This expansion will also enable L7 to work closely with its European partners, fostering collaborations that drive the adoption of scientific data and process management platforms as opposed to point solutions that are prevalent in the market today. -- About L7 Informatics:L7 Informatics, Inc is a leading provider of integrated scientific data and analytics solutions. The company offers a comprehensive platform that enables seamless data integration, advanced analytics, and collaborative workflows, empowering scientists and researchers to accelerate discoveries, improve operational efficiencies, and drive innovation. L7's mission is to revolutionize how scientific data is managed, analyzed, and utilized, facilitating breakthroughs in research, drug discovery, development, and manufacturing. To read the original press release, click here. ### L7|ESP Manufacturing Execution System (MES) – Sample Plans, Sample Points, and Dynamic Execution Plans L7 | CHATSproduct update@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFthdXRob3J0aXRsZV0gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Introduction Following on from the L7 MES app introduction, let us have a deeper dive into the features that set the L7 MES app as the right choice for pharmaceutical manufacturing. One of our guiding principles in designing the L7 MES app was to build the core regulatory compliance requirements all cGMP processes must adhere to, out of the box, and additionally, how to support the timely dispositioning of manufactured finished products.Sample Plans Sample plans are an essential element of quality control and testing for the disposition and release of products to any market. Each market and governing body require potentially different release testing to verify the product was manufactured in a controlled state. Methods are developed to determine the safety, quality, identity, potency, and purity of the produced batch. Managing the methods associated with sample types and the collection and storage conditions of the samples is paramount to the testing and sample retain process. The sample plan documents these set requirements associated with products to ensure correct testing for release is carried out for each batch. Sample plans help ensure that the manufacturing process is consistent and reproducible. Sample plans help detect any potential problems early in the manufacturing process, which can help prevent costly delays and recalls. Sample plans help ensure that the final product is safe and effective for human use. How the L7 MES application adds industry knowledge to our solution Sample Plan Build your QC samples, retain and in-process samples into one, easy-to-navigate dashboard of your product specific sample plan. Built into your master batch recipe (MBR) and extendable for different approved sample plans and ad-hoc customer requests for any given MBR. One process recipe, multiple products. Add sample points with multiple sample types anywhere in your process. Print labels pre-batch and reprint as needed during execution. Keep track of samples taken and by whom. Reconcile labels printed to labels used easily after batch is complete. Use barcodes to scan into EBR during collection and watch sample plan update with relevant information. Review and generate document of recorded samples. Each sample is a child of the batch. Chain of Custody and Chain of Identity is tracked throughout the sample-test lifecycle. Testing conducted on same system in LIMS app for in-process testing and QC testing. Use legacy systems with the L7 MES app to document sampling in EBR. Figure 1: Sample plan dashboard and corresponding Sample point for adding samples in EBR. Dynamic Execution Plans Approved Sample Plans can be created for any MBR to overwrite the default settings and expand the product choice on each master batch record, choose the combination at batch start. Multiple approved Sample plans easily created and ready to use for every product. Customer requests for additional samples prior to execution become a simple task. Centralized control over sample plans. Reduce the number of MBRs required to execute assorted products on the same process train. Quality assurance can confirm correct plans are chosen prior to execution. Choose your plan and print the correct labels for every variation in sampling and testing requirements. Annual or biannual characterization, requalification samples are dynamically added to your EBR. Full control of product execution without red lines and messy comments. Documented record of plans used in batch production. End to End Chain of Custody and Chain of Identity from batch to QC testing. Figure 2: Dynamic Execution Plan pulls available sample point fields to create a new adjustable sample plan. The L7 MES application, as part of the L7 Enterprise Science Platform (L7|ESP), provides a holistic manufacturing operations management experience. We are continually improving and adding additional applications to our unified platform to really tackle the needs of our customers and to provide the end-to-end infrastructure required to really accelerate and normalize biotech and C> businesses to their full potential. The L7 MES app system is designed for developing and then progressing to cGMP production seamlessly, with data and process automation at the heart of the process development, CMC work, and tech transfer to commercial production. We are cGMP-ready from the start but are flexible enough to support the early-stage process development, capturing and curating your data resource across your journey to clinical and commercial production. Standard functionality and features of the L7 MES app for your CMC, Development, Tech transfer, and CGMP needs:ABOUT THE AUTHOR ### L7|LIVE SF: Operational Excellence with Digital Systems in Life Sciences Participant: Vasu Rangadass, CEO & President at L7 Informatics Information: The Life Sciences industry is rapidly evolving, and digital systems and technologies have become essential tools for driving innovation, improving patient outcomes, and accelerating drug development. However, achieving operational excellence in Life Sciences with digital systems requires a strategic approach that aligns with an organization’s goals. By leveraging the latest digital technologies and best practices, organizations can optimize their processes, streamline operations, and increase productivity to gain a competitive edge. With the right approach, digital systems can enable organizations to achieve operational excellence by driving operational excellence, innovation, and success. ### L7|LIVE SF: Informatics as a Service: Reimagining Scientific Computing for Modern Drug Discovery Participant: Dan Weaver, Ph.D., CEO at Boulder BioConsulting Information: Modern drug discovery is a dynamic, collaborative process in which companies engage both internal and external resources to orchestrate their development programs. This paradigm allows companies to leverage partners for much of the scientific work, increasing scientists’ efficiency and reducing costs for lab space. On the IT side, outsourcing has traditionally been limited to basic support roles with scientific tasks remaining in-house. As software and data management tasks continue to evolve, maintaining the mix of development, administration, and analytical roles is proving challenging. The pool of available informatics resources is limited and, just like lab services, not all skills are needed all the time. In this talk, we explore a new model for informatics in which the entire informatics role is handled as a service. “Informatics as a Service” provides companies with access to a range of skills at a fraction of the cost of in-sourcing, allowing companies to focus on their core mission while leveraging expert resources to handle their informatics and analysis needs. ### L7|LIVE SF: Decentralized Manufacturing Operations with Unified Platforms Participant: Steven Barash, Vice President, Strategy & Development at L7 Informatics Information: With the rise of Industry 4.0, manufacturers are increasingly adopting digital technologies to improve efficiency, reduce costs, and enhance quality. However, managing operations across multiple sites and geographies can be challenging, particularly when using disparate systems and technologies. The presentation covers the benefits of using a unified platform for managing decentralized manufacturing operations. By centralizing data and workflows, manufacturers can streamline operations, improve collaboration, and gain greater visibility into their supply chains, leading to increased efficiency and flexibility. ### L7|LIVE SF: Highlighting Challenges and Benefits of Digitalization of Cell and Gene Therapy Laboratory Workflows through Case Studies Participant: Menhaz Husain, Senior Business System Analyst at Zifo RnD Solutions Information: Cell and gene therapy (CGT) is the growing focus area in the field of personalized medicine. The digitalization of CGT laboratory workflows has the potential to revolutionize the way these therapies are developed and delivered to patients. This presentation highlights some of the key benefits and challenges in the digitalization of cell and gene therapy workflows using case studies. By automating and standardizing laboratory processes, digitalization can improve the reproducibility and reliability of cell and gene therapies, leading to more consistent treatment outcomes for patients. Digitalization can also enhance the efficiency of laboratory workflows, reducing the time and cost required to develop and manufacture these therapies. This efficiency can help to accelerate the development of new treatments and improve patient access to these therapies. Furthermore, digitalization can enable the integration of data from different stages of the cell and gene therapy development process, allowing researchers and clinicians to better understand the factors that influence treatment outcomes. This integrated approach can lead to the identification of new biomarkers, the development of personalized treatment regimens, and the optimization of manufacturing processes. This digitalization offers transformative benefits, but also presents significant challenges. One of the key challenges involved in developing and manufacturing these therapies is the complexity of the laboratory workflows due to the need to handle biological materials that are often fragile and require precise control of environmental conditions. Digitalization of these workflows requires the integration of multiple technologies, including robotics, data management systems, and artificial intelligence, to enable the automation and standardization of laboratory processes. Achieving this level of integration and standardization requires significant investment in infrastructure, personnel, and training. ### L7|LIVE SF: Tag.bio: An End-to-End Data Mesh Platform for Innovation Participant: Sanjay Padhi, Ph.D., Chief Technologist and Executive Vice President at Tag.bio Information: The global need to securely derive (instant) insights have motivated (centralized) data architectures from local storage, to data lakes, data warehouses, and lake-houses. In this talk we describe Tag.bio, a next-generation end-to-end (distributed) data mesh platform consisting of vital elements: domain centricity/ownership, data-as-products with embedded (AI/machine learning) algorithms, with a federated computational layer using microservices. The platform also combines a dynamic cohort builder with analysis protocols and apps (low-code) to drive complex analysis workflows. We also introduce TagGPT, an application layer within the data mesh, that uses foundational models (GPT3.5, BLOOM, LLaMA) along with data products (such as various phases of clinical trials) to build, refine and deploy fine-tune domain-centric (private) models and apps with built-in governance. Join us for a talk on Tag.bio and learn how major pharma, non-profit organizations, and health systems are using this technology to find cures for devastating diseases, precision medicine, commercial insights/decisions, clinical trials, drug discovery, and promote collaboration (without explicitly moving data around). We show how the platform can combine clinical and genomics data products (with millions of variants and thousands of clinical parameters) using smart APIs and also connect clinical trials to RWE/RWD, adverse effects (FAERS), health economics, and outcomes. ### L7 Informatics Supports Cancer Research at Dana Farber Cancer Institute with L7|ESP™ L7|ESP™ streamlines operations and facilitates a seamless flow of information. AUSTIN, Texas, June 13, 2023 /PRNewswire/ -- L7 Informatics, provider of the leading unified platform for integrated data and workflow solutions for the life sciences industry, announces the implementation of their flagship product, L7|ESP software, at the Connell and O'Reilly Families Cell Manipulation Core Facility (CMCF) of the prestigious Dana-Farber Cancer Institute (DFCI). Dr. Jerome Ritz, a renowned cancer research pioneer and Executive Director of CMCF, spearheaded the adoption of L7|ESP to enhance the manufacturing of cellular therapy products and improve patient outcomes. As an expert in cellular therapy and a pioneer in stem cell transplantation, Dr. Ritz leads the CMCF team that manufactures innovative cell-based therapies for cancer patients enrolled in novel therapeutic clinical research protocols. Additionally, Dr. Ritz's laboratory supports clinical research studies aimed at evaluating the safety and efficacy of these groundbreaking treatments. At the March L7|LIVE event in Boston, Dr. Ritz shared his firsthand experiences with L7|ESP, shedding light on how the project will improve processes and accelerate the discovery of new treatments. "We have many computer systems that do not talk to each other with a lot of paper in between each of these different systems." Dr. Ritz mentioned. "We looked for a system for two years and selected L7 for several advantages." The implementation of L7|ESP software will revolutionize CMCF's electronic manufacturing system, eliminating the burdensome use of 200–400-page batch records for each product. By unifying data, processes, and business applications across research, process development, quality control, manufacturing, and quality review, L7|ESP will streamline operations and facilitate the seamless flow of information within the facility while meeting stringent regulatory standards. This transformation is particularly significant, as many health systems struggle with paper-based batch records and have been actively seeking solutions for their digital transformation initiatives. L7|ESP's GXP-enabled software platform for Health Systems emerged as the ideal choice for DFCI and other leading organizations due to its unique combination of features. L7 Informatics President and CEO Dr. Vasu Rangadass commented on the milestone, stating, "With the robust power and flexibility of L7|ESP, our vision and goal is to take these precision medicine principles and make life easier and healthier, ultimately taking several billion dollars of waste out of our healthcare ecosystem in the process." L7 Informatics remains committed to advancing precision medicine and transforming the healthcare industry through its innovative solutions. About L7 Informatics:L7 Informatics reimagines data intelligence for modern life sciences and healthcare organizations, optimizing the flow of information between processes and people, and unlocking innovation at every stage of the clinical, research, and manufacturing value chains. Our comprehensive operating environment and software stack bring flexible, secure, and collaborative data+intelligence to life sciences organizations. Our end-to-end transformation engine helps solve today's challenges and realize tomorrow's opportunities. For more information, please visit www.l7informatics.com. To read the original press release, click here. ### Streamlining Sample Management in Biotechnology: Introducing the Biorepository App L7 | CHATS product update @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyYW5kb24gVmFyZWxhIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@Introduction In the fast-paced world of biotechnology, efficient sample management is crucial for laboratories to operate at their full potential. However, the process of registering, receiving and processing samples can often be challenging due to scattered information, mismatches, and the risk of losing valuable samples. These inefficiencies not only lead to delayed results and operational setbacks but also impact profitability and the overall reputation of the company. To address these challenges head-on, we proudly introduce the Biorepository app, a game-changer in the field of sample management.Efficient Sample Processing with the Biorepository App The Biorepository app simplifies the way Sample Managers handle sample registration, receipt, and processing. By offering a centralized application within L7 Informatics’ Enterprise Science Platform ecosystem, this innovative solution empowers laboratories to overcome the hurdles associated with managing sample information across multiple files or systems. With the Biorepository app, labs can streamline their operations and ensure efficient sample processing, leading to improved productivity and enhanced customer satisfaction.Key Features Simplified Sample Registration The app allows Sample Managers to easily register sample manifest files or create samples manually, eliminating the hassle of scattered information and ensuring a streamlined process from the very beginning. Seamless Sample Receipt Management With the Biorepository app, managing the receipt of samples becomes a breeze. Even when samples are not listed in the manifest file, the app enables Sample Managers to effortlessly add them to the system. This functionality eliminates the risk of mismatched or misplaced samples, reducing operational inefficiencies and ensuring accurate sample processing. Convenient Sample Labeling The app offers the ability to print sample labels, providing Sample Managers with an efficient way to identify and manage samples. By simplifying the labeling process, the Biorepository app minimizes the chances of errors and helps maintain sample integrity throughout the entire workflow.Maximizing Efficiency and Customer Satisfaction By embracing the Biorepository app, laboratories operating in the biotechnology sector can experience a multitude of benefits. Increased operational efficiency allows labs to work at their full capacity, leading to faster turnaround times and reduced delays in delivering results to patients. Additionally, the risk of losing samples is significantly minimized, safeguarding valuable resources and preventing financial losses. By optimizing sample management processes, the Biorepository app helps biotechnology companies build a strong and positive reputation within the industry.The L7 team worked very closely with us to develop a custom LIMS and were very responsive and creative throughout the process, from requirement gathering to development to testing.Conclusion In an era where efficiency and accuracy are paramount in the biotechnology sector, the Biorepository app emerges as a game-changing solution for streamlined sample management. With its centralized approach, seamless sample registration, efficient receipt management, and convenient labeling capabilities, laboratories can optimize their operations and overcome the challenges associated with scattered sample information. Embrace the power of the Biorepository app today and witness a new era of efficiency, productivity, and customer satisfaction in your biotechnology endeavors. ### Global Value Web Partners with L7 Informatics to Drive Integrated Value Chain Processes for Better Patient Outcome L7 | CHATSpartnership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEw3IEluZm9ybWF0aWNzIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@Global Value Web (GVW) is proud to announce a partnership with L7 Informatics, a thought leader in providing integrated technology platforms for Life Science and Pharma companies. This partnership extends GVW’s vision of a globally connected Life Sciences Value Chain that focuses on better patient outcomes. Global Value Web’s expertise in connecting data across the value chain combined with L7 Informatics Technology enables handling the challenges of integrating datasets, preventing data silos, and bridging the gap between life sciences and healthcare data. This unique and like-minded partnership between GVW and L7 Informatics aims at driving the process and data-centric approach vs. the traditional product-centric siloed approach in pharma and life science value chain by: Building a standardized data backbone across the value chain of pharma and life science enterprise to give end-to-end visibility enabling informed decision-making. Creating a unified enterprise science platform to drive more efficient digitization and effective tech transfer, resulting in overall cost reduction through time savings. Removing the multiple data /technology silos through connected and accessible processes to enable the industry to react rapidly and timely manner to disruptions and support the better patient outcomes. Improving technology utilization and efficiency through flexible, compliant and integrated platform GVW’s Founder and CEO, Louis Hendriks says, "We are a trusted transformation partner for our clients. GVW has the subject matter experts, in-depth industry knowledge, technical knowhow to make the technologies work successfully. GVW’s partnership with L7 Informatics will address one of the biggest challenges in pharma – siloed data and technologies. Together we will combine data intelligence and Integrated technology platform to bring the data-process-people and technology together so that industry can bring quality drug products to people". Vasu Rangadass, Ph.D., President and CEO of L7 Informatics, is also excited about the partnership, stating, "We believe that digital transformation in the pharma and life science industry requires breaking down the barriers of data silos and embracing a process and data-centric approach. This methodology creates a more efficient, cost-effective, and sustainable model. Through our partnership with Global Value Web, we are committed to building a standardized data backbone, removing technology silos, and enabling rapid and informed decision-making." About Global Value WebGlobal Value Web drives business transformation for Pharma & Life Sciences, Healthcare and Energy organizations by connecting the dots across their value chain and enabling operational excellence in their digital transformation journey. Our solutions & services integrate People, Data, Process, and Technology that enable our clients to optimize operational efficiencies, maximize financial results, and allow them to serve their customers better. To learn more, visit https://global-value-web.com L7 InformaticsL7 Informatics reimagines data intelligence for modern life sciences and healthcare organizations. Beyond simple data management, L7 provides tools that optimize the flow of information between process and people, unlocking innovation at every stage of the clinical, research, and manufacturing value chains. Our comprehensive operating environment and software stack bring flexible, secure, and collaborative data intelligence to your entire operation. From regulatory compliance and workflow orchestration to customized applications and integrations, our end-to-end transformation engine helps organizations solve the challenges of today and realize the opportunities of tomorrow. To learn more, visit https://l7informatics.com/. Listen to an interview of L7's CEO Vasu Rangadass, Ph.D. and GVW's founder Louis Hendriks by the Science Advisory Board at Cell and Gene Meeting on the Med 2022. ### Achieving Digital Transformation: Unlocking Cost Reduction, Clinical Excellence & Precision Therapeutics Manufacturing ### L7 Informatics at Cell and Gene on the Med 2023 Participants: Vasu Rangadass, CEO & President at L7 Informatics​ Information: In this recording, Vasu Rangadass, President and CEO at L7 Informatics, discusses how applying the 4th Industrial Revolution principles can accelerate therapeutic development. By digitalizing data and workflows, streamlining operations, and embracing innovation, drug development can be accelerated, ultimately improving patient outcomes. For instance, leveraging AI, machine learning, and real-world data collection can help improve decision-making, reduce time to market, and streamline collaboration. With a culture of innovation and continuous improvement, organizations can quickly adapt to changes and accelerate drug development, ultimately resulting in a more effective healthcare system. ### L7's Vasu Rangadass Is Creating Unified Systems in Healthcare ### Solving Laboratory Note-Taking Problems with L7|ESP’s Electronic Lab Notebook App - A Digital First Implementation L7 | CHATSproduct update@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEw3IEluZm9ybWF0aWNzIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@Lab research, which is crucial for scientific advancement and innovation, has always relied on note-taking to keep track of experiments, observations, and results. Unfortunately, traditional paper notebooks pose several problems for researchers, including the risk of loss or damage, logistical issues, and difficulty in structuring the data for analysis. Some organizations use an Electronic Lab Notebook (ELN) point solution, however, these also have their own limitations, such as a lack of integration with other lab systems, challenges in data sharing and management, and the need for manual data entry. L7's Enterprise Science Platform, or L7|ESP™ for short, is a unified software platform that can address these challenges and provide several additional benefits to the scientific community. L7|ESP provides end-to-end capabilities for laboratory data management, analysis, and reporting. Unlike point solutions that only address a single aspect of the data management process, L7|ESP offers a comprehensive suite of business applications that work seamlessly together, such as LIMS, LES, MES, ELN, Clin Ops, etc..., to support life sciences and healthcare organizations' entire data and workflow management. Here are some of the key benefits of L7|ESP's ELN app: A unified platform allows data to exist across multiple applications but still be referenced and used as a whole, meaning researchers can connect their notes to other relevant data, such as entities, samples, and instruments, creating a more comprehensive view of their research. A unified platform can help structure unstructured data to enable better searching and analysis. This feature allows researchers to save time by finding relevant information quickly, and making it easier to identify trends and patterns across experiments. Using a unified platform across different lab functions reduces the cost of learning and maintenance, since researchers can use the same system for multiple purposes. Automatic data capture from instruments to the notebook reduces the chance of manual entry errors, saving time and improving data quality. A unified platform also enables researchers to move their protocols up the continuum from research to product development and manufacturing. This reduces the time and cost of tech transfer, which can be a significant hurdle for researchers looking to bring their discoveries to market. As a scalable, cloud-based platform, L7|ESP provides a centralized repository for lab data, automatic data capture from instruments and sensors, and integration with other lab systems. The platform enables organizations to better organize and structure their lab data, reducing the need for manual data entry and improving data sharing and management. In other words, by providing a digital-first implementation with a more comprehensive view of lab data, improved data quality, and reduced time and cost of tech transfer, L7|ESP enables researchers to spend more time focused on their science and less time worrying about data management. If you're interested in streamlining your laboratory data management and want to see firsthand how L7|ESP can help your organization, we invite you to schedule a demo. Our team of experts will walk you through the platform and show you how L7|ESP can address the challenges of traditional point solutions, improving productivity and scientific advancement. Contact us today to learn more! ### L7 Releases L7|ESP™ 3.1 with New Features and Updates L7 | CHATS product release @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEw3IEluZm9ybWF0aWNzIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@With the release of L7|ESP 3.1, L7|ESP has been enhanced to include the ability to create signature flows and added a new Manufacturing Execution System application. Application-specific updates are included Builders, Notebooks, and L7|HUB™. Improvements have also been made to notification display and general performance updates. Introduction of a new application: Manufacturing Execution System (MES) Execute and manage controlled manufacturing processes. The Manufacturing Execution System (MES) app in L7|ESP is used for electronic data capture and management of batches as they proceed through the manufacturing process. MES allows the capture of steps performed, observations, equipment employed, inventory consumption and asset usage. Other features of MES include tracking of Bill of Materials (BOM) and specifications, and management of Sample labels, usage, and reconciliation. In addition the Quality Review features provides an easy way to review entered data and track any changes to that data after Electronic Batch Record submission. Builders Expanded capabilities to make workflows more efficient. Container Type Builder Specify which Entity Types, Item Types, or Container Types can be stored, along with the min and/or max quantities. Protocols Builder New parameter for Resource Link If the Link Type is an Entity Class, Container, Item, or Service Type a multi-select picklist for “Restrict To” will appear to restrict by: Entity Type, Container Type, Item Type, or Service Type Protocol Actions New Conditions: All rows rejected and Any row rejected New Actions: Archive Objects and Fail Samples Signature Flows Ability to utilize a flexible signature flow, which gives users the ability to define the different steps of a signature and assign them to a user, role, or workgroup as well as nominate the Users/Role/Workgroup who needs to sign next during execution. Utilize signature flows in LIMS, Notebooks, or MES Define data rules based on signatures to be used in MES and LIMS Dynamic Execution Plans Notebooks Capture data while executing dynamic experiments for research and protocol/method/assay development. Notebooks enables users to seamlessly move dynamic experiments into protocols while lowering the risk of data loss due to manual transferring of experiments from paper to electronic tracking methods. Improvements to protocols Utilize the same protocols you would use in LIMS and MES directly in the Notebooks, to allow for more streamlined analysis of data captured Signature Flow Define and use signature flows to ensure that documents are signed by the right people at the right time Comments Individualized comments, that allow you to mention other users, and add feedback to entries without editing the actual entry. Linking of entities to items through-out L7|ESP Connect you samples, projects and instruments in the system, while reducing manual re-entry by allows users to link these together PDF Generation Generate PDF of closed entries, including all audit history to help streamline submissions and sharing of data with people outside of ESP Notebooks Dashboard Quickly see the status of your notebooks, and the actions that need to be completed. Easily see where you left off and get there quickly Ability to move templates between environments Build out your templates in the development environments, and easily move them to your production environment through the L7|HUB Entry Locking Lock entries when work has been completed to ensure no changes are made after completion of the experiments L7|HUB Create bundles that have the correct dependencies for the correct users. Performance improvements Within the L7|HUB tab, caching was implemented to improve loading performance. Use the refresh button next to the Locations dropdown to refresh the cache. Install performance improvements. New L7|ESP Models supported from the user interface Notebook Entry Templates, Signature Flows, FlexView and Configurations are now supported from the user interface. For security reasons, Configurations must be whitelisted in the Config App for them to be visible in the L7|HUB. Permissions granularity configured using the IAM app Bundle Creation user experience Bundle Creation Wizard walks you through the steps necessary to create a Bundle: Check Dependencies: ensure no required dependencies are missing. Specify Bundle Details: specify a name, description, tags, and created and tested in L7|ESP versions if applicable. Review Bundle Details: review Bundle contents and details before creating the Bundle and promoting it to a configured L7|HUB server or downloading it as a zip file. Collections Pinning Collections can be versioned and pinned to prevent changes from being made inadvertently. Collections History Collections now include a history tab. Easily inspect what has changed and troubleshoot issues that arise between Collection versions. Export Collection history to share with colleagues. ### Introducing L7|ESP Manufacturing Execution System (MES) – A Unified Platform approach to Manufacturing Operations Management L7 | CHATSproduct update@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFthdXRob3J0aXRsZV0gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Introduction Previously, we have looked at the major pain points affecting precision therapeutics manufacturing capabilities. The reliance on paper-based processes and spreadsheets for operations can cause major bottlenecks in production and release of C> products to patients. Current solutions don’t have the flexibility or composability needed in this industry. The earlier the correct digital strategy is employed, the sooner efficiencies and quality by design can be applied to your processes and thus alleviate a paper or a siloed digital approach. How L7 approached the MES Solution We first looked at all the current capabilities in L7|ESP that could be leveraged to build a holistic digital solution to using paper and spreadsheets in manufacturing. At the core of digitization is the desire to automate the governance and procedures that keep the process in control and, ultimately, the patient safe. Additionally, managing the data resources accurately and cleanly, that are created during development, CMC, and manufacturing, drives innovation in the manufacture of today's and tomorrow’s novel C> treatments. With L7|ESP’s ability to build complex business workflows and automate procedures, we expanded the functionality by looking at: Customers CGMP manufacturing requirements and constraints. Focusing on digitizing where “people meet process”. Keep the solution familiar and easily adopted. Replace paper and spreadsheet transactions with a digital solution. Build quality by design (QbD) and real-time feedback in the solution. Build as an extension of ESP that works seamlessly with all ESP applications. Elevate the UX/UI for our Customers. Speed up disposition of product by providing all the elements needed. How to work across product development to CGMP in one solution Let’s look at a typical cleanroom manufacturing system in Figure 1. We can see many departments interacting, passing information, documents, materials, equipment, samples, and products through preparation, production, testing, release, and shipment. Represented by the separate and colored business process flow paths.Figure 1 Typical Cleanroom Manufacturing System with multiple departmental touchpoints The Precision Therapeutics manufacturing relies heavily on paper batch records, forms, and spreadsheets to fill the functional gaps manufacturing operations require for day-to-day operation. Traditional MES is very rigid and siloed from other systems and equipment, leaving operations still relying on forms and spreadsheets to function. L7 MES Provides Value-add functionality for CMC to CGMP Manufacturing Easy navigation at all levels of the process. Familiar layout of a batch record with automatic numbering for batch section, step, and sub step. Quality by design, build-in limits and exceptions to automate your inline checks and get real-time feedback. Interoperability with equipment and systems to connect to primary source of data. Sequential execution control with role and individual-based permissions. On screen tabs for real-time in-process data and quality oversight with a click. 21 CFR part 11 compliance with data integrity and electronic signatures designed for your CGMP purposes. Communicate effectively with images and tables to support written instructions. Add multiple comments on every entry in execution and after in quality review. Easy retrieval of relevant digital standard operating procedures (SOP) during execution, connect to electronic document management system for current documents. Attach files or images of setup, associated printouts, or data files at appropriate steps or to the batch. Run complex calculations and generate real-time trends and graphs to support decision making. Connect to your Pi-Historian to get discreet data points from tags or across a period for tables and time-lapse. Figure 2: L7 MES Electronic Batch Record View Figure 2. presents the L7 MES app with an overview of the electronic batch record (EBR) view that an operator would use to execute the batch. The EBR has multiple features, as described above, that cover automating your procedures in a digital format while capturing the execution data in a way that is familiar to someone who is used to paper. The added real-time checks reduce the chances of entry error and ensure your procedural controls are applied during day shift at 5:00 PM or at 5:00 AM on a weekend shift, just before handover. The L7|MES system is designed for developing and then progressing to CGMP production seamlessly. We are CGMP-ready out of the box and provide the flexibility to support the early-stage process development, capturing and curating your data resource across your journey to clinical and commercial production. We have touched on our EBR functionality in the MES system, and we will delve deeper into the exciting features we bring to the MES solution table in my next blogs. How L7 MES seamlessly interacts with the rest of L7 Enterprise Science Platform (ESP) and how that builds in functionality that will make manufacturing connected and traceable across a manufacturing system such as in figure 1. Standard functionality and features of the L7 MES app for your CMC, Development, Tech Transfer, and CGMP needs: Problem MES Solution L7 MES APP 1 Make-to-order product critical speed of delivery Streamline through Automation of calculations and equipment interoperability with L7 MES. Schedule slots and request setup preparation for equipment, BOM dispense and kitting, Request Test plans in QC, automate procedures ✓ 2 Right first time, every time - Speeding up delivery of treatments to patients Quality by design – L7 MES provides inline checks and guardrails to ensure correct materials, recipes, expirations, parameters, samples, and procedures are taken and followed throughout the process. ✓ 3 Regulatory and compliance - Manufacturing in a CGMP environment to produce products requires adherence to established FDA and regulatory body requirements and standards for IT infrastructure The L7 MES system can build in compliance and procedural rules across the process and provide the infrastructure and toolset to apply requirements for every batch and product. Create inline checks that follow all your supporting GMP documentation and ensure robust production processes with proper oversight and governance. L7 MES provides audit trails of all actions taken in the system and connects directly to primary sources of data to capture accurate, time-stamped, attributed data. L7 MES provides 21 CFR part 11 compliance controls with data integrity and e-signatures to restrict performers and verifiers to trained personnel. ✓ 4 Executing and Reviewing paper-based documentation is slow and error-prone and multiple procedural documentation is required Quality Review using ‘review by exception’ and inline checks and controls in EBR reduces human error and time for costly investigations. Real-time feedback allows immediate response and course correction to mitigate problems and increase success rates. Ensure process is executed in correct order with flexibility to cover all eventualities. Add comments, flag deviations, review in parallel to steps being complete. ✓ 5 Scalability of products and processes Agile build and deploy of MES recipes, L7 MES allows composability of built validated recipes to reuse and redeploy quickly for new similar process tech transfers. Scale from development to production and use the same recipes ✓ 6 Chain of Identity (COI) and chain of custody (COC) across entire value chain Reduce the use of documentation and spreadsheets to track COC and COI of your specimens, product, and samples, digitally across your clinic to manufacturing operation using L7 MES. Build in barcodes and labeling for scanning and checking throughout manufacturing. Using L7 MES as part of the ESP unified platform allows COC and COI to transition across the entire value chain. ✓ 7 Data Silos: Paper-based and disconnected point solutions separate and hide data and insight L7 MES, as part of manufacturing operations management application suite or unified platform, digitizes business processes and collects records of all KPI data as a context-rich data fabric across the whole operation. One source of truth, one architecture, curated data ready for reporting and business insights ✓ 8 Manufacturing Intelligence and business insight Generate useful, accessible, contextual, curated data all in one place. Need data-centric MES, not traditional process-centric. Break down data silos across applications and process stages. ✓ ABOUT THE AUTHOR ### Empowering Life Sciences While Reducing Operational Costs and Driving Efficiency ### Digital-First Implementation Breaks Down Data Silos to Solve Laboratory Data Management and Workflow Challenges ### L7 Informatics at Reuters Pharma USA 2023 Participants: Vasu Rangadass, CEO & President at L7 Informatics Information: Vasu Rangadass, President and CEO at L7 Informatics, explores the potential of applying principles from the 4th Industrial Revolution and systems thinking to speed up therapeutic development. The key lies in digitizing data and workflows, optimizing operations, and embracing innovation. By harnessing AI, machine learning, and real-world data collection, decision-making can be enhanced, time to market can be reduced, and collaboration can be streamlined. By fostering an innovative culture and focusing on continuous improvement, organizations can swiftly adapt to changes, leading to accelerated drug development and a more effective healthcare system. ### L7|LIVE Boston: Applying Principles of the 4th Industrial Revolution and Systems Thinking to Accelerate Novel Therapeutic Development Participants:Vasu Rangadass, CEO & President at L7 Informatics Information:After a brief speaker introduction from Jared Fine, Partner at Goodwin, Vasu Rangadass, Ph.D., President & CEO of L7 Informatics, kicks off L7|LIVE Boston and walks us through the elements of digitalizing operations and how this can empower organizations while driving efficiencies and reducing operational costs. With over 30 years of experience, Vasu has a successful background in incorporating innovative approaches to building products that create and deliver tremendous value to the marketplace. ### L7|LIVE Boston: Connell and O'Reilly Families Cell Manipulation Core Facility - CMCF​/DFCI​ Participants:Dr. Jerome Ritz, Executive Director of the Connell and O'Reilly Families Cell Manipulation Core Facility at the Dana Farber Cancer Institute. Information:Dr. Jerome Ritz is the Executive Director of the Connell and O'Reilly Families Cell Manipulation Core Facility at the Dana Farber Cancer Institute. Dr. Ritz is a pioneer in cancer research, and we are honored and pleased to have him with us at L7|LIVE Boston. Dr. Ritz shares more about the incredible work they are doing at CFCM and how he sees digital transformation enabling his organization to reach its goals. ### L7|LIVE Boston: L7|ESP Live Demo Participants:Steven Barash, VP, Strategy & Development at L7 InformaticsJeff McDaniel, Head of Solutions Consulting at L7 Informatics Information:Take a closer look at the L7|ESP platform with L7 team members Steven Barash, Head of Strategy & Development, and Jeff McDaniel, Head of Solutions Consulting. Combined, Steven and Jeff have over 25+ years of experience and in-depth product and marketplace knowledge in life sciences digitalization. ### L7|LIVE Boston: The Digital Transformation Challenge Participants:Jane Lomax, Ph.D., Head of Ontologies at Scibite Information:Jane Lomax, Ph.D., Head of Ontologies from Scibite, join us for L7|LIVE Boston from the UK! Jane is an ontology extraordinaire with over 20 years of experience and has a lengthy list of published scientific papers on that subject. Jane shares how mastering ontologies can eliminate some of the challenges of digital transformation and help build a solid digital foundation that is needed for future technologies. ### Streamlining Data-Intensive Scientific Workflows and Supply Chains Through FAIR Data, Data Models and Applications L7 | CHATSpartnership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEw3IEluZm9ybWF0aWNzIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@A Partnership Between L7 Informatics and SciBite With increasingly complex manufacturing and supply chains in the life sciences, there is a requirement for flexible and extensible tools to support data management. Through partnership, L7 Informatics and SciBite are leveraging FAIR (Findable, Accessible, Interoperable, and Reusable) to deliver an ontology-backed data unification solution to address this unmet and growing need. This connection, and use of both systems, will help you end up making use of your data, and providing limitless data intelligence. Shifting Data Needs Within the Life Sciences Utilization of big data in the life sciences remains a significant hurdle, hampering scientific progress and realization of data value. Unstructured data is siloed in specialized applications used for specific tasks within organizations. There is a prevalence of legacy data and downstream applications for this data were also not considered when it was captured. Layered on top of this is a lack of standardized terminology within the life sciences, impeding search, analysis, and extraction of meaningful insight from the data. The biopharma industry is adapting to the pressures of dwindling drug pipelines, ever-increasing development costs, and complexity of new biologic therapies and personalized medicine. Pharma companies are bolstering pipelines through mergers and acquisitions and increasingly outsourcing development and manufacturing to contract development and manufacturing organizations (CDMOs). This outsourcing model is streamlining processes and shortening the path to market; something that was exemplified during the development of COVID-19 vaccines. This outsourcing model is predicted to grow alongside a transition from fee-for-service models to more strategic partnerships with biopharma. This was seen during the COVID pandemic, with AstraZeneca announcing large partnerships with Emergent Biosolutions, Catalent, and Lonza. This trend in outsourcing development and manufacturing can potentially exacerbate existing data access and utilization problems by introducing data silos. Increasingly complex manufacturing processes involving genomic profiling require complex workflows and supply chains. Specialized teams work in different parts of the workflow or supply chain, needing tools to support the capture and management of data associated with specific parts. Participants in these workflows may also be geographically separated and may work in different organizations. How will the industry address this, and what tools will be required? Leveraging FAIR Supporting complex workflows and supply chains requires dedicated tooling, capturing data with downstream utility in mind. The concept of FAIR (Findable, Accessible, Interoperable, and Reusable) provides an ideal framework for capture and reusability, but how are L7 Informatics and SciBite implementing this to address these challenges? Through its Enterprise Science Platform (L7|ESP), L7 has taken a platform approach to support these complex workflows and supply chains, providing a unified view of data across the entire process. L7|ESP is in fact the only regulatory-compliant platform designed to manage the unique complexities of precision healthcare across scientific research, diagnostics, therapeutics, and medicine. The platform has native applications including LIMS, ELN, MES, inventory, and more. It can integrate with existing third-party applications, lab instruments, and devices to capture all data in a single data model. Its low-code/no-code workflow designer and hundreds of pre-built connectors enable rapid time-to-value and end-to-end automation. And through the application of FAIR principles not only to data but to data models and applications, L7 delivers a composable platform that is highly configurable from simple reusable components, streamlining the implementation, and making it highly extensible. Through the partnership, SciBite is supporting L7 Informatics in delivering its vision of FAIR within L7|ESP. As an industry leader in semantics, SciBite supports the digital transformation strategies of many leading pharma and biotech organizations. Employing a rule-based approach through the application of ontologies to structure data and provide machine-readable clean data for downstream applications, such as robust search, analytics, or knowledge graphs. CENtree, SciBite’s proven and established ontology management tool, is utilized by L7 to develop dedicated ontologies aligning with public ontologies. These support specific workflows within L7|ESP. L7’s subject matter experts can centrally manage and extend these public ontologies, or develop new ontologies from scratch for specific domains or applications. These ontologies, managed by L7 in CENtree, are distributed to customers within L7|ESP. Existing CENtree users can also directly use their own ontologies within L7|ESP. Ontologies are used within L7|ESP to capture semantically aware, standardized data by populating pick lists. These guide the user to enter ontology-backed terms upon data entry. Since these ontologies apply an explicit, unique meaning and description to scientific terms, this ultimately brings semantic intelligence to L7|ESP. So, for example, rather than being a random string of letters, the term ‘NIDDM’ can be understood as referring to the indication ‘non-insulin-dependent diabetes’. Ontologies also encapsulate the hierarchical relationships between terms, such as that multiple sclerosis is an autoimmune disorder. This is key to data interoperability and enabling robust search and analytics over this data and extracting scientific insight. The composability of L7|ESP makes it quick to deploy using reusable components, including data models in the form of ontologies. By embedding CENtree directly into L7|ESP, users can collaboratively extend these ontologies and tailor them to their own data and workflows. CENtree provides a complete governance framework, controlling who can edit or approve edits to ontologies and handling this entire process. This provides a complete audit trail of when edits to the ontology were made, by whom, as well as offers the ability to roll back these changes. In addition, compartmentalizing changes in public ontologies from edits made by users, allows the public ontologies and user-defined edits to evolve independently. Summary Combining L7|ESP and SciBite’s CENtree ontology management solution provides L7|ESP users with a powerful, ontology-backed data capture and unification tool to support complex life science workflows and supply chains. It is quick to implement, and extend and provides a powerful data management tool aligning with FAIR data principles. If you would like to learn more about the L7 Informatics and SciBite partnership, please download this collateral or contact us through our website. ### What are L7|ESP Scientific Digital Content? L7 | CHATS product update@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyYW5kb24gVmFyZWxhIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@Our Enterprise Science Platform (L7|ESP) is an extremely flexible and configurable platform, which empowers our customers to accurately digitalize their operations. In order to configure their ESP servers, our customers leverage L7|MASTER to represent their methods and operational processes. In this article, we describe the main ESP Scientific Digital Content that are also available in our L7|HUB server. Data Models Entity Classes are used as a broader classification of Entity Types, which can then be accessed in a separate Application. For example, one could create an Assets Entity Class, which would include different Entity Types, such as Sequencers, Liquid Handlers, etc. Entity Types are used to identify what Entities we are working with. Different Entity Types can have different custom variables. For example, a DNA Extraction Entity Type could include variable fields for Extraction Date, Extraction Kit Used, etc. Container Types are used to track the location of our Samples. Containers can be configured to have two dimensions, as well as custom variables. Container can be nested, which means our users can configure as much granularity as they need for their operations. For example, the following server includes 5 Container levels: Room A Freezer 1 Shelf B Rack 2 96-Well Plate C SAMPLE0001 … Item Types are used to track Inventory Item details and usage. L7|ESP can be configured to alert users when Inventory Items go under a configured threshold to prevent running out of critical Inventory Items, which would bring operations to a halt. Processes Processes are used to map scientific operational processes, which are then used in LIMS to collect relevant process data for our Samples. Protocols are the smallest building blocks. They represent ordered steps in a larger process, the Workflow. Protocols can be used to collect process data, run analytical pipelines or create relationships between different Samples -e.g. create a Sample aliquot and track its genealogy. Workflows are the intermediate building blocks. Workflows are sets of ordered Protocols. Workflows can be chained together to digitalize end-to-end more complex processes. Workflow Chains are sets of logically chained Workflows. Workflow Chains support repeating or skipping Workflows as needed. For example, if a step fails, then the relevant Samples can be re-submitted to the appropriate Workflow. In the example below, The Illumina Sequencing Workflow Chain is composed of three Workflows (1) Library Preparation and QC, (2) Library Pooling and QC, and (3) Illumina Sequencing. Extensions Applets are used to streamline specific areas of our customers’ operations Reports are used to extract insights from an L7|ESP database. Pipelines Pipelines are used to run a computational process. These can range from parsing files and associate the resulting data to Entities or process data, generate physician ready reports, run bioinformatics analysis, connect to external databases, and more. Pipelines are composed of smaller reusable building blocks called Tasks. ### Intro to L7|HUB L7 | CHATSproduct update@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEJyYW5kb24gVmFyZWxhIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@L7 Informatics Inc. is excited to unveil the L7|HUB, a groundbreaking application that is set to revolutionize the way scientists collaborate and share digital scientific content, including data models, instrument connectors, manufacturing recipes, workflows, and many more. Current systems often fall short when it comes to collaboration and managing and sharing digital scientific content in a robust and repeatable manner. The L7|HUB changes that by providing scientists with an easy way to collaborate and share digital scientific content with their peers, colleagues, and trading partners. At L7, we are dedicated to revolutionizing the way science is done. Our Enterprise Science Platform (L7|ESP) is an extremely flexible and configurable platform, empowering our customers to digitalize their operations. Scientists can easily create and maintain digital scientific content that accurately represents their scientific methods and operational processes using the L7|MASTER. With the addition of L7|HUB capabilities, scientists can now securely move and share content between instances of L7|ESP (Development, QA, UAT, and Production) and their colleagues across the globe. This will allow L7 customers to rapidly roll out new scientific content across their global ecosystem of labs ensuring repeatability and reproducibility of their science. In addition, L7 is developing standard digital scientific content so that scientists have these assets at their fingertips. These assets include L7|ESP configurations and data models needed to process samples, genomic sequencing workflows, compendial QC methods, and many more. With just a few clicks, L7 customers can connect from their instance of L7|ESP to the L7|HUB server hosted by L7 Informatics, browse through the content library, and install industry-standard digital scientific content. For example, a scientist could easily install workflows to perform next-generation sequencing on blood samples, including preparing samples, connecting to common instruments to exchange data, performing data analyses, and creating reports to uncover new insights to share with colleagues. "With the L7|HUB and industry-standard scientific content, we are striving to revolutionize how the scientific community creates, collaborates, and shares digital assets to foster scientific discoveries," said Brandon Varela from L7’s Product Development team. ### How an Agile MES as Part of a Unified Platform Can Remove Barriers to Scale and Provide Faster Paths to Approval in Precision Therapeutics L7 | CHATSthought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFthdXRob3J0aXRsZV0gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@The precision therapeutic industry has several major challenges to overcome, to bring more consistent and cheaper treatments to a larger population of patients: Gaining regulatory approval for these cell and gene therapies is no trivial task, as the characterization, manufacturing, and control (CMC) process is challenging due to the variability of live cell-based products and the inherent differences in cells from one person to another. This variability makes it hard to find consistent safety, quality, efficacy, potency, and identity data for comparability from the laboratory through scale-up for tech transfer to manufacturing sites. Scaling production entails scaling out the process, which carries a high cost for clean room space and expensive equipment and talent to run the processes. This approach also increases the chances of cross-contamination of different patient products, which could have deadly outcomes if chain of custody and chain of identity is managed in paper and spreadsheets, as is the case in many CGT companies. Tech transfer of laboratory scale to production scale is not well defined due to the lack of deep understanding of the product and how variations can affect clinical data needed for BLA regulatory submission. Exorbitant costs of manufacturing and testing for clinical studies and commercial production inhibit the growth of the industry and usually leave the cell and gene therapy as the last line of attack after older, cheaper, and more aggressive approaches are provided to the patient first. These challenges can be partially traced back to the industry's heavy reliance on paper-based processes and could be greatly reduced by digitizing the entire value chain on a unified platform. Creating paper silos inhibits collaboration, reduces understanding and insight, blocks process improvement, drastically slows delivery, and ties up your talent in reviews, corrections, and investigations. An MES as part of a unified platform, can automate process and capture data where people and equipment meet the process. With a digital-first approach, you can add meaning and context to your data across the entire process and across developmental stages while adhering to CGMP practices and governance. The Data is the Product The CMC approach must change to incorporate learnings from the development stage through the technical transfer to the manufacturing stage, building layers of deep learning of what are critical process parameters and what critical quality attributes they affect. The earlier this process begins, the better. Notebooks and paper batch records lock the learning away and make it difficult to build a comprehensive picture of each unit operation's effect on the intermediates and final product during the process. Data becomes the product when it leads to an understanding of how to improve the outcome by affecting a change in the upstream process. A process is then allowed to evolve and change over time to create the best outcomes and optimize based on prescriptive analytics. When the process needs to change, or parameters need to be flexible to get the best outcomes, the data drives the models that course correct. The amount and complexity of the data the industry needs to collect to achieve this must be contextualized, curated, and ready to analyze, and MES, as part of a unified platform, can unleash this resource and drive down costs in the industry. Capturing the data at every stage on one system allows for collaboration and comparison across the entire development and implementation of the therapeutics value chain. Visibility and insight is the name of the game for optimizing CGT and generating the knowledge of how to set optimal conditions for each production run. Make the data the product that can be transferred and applied to new indications in CGT. Scale your Process and Production It is necessary to scale out to increase production in the CGT space, as each batch represents one patient's therapy. Allogenic processes also start with an individual donor, although the donor is healthy, the process of selection and cell culture are mostly identical to autologous processes and have the same barriers constraining their scaling. To protect against cross-contamination and incorrect handling through this horizontal scaling, a digital solution for chain of custody (CoC) and chain of identity (CoI) must be established that builds in confidence on where a material, sample, specimen, or product is, what condition it is being stored in, how long it stays there, and ensuring it is what we expect. An MES as part of a manufacturing operations management application suite, can provide this key information and alert to any mistakes in real-time and avert costly and potentially life-threatening mistakes being made. Adding labels and scanning to these items removed another source of error, typing, and allows all the metadata associated with the item to be retrieved and used for real-time checks. Additionally, adding in flexible, IOT-ready equipment capable of producing many products and adding robust analytical capabilities, all build into a pharma 4.0 approach. Quality by design (QbD), digitizing and automating your process Quality by design approach can be automated in an MES system, essentially engineering in your quality checks, where people meet process. This automation of quality checks reduces the potential for human error and streamlines the review process using "review by exception" at the end of each section or the process. Deviations are avoided during processing as the guard rails designed into the MES can detect and document any deviations as they occur, allowing course corrections and proper regulatory compliance in real-time. Using an MES on a unified platform to build in QbD and automate the documented controls into your process supports a right-first-time, every-time manufacturing environment. Building to faster, more successful, and more robust product with positive impact for the patient and business needs. Conclusion Removing paper and replacing it with the right digital solution for data and process automation can supercharge the precision therapeutics industry and provide the infrastructure needed to avoid and overcome the abovementioned challenges. Connected, meaningful, contextualized data across the entire CGT value chain with process automation where people meet process is a must to bring the promise of precision therapies to the masses in a cost-effective and attractive way.ABOUT THE AUTHOR ### L7 and Tag.bio Team Up to Accelerate Digital Transformation ### Global Value Web + L7 Informatics Webinar | Unified Platform for Life Sciences Value Chain: People, Data, Process Participants:Louis Hendriks, Founder & CEO at Global Value WebVasu Rangadass, CEO & President at L7 Informatics​ Information:A complex life sciences environment demands a resilient value chain and transformed business model that break down data silos, reduces turnaround times, and places patients at the center of your operations. With an industry-wide connected value chain, data is readily available and accessible, which enables informed decision-making and quick reactions to disruptions in the supply chain. This also contributes to data integrity and on-time delivery of quality products. Please join us for this webinar with L7 CEO Vasu Rangadass and GVW Founder & CEO Louis Hendriks. We will discuss its approach toward a life sciences value chain data backbone of the future by integrating People, Data, and Process to deliver better business and patient outcomes. Key Takeaways • Building a Life Sciences Value Chain Data Backbone of the future • Creating a Unified Enterprise Science Platform for Pharma Operations • Improving Utilization and Efficiency through Data Intelligence • Ensuring real-time availability of data • Integrating the right digital innovation and strategy • Engaging with Industry peers and sharing Common Learnings Who Will Benefit From C-level executives through Quality VPs, Directors, from managers to the knowledgeable professionals in the lab. ### An Introduction to MES and Its Importance to the Precision Therapeutics Value Chain L7 | CHATSthought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFthdXRob3J0aXRsZV0gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Precision Therapeutics as a New Class of Biologics Precision therapeutics refers to the new classes of treatments that have been developed to treat diseases with specific characteristics, whether it be genetic defects, immunological deficiencies, or molecular profiles. Examples of precision therapeutics include but are not limited to the following: Gene Therapy - the transfer of genetic material (RNA or DNA) into the cells of a patient's body either through extracted cells to reintroduce or directly using viral vectors or lipid nanoparticles to carry to the disease causing area. CAR-T and CAR-NK - Chimeric Antigen Receptors (CAR) is the addition of specific proteins on the surface of native or donor immune cells to create targeted responses to cancer or disease generating cells in a patient's body. Neogenomic Vaccines - specific to an antigen produced in the microbiome of the diseased cells and used to identify and flag these mutated or diseased cells for destruction. Viral vector and plasmid production - using CRISPR/Cas9 to create plasmids encoding desired protein antigens, the plasmid can be delivered using viral vectors like AAV or lipids to deliver to cells in-vivo or ex-Vivo. CRISPR/Cas9 - CRISPR can be used as a tool to edit the base pairs of genes and CAS9 acts as a genetic scissors to cut genes in a specific region where deletion, disruption and correction are required. Bioprocess Design of Precision Therapeutics Bioprocess design has become a well-structured and documented methodology for traditional biologics such as monoclonal antibodies. A typical design approach will use standard process templates to perform design of experiments for process characterization and identification of CPPs and CQAs through failure modes and effects strategies. In this design approach, process variability commonly falls within the accuracy tolerance of analytical control methods used to evaluate products – hence the terminology “well characterized” biologics. With the arrival of novel gene, cell and tissue therapies, a different type of processing is introduced in which the variation in processing outcomes is less “testable”. Multiple process and analytical measurements are real-time used to choose what process path to follow, almost a choose your own story. The QC method becomes part of the process and potency measurements will often involve the same product manipulation techniques as the manufacturing process (cell expansion, infection). For process design, it can seem virtually impossible to repeat the same process more than once and one ends with a multiplicity of related but non-identical processes and QC results. In this situation, we are pushed beyond the traditional “process is the product” paradigm into a new realm where the “data is the product”. Manufacturing with Data Intelligence A Manufacturing Execution System, or MES, is a digital solution used in manufacturing or production of life science products that replaces paper-based documentation to digitally execute manufacturing processes and capture a record of the who, what and when of the entire production process from raw materials to intermediate or finished goods. It is an integral part of any manufacturing operations management (MOM) in the life sciences and a keystone of a digital manufacturing 4.0 plan overall. Step one is digitalizing and contextualizing your data and process, and MES is the keystone to achieving this. The therapeutics industry also generates massive amounts of data and this needs to be stored and curated in a format that makes it accessible and interrogatable at all levels of the value chain. MES as part of a MOM application suite extends the MES capabilities as a unified platform, to manage the inputs (Schedule, Materials, Assets, Personnel) and the outputs (Product, Intermediates, Samples, Data and documentation). MES as part of a manufacturing operations management application suite can intensely improve the following pain points in manufacturing precision therapeutics: PROBLEM SOLUTION 1 Make-to-order product and speed of delivery Streamline through Automation of process and data with an MES 2 Right first time, every time - Speeding up delivery of treatments to patients Quality by design - MES provides inline checks and guardrails to ensure correct materials, recipes, expirations, parameters, samples, and procedures are taken and followed throughout the process. 3 Regulatory and compliance - Manufacturing in a CGMP environment to produce products requires adherence to established FDA and regulatory body requirements and standards for IT infrastructure The right MES system can build-in compliance and rules across the process and provide the infrastructure and toolset to apply requirements for every batch and product. Create inline checks that follow all your supporting GMP documentation and ensure robust production processes with proper oversight and governance. MES provides audit trails of all actions taken in the system and connects directly to primary sources of data to capture accurate, time-stamped, attributed data. MES provides 21 CFR part 11 compliance controls with data integrity and e-signatures to restrict performers and verifiers to trained personnel. 4 Talent pool is small and expensive- tied up with review cycles for paper-based batch records or investigations of deviations Review by exception and inline checks and controls allows a redeployment of valuable staff to value add activities like manufacturing, dispositioning, continuous improvement. 5 Scalability of products and processes Agile build and deploy of MES, must allow composability to cater to many customers, speed up tech-transfer from development to production, reuse and repurpose validated blocks of executable processes. 6 Chain of Identity (COI) and chain of custody (COC) across entire value chain Reduce documentation and spreadsheets to track COC and COI of your specimens, product, and samples digitally across your clinic to manufacturing operation using MES. Build in barcodes and labeling for scanning and checking throughout manufacturing. Using MES as part of a unified platform allows COC and COI to transition across the entire value chain, whether internally in manufacturing suites or externally across multiple sites and functions in the value chain. 7 Data Silos- Paper-based and disconnected point solutions separate and hide data and insight MES as part of manufacturing operations management application suite or unified platform digitizes business processes and collects records of all KPI data as a context rich data fabric across the whole operation. One source of truth, one architecture, curated data ready for reporting and business insights 8 Manufacturing Intelligence and business Insight Generate useful, accessible, contextual, curated data all in one place. Need data centric MES, not traditional process-centric. Break down data silos across applications and process stages. ABOUT THE AUTHOR ### Digital Transformation: Integrating Automated Data Management Systems to Advance CGT Manufacturing and Improve Process Control Participants:Trent Carrier, Ph.D., Chief Operating Officer, L7 Informatics (moderator) Speakers:Sammy Datwani, Ph.D., Senior Vice President, Development, SynthegoKevin Gordon, Chief Digital Officer, Ori BiotechDelara Motlagh, Ph.D., General Manager, Cell Therapy Technologies, Terumo BCTYan Zhang, Ph.D., CEO, Mission Bio Information:This workshop discussion explore​s​ ways in which advancements in data capture, data interrogation and analytics ​can improve advanced therapies product manufacture. Innovations in data processing ​can help to optimize manufacturing and process development efforts, decreasing associated time and costs. The session explores how some of the most advanced technology companies are refining and implementing these processes. ### Panel Discussion at CGT Manufacturing and Commercialization US 2022 - Overcoming Manufacturing Capacity and Security of Supply Chain Challenges Moderator:Shashi Murthy - CTO and Co-Founder, Nanite Inc. Panelists:Heather Erickson - Vice President, Supply Chain Management & Business Operations, Sangamo Therapeutics, Inc​.​Tom Walls - Global Planning and Logistics Lead, Spark TherapeuticsChris Baldwin - Sr Director, Cell & Gene Therapy Supply Chain, GSK, UKTrent Carrier - Chief Operating Officer, L7 Informatics, Inc., USA Information:L7's COO, Trent Carrier, PhD, MBA, and other industry leaders are joining the Plenary Discussion Panel "Increasing Control and Security of Supply Chain" on The Cell & Gene Therapy Manufacturing & Commercialization event. Moderated by Shashi Murthy, CTO and Co-Founder of Nanite Inc., the discussion focuses on several topics of the supply chain flow such as strategies to ensure supply chain and raw material security and adaptations to raw material constraints. ### Interview with Ernie Bognar, Chief Operating Officer at Gradalis ### Future Labs Live Basel 2022 - Digital Transformation: A Unified Platform Approach For Data Intelligence for Scientific Enterprises Guest Speaker:Vasu Rangadass, President and CEO at L7 Informatics Information:Vasu Rangadass, Ph.D., L7 Informatics' President and Chief Executive Officer talks about digital transformation, and the benefits of a unified platform approach for data intelligence for scientific enterprises. ### L7 Informatics Raises $38 Million Growth Investment to Digitalize Precision Healthcare ### ISCT SF 2022 - "Digitalization of Cell Therapy Laboratories" Roundtable Discussion Panelists:Jonathan Jacobs PhD, Senior Director of Bioinformatics, ATCCBrian Hawkes, PhD, Chief Technology Officer, Pluristyx, Inc.Marcia Blackmoore, CMC Project Leader, Genomic Medicines Unit, SanofiMichael Ambrose, PhD, Director of Product Quality & Analytical Methods in Digital & Informatics, USP Moderator:Trent Carrier, Chief Operating Officer at L7 Informatics Information:Joined by industry leaders, Trent Carrier Ph.D., MBA, L7 Informatics' Chief Operating Officer facilitates an interactive discussion regarding the key factors for cell therapy laboratories to consider when implementing a digitalization strategy. ### L7 Informatics and GVW Interview by ScienceBoard.net - Meeting on the Med, Barcelona, April 2022 Guest speakers:Louis Hendriks, Founder & CEO at Global Value WebVasu Rangadass, Ph.D., President and CEO at L7 Informatics Moderator:Walt Schoenborn, Vice President - Digital Media at ScienceBoard.net Information:Walt Schoenborn, Vice President - Digital Media at ScienceBoard.net, part of Science and Medicine Group, interviews Louis Hendriks, Founder & CEO at Global Value Web and Vasu Rangadass, Ph.D., President and CEO at L7 Informatics, during the 2022 Cell and Gene on the Med conference in Barcelona. ### L7 Releases L7|ESP 3.0 with New Features and Updates L7 | CHATS release news @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFthdXRob3J0aXRsZV0gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@With the release of L7|ESP 3.0, L7|ESP now includes new features and updates in five specific areas: Builders, ELN, LIMS, L7|HUB, and the L7|ESP architecture. Release notes can be found here. In Builders, L7|ESP 3.0, every instance includes three template entity classes and allows containers and items to be moved through the system and processed in the same way as other entities or samples. Additionally, with the added custom view for entity classes, users can define a custom view and allow users to have access to actionable insights. Also, with 3.0, versioning of these types is now available, so entities can be migrated to reflect a version change, or newly created entities can be migrated back to a previous version. Workflow versioning in 3.0 enables users to see which version of a workflow a test has been run against and offers the ability to PIN a version. With that, the workflow chains in 3.0 have an updated UI and the addition of a swimlane workflow design when creating a workflow chain. This is an easy, visually distinguishable process based on a functional area. The new signature option offers increased integration, including Adobe Sign and DocuSign. This allows the user to send, sign, track, and manage signature processes. Additionally, doclets now have their own application in Builders with interactive documentation explaining how different features within L7|ESP are intended to work, while standard doclets are downloadable from L7|HUB. L7|ELN With ELN, L7|ESP 3.0 offers the ability to digitalize the historically paper-based process. This gives users widget-based page elements and the ability to templatize notebook entries and drag-and-drop functionality. The 3.0 configuration application has improved readability of configurations with easier methods to minimize and view configurations. Additionally, the entities application has added support for bulk edit, showing multiple entity types on the same grid, saving filters to user profile, column management, and intelligent links between resources. L7|ESP LIMS 3.0 offers numerous enhancements to our LIMS application , including the following: The cache is stored locally with every change for any cell in the worksheet, and then it is sent to a server every 3 minutes by default. A cache can also be sent manually. Un-Delete Ability to edit cells within completed samples in LIMS for users with proper permissions. Include comments from the table and transposed views Edit (adding/removing) samples from experiments already submitted. Samples in currently running experiments cannot be edited. Improved support for concurrent users executing complex automation processes within the LIMS application. Updates to allow Containers to go through workflows Updates to the Experiment modal to support removing a sample from a completed experiment. Users can now complete a row where they have started editing a cell but have not yet exited edit mode. The dropdown selection for date format now allows the user to input a custom date format string. When choosing a column/custom field type, the dropdown label now displays “Date/Time” Added date/time minimum/maximum validation constraints. Attachment picker updates Support for multiple selections Support for drag and drop File type validation Support to re-upload an attachment or change the attachment's name. Send samples to next workflow button added to the last protocol of the workflow automatically Date column updates: The ability to enter a custom date format string. The setting of date and time is now an option for users. Validation constraints on date/time entry (max and min values) Protocol Actions Protocol actions allow protocol authors to add behaviors to protocols that are executed when the protocol is saved or at certain other key points in the life cycle of a worksheet. L7|ESP 3.0 now offers access to the L7|HUB. L7|HUB is a collaboration tool and is a repository of robust and standard content. As a collaborative tool, collections enable content developers to easily create iterative bundles and build solutions over time. Also, users can share content in real-time and minimize system downtime. As a repository, users can use L7|HUB to search for and select content that could be useful to their operations. Lastly, with regards to architecture and deployment updates, L7|ESP’s standard deployment is now managed via docker-based containerization. And the L7|ESP server has changed from python 3.5 to python 3.9. Customers with significant server-side extensions should evaluate those extensions for python 3.9 compatibility, but no major upgrade problems are anticipated. And with 3.0, multi-tenancy offers the ability to share resources while separating data and configurations.ABOUT THE AUTHOR ### L7 Informatics and Sanofi at Lab of the Future USA - March 2022 Guest speakers:Yves Fomekong Nanfack, Ph.D., Director, Head of Operations Digital Biologics Platform at SanofiVasu Rangadass, Ph.D., President and CEO at L7 Informatics Information:L7 President & CEO Vasu Rangadass presents with Sanofi's Yves Fomekong Nanfack in the Digital Lab Track at Lab of the Future USA 2022. Vasu speaks about how implementing a next-generation unified platform like L7|ESP can help break costly and inefficient data and process silos while creating Data + Intelligence for the Scientific Enterprise. ### Precision Research eBook @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9leGNlcnB0Iiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiIiwiYWZ0ZXIiOiIiLCJ3b3JkcyI6IiIsInJlYWRfbW9yZV9sYWJlbCI6IiJ9fQ==@ ### Precision Diagnostics eBook @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9leGNlcnB0Iiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiIiwiYWZ0ZXIiOiIiLCJ3b3JkcyI6IiIsInJlYWRfbW9yZV9sYWJlbCI6IiJ9fQ==@ ### Precision Medicine eBook @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9leGNlcnB0Iiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiIiwiYWZ0ZXIiOiIiLCJ3b3JkcyI6IiIsInJlYWRfbW9yZV9sYWJlbCI6IiJ9fQ==@ ### Precision Therapeutics eBook Accelerate cell & gene therapy processes with workflow automation and data compliance by digitalizing research-to-commercialization. ### Precision Agriculture eBook Improve overall velocity and efficiency by digitalizing sample-to-report. ### L7 | ESP 3.0 L7 | CHATS release news @ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFthdXRob3J0aXRsZV0gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@​​Data is the lifeblood of any organization. L7 is focused on ensuring that all of your data is readily available and error-free so you can gain valuable insights across your enterprise. We produce intelligent tooling to help transform how you look at the data in ways you never thought possible. We are constantly working with our customers and prospective customers to make sure that we are driving our roadmap forward in a meaningful way. With the upcoming release of L7|ESP 3.0, we are excited to announce a few of the strategic enhancements: Increased collaboration: L7 understands the need for a unified data platform to reduce siloed data and the need for a diverse software ecosystem that requires multiple systems that talk to each other. We understand the need to do this quickly, with ease and flexibility, in a low-code/no-code (LC/NC) fashion that L7 and your citizen developers can use to accelerate your science. Increased velocity + efficiency: The ability for a unified platform to help reduce your data silos, improve operational efficiencies, and reduce errors are paramount to L7, continuing to build on our 20 + applications and ensuring we are not only helping to grow with you as a customer but also with the ever-increasing speed of scientific change. We want to immediately impact how a system like ours gets to you and what you can do with it. Increase compliance: L7 wants to be a part of your regulatory roadmap, helping to support you in all your needs, including any submissions such as 510(k) companion diagnostic for a medical device. Increased composability: The way software is transferred to customers and installed is essential, so ensuring we think about the future ways of doing that either by container type deployments or the ability to have shared the data with CROs or external partners in a secure way. We are eager to share these new enhancements and more with you as part of L7|ESP 3.0, which will be available later this spring. Have questions or thoughts on our areas of focus or 3.0? We are always looking for partners to help shape the future of our roadmap. Please feel free to drop us a line.ABOUT THE AUTHOR ### Interview with Justin Wright, CSI-Dx Executive VP of Data Analytics ### The Jackson Laboratory Goes Live with L7|ESP Data+Intelligence Unified Platform ### JAX® goes live with L7|ESP L7 | CHATSannouncement@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEw3IEluZm9ybWF0aWNzIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@ L7 Informatics, the leader in DATA+INTELLIGENCE for the scientific enterprise, announced today that The Jackson Laboratory (JAX) has gone live with the L7|ESP platform. As a comprehensive Digital Life-Sciences Platform, L7|ESP provides the environment for scientists and engineers to co-innovate to improve process velocity, operational efficiency, and compliance via data-integrity, with continuous improvement and increasing 'data+intelligence'. The Jackson Laboratory, an independent nonprofit biomedical research institution, leverages its unique combination of research, education and resources to achieve its mission: to discover precise genomic solutions for disease and empower the global biomedical community in its shared quest to improve human health. The Research IT team at JAX is responsible for supporting this diverse and complex research environment from data management, HPC, and Cloud computational services to scientific pipelines, image analysis and AI/ML solutions. The Research IT team will work with L7 to deploy the service to internal labs within JAX including protein sciences – a service at JAX which provides expertise and high-throughput analyses for metabolomics, proteomics, and targeted studies – to automate lab processes, instrument integrations for automated test runs and data integrations for seamless correlation of results across labs and service. Vasu Rangadass, Ph.D., President, and CEO of L7 Informatics said "We are inspired by The Jackson Laboratory's mission to improve human health. L7|ESP empowers users to bring data to life at the intersection of information, process and people." Read the Cision PR Newswire press release.ABOUT THE AUTHOR ### L7|ESP; Data+Intelligence for the Scientific Enterprise L7 | CHATSthought leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFZhc3UgUmFuZ2FkYXNzIHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@ L7 Informatics aspires to help life-sciences, research, and manufacturing organizations accelerate success in today’s data-driven world. At the intersection of information, process, and people - we see the opportunity for your company to achieve “data+intelligence.” The ability to “unlock” your organizational capabilities and create an engine for growth and transformation - to realize the ultimate value of your data and processes - all while confidently navigating a complex business and regulatory landscape. As a comprehensive Digital Life-Sciences Platform, L7|ESP provides the environment for your scientists and engineers to co-innovate to improve process velocity, operational efficiency, and compliance via data-integrity, with continuous improvement and increasing ‘data+intelligence.’ This is what L7’s customers are accomplishing with L7 today. Whether it is increasing velocity for rapid whole-genome sequencing to diagnose rare diseases, improving the efficiency of cell manufacturing, QC, and clinical trials - or strengthening the integrity for CAR-T quality control and manufacturing - L7’s Digital Life-Sciences Platform accelerates the journey while unlocking your collective data+intelligence. I invite you to explore our customer case studies and be inspired by the many ways L7 could help your scientific-enterprise realize ‘data+intelligence’ across the how, when, and where your data is created and used across enterprise & scientific processes, including key partners. Take the first step and contact L7 to speak with one of our application scientists. We are eager to hear about the kind of ‘data+intelligence’ you envision driving your next phases of discovery and growth.ABOUT THE AUTHOR ### Astrix Digital Transformation Webcast Series - L7 Informatics Presents Lab Automation, Tomorrow's Reality is Starting Today Participants:Patrick Rose, Director, Product Management at L7 Informatics Information:In their Digital Transformation Webcast Series, Astrix Technology Group brings together innovative informatics solutions providers from across the industry that are at the forefront of technology to present cutting edge solutions that will enable the transformation of your laboratory into the digital lab of the future. We're thrilled to be part of this unique webcast series with this session presented by L7 Informatics' Director of Product Management, Patrick Rose. Rose looks at how L7 can enable companies to achieve level 4 of the digitalization path towards industry 4.0, and examines the needs and benefits of standardization and automation of the lab, including external value chain partners. Rose discusses how with L7|ESP, this is achieved via collecting the data from automation and connected workflows, harmonizing data via scientific ontologies adhering to public standards and FAIR data principles, and ultimately applying Advanced Intelligence to visualize and analyze and unlock the value from all your operational data. ### L7 Informatics at the 5th Annual Gene Therapy for Rare Disorders Europe Guest Speaker:Karri Unruh, Director, Product Management at L7 Informatics Information:Our very own Karri Unruh, Director of Product Management, is presenting at the 5th Annual Gene Therapy for Rare Disorders Europe event. Listen to Unruh as she discusses how digital transformation in Precision Medicine helps address regulatory and compliance demands. ### L7 Informatics at Neoantigen Based Therapies Summit Guest Speaker:Kevin McMahon, Associate Director, Precision Therapeutics Solutions at L7 Informatics Information:L7 Informatics' Precision Therapeutics Lead, Kevin McMahon, is presenting at the Neoantigen Based Therapies Summit. Listen to McMahon as he discusses how digitalization can accelerate the identification of neoantigens for use in vaccine immunotherapies. ### L7 Informatics at 20/15 Visioneers’ Cloud Labs, HTE and Lab Automation Conference Guest Speaker:Patrick Rose, Product Management Director at L7 Informatics Information:Our very own Patrick Rose is presenting at the 20/15 Visioneers' Cloud-Labs, HTE and Lab Automation Virtual Conference. Listen to Patrick as he discusses digital transformation of the lab through standardization and automation. Our webinar "Taking on the Pandemic: Transforming Your Clinical Lab Into A COVID-19 Ready Lab" is a joint presentation with Contamination Source Identification (CSI) During this webinar, we will hear first-hand from Co-founders of CSI, Justin Wright & Dr. Regina Lamendella, who recently transitioned their lab into a COVID-19 Ready lab in a matter of weeks. Working with L7, CSI transitioned and was fully operational with a CDC COVID-19 workflow. This rapid implementation has enabled CSI to participate in the race to aid our nation's efforts with COVID-19. Presenters Justin WrightCo-FounderContamination Source Identification (CSI) Dr. Regina LamendallaCo-FounderContamination Source Identification (CSI) Trent Carrier, Ph.D.Chief Operating OfficerL7 Informatics, Inc. Robert Zeigler, Ph.D.Director of Product and Customer SolutionsL7 Informatics, Inc. ### L7 Informatics at Cell and Gene Meeting on the Mesa 2021 Guest speaker:Vasu Rangadass, Ph.D., L7 Informatics' President and CEO Information:In this talk, L7 Informatics' President and CEO, Vasu Rangadass, Ph.D., discusses a unified platform approach to digitalize operations across research, clinical, manufacturing, QC, and diagnostics, without creating new digital silos. ### 2024 Hype Cycle for Life Science Manufacturing, Quality and Supply Chain ### Gartner Cool Vendor Report ### L7|ESP for precision diagnostics ### L7|ESP for precision therapeutics ESP provides real-time monitoring of samples with integration to instruments, process equipment, EMS, QMS and ERP systems. ### Learn what makes L7|ESP™ an ideal operating platform Learn what makes L7|ESP™ an ideal operating platform ### L7|ESP for precision agriculture The increase in data volumes along with siloed software systems in crop sciences research and development requires a modern end-to-end scientific information management solution that automates and synchronizes processes across all stakeholders giving complete visibility, control, and compliance. ### QIAGEN: Trustworthy by Design Everyday discoveries in pediatric genomics are creating new possibilities to understand and treat rare genetic diseases. This work requires robust computational strength in order to process, analyze, and manage large data sets. Please fill out the form to view the Rady Children's case study ### 7 Questions with L7: Patrick Rose L7 | CHATSinterview@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFthdXRob3J0aXRsZV0gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@1. What is the biggest pain point of the lab today? Data silos. Over the years the labs have built up a very complex infrastructure of disparate and sometimes archaic tooling to perform the day-to-day functions of the lab. As these pieces were added, there was no thought on what it would mean to the pieces that were already there, or what pieces would come after it. With this, there was no way to make informed decisions based on the information collected in each of the systems. This is why at L7 we are building a unified platform approach, which allows our customers to break down those silos and make the connections needed. 2. What do you think is the next big opportunity for digital transformation? I believe it is in the realm of data standards and harmonization with various solutions. Once you have your tools and data coming through a unified platform, allowing those tools to speak in the same language or understand and translate the language of another tool in a standard way, allows all labs, systems, and people to start having an understanding of what goes on where and when in the same way. This ensures, when you start thinking about what is next with the data, you have a common standard. 3. Once you have the data standardized, what is next? The fun…. Once you have your unified platform, which has broken down the silos and aggregated the data, and have the standards in place which have given you a common language, now you can do something with it. This is where pulling the information together, and utilizing predictive analytics based on tools that use AI/ML, you can build a closed loop system that allows you to feed back and forth to yourself, improvements and optimizations of your lab and science that weren't possible before you started. 4. What makes L7’s approach different from the competitors? First, L7|ESP offers a uniquely flexible and customizable unified platform compared to peers’ point solutions - this is unmatched in the industry place today. And our workflow and implementation customization on L7|ESP allows customer-specific solutions. At L7 Informatics, with our pioneering technology, we're dedicated to our clients’ success and our attentiveness to clients from proof of concept to platform adoption and implementation is best in class. Strategically L7’s deep knowledge across industries is difficult to find with competitors. Over 90% of our implementation team members have Ph.D. or Master’s degrees in the very fields we serve. 5. When is the best time to bring in a unified platform? As soon as you can, while we are working with a lot of large companies to transform their data and their software landscape, the sooner we come in the easier it is. Having a customer come to us earlier, ensures we can help you start with the right process instead of having to repair some of the fractures already in place by having these disparate systems. 6. What is the biggest stumbling block when it comes to digitizing your lab? Trying to take too big of a bite. You want to evolve your lab by taking a piece-wise approach and having a platform work with your lab and slowly update individual pieces as they make sense. Doing this allows you to get past the inertia stage while faced with such a large undertaking, and allows you to start connecting your ecosystem one by one until you have digitalized your lab. 7. Why is automation so important in digitizing the lab? Automation benefits the lab in various different ways. One of the most important is reducing human interaction with the tasks. The benefit of this is three-fold: one, it increases the quality of the data by reducing error prone manual steps. It also helps to optimize the lab, if the scientists don’t need to spend the time on laborious manual steps they can focus on the science and moving it forward. Finally, it increases the performance of the lab by allowing the flow of results and data faster and more efficiently. ABOUT THE AUTHOR ### Lab of the Future Digital Dialogues: Digital Transformation from Research to Manufacturing WatchDate: Thurs May 13th, 5:15-6:45 pm ET - LIVE Participants: Vasu Rangadass, Ph.D., President & CEO of L7 Informatics, Inc. Ernie Bognar, Chief Operating Officer at Gradalis, Inc. Trent Carrier, Ph.D., MBA, Chief Operating Officer at L7 Informatics, Inc. John Conway, Chief Visioneer, 20/15 Visioneers Information: Precision medicine and new classes of precision therapeutics, including cell and gene therapies, require a new category of companion informatics that automates and digitalizes complex manufacturing, quality management, and clin-ops processes. This digital transformation can reduce time to market, reduce development costs, and streamline scaling and development of these medicines. This discussion will feature an in-depth discussion on digital transformation for advanced therapeutics, a case study with Gradalis, a clinical-stage immunotherapy company, and a demo featuring L7|ESP, a platform that simplifies data management and digitalizes and automates workflows in therapeutics to enable breakthrough efficiencies, better compliance, reduced costs, and improved operational velocity. ### L7 at PMWC 2021 - Digital Transformation of Precision Medicine Pathways: A NICU Case Study Join our President & CEO, Vasu Rangadass, Ph.D. for a 15-minute talk about the benefits of digitalization. Date: Thurs May 13th, 5:15-6:45 pm ET - LIVE Participants: Vasu Rangadass, Ph.D., President & CEO of L7 Informatics, Inc. Ernie Bognar, Chief Operating Officer at Gradalis, Inc. Trent Carrier, Ph.D., MBA, Chief Operating Officer at L7 Informatics, Inc. John Conway, Chief Visioneer, 20/15 Visioneers Information: Precision medicine and new classes of precision therapeutics, including cell and gene therapies, require a new category of companion informatics that automates and digitalizes complex manufacturing, quality management, and clin-ops processes. This digital transformation can reduce time to market, reduce development costs, and streamline scaling and development of these medicines. This discussion will feature an in-depth discussion on digital transformation for advanced therapeutics, a case study with Gradalis, a clinical-stage immunotherapy company, and a demo featuring L7|ESP, a platform that simplifies data management and digitalizes and automates workflows in therapeutics to enable breakthrough efficiencies, better compliance, reduced costs, and improved operational velocity. ### L7 Informatics at Biotech Week Boston 2021: Trends for the Future of Biomanufacturing Participants:Trent Carrier, Chief Operating Officer at L7 InformaticsRichard Love, Senior Data & Bi Architect at L7 Informatics Information: L7 Informatics is excited to be part of the Advanced Regenerative Manufacturing Institute (ARMI) | BioFab USA workshop and Bio Fabrication - the Path to Commercialization at BioProcess International. Join us for this "Trends for the Future of Biomanufacturing" session, co-presented by Trent Carrier, Ph.D., L7's Chief Operational Officer, and Richard Love, Senior Data & Bi Architect at L7 Informatics. ### L7 Informatics Signs Agreement with ATCC, a Premier Biological Materials Company ### L7 Informatics Releases L7|HUB™ On Top Of Industry-leading Enterprise Science Platform, L7|ESP™ ### Product Release: version 2.4.1 of L7|ESP Platform L7 | CHATS product release@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IFthdXRob3J0aXRsZV0gfCBwb3N0ZWQgb24gIiwiYWZ0ZXIiOiI8L2gzPiIsImRhdGVfZm9ybWF0IjoiY3VzdG9tIiwiY3VzdG9tX2RhdGVfZm9ybWF0IjoiRiBkLCBZIn19@Thanks for visiting our September product updates blog. We’re pleased to release version 2.4.1 of L7|ESP Platform. New Features User Experience Enhancements In version 2.4.1 we have added the ability to allow users to pick and choose which applications they are shown on their home page, this cleans up the user interface and ensures the users can only see the items that are most important to them. They will still be able to utilize and navigate to these items but will not take up real estate of the home page or side bar if they are not one of the users most used applications. Increased Compliance Features Added more fine-grained auditing features in both protocols and workflow design as well as enhanced the when the audit log is used as well as exported to ensure data is easily accessible when the user needs it. Ingest Application In 2.4.1 the ingest application gave has some key feature enhancements to make the ingest, transformation and processing of data easier those enhancements include: Preprocessors This allows users to take a file, and transform it into a format the system can understand and process, from other file types that are not readily available in the system Mapping of data fields to custom attributes on the system Tagging newly created samples, either from defined tags in the file itself, or pre-set tags for the entire system Protocol Report Tool Advanced reporting capabilities Gives users interactive way to change, update or create data in a protocol Custom widgets Utilizes flexview component libraries General Feature Enhancements Performance Tuning Reduction in load times for projects and experiments pages Project performance tuning to allow for fast load times for both the project details as well as the workflow roll ups Context Sensitive Help Context sensitive help, which allows users to see the documentation based on the page they are on, and quickly see the information they want Archival Support Added the ability to archive experiments, so as experiments or projects are no longer needed, the user can archive them, this allows them to not show up in standard searches but are still available as the user needs them. Enhanced sample archival to add a reason for archiving, this will allow for an audit of why a sample was archived, in order to look back at it if the lab user is no longer with the company or cannot recall why they archived it ABOUT THE AUTHOR ### Gartner Research Gartner ResearchAccording to Gartner, “Success in CGT requires a holistic and outcomes-based view of the development process, but many LSO leaders aren’t approaching their programs holistically. They view delivering CGT capabilities as a series of discrete projects, which puts their business goals at risk.”¹ L7 Informatics believes in a better path forward. Our platform, which is mentioned in the report, enables life science companies to avoid siloed systems that require expensive integration and validation, while enabling a unified data + intelligence approach that will scale with the business. “With L7|ESP, unified data intelligence platform and best of breed business applications (such as LIMS, EBR, etc.), we enable you to create a single source of truth for data and process while leveraging your existing systems,” said Vasu Rangadass, PhD, President & CEO at L7 Informatics To read more Gartner insights for CIOs making investments in this space or how a CGT strategy will require IT teams to deliver brand new capabilities, please click below for complimentary access to this report ¹ Source: Life Science CIO’s Strategy for Delivering Cell and Gene Therapy Capabilities Published 4 October 2021 - ID G00748735 - By Michael Shanler, Jessica HongDOWNLOAD RESEARCH L7 is one of only five companies recognized in the Cool Vendors in Life Sciences report that technology leaders should watch to help accelerate life science business results. According to the report, “life science companies are increasingly looking to technology-based innovation to drive R&D pipelines, digital capabilities, novel therapies and new commercial engagement models. CIOs should consider these new, disruptive vendors that are poised to help accelerate life science business results.”L7 was also identified as a sample vendor in eight Gartner Hype Cycle reports: Gartner, “Hype Cycle for Life Science Research and Development 2020,” Analysts Jeff Smith, Michael Shanler, 13 August 2020. Gartner, “Hype Cycle for Life Science Manufacturing, Quality & Supply Chain, 2020, Analysts Michael Shanler, Stephen Meyer, Andrew Stevens, 12 August 2020. Gartner, “Hype Cycle for Life Science Commercial Operations, 2020, Analysts Animesh Gandhi, Michael Shanler, 6 August 2020. Gartner, “Hype Cycle for Healthcare Providers, 2020, Analysts Laura Craft, Mike Jones, 5 August 2020. Gartner, “Hype Cycle for Digital Care Delivery Including Telemedicine & Virtual Care, 2020, Analysts Sharon Hakkennes, Laura Craft, Mike Jones, 10 August 2020. Gartner, “Hype Cycle for Consumer Engagement With Healthcare and Wellness, 2020, Analysts Mark Gilbert, Jeff Cribbs, 13 August 2020. Gartner, “Hype Cycle for Healthcare Providers”, 2021, Analysts Mike Jones and Sachin Dev, 12 July 2021. Gartner, “Hype Cycle for Digital Care Delivery Including Virtual Care”, 2021, Analysts Sharon Hakkennes and Mike Jones, 13 July 2021. The GARTNER COOL VENDOR badge is a trademark and service mark of Gartner, Inc. and/or its affiliates and is used herein with permission. All rights reserved. Gartner does not endorse any vendor, product or service depicted in its research publications and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s Research & Advisory organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose. Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, express or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose. GARTNER is a registered trademark and service mark of Gartner, Inc. and/or its affiliates in the U.S. and internationally and is used herein with permission. All rights reserved. ### L7|ESP™ to Support Genome Engineering at Washington University ### ​Is Your Technology Keeping Pace with Your Science? L7 | CHATSThought Leadership@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMT4iLCJhZnRlciI6IjwvaDE+In19@@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9kYXRlIiwic2V0dGluZ3MiOnsiYmVmb3JlIjoiPGgzPmJ5IEpvaG4gQ29ud2F5IHwgcG9zdGVkIG9uICIsImFmdGVyIjoiPC9oMz4iLCJkYXRlX2Zvcm1hdCI6ImN1c3RvbSIsImN1c3RvbV9kYXRlX2Zvcm1hdCI6IkYgZCwgWSJ9fQ==@Science and technology are evolving at an unprecedented pace. Great care is called for when gathering requirements and making choices for scientific informatics and software needs. There are few more vexing challenges than inheriting a poorly performing and entrenched legacy enterprise IT environment riddled with data and process silos. The cost, politics, and persuasion needed for change can overwhelm those who haven’t been shown the true value and potential upside. The European Commission and Price Waterhouse Cooper published The Cost of Not Having FAIR Research Data in 2019, showing that this shortcoming alone costs the European Union ~ € 26 billion a year. We suspect this figure may be low as our analysis shows the cost per researcher being kept busy “wrangling data” forty percent of their time is higher. Pursuing Digital and Insilco Model-First strategies become unattainable, along with the ability to fully leverage “Big Data.” Disjointed processes and siloed data systems contribute to excessive costs, reduced quality, and elevated risk. So, you should care because the cost, poor performance, inefficient processes are not only eroding your organization’s capabilities but are also limiting the achievements of your research and development teams. The goal is more efficient scientific business processes, leading to a better quality of life for scientists/researchers, and the consumers we are working for. Until now, there are very few enterprise scientific IT platforms that can span the continuum of life and material science organizations (Discovery to Product). The flexibility, scalability, and ability to impose rigor on complex processes will drive reproducibility, compliance, and FAIR data and processes. This improvement will ultimately deliver reproducibility in science, better availability and use of Model-Quality Data, and smoother or even seamless knowledge and tech transfer. L7 Informatics, Inc. has built one of the best scientific unified platforms on the market called L7|ESP™. With this, L7 has raised the bar for enterprise scientific software with its “no code/low code” capabilities and its efficiency in gaining Composable Architecture. The composable architecture mentioned above, and the flexibility and preparedness it delivers, provide a blueprint for L7|ESP. It is a unified platform ecosystem that continually adds functionality (new business applications, instrument and equipment connectors, scientific content) and capabilities; with a rate of innovation that sets the standard in the field. Just last year, L7 Informatics was recognized by Gartner as Cool Vendor in Life Sciences and has been identified as a sample vendor in eight Hype Cycle reports. Recently L7 was featured and presented case studies with customers Cognate BioServices and Gradalis at ISCT and ASGCT respectively. In drug discovery or therapeutics R&D, research typically proceeds in a dynamic state (with pockets of stability) then progresses to a more static state as a new product moves closer to manufacturing. Some other differences that impose exogenous constraints are the need for GXP and validation, which is on the Development, Clinical, and Manufacturing side of the house. The opportunity to reduce a company’s IT footprint is substantial and pressing. There are platforms available that can replace multiple legacy and antiquated tools and do it with speed, flexibility, and risk reduction. Composable approaches will help drive these efficiency gains by reducing costs associated with disconnected IT. The current Biopharma and Healthcare verticals are not that simple for existing environments, vendor partners, and externalization and collaboration, all of which carry a vast amount of legacy IT. Brilliantly L7 integrates with existing systems and environments, allowing for a plug-and-play approach to evolving hybrid solutions while staying positioned to consolidate and simplify the overall IT footprint. Each step reduces unnecessary complexity, driving digitalization strategy in a coherent and manageable manner. This approach results in FAIR data and processes, opening the door to an Entity Life Cycle management approach that can drive innovation. A city planning analogy would be Boston versus Chicago. Have you ever been lost in Boston for hours trying to figure out how you will find your way back? (Thank the Gods for GPS.) L7|ESP allows a well-written and architected tool to handle the complexities in major data-driven organizations. Whether it is gene editing data and processes, cell therapy, small molecule or large molecule development and manufacturing, companion diagnostics development, or agricultural sciences, the L7|ESP platform can handle the workflows due to its flexibility, scalability, and the reuse delivered by a composable architecture. Complex biologics development and manufacturing groups, including CDMOs, quickly see the value in this approach as their business processes can be become very variant due to the emergence of new modalities and precision medicine therapies. What makes L7|ESP stand out as a unique Next-Generation platform are its reusable, FAIR-compliant building blocks. Scientific business processes are not only well defined but exist as a primitive or building block. Need to combine processes? No problem! Want to do this with data models? You can do it! And with the L7 approach data models, scientific workflows, instruments, applications, and services connectors are also part of the primitive framework. There is a growing element of COTS (Commercial Off the Shelf) but the ability to create new connectors becomes routine. Complexity in processes can be a precarious thing. If the complexity is due to poor processes, poor curation, and/or bureaucracy, only significant change management can address the problem. If the complexity is due to science and technology processes alone then L7 can reduce and manage it through its L7|ESP platform. The details of implementation will depend on the current and type complexity of each environment, and the role L7|ESP will play initially or in the months and years ahead. Remarkably, it does not take a year to configure the system, rather, it can become fully operational in weeks. This ultimately means lifesaving or altering products will get to market faster. Interested to learn more? Click here to access a full technical white paper on this subject.ABOUT THE AUTHOR ### Composable Architecture Enables Digital Transformation for Data-Driven Organizations ### Future Labs Live 2021: Digitalization Journey In Life Sciences L7 Informatics' President & CEO, Vasu Rangadass, Ph.D. talks about the digitalization journey in life sciences: from research to manufacturing and beyond – a unified platform approach Date: Thurs May 13th, 5:15-6:45 pm ET - LIVE Participants: Vasu Rangadass, Ph.D., President & CEO of L7 Informatics, Inc. Ernie Bognar, Chief Operating Officer at Gradalis, Inc. Trent Carrier, Ph.D., MBA, Chief Operating Officer at L7 Informatics, Inc. John Conway, Chief Visioneer, 20/15 Visioneers Information: Precision medicine and new classes of precision therapeutics, including cell and gene therapies, require a new category of companion informatics that automates and digitalizes complex manufacturing, quality management, and clin-ops processes. This digital transformation can reduce time to market, reduce development costs, and streamline scaling and development of these medicines. This discussion will feature an in-depth discussion on digital transformation for advanced therapeutics, a case study with Gradalis, a clinical-stage immunotherapy company, and a demo featuring L7|ESP, a platform that simplifies data management and digitalizes and automates workflows in therapeutics to enable breakthrough efficiencies, better compliance, reduced costs, and improved operational velocity. ### SciBite and L7 Informatics Partner to Deliver Data Ontology Search Through L7|ESP™ ### ISCT Annual Meeting 2021 - Tutorial Session: A Case Study With L7 Informatics & Charles River Participants: Trent Carrier, Ph.D., MBA, Chief Operating Officer at L7 Informatics, Inc.Brennen Wright , Field Application Scientist at L7 Informatics, IncSteven Barash, Director, Regulated IT at Charles River LaboratoriesJohn Conway, Chief Visioneer at 20/15 Visioneers (moderator) Information: Life science companies are increasingly looking to technology-based innovation to help drive R&D pipelines, digital capabilities, novel therapies, and new commercial engagement models. Watch this ISCT tutorial session featuring a case study with L7 Informatics and Charles River, followed by a demo of the L7|ESP platform, which simplifies data management and digitalizes and automates workflows in therapeutics to enable breakthrough efficiencies, better compliance, reduced costs, and improved operational velocity. Date: Thurs May 13th, 5:15-6:45 pm ET - LIVE Participants: Vasu Rangadass, Ph.D., President & CEO of L7 Informatics, Inc. Ernie Bognar, Chief Operating Officer at Gradalis, Inc. Trent Carrier, Ph.D., MBA, Chief Operating Officer at L7 Informatics, Inc. John Conway, Chief Visioneer, 20/15 Visioneers Information: Precision medicine and new classes of precision therapeutics, including cell and gene therapies, require a new category of companion informatics that automates and digitalizes complex manufacturing, quality management, and clin-ops processes. This digital transformation can reduce time to market, reduce development costs, and streamline scaling and development of these medicines. This discussion will feature an in-depth discussion on digital transformation for advanced therapeutics, a case study with Gradalis, a clinical-stage immunotherapy company, and a demo featuring L7|ESP, a platform that simplifies data management and digitalizes and automates workflows in therapeutics to enable breakthrough efficiencies, better compliance, reduced costs, and improved operational velocity. ### ASGCT 2021: A Case Study in Digital Transformation in Advanced Therapeutics with L7 Informatics, Inc. & Gradalis, Inc. Participants: Vasu Rangadass, Ph.D., President & CEO of L7 Informatics, Inc. Ernie Bognar, Chief Operating Officer at Gradalis, Inc. Trent Carrier, Ph.D., MBA, Chief Operating Officer at L7 Informatics, Inc. John Conway, Chief Visioneer, 20/15 Visioneers Information: Precision medicine and new classes of precision therapeutics, including cell and gene therapies, require a new category of companion informatics that automates and digitalizes complex manufacturing, quality management, and clin-ops processes. This digital transformation can reduce time to market, reduce development costs, and streamline scaling and development of these medicines. This discussion will feature an in-depth discussion on digital transformation for advanced therapeutics, a case study with Gradalis, a clinical-stage immunotherapy company, and a demo featuring L7|ESP, a platform that simplifies data management and digitalizes and automates workflows in therapeutics to enable breakthrough efficiencies, better compliance, reduced costs, and improved operational velocity. Date: Thurs May 13th, 5:15-6:45 pm ET - LIVE Participants: Vasu Rangadass, Ph.D., President & CEO of L7 Informatics, Inc. Ernie Bognar, Chief Operating Officer at Gradalis, Inc. Trent Carrier, Ph.D., MBA, Chief Operating Officer at L7 Informatics, Inc. John Conway, Chief Visioneer, 20/15 Visioneers Information: Precision medicine and new classes of precision therapeutics, including cell and gene therapies, require a new category of companion informatics that automates and digitalizes complex manufacturing, quality management, and clin-ops processes. This digital transformation can reduce time to market, reduce development costs, and streamline scaling and development of these medicines. This discussion will feature an in-depth discussion on digital transformation for advanced therapeutics, a case study with Gradalis, a clinical-stage immunotherapy company, and a demo featuring L7|ESP, a platform that simplifies data management and digitalizes and automates workflows in therapeutics to enable breakthrough efficiencies, better compliance, reduced costs, and improved operational velocity. ### Data and AI Accelerate Digital Transformation in Pharma read ### Digital Transformation in Molecular Diagnostic Labs: A Case Study with Genome Technology Access Center, Washington University School of Medicine In this webinar, participants will discuss the automation of all lab operations at the Genome Technology Access Center (GTAC@MGI) in the McDonnell Genome Institute at the Washington University School of Medicine. This work started with COVID-related workflow, which played a vital role in enabling rapid testing of many people. Speakers will also provide insights into the overall digital transformation of a molecular diagnostic lab, including the scope, timing, flexibility, agility of implementation, results, and key findings. The L7's Enterprise Science Platform (L7|ESP) gives diagnostic companies (including companion diagnostics, IVD, LDT) total visibility over all their operations while digitalizing, integrating, and automating scientific, analytical, and operational workflows. L7|ESP increases sample throughput and quality assurance in results and provides reliable documentation for regulatory review (CAP/CLIA/GLP/cGMP). In this webinar, participants will discuss the automation of all lab operations at the Genome Technology Access Center (GTAC@MGI) in the McDonnell Genome Institute at the Washington University School of Medicine. This work started with COVID-related workflow, which played a vital role in enabling rapid testing of many people. Speakers will also provide insights into the overall digital transformation of a molecular diagnostic lab, including the scope, timing, flexibility, agility of implementation, results, and key findings. The L7's Enterprise Science Platform (L7|ESP) gives diagnostic companies (including companion diagnostics, IVD, LDT) total visibility over all their operations while digitalizing, integrating, and automating scientific, analytical, and operational workflows. L7|ESP increases sample throughput and quality assurance in results and provides reliable documentation for regulatory review (CAP/CLIA/GLP/cGMP). ### L7 Informatics at CAR-TCR Europe 2021 Join us for a discussion with our President & CEO, Vasu Rangadass, Ph.D. regarding the streamlining of digital transformation to reduce data and process silos in precision therapeutics Join us for a discussion with our President & CEO, Vasu Rangadass, Ph.D. regarding the streamlining of digital transformation to reduce data and process silos in precision therapeutics ### L7 at Phacilitate ATC: Streamlining digital transformation and reducing data and process silos in Advanced Therapies Please join President & CEO Vasu Rangadass, Ph.D. for an in-depth look at the future of the lab and the digitalization of cell and gene therapy space. This session will also explore L7's work with Gradalis, a late-stage biotechnology company focused on the development and commercialization of novel personalized therapeutics to treat cancer. ### L7 Informatics Raises $13M in Series B Financing read ### L7 Informatics deploys ESP Software Platform for COVID-19 Workflow at University of Oregon read ### Gradalis: Cell Manufacturing, QC, Clinical Trials Everyday discoveries in pediatric genomics are creating new possibilities to understand and treat rare genetic diseases. This work requires robust computational strength in order to process, analyze, and manage large data sets. Please fill out the form to view the Rady Children's case study ### Cognate BioServices, the Leading Biologics CDMO, Selects L7 Informatics to Implement L7|ESP for Integrated Manufacturing and Lab Operations read ### L7 Informatics at World Vaccine & Immunotherapy Congress Please join President & CEO Vasu Rangadass, Ph.D. for an in-depth look at the future of the lab and the digitalization of cell and gene therapy space. This session will also explore L7's work with Gradalis, a late-stage biotechnology company focused on the development and commercialization of novel personalized therapeutics to treat cancer. Please join President & CEO Vasu Rangadass, Ph.D. for an in-depth look at the future of the lab and the digitalization of cell and gene therapy space. This session will also explore L7's work with Gradalis, a late-stage biotechnology company focused on the development and commercialization of novel personalized therapeutics to treat cancer. ### L7 at Future Labs Live USA - Digitalization of the Lab Please join President & CEO Vasu Rangadass, Ph.D. for an in-depth look at the future of the lab and the digitalization of cell and gene therapy space. This session will also explore L7's work with Gradalis, a late-stage biotechnology company focused on the development and commercialization of novel personalized therapeutics to treat cancer. Please join President & CEO Vasu Rangadass, Ph.D. for an in-depth look at the future of the lab and the digitalization of cell and gene therapy space. This session will also explore L7's work with Gradalis, a late-stage biotechnology company focused on the development and commercialization of novel personalized therapeutics to treat cancer. wasda ### L7 Informatics Automates Lab Operations and Supports Washington University School of Medicine with Workflow for Its Saliva-based COVID-19 Test read ### Breaking Down Data Silos in the Lab ### L7 Informatics to deploy ESP in QIAGEN's Genomics Service Labs to improve laboratory workflows and data management. AUSTIN, Texas, Sept. 22, 2020 /PRNewswire/ -- L7 Informatics, a leader in life sciences workflow and data management, announced today that the Company will deploy its software platform, Enterprise Science Platform or ESP, in QIAGEN's Genomics Service Labs. Following the installation of ESP, additional development projects are planned to further enhance Sample to Insight workflows across QIAGEN's research and diagnostics portfolios. ESP fosters digitization, automation, collaboration and expedites genomics research by building an integrated platform to manage scientific knowledge, processes and data in one place, yielding better access to information and faster discoveries. ESP automates sample management, bio-repository management, lab data collection & analysis, data visualization, integration to all instruments and bar code scanning. The ESP platform provides out of the box apps including ELN, LIMS, inventory, assets, location, analysis, data, projects, dashboards, and reports. Vasu Rangadass, CEO at L7 Informatics added, "Our goal at L7 is to enable precision health and we are delighted to partner with QIAGEN, a global leader in molecular solutions, to help researchers achieve new data insights through the automation of laboratory workflows and data management." L7 Informatics was named as a Cool Vendor in Gartner's May 2020 Cool Vendors in Life Sciences. Gartner, "Cool Vendors in Life Sciences", Michael Shanler, Jeff Smith, Animesh Gandhi, Seth Feder, 27 May 2020. ### The New Digital Age of The Laboratory At L7 Informatics, we spend a lot of time talking about the importance of data provenance, and often how the need for robust provenance gets overlooked in even the most sophisticated laboratory setting. The conversation always brings up some very interesting scenarios and questions: “Yes, of course I keep track of it all. I have a LIMS.” Sure, everyone has a LIMS (well ok, not everyone), but does the LIMS you use track everything you need to track? Also importantly, does your LIMS withstand the barrage of information that's associated with more data-intensive technologies, such as next-gen sequencing (NGS)? What about tracking samples through data analysis? Does anyone have LIMS that natively tracks analytical processes on their high-performance computing infrastructure? How about repeating an NGS experiment (including NGS analysis), whether it’s your own experiment, or whether it’s someone else’s? Do you know exactly which algorithm the bioinformatician used, or what version of the aligner they used? Do you even know what your bioinformaticians are doing? If everyone is keeping great records (which they probably aren’t), then can the scientific community trust the results that are coming from any given lab? And so on, and so on (welcome to our rabbit hole)… So we took a step back and thought about the way that data should be maintained and managed. There are a lot of considerations to take into account when setting up a robust data provenance system. While yes, we did form a company to build a robust software platform, we still believe that the entire subject does not get enough attention or conversation. Therefore, we commissioned an eBook to discuss this topic and to bring to light many of our own internal discussions. I hope that you will take a look at the content, and then please get back to me with your thoughts, input, and feedback on your processes. ### L7 Informatics Recognized as a Cool Vendor in the May 2020 Cool Vendors in Life Sciences Report by Gartner AUSTIN, Texas, June 9, 2020 /PRNewswire/ -- L7 Informatics announced today that it has been recognized as a 2020 Cool Vendor in Gartner's Cool Vendors in Life Sciences report. L7 is one of only five companies recognized in the Cool Vendors in Life Sciences report. "We are honored by this recognition and excited about the opportunity to be part of realizing the promise of precision medicine across healthcare delivery, therapeutics, diagnostics, research, and agriculture. We believe workflow and data management are essential tools to moving from the current challenges with massive data lakes to the actionable decisions needed for precision medicine," said Vasu Rangadass, CEO of L7 Informatics. According to the report, "life science companies are increasingly looking to technology-based innovation to drive R&D pipelines, digital capabilities, novel therapies and new commercial engagement models. CIOs should consider these new, disruptive vendors that are poised to help accelerate life science business results." Gartner, "Cool Vendors in Life Sciences", Michael Shanler, Jeff Smith, Animesh Gandhi, Seth Feder, 27 May 2020 Gartner Disclaimer: Gartner does not endorse any vendor, product or service depicted in our research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner's research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose. About L7 Informatics Inc. L7 Informatics provides software and services that enable synchronized solutions for science and health. L7's Enterprise Science Platform (ESP) is a scientific information management (SIM) solution that enables life science and healthcare companies to connect people, processes, and systems to accelerate discoveries and drive precision healthcare. For more information, visit wwwL7informatics.com. Media Contact Jessica Tobey L7 Informatics, Inc. jessica.tobey@l7informatics.com 978-771-1529 SOURCE L7 Informatics, Inc. ### L7|ESP Rapid Response to Covid19 ### Taking on the Pandemic: Transforming a Clinical Lab Into a COVID-19 Ready Lab L7 Informatics and Contamination Source Identification (CSI) partner in rapid implementation of testing for COVID-19 patient screening Read the full article online here ### COVID19 - A Letter to Our Valued Partners ### USDA-USMARC Streamlines Research Operations with L7 Informatics NGS LIMS System USDA upgrades from traditional LIMS system to L7 Enterprise Science Platform (ESP) - with advanced functionality to support complex multi-omics laboratory workflows Read the full article online here ### Software and Analytics Company to Deploy Cutting Edge Platform for Leading Fertility Organization Read the full article online here ### Inari Agriculture Selects L7 Informatics' Enterprise Science Platform to Unify Global Operations Read the full article online here ### G-CON Manufacturing and L7 Informatics Announce a Collaboration to Develop ESP G-CON smartPOD, the First-of-its-Kind Integrated Cleanroom Software Platform G-CON Manufacturing, the leader in prefabricated flexible cleanroom solutions and L7 Informatics, the leader in life science process automation software, today announced a collaboration to develop a fully integrated cleanroom and manufacturing software solution to improve biologics manufacturing. The companies will integrate L7’s Enterprise Science Platform (“ESP”) into G-CON’s proprietary cleanroom technology (“PODs”). The smartPOD will provide an integrated hardware and software solution that provides traceability, key performance indicators, product trending statistics and one single interface to access equipment data. The smartPOD will enable advanced intelligence and predictive analytics so that clients can address issues in advance as opposed to reacting to equipment issues after the fact. The value for the client: reduced down time, improved cycle time and lower maintenance costs. Read the full article online here ### LIMS Migration Strategy The need for better organization of laboratory operations is well known. While today’s selection of commercial laboratory information management systems (LIMS) is a good start to organizing and running a lab, these solutions are only geared towards the management of wet lab operations. Existing solutions are inefficient for data-intensive laboratory operations that require significant bioinformatic data analyses. Therefore, in labs already burdened with the inefficiencies caused by unlinked functional silos, current LIMS solutions do nothing to resolve inefficiencies, and worse, laboratory operations remain fragmented. Another commonly held view on LIMS is that they tend to be difficult to use. In many cases, compliance with LIMS utilization is difficult to maintain and users tend to work around these systems rather than working with them. This has become an even bigger issue today as labs become increasingly data-heavy, with some labs generating several terabytes of data daily. It’s time for data-intensive labs to explore a more comprehensive solution, such as the L7 Informatics Enterprise Science Platform (ESP), that connects all facets of your lab, from samples to analysis. Since change can be scary and difficult to tackle, this white paper explores factors to consider in making the transition from legacy LIMS to ESP. ### Rethinking Data Management to Accelerate Discoveries in Life Sciences In a library, readers generally use a catalog to search for a specific book in order to avoid the time and energy of searching for books on every shelf. Similarly, this is precisely what L7 Informatics Enterprise Science Platform (ESP) does in the life-sciences big data space. “In the current digital health scenario, large volumes of data is generated on a constant basis is often not cataloged in an appropriate manner,” states Vasu Rangadass, Ph.D., President and CEO, L7 Informatics, “making it difficult for analysts to glean insights from them.” Unlocking the full potential of clinical research and trials, L7 ushers in a focused way of managing data and solving complex problems in the life sciences world. This customer-centric scientific information management (SIM) solution provider enables life science and healthcare companies to connect people, processes, and systems to accelerate discoveries and drive precision healthcare. As revealed by Rangadass, there are a lot of silos between various process owners in precision medicine and translational research workflows. Information does not flow easily between the various departments such as sample/bio-repository management, wet lab and bio-informatics. Information flow is even poorer across companies – between life sciences companies, Clinical Research Organizations (CROs), Contract Manufacturing Organizations (CMOs) and the health systems. This lack of information flow regarding the patients and samples obstructs the workflow and hinders positive operational and health outcomes. Read the full article online here ### Gradalis Deploys L7’s Enterprise Science Platform for Next-generation Life Science Companies in Record Time to Support Mission-critical Immunotherapy Manufacturing and Clinical Trial Processes DALLAS, October 3, 2018 – Gradalis, Inc., a Dallas-based, clinical-stage, vertically-integrated immunotherapy company, announced today it has successfully implemented and launched L7’s Enterprise Science Platform (“ESP”). L7 Informatics, Inc., is the leading software and analytics company for life science research and manufacturing companies. Gradalis recently upgraded its Carrollton, TX manufacturing facility to support the launch of a Phase 3 registration trial of Vigil in Ewing’s sarcoma. Gradalis’ vertically integrated research, clinical and manufacturing business model creates complex master batch record (“MBR”) requirements that few technology providers can support. Enter L7’s ESP. L7’s ESP next-generation life sciences platform provides a secure, flexible and scalable technology solution to support cell and CAR-T therapy companies processes and data. ESP’s open architecture supports electronic record needs by managing all mission-critical workflows for research, clinical and manufacturing operations and integrations to process equipment and instrumentation in single platform. For Gradalis, L7’s ESP serves as the technology hub for its integrated bench-to-bedside operations, and ESP automates Gradalis’ manufacturing records, ensuring its cancer vaccine meets or exceeds regulatory, clinical, manufacturing, provider and study participant needs. “Our Phase 3 trial in Ewing’s sarcoma is a major milestone for our company and the Ewing’s sarcoma community. Given the rare occurrence of this pediatric cancer, families have limited treatment options, therefore, it is imperative we execute flawlessly to serve these patients,” said Ernest Bognar, Gradalis’ Chief Operating Officer. “We implemented L7’s platform in a phased approach with results rarely seen with technology projects: ‘on time’, ‘on functionality’, and ‘on budget’. By running our manufacturing operations on L7’s ESP platform, we remove major risk factors and improve visibility and accountability. Our quality assurance team views the batch procress in real time and provides in-process approvals or interventions as the situation requires. The company can see the status of each batch of Vigil manufactured in L7’s operational dashboard. Because of its open architecture and intuitive design, we are adding new apps and workflows to the ESP platform with minimal technical resources.” “We developed ESP to minimize manufacturing and clinical risk so gene and cell therapy companies like Gradalis can successfully deliver immunotherapy treatments to patients. In the case of Ewing’s sarcoma, we are talking about children and young adults fighting an aggressive cancer. ESP provides end-to-end visibility for Gradalis to achieve its mission,” said Vasu Rangadass, CEO at L7 Informatics. “L7 is humbled and energized to partner with companies like Gradalis who are bringing innovative personalized immunotherapies to market.” For more information about Gradalis and its Ewing’s sarcoma clinical trial, go to FDA’s Clinical Trials portal please visit https://clinicaltrials.gov/ct2/show/NCT03495921. Researchers, clinicians, manufacturing executives and technology partners, please go to L7’s ESP platform digital home at https://l7informatics.com to discover how leading biotech, research institutes and pharmaceutical companies are using the platform. About Gradalis, Inc. Gradalis is a late clinical stage biotechnology company focused on the development and commercialization of novel personalized therapeutics to treat cancer. We are developing Vigil, our proprietary immunotherapy platform in multiple advanced cancer indications with the lead program for the treatment of patients with Ewing's sarcoma. For additional information, please visit http://www.gradalisinc.com About Vigil by Gradalis Vigil is a proprietary, investigational cellular immunotherapy technology that combines genetic engineering with the science of immuno-oncology. Vigil is intended to stimulate and enhance the body’s natural mechanism for recognizing and killing cancer cells. It utilizes the patient’s own cancer cells to create a fully personalized cancer immunotherapy. By utilizing the patient's own tumor as the antigen source, Vigil is designed to elicit an immune response that is specifically targeted and broadly relevant to each patient's unique tumor antigens. Vigil is being studied in Ewing's sarcoma, in gynecological cancer and advanced women’s cancer in combination with PD-L1 inhibitors, and ovarian cancer as a single agent. About L7 Informatics Our mission is to revolutionize scientific information management in order to accelerate discoveries and drive higher quality of healthcare. Our end-to-end solutions and services yield efficiencies that enable researchers to make more breakthroughs and healthcare companies to provide superior care. To learn more about L7’s Enterprise Science Platform, go to https://l7informatics.com/esp/ Media and Investor Inquiries: Walter Chen Vice President – Corporate Development Gradalis, Inc. 214-442-8100 wchen@gradalisinc.com ### L7 Informatics Releases L7 Enterprise Science Platform 2.0 with Pre-Built Microsoft Genomics Integration AUSTIN, Texas, Oct. 10, 2018 /PRNewswire/ -- L7 Informatics, Inc., formerly Lab7 Systems, a leader in informatics solutions and services for data intensive scientific applications and personalized medicine, is pleased to announce today the release of Enterprise Science Platform 2.0 (ESP) with a validated pre-built Microsoft Azure connector to the Microsoft Genomics service on the Azure cloud. The upcoming ESP 2.0 release has a number of new modules and enhancements, including but not limited to: Workflow Chaining, supporting the execution of sophisticated processes, such as conditional process execution/branching, repeats, and other intelligent, multi-variable process requirements New UI, with emphasizing increased responsiveness and an improved user experience Improved integration of Software Development Kit capabilities (SDK) as well as new extension and customizability options along Content support for next-generation sequencing, translational research, and cell therapy applications Validation of ESP on the Azure platform, enabling the management of and running bioinformatics pipelines on Microsoft Genomics cloud ESP 2.0 marks a major milestone for L7. With this release, ESP can now support a wide range of life science companies: from the venture-backed cell therapy company, established laboratories and research clinics, to the largest of the global biotechnology and pharmaceutical companies. All these companies share a common need: a highly adaptive "bench-to-bedside" technology platform to eliminate processing and technological silos. "L7 has worked tirelessly since last May, when we announced our partnership with Microsoft Genomics. We have focused our attention to empower our mutual customers to easily implement our integrated and validated offering," commented Vasu Rangadass, Ph.D., L7 Informatics' CEO. "Our partnership with Microsoft shows their confidence in L7's ability to deliver. We are humbled by Microsoft's trust." L7 Informatics and Microsoft are presenting the latest enhancements to the ESP + Microsoft Genomics platforms at the 2018 American Society of Human Genetics (ASHG) Conference in San Diego, CA (October 16-20, 2018). L7 Informatics will also host a demo at the Microsoft booth (#1535) on Thursday, October 18th at 11:30 am. L7 team members will be readily available to answer questions. "We're very excited about our partnership with L7 because they appreciate and align their product and commercialization strategy with the market landscape of precision medicine and multi-omics opportunities," mentioned Trent Norris, Senior Program Manager, Microsoft Genomics. "When markets move at this speed, companies must be agile and take calculated risks in order to drive innovation that leads to sustained growth. L7 is reshaping the way companies should think about laboratory information management systems and we're pleased that they chose to do it on Azure and with the Microsoft Genomics service." About L7 Informatics: L7 Informatics, formerly Lab7 Systems, provides software and services that enable synchronized solutions for science and health. L7's Enterprise Science Platform (ESP) is a scientific information management (SIM) solution that enables life science and healthcare companies to connect people, processes, and systems to accelerate discoveries and drive precision healthcare. Global, venture-funded and public health organizations such as Astra Zeneca, Gradalis, and USDA trust L7's ESP. For more information, visit www.l7informatics.com. Contact: Jessica Tobey Speaks Marketing Group jessica@speaksmarketing.com SOURCE L7 Informatics, Inc. Related Links https://l7informatics.com ### The L7 Informatics High-Performance Genomic Cloud Powered By IBM There are a lot of options today for selecting a cloud partner for bioinformatics, and the big guys seem to all have a one-size-fits-all approach, since they serve a variety of industries. Clouds that were designed to handle less data-intensive, mass-market consumer tasks such as file and photograph storage, video sharing/streaming, database hosting, and web application deployments are not clouds that are optimal for processing complex tasks, such as those required for next-generation sequencing. Plus their cost structures are such that fees related data transfer, computing, and storage can quickly spiral out of control, especially when you're dealing with peta-scale data. With this in mind, L7 Informatics worked with our partners at IBM Bluemix Cloud to build a new cloud environment from the ground-up. Using IBM's capacity for mix-and-match provisioning of resources in each of its global data centers, we were able to create the High-Performance Genomic Cloud specifically to handle data-intensive scientific workloads. Using a combination of IBM Spectrum LSF, IBM Spectrum Scale, and 10g internal networking, all run by L7 Informatics's Enterprise Science Platform, the Genomic Cloud represents the industry's fastest and most cost-effective cloud computing resource for scientists. If you're interested in digging more into our solution, I invite you to check out our Genomic Cloud White Paper. If you'd like answers to specific questions, I invite you to contact us anytime, and we'll be more than happy to chat! ### Lab7 Systems Appoints New CEO and Changes Name to L7 Informatics AUSTIN, Texas, May 15, 2018 (GLOBE NEWSWIRE) -- Lab7 Systems, a leader in informatics solutions and services for data intensive scientific applications and personalized medicine, announced today its name change L7 Informatics, Inc. to reflect the expansion of its product offering. In conjunction with the name change, L7 is proud to announce the appointment of Vasudev Rangadass, Ph.D., as its CEO. As L7 Informatics, the company is well positioned to address its mission of providing synchronized solutions for science + health and to pioneer scientific process and data management (SPDM) in order to accelerate discoveries and drive higher quality of healthcare. Together with the new name L7 announces its new website at www.l7informatics.com. Dr. Rangadass joined the company in early December, bringing his experience in transforming healthcare operations into well-organized enterprises through the successful growth of Net.Orange, which he guided to an acquisition by NantHealth. With his proven leadership building enterprise software companies, Dr. Rangadass has enabled Christopher Mueller, Ph.D., the founder and Chief Technology Officer of L7 Informatics, to focus his energies on the expansion of the capabilities of L7’s flagship software, the Enterprise Science Platform (ESP). “Launching our new name and Vasu coming aboard are welcomed changes as we transition to the growth phase of L7 Informatics,” commented Dr. Mueller. “Vasu’s experience in building Net.Orange will help guide L7 to becoming a dominant player in the healthcare and life science enterprise software industry. I’m especially excited that I can now devote myself to carrying out my vision for ESP.” “I’m very happy to be leading L7 through this next chapter in our growth,” added Dr. Rangadass. “What the company built with ESP serves as a strong foundation for building automated precision health solutions in the Academic and Industry Research Centers, life science, pharmaceutical, NGS-based diagnostics lab, and healthcare markets. If I’ve learned anything in my experience, it’s that a company cannot succeed without a very strong platform. I’m very much looking forward to building upon the successes of Chris and his team.” Prior to Lab7 Systems, Dr. Rangadass was the Chief Strategy Officer at NantHealth following its acquisition of Net.Orange, the company he founded to provide enterprise solutions to the healthcare industry. Prior to Net.Orange, he was the first employee of i2 Technologies, which he was instrumental in growing into a global company that revolutionized the supply chain market. L7 Informatics is presenting its solutions at the 2018 Bio-IT World Conference and Expo in Boston, May 15-17. In addition to exhibiting in booth 343, Dr. Mueller will present a talk titled “Operational Informatics: A Whole Lab Approach to Actionable Data Insights” and Varshal Davé, Vice President of Sales and Marketing, will be chairing a session on Data and Standards Approaches for Statistical Analysis, both on Wednesday, May 16. About L7 Informatics: L7 Informatics, formerly Lab7 Systems, provides software and services that enable synchronized solutions for science + health. L7’s novel Enterprise Science Platform (ESP) is a scientific process and data management (SPDM) solution that enables life science and healthcare companies to connect people, processes, and systems to accelerate discoveries and drive precision healthcare. For more information, visit www.l7informatics.com. Media Contact: Varshal K. Davé Vice President of Sales & Marketing L7 Informatics, Inc. 1219 West 6th Street Austin, TX 78703 (888) 461-5227 ext. 701 ### Benefitting From Business Process Management Principles In Your Lab Business process management (BPM) focuses on improving corporate performance by managing and optimizing a company's business processes to achieve business goals. BPM enables organizations to be more efficient, more effective, and more capable of customer-driven change. By translating the core principles of BPM to scientific laboratory operations, L7 Informatics is creating a new category of enterprise software: Scientific Process & Data Management (SPDM). Think of SPDM as taking all your scientific processes to the next level of organization by having all the machine and human components blended together into one seamless workflow. L7’s Enterprise Science Platform (ESP) software is the first platform to fully enable SPDM by providing full transparency into your operations through streamlined sample tracking, data acquisition, and process coordination. An overview of the streamlined workflow using SPDM principles available with L7 ESP. Translating BPM Benefits to SPDM Benefits The real question in assessing how BPM principles can be applied is: how does this benefit my lab’s operation? Here we present a brief overview of the science twist on some of the key benefits of BPM: Agility—Rigorous SPDM enables organizations to make changes to processes with minimal costs, while still maintaining the flexibility to customize solutions to the requirements of the organization. Productivity—Laboratories that process large numbers of samples in a production environment employ many routine workflows with repetitive protocols and analyses that SPDM can automate, freeing up technicians’ and bioinformaticians’ time to focus on processing more samples. Efficiency & Reduced Risks—Integrating all laboratory processes through SPDM enables the organization’s management to easily identify areas of inefficiency. Compliance & Transparency—SPDM ensures that laboratory organizations can implement regulatory requirements quickly, and labs using ESP as the backbone of their SPDM are assured of deep data provenance on all aspects of their workflows. Employee Satisfaction—The removal of traditional interfunctional silos relieves significant operational stress that is felt not only by the process itself, but also by the operators involved. Consistency, Repeatability, Transferability & Sustainability—With SPDM, each step of a laboratory workflow is carefully planned and documented, then executed as designed. Problems arising in these workflows are all addressed the same way, regardless of the operator. Measurability—With the full operational process in a laboratory maintained through SPM, organizations gain full insight into all aspects of their workflows. All processes can be measured and quantitatively analyzed for efficiency, productivity, and profitability. Technology Integration—With the whole lab running in concert, the traditional communication silos (e.g. wet lab vs. bioinformatics), are broken down, all laboratory platforms can be monitored, and inefficiencies can be more easily pinpointed and remedied. ### 2017 Recap and Heading Into 2018 2017 ended in a flurry of activity for Lab7. We started the Fall with pumpkin spice lattes and a trip to Washington, D.C. for the Next Generation Dx Summit. Whereas in the past, this conference was essentially a how-to manual on setting up a NGS diagnostics lab and navigating regulatory issues, this year’s meeting gravitated toward informatics. Scientists focused on ways to better analyze, organize, and track both the samples and data coming off increasing numbers of sequencers. There was also a great deal of discussion around data sharing: how can groups from different labs, clinics, and hospitals begin collaborating around de-identified patient data? November marked Lab7 Systems’ first year sponsoring the Plant Genomics and Gene Editing Congress. The team had a great time in Philadelphia’s Historic District learning about the expanding use of genomics in agriculture. We were proud to share how implementing Lab7’s Enterprise Science Platform for over one million samples at the USDA’s US Meat Animal Research Center created operational efficiencies and increased productivity for the group. We closed out the year in Boston at the Proventa Bioinformatics Strategy Meeting where our Founder and CTO, Chris Mueller, lead an engaging round table discussion on building stable, scalable informatics infrastructures to increase efficiency and reduce laboratory costs. The attendees (mostly from large pharmaceutical companies) shared that the challenge of data intensive scientific applications has shifted. A few years ago scientists were drowning in data. They were simply trying to keep up. Today, with tools like NoSQL databases, Spark, Docker, Jupyter, etc., folks are more comfortable dealing with the influx of data and are working on ways to organize, curate and track the many transformations of their data. Looking forward, 2018 is lining up to be a breakthrough year for Lab7! We’re kicking things off at the Plant and Animal Genome Conference in San Diego Jan. 13 - 18, followed by the Molecular Medicine TriConference in San Francisco Feb. 11 - 16. Come check us out! ### 5 Strategies To Improve Lab Efficiency We can all agree that labs are being inundated with more and more tasks, more data-rich technologies, and the need to develop new strategies for dealing with this new reality. Just as we have become more efficient in managing our lives (think about the impact of smartphones), it’s important to apply similar principles of efficiency to our labs. While existing laboratory information management systems (LIMS) provide a good start to tackling this problem, there remain inefficiencies prevalent in the laboratory environment, especially as samples move from person to person and through the laboratory process, including steps in the wet lab, in data generation, and in computational/bioinformatics environments. At L7 Informatics, our highly experienced core team is quite familiar with the inefficiencies present in most labs. This white paper identifies five inefficiencies we’ve commonly seen and explores ways you can make your lab more efficient using a fully customizable workflow engine. ## Pages ### Zaether L7 | Partner Resourceswebinars + presentations case studies datasheets white papers videos ebooks analyst reports latest news resources by verticalPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTUREPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTURE ### L7|INTELLIGENCE® L7 | INTELLIGENCE® unlocking contextualized data for better decisionsdata is not the new gold... contextualized data is In a world where data is often called the new gold, many organizations are finding that raw data alone doesn't guarantee success... and they are right. Without proper context, data remains underutilized—trapped in silos and failing to generate actionable insights. The life sciences industry needs a solution that makes data accessible, contextualized, and AI-ready. That’s the new gold we're talking about. meet L7|INTELLIGENCE L7|INTELLIGENCE is a strategic solution designed to bring your data to life. By eliminating silos and making complex scientific and operational data easily accessible, it empowers faster, smarter decisions across R&D, Manufacturing, Quality Control, Supply Chain, and Diagnostics. L7|INTELLIGENCE is more than just a data tool—it’s a critical enabler of advanced analytics and AI, turning data into a competitive advantage. key features of L7|INTELLIGENCESelf-Service Access to Contextualized Data Models Simplifies how users interact with Star Schema data models, significantly reducing complexity and costs compared to traditional ETL processes.AI-Ready Data Converts contextualized data into easily queryable, AI-ready formats, enabling advanced analytics and unlocking the potential of Large Language Models (LLMs).Real-Time Operational Insights Leverages real-time data for reporting and visualization with tools like Tableau, Power BI, and Spotfire, ensuring insights are available when you need them.Flexible Integration Integrates seamlessly with external data lakes and warehouses like Snowflake, offering scalability and comprehensive solution.Compliance-Driven Data Preparation Features built-in reference models to ensure all data is ready for FDA submissions and other regulatory needs, streamlining the compliance process.L7|INTELLIGENCE's capabilities Reduced Time-to-Value (TTV): Contextualized data is ready for immediate analysis, speeding up insights, enhancing decision-making, and reducing time to market. Cost Efficiency: Automates manual data processes and streamlines workflows, optimizing resource allocation and cutting operational costs. Enhanced Product Quality and Compliance: Integrates operational data with quality management systems to maintain product consistency while meeting regulatory standards efficiently. Accelerated Regulatory Submissions: Automates regulatory documentation processes, simplifying FDA submissions and accelerating compliance timeframes. L7|INTELLIGENCE within the L7|ESP unified platformL7|INTELLIGENCE is part of the L7|ESP® platform, where process orchestration and data contextualization drive digital transformation and turn your data into a competitive advantage.Key Components of the L7|ESP Platform L7|MASTER: A low code/no-code scientific data modeling and process design tool. L7|HUB: An application for findability, accessibility, interoperability, and reusability (FAIR) of digitalized experiments, scientific methods, manufacturing recipes, master data models, instrument, and equipment connectors. L7|ESP: The core execution engine that connects to instruments, equipment, and other software and data analysis tools to generate experimental results, batch manufacturing records, and certificates of analysis. L7|INTELLIGENCE: The business intelligence framework that extracts data collected during scientific process orchestration and provides key stakeholders with operational and scientific intelligence and reporting. resources Dive deeper and see how L7|INTELLIGENCE and L7|ESP can transform your operations:L7|INTELLIGENCE datasheetL7|ESP brochure L7|ESP explainer video L7 Notebooks app datasheet L7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet ready to take your data to the next level? ### L7|MASTER® L7 | MASTER® a low code/no code authoring tool that enables the creation of any scientific data and process model as a single digital standard why Life Sciences need an "MP3-moment" In today's scientific landscape, the reliance on paper-based or simple computer-assisted approaches, such as Excel, for planning and documentation is prevalent. Unlike the well-established standards for documents (Word, PDF) or music files (MP3), these methods offer limited to no standardization. The absence of standardized digital representations in research, development, diagnostics, and manufacturing processes hinders true digital transformation within the life sciences.Global collaboration, version management, data integrity, and regulatory controls all demand a digital standard that can efficiently represent, execute, and share scientific processes. Much like how an MP3 surpasses sheet music, science must evolve beyond static documents to a dynamic digital standard. why life sciences need an 'MP3-moment' Relying on paper and Excel is like sticking to sheet music in a world of MP3s. Life sciences need a digital standard to truly transform—one that enables global collaboration, ensures data integrity, and streamlines compliance. It’s time to move beyond static tools and embrace a dynamic digital future. meet L7|MASTER L7|MASTER is your solution to these challenges. As a foundational application of the L7 Enterprise Science Platform (L7|ESP®), L7|MASTER is a low code/no code authoring tool designed to create scientific data and process models as a single digital standard. This tool revolutionizes how scientific processes are defined, shared, and executed, bringing us closer to true digital transformation in life sciences. key features of L7|MASTERACCELerate new product introductions Leverage a library of ready-to-use standard content to kickstart your digitalization journey, reducing both, time and cost.streamline technology transfers Facilitate seamless collaboration, sharing, and distribution of experiments, master batch records (MBRs), or diagnostic assays between organizations. efficient change management Empower scientific users to independently configure and version scientific processes, minimizing reliance on centralized IT teams.enhance training and adoption Simplify employee onboarding with digital versions of scientific processes that can be directly executed in other L7 applications.reduce total cost of ownership Decrease the need for extensive IT resources with a user-friendly library of scientific processes. comprehensive compliance Ensure compliance with audit trails, version control, and GMP/GCP/GLP standards, supported by a validated database.L7|MASTER's capabilities Versatile Process and Data Modeling: Create and manage building blocks for all types of scientific processes with integrated audit trails and version control. Business Object Management: Oversee the movement of samples, documents, instruments, and equipment through complex workflows. Seamless Integration: Connect with ontology management systems, terminology servers, and external instruments to enhance business intelligence and predictive modeling. Intuitive Authoring Tool: Use a drag-and-drop interface for easy process modeling, extendable via HTML for customized needs. Out-of-the-Box Data Models: Utilize pre-built models for scientific essentials, such as reagents, freezers, and plate layouts. Collaborative Workflow: Enable teams to work together on data and process models, fostering innovation and efficiency. Digital First Framework: Generate human-readable PDFs like MBRs to support a digital-first approach while retaining the ability to distribute in traditional formats. L7|MASTER within the L7|ESP unified platformL7|MASTER is an integral component of the L7|ESP Unified Platform, which orchestrates workflows and contextualizes data across various scientific applications, including L7 Notebooks, L7 LIMS, L7 MES, and L7 Scheduling. This synergy ensures that every aspect of your scientific process is connected, streamlined, and optimized for maximum efficiency.Key Components of the L7|ESP Platform L7|MASTER: A low code/no-code scientific data modeling and process design tool. L7|HUB: An application for findability, accessibility, interoperability, and reusability (FAIR) of digitalized experiments, scientific methods, manufacturing recipes, master data models, instrument, and equipment connectors. L7|ESP: The core execution engine that connects to instruments, equipment, and other software and data analysis tools to generate experimental results, batch manufacturing records, and certificates of analysis. L7|INTELLIGENCE: The business intelligence framework that extracts data collected during scientific process orchestration and provides key stakeholders with operational and scientific intelligence and reporting. resources Dive deeper and see how L7|MASTER and L7|ESP can transform your operations:L7|MASTER datasheetL7|ESP brochure L7|ESP explainer video L7 Notebooks app datasheet L7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet ready to take your data to the next level? ### L7HUB L7 | HUB® a findability, accessibility, interoperability, and reusability (FAIR) application for digitalized Experiments, Scientific Methods, Manufacturing Recipes, Master Data Models, Instrument and Equipment Connectors, and more. streamlining digitalization across the value chain & entire organizations In the fast-evolving digital world, managing the growing volume, complexity, and versions of scientific content is a significant challenge. This is particularly true when multiple teams work collaboratively on research studies, molecule development programs, assay development, or manufacturing processes. Effective collaboration and tech transfer across these globally diverse teams require efficient management of digitalized scientific protocols, version control, multi-step approval processes, and secure deployment. meet L7|HUB L7|HUB is designed to facilitate scientific protocol management, streamline collaborations, and accelerate the deployment of standard methods and protocols. As a key component of the Unified Platform L7|ESP®, L7|HUB serves as a no-code collaboration and deployment resource, providing a repository of robust, rich, and growing configurable scientific digital content. With its intuitive interface and streamlined digitalization process, L7|HUB reduces the time to achieve research, development, and manufacturing goals, enabling the FAIRification of scientific assets. key features of L7|HUB L7|HUB offers a comprehensive solution for managing scientific methods, recipes, data models, and more. Here’s what makes L7|HUB indispensable: Centralized Repository Organizes scientific methods, recipes, data models, instruments, and equipment pipelines in one place. Ready-to-Use Protocols: A rich compendium of digital protocols and methods ready for immediate use. Centralizes and streamlines internal protocol and method sharing (e.g., SOPs). Provides access to a growing repertoire of configurable standard workflows by L7 Informatics. Comparison and Approval Tools: Supports scientific method and protocol comparisons and approvals prior to promotion into validation and production. benefits of using L7|HUB Organized Scientific Methods: Store all methods in one, access-controlled location. Integrated Search and Filter: Discover relevant scientific protocols and methods easily. Informed Decisions: Compare scientific methods and protocols to select the best fit for your operations. Reduces the time to find the necessary protocols and methods. Collaborative Sharing: Effortlessly share protocols and methods across teams, departments, and the entire organization. User-Friendly Collaboration: Deploy digital protocols without requiring advanced technical skills. Efficient Tech Transfer: Empower scientists and lab managers to efficiently share and move data model definitions between L7|ESP servers, accelerating tech transfer and improving reusability of science. L7|HUB within the L7|ESP unified platform L7|HUB is an integral part of the L7|ESP Unified Platform, which includes L7 Notebooks (ELN), L7 LIMS, L7 MES, and other scientific data and process management applications. The platform leverages existing L7|ESP workflow chain configurations through L7|MASTER to automate task orchestration, offering a holistic approach to lab process management. These automated tasks are packaged, shared, and promoted via L7|HUB, ensuring seamless integration within operations. Key Components of the L7|ESP Platform L7|MASTER: A low code/no-code scientific data modeling and process design tool. L7|HUB: An application for findability, accessibility, interoperability, and reusability (FAIR) of digitalized experiments, scientific methods, manufacturing recipes, master data models, instrument, and equipment connectors. L7|ESP: The core execution engine that connects to instruments, equipment, and other software and data analysis tools to generate experimental results, batch manufacturing records, and certificates of analysis. L7|INTELLIGENCE: The business intelligence framework that extracts data collected during scientific process orchestration and provides key stakeholders with operational and scientific intelligence and reporting. resources Dive deeper and see how L7|HUB and L7|ESP can transform your operations: L7|HUB datasheet L7|ESP brochure L7|ESP explainer video L7 Notebooks app datasheet L7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet ready to take your data to the next level? ### L7|ESP for Takeda Empowering Takeda’s Innovation with L7|ESP®transforming data into discovery The drive for breakthroughs in medical research and development defines Takeda's global mission, presenting both extraordinary opportunities and complex challenges. In this dynamic environment, managing extensive data and streamlining processes are critical for accelerating discovery and enhancing productivity. At L7 Informatics, we specialize in advancing data management and workflow orchestration tailored to meet the evolving needs of global healthcare leaders. Our L7|ESP solution is designed to harness and transform vast amounts of data into actionable, insightful information, enabling more informed decision-making and operational efficiency. We're convinced that our unified platform can empower Takeda to accelerate discovery, grow your molecule portfolio, and enhance overall productivity.unlocking new horizons in pharmaceutical research for TakedaNavigating the complexities of pharmaceutical research demands a data management platform that understands and anticipates innovators' needs. L7|ESP proposes a fully integrated unified platform that aims to revolutionize Takeda's approach to research, enhancing data traceability, streamlining workflows, and fostering an environment ripe for discovery and innovation. Imagine a world where Takeda's data becomes its greatest asset, driving forward the development of groundbreaking treatments with unprecedented speed and efficiency. redefining manufacturing excellence for TakedaIn the quest for manufacturing excellence, agility, compliance, and precision are paramount. L7|ESP, specifically designed to transform traditional manufacturing processes, would offer Takeda a pathway to streamlined operations that align with global standards and reduce time-to-market. By adopting L7|ESP, Takeda could achieve a seamless integration of data across all manufacturing stages, ensuring not just compliance but a leap toward greater productivity and operational transparency.INSERT RELEVANT ILLUSTRATION HEREarchitecting the future of Takeda’s IT infrastructureLarge pharmaceutical companies have invested heavily in IT for research, development, and manufacturing. However, challenges persist as these departments are data-rich but information-poor, with disparate data islands. L7 Informatics offers a regulatory-compliant data contextualization and workflow orchestration platform, L7|ESP, based on FAIR data and process principles. This platform blends and contextualizes data in real time, overcoming the limitations of traditional approaches like data warehouses and lakes. L7|ESP integrates with legacy systems, enabling faster data contextualization, tech transfer, and real-time business insights without requiring the sunset of existing systems, saving as a result, millions of dollars compared to traditional methods. INSERT RELEVANT ILLUSTRATION HEREsupporting case studyConnect with the L7 Team to find out more about the work we did with a Top 10 big pharma company. they talk best about itadditional resourcesDive deeper and see how L7|ESP can transform your operations: L7|ESP brochureL7 LIMS app datasheetL7 MES app datasheetL7 scheduling app datasheetbig pharma case studyL7|ESP blog postGartner IT reportL7 Precision Research eBookresourcesDive deeper and see how L7|ESP can transform your operations:L7|ESP brochurecomposable architecture white paperL7|ESP explainer videoL7 Notebooks app datasheetL7 LIMS app datasheetL7 MES app datasheetL7 scheduling app datasheet ready to take your data to the next level?schedule a demoConnect directly with our experts to see L7|ESP in action tailored to Takeda’s needs. We're looking forward to connecting with you! get started with L7|ESPContact a team member with any questions you have on L7|ESP, and how it can be tailored to meet Takeda’s needs. We're looking forward to connecting with you!L7's clients + partnersthe latest about L7 Informatics ### L7 Scheduling L7 Scheduling a comprehensive scheduling solution to maximize production capacity and meet operational efficiency challenging the resource scheduling status quo Manufacturing pharmaceutical products and managing patient treatments are complex and highly regulated processes. The need for efficiency and cost-effectiveness compounds these challenges. Speed is crucial to treatment efficacy in cell and gene therapy production and patient treatment management. Similarly, the production of biologics, such as monoclonal antibodies, must be conducted at the lowest possible cost while maximizing production capacity and enhancing operational agility. This is vital for any therapeutics manufacturing facility or laboratory. The industry faces a significant challenge in suboptimal production and planning schedules, which lead to operational inefficiencies. An optimized production and planning schedule is essential for the swift and cost-effective delivery of high-quality therapeutic products. This involves maximizing the use of available resources—qualified staff, instruments, and equipment. Additionally, strict adherence to regulatory standards and full compliance are imperative, all without compromising operational efficiency. introducing L7 Scheduling L7 Scheduling provides a robust solution to the production and patient treatment management challenges faced by pharmaceutical manufacturing departments and organizations. Smart Data Linking Dynamically and automatically connects entries to L7|ESP's schedulable data sources. Priority-Based Scheduling Enables efficient resource allocation based on task priority, expected completion dates, and duration. Integrated Assignee Details Incorporates essential assignee information, including workgroup, location, and equipment, into the scheduling process. Unified Platform Integration Seamlessly integrates into the L7|ESP Unified Platform, contextualizing data and orchestrating workflows across the analytical and manufacturing ecosystem. System Synchronization Ensures automatic synchronization with MES and LIMS applications for streamlined operations. Complex Supply Chain Support Addresses the complexities of real-world process supply chains and their scheduling demands. Regulatory Compliance Guarantees compliance with 21 CFR Part 11 for the production of small molecules, biologics, and cell and gene therapy products. L7 Notebooks outperforms traditional ELN systems L7 Scheduling is part of the L7|ESP unified platform L7 Scheduling integrates seamlessly with the L7|ESP Unified Platform, featuring a robust Workflow Orchestration and Data Contextualization System. This system centralizes data from MES, LIMS, inventory, and many other applications in a single database. Utilizing the existing L7|ESP workflow chain configurations, the system automates task orchestration, offering a comprehensive approach to lab process management. L7|ESP can also be enhanced with data trending and charting tools for detailed single-batch and cross-batch analysis and reporting. L7 scheduling app datasheet L7|ESP brochure L7 SCHEDULING blog postBy utilizing L7 Scheduling as part of the L7|ESP Unified Platform allows researchers to run their laboratories at capacity with optimized resource utilization and staff schedules. Automating the administrative burden with L7|ESP allows laboratory staff to focus on high-value activities while optimizing production cost-effectiveness. ready to take your resource scheduling to the next level? ### L7 Notebooks L7 Notebooks L7 Notebooks captures unstructured and structured data for research, assay, process, and analytical developmentchallenging the ELN status quo Traditional methods like paper-based lab notebooks and spreadsheets are increasingly insufficient due to their well-known logistical, scientific, and data-related challenges. Annotating experiments, compiling results, and maintaining diligent records are labor-intensive, time-consuming, and prone to errors. Furthermore, the advent of advanced technologies, such as high-throughput and high-frequency measurement devices, has significantly increased the volume and complexity of data produced in R&D studies and experiments. The outdated paper and spreadsheet paradigms are ill-equipped for the realities of modern R&D. They lack the scalability needed to meet current business and scientific demands, offer no structure for data analysis in downstream processes, fail to integrate with broader laboratory systems, hinder collaboration, and complicate the retrieval of historical data.introducing L7 NotebooksL7 Notebooks provides a robust solution to the numerous challenges faced by life sciences research organizations, particularly those requiring streamlined operations, enhanced flexibility, and the capacity to swiftly adapt to market fluctuations. Streamlined Protocol Transfer Efficiently transition protocols from research to production, minimizing tech transfer times and ensuring consistent data recording and analysis.Standardized Lab Processes Create reusable templates that standardize laboratory processes, enhancing productivity and precision.Enhanced Data Security and Access Control Implement role-based user access and robust data security measures to facilitate secure cross-departmental collaboration.Efficient Data Reporting Rapidly query and report laboratory data for presentation to customers, managers, and other stakeholders.L7 Notebooks outperforms traditional ELN systemsL7 Notebooks is part of the L7|ESP unified platformL7 Notebooks is an integral component of the L7|ESP Unified Platform, which consolidates protocols and notebook library data within the same database that houses LIMS, inventory data, scheduling tools, and various other applications. This system leverages the existing workflow chain configurations of L7|ESP to automate task orchestration seamlessly. For instance, when a benchtop researcher logs a sample collection in Notebooks, the system automatically schedules the corresponding analytical procedure in L7 LIMS and then retrieves the results back into Notebooks for analysis and interpretation.L7 Notebooks app datasheetL7|ESP brochureL7 Notebooks blog postBy utilizing L7 Notebooks as part of the L7|ESP Unified Platform, researchers benefit from a seamless integration of structured and unstructured data which is what most experimental paradigms require. This ultimately leads to efficient tech transfer from research to production and streamlined research and production operations. ready to take your lab data to the next level? ### L7 MES L7 MES a comprehensive manufacturing execution system for the precision therapeutics workflow challenging the MES status quo The manufacturing of pharmaceutical products is fraught with complexity and time constraints, frequently leading to delays, deviations, and escalating costs. Traditional methods rely on cumbersome, paper-based ecosystems and inflexible electronic systems, further compounded by non-compliant spreadsheets that create bottlenecks and delay product releases. data+intelligence for the scientific enterprise L7 | ESP is designed to unlock innovation at every stage of the clinical, research, and manufacturing value chain. From data and workflow orchestration – to custom apps and integrations, L7 | ESP is an end-to-end transformation engine to help solve the challenges of today and realize the opportunities of tomorrow. introducing L7 MES L7 MES is a flexible, digital, and process-oriented solution designed to overcome traditional pharmaceutical manufacturing bottlenecks, while ensuring 21 CFR Part 11 compliance for the production of small molecules, biologics, and cell and gene therapy products. Efficient Recipe Management Rapid configuration of Master Batch Records, Intermediates, and Drug Product recipes. Enhanced Operational Control Supports configurable electronic signatures, sample plan management, and label reconciliation. Comprehensive Documentation Integration Enables Electronic Batch Records (EBR), Bill of Materials (BOM), Sample Plan Management, Specifications, Quality Review, Signature Sign-Off, and automatic Batch Reports. L7 MES outperforms traditional manufacturing execution systems L7 MES is part of the L7|ESP unified platform L7 MES is integrated into the L7|ESP unified platform, sharing a common database with LIMS and inventory systems. It leverages the existing L7|ESP workflow configurations to accurately represent and manage the manufacturing process. Throughout production, it collects samples to be analyzed by LIMS. Additionally, L7|ESP supports enhancements with data trending and charting tools, enabling both single-batch and cross-batch analysis and reporting. L7 MES app datasheet L7|ESP brochure what customers are saying The decision to deploy L7|ESP reflects our commitment to staying at the forefront of innovation in this dynamic field. ready to take your MES data to the next level? ### L7 LIMS L7 LIMS a flexible and fully functional LIMS, integrated into the L7|ESP unified platform with workflow orchestration challenge the LIMS status quo The landscape of laboratory experiments and study protocols has been dramatically transformed due to the advances in high-throughput and high-frequency measurement technologies, groundbreaking technological progress, and complex drug modalities. Traditional methods like paper and Excel are now obsolete, struggling to meet the modern demands of research and clinical laboratories. These old systems fail to scale, hinder data structuring for downstream analysis, disconnect from the wider laboratory environment, complicate collaborations, and obstruct historical data retrieval. Consequently, this results in escalating technical debt, obscuring a comprehensive view of the overarching process. introducing L7 LIMS L7 LIMS provides an effective and clear solution to address these challenges by streamlining laboratory operations. The result is a highly efficient and accurate process at reduced cost. Streamlined Laboratory Operations L7 LIMS streamlines your lab's operations, resulting in a more efficient, accurate process at a reduced cost. Automated Workflow Optimization Automate and optimize lab workflows and tasks, leading to higher efficiency and a reduction in manual errors. Enhanced Sample Management Efficiently track and manage samples from collection to disposal, capturing details like location, storage conditions, and testing history. This reduces mix-ups and increases traceability. Resource Management + Optimization Manage and optimize all lab resources, including consumables, equipment, and personnel, ensuring optimal allocation and preventing shortages. Centralized Data Access Make data, results, protocols, and documentation accessible across your organization and to collaborators through a centralized repository, enhancing transparency and organization. Robust Data Integrity Maintain data integrity through role-based user access controls, comprehensive audit trails, and secure electronic signatures. L7 LIMS add-on applicationsL7 Environmental Monitoring (EM) L7 EM is used for executing environmental monitoring and testing of cleanroom surfaces, air monitoring, and personnel monitoring. L7 EM provides scheduling capability as an add-on app to L7 LIMS to support all the testing.L7 Stability L7 Stability, an add-on to L7 LIMS, is used for the automated scheduling of stability studies of manufactured batches of drug products and drug substances.L7 Biorepository L7 Biorepository simplifies the way Sample Managers handle sample registration, receipt, and processing. With L7 Biorepository, labs can streamline their operations and ensure efficient sample processing, leading to improved productivity and enhanced customer satisfaction.L7 LIMS outperforms traditional LIMS systems L7 LIMS is part of the L7|ESP unified platform L7 LIMS is an integral component of the L7|ESP Unified Platform, encompassing Workflow Orchestration and Data Contextualization. This comprehensive system centralizes where samples are logged, experiments conducted, and inventory managed, integrating these elements seamlessly with protocols, workflows, Notebooks, inventory data, scheduling tools, and various other applications—all within a single database. The system automates task orchestration by leveraging pre-configured workflow chains, delivering a holistic approach to laboratory process management. L7 LIMS app datasheet L7|ESP brochure L7 LIMS blog postThe L7 LIMS app offering, fully integrated into the Unified L7|ESP Platform with its Workflow Orchestration system, is the ideal solution for us to modernize, adapt, and improve our internal Excel spreadsheet-based processes to formalize our SOPs and to manage all entities and data in one single source of truth. ready to take your lab data to the next level? ### Datasheets - Partners L7 | Datasheets ### Datasheets L7 | Datasheets ### Cookie Policy Cookie Policy Please note: To access certain gated resources in the L7 resource center, cookies must be accepted. These resources will only display once cookies have been accepted and the required form has been submitted. ### L7 Voice of Customer Program L7 Voice of Customer Programyour voice, our commitment We're excited to embark on a meaningful journey together—one that revolves around enhancing your L7|ESP platform experience. At L7, we're not just dedicated to delivering a powerful platform; we're committed to creating an environment where your insights and needs shape our every move. Our 'Voice of Customer' initiative is about us embracing your aspirations, questions, and challenges. As we dive into the vast world of Therapeutics, Diagnostics, Medicine, Research, and AgBio workflows supported by L7|ESP, we're here to learn from you. Your contributions are the compass guiding us as we forge ahead, meticulously crafting a platform that doesn't just meet, but surpasses your expectations. Thank you for being an essential force propelling us towards a new standard of user experience excellence.share your insightsConnect with us today for any inquiries, immediate feedback, or to express your interest in becoming an active contributor to the Voice of Customer Program. We’re excited to see the conversations unfold!supporting case studyConnect with the L7 Team to find out more about the work we did with Triumvira. L7's clients + partnersthe latest about L7 Informatics ### L7 UNIVERSE 2023 Agenda Agenda 2023 agenda Please check back regularly as we continue to add more details about our sessions and confirmed speakers. Sessions and topics are subject to change. tuesday, september 12 5:00 PM CDT Welcome Reception Kick off your UNIVERSE experience by joining us for a remarkable welcome dinner in the heart of Austin, TX, where you can savor the city's offerings while mingling with fellow attendees. Expo Hall - Waterloo Salons - Level 5wednesday, september 13 7:30 AM CDT Breakfast Join us and set the tone for a fantastic day ahead with a mouthwatering breakfast Expo Hall9:00 AM CDT Welcome Steven Barash, Vice President of Strategy & Development, L7 Informatics General Session9:15 AM CDT Keynote: Achieving Growth, the Lifeblood of Life Sciences and Diagnostics Companies, with L7|ESP Operational expenses are coming under scrutiny with value generation and return on investment taking center stage. Despite automation efforts, science product process design has remained a mostly manual, cognitively demanding task, making it time-consuming, labor-intensive, and error-prone. Not making it any easier, the life sciences product value chain is complex and very opaque. One of the reasons for this is the complex and disjointed IT infrastructure that has evolved over several decades. The fully digitalized novel platform L7|ESP will enable the much-needed growth of life science and diagnostics companies to accelerate science, by improving the speed to market products, simplifying IT infrastructure, and optimizing resource utilization across the entire product value chain. Vasu Rangadass, Ph.D., President and CEO, L7 Informatics General Session10:00 AM CDT Delivering Fast, Flexible, Reliable Biologic Development and Manufacturing Through Digital Technology We are seeing ever-faster adoption of transformative digital technologies in drug development and manufacturing. These advances include integrated data systems, predictive process modeling, real-time product quality sensors, electronic batch records, AI/ML, and advanced process control. Equipment is delivering more data streams, the technology ecosystem is becoming more open, process models have gained fidelity and regulatory acceptance, and the workforce has become more adept at data intenstive methodologies. Yet much more work and innovation is needed to make the digital layer truly fundamental to how we make and deliver drugs to patients. We will review Cytiva's holistic approach to digitally enabled hardware, consumables, and how we deliver speed and performance through data access, predictive modeling, and virtual reality. Tim Gardner, Digital Strategy Leader, Cytiva General Session10:30 AM CDT Morning Coffee and Networking Take advantage of the morning break to recharge and mingle. Sip on coffee, share ideas, and make the most of this short intermission. Foyer11:00 AM CDT Panel Discussion - Coming of Age: Cell & Gene Therapy Digitalization Panelists share approaches and challenges associated with digitalization of manufacturing, testing, release, and supply chain management of cell and gene therapies. Moderator: Marcia Blackmoore, Vice President of Customer Solutions - Therapeutics, L7 Informatics Panelists: Olive Sturtevant, MHP, Administrative Director, Dana-Farber Cancer Institute Dominic M Clarke, Ph.D., Chief Scientific Officer, Orange County Bio Lindsey Stinson, GMP Application Systems Specialist, Vernal Biosciences Trent Carrier, Ph.D., MBA, Chief Operating Officer, L7 Informatics General Session12:00 PM CDT Lunch Gather for a delicious networking lunch, fostering connections and conversations that will lay the groundwork for an afternoon filled with captivating discussions and insights. Expo Hall1:00 PM CDT Design & Implement, End to End NK Cell Therapy Supply Chain Model Sanofi’s K-NK platform is designed to deliver potent NK cells as an off-the-shelf NK-cell therapy product for a broad patient population across a wide range of indications. Our process allows K-NK cells to be expanded with a PM21 particle technology in an industrial GMP-compliant process to enable high dose, low cost, and scalable production without the risk of residual tumor cells in the final product. However, the manufacturing of cell therapies requires precise coordination across multiple teams and stages of the supply chain, from sourcing suitable cells from donors to delivering the final product to patients. The various working teams in manufacturing generate numerous heterogeneous data sets using different data management practices and tools. The result of which is a decentralized pool of unstructured data. To address this challenge, it is imperative to implement a track and trace system to ensure end-to-end traceability and data integrity in the manufacturing process of drug product. Rana Nikzad, Principal Scientist, Sanofi General Session1:30 PM CDT Implementation of L7|ESP LIMS for an Academic GMP Cellular Therapy Manufacturing Facility Over the past year, an L7 implementation team has worked with the to implement LIMS for the Connell and O’Reilly Families Cell Manipulation Core Facility at the Dana-Farber Cancer Institute. The compendium of the facility has been implemented in L7|ESP, 1/3 of the assays going paperless, as well as key product traceability workflow. In future releases, additional workflows will become paperless, testing instruments will be integrated, and the product disposition workflow will be captured in L7|ESP, leading into the implementation of L7's manufacturing execution system implementation for standard of care and IND manufacturing. Joshua Geary, IT Manager, Cell Manipulation Core Facility, Dana-Farber Cancer Institute General Session2:00 PM CDT L7|ESP has enabled QIAGEN laboratory digitalization At the heart of QIAGEN’s business is a vision to make improvements in life possible. We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe. QIAGEN Manchester is a world leading centre for molecular diagnostic applications, expanding and enhancing the delivery of life-improving diagnostic systems for existing and emerging medical needs, with a focus on companion diagnostics and personalized healthcare in infectious disease and oncology. Working in a regulated environment comes with strict documentation practices. Transitioning from recording everything on paper to a digitalized system brings it’s challenges but also its rewards. This presentation will introduce how QIAGEN has been successful in using L7|ESP and customizing it to our needs to bring QIAGEN Manchester into the digitalization world. Helen Pye, Manager, QIAGEN General Session2:30 PM CDT Think Bioscience & Boulder BioConsulting: Delivering a unique biosynthetic platform on L7|ESP through 'Informatics as a Service' Think Biosciences utilizes an innovative biosynthetic platform to identify small molecule inhibitors against challenging protein targets. This synthetic platform presents unique informatics system requirements to support and accelerate their drug discovery projects. To rapidly overcome the informatics hurdles while maintaining cost-efficiency, Think partnered with Boulder BioConsulting (BBC). BBC is a life science informatics consulting company specializing in solutions and services for small- and mid-sized pharma and biotech enterprises. Through the "Informatics as a Service" approach, Think Biosciences and BBC jointly identified L7 Informatics as the ideal foundation to address Think's use case. This talk will describe Think Bioscience's novel platform, explore their successful collaboration with Boulder BioConsulting, and elaborate on the process used to identify L7 Informatics as the optimal solution. The presentation will showcase how this three-way partnership culminated in the swift and efficient delivery of Think Biosciences' desired informatics solution. Attendees will also gain insights into the power of "Informatics as a Service" in catalyzing groundbreaking advancements within the biotech industry. Joel Kralj, Director, Platform Innovation, Think Bioscience Dan Weaver, President, Boulder BioConsulting General Session3:00 PM CDT Afternoon Coffee Networking It's time for a quick afternoon breather – a chance to relax and recharge before we continue our afternoon agenda. Foyer3:30 PM CDT Challenges of Digitalization of Cell and Gene Therapy Workflows Cell and gene therapy represent major advancements in industry and medicine. The possibilities to treat and potentially cure diseases at the genetic level offer great hope to many. However, complex workflows and intricate processes can pose many challenges. This presentation will examine the CGT manufacturing process, the goals of digitalizing CGT workflows, typical challenges, and insights. Anthony Forte Jr., Senior Business Analyst, Zifo General Session4:00 PM CDT "Talking Digital to Doing Digital" - Enabling the Life Science Value Chain Together During this presentation, Louis Hendriks will share insights on how GVW is enabling a data-centric digital transformation in Life science and Pharma by developing a roadmap towards a value chain data backbone. The talk will also reflect on the use cases on GVW - L7 client-focused collaboration - the knowledge provided, insights acquired, and experience learned. Together, we are enabling experts to work more efficiently to deliver better business, science, and patient outcomes. Louis Hendriks, Founder & CEO, Global Value Web General Session4:30 PM CDT Optimizing Research and Diagnostics Value Streams Using L7|ESP Standard Content This presentation will explore the various challenges faced by end users in research and diagnostics laboratories and how L7|ESP provides dynamic value to overcome these challenges. Value streams for these various end users will be presented, demonstrating how use of L7|ESP standard content achieves significant efficiencies across various functions. Interactive demos will guide discussions through L7|ESP Standard Content usage for each end user type. Oana Lungu, Ph.D., Associate Director of Diagnostic Solutions, L7 Informatics General Session6:00 PM CDT Dinner Join us for an evening of culinary exploration as we gather for a delightful dinner, discovering the tastes of Austin, TX, and creating memorable connections. Onyx at the Line Hotelthursday, september 14 7:30 AM CDT Breakfast Join us for a delicious breakfast as we prepare to tackle the day ahead. Expo Hall9:00 AM CDT Keynote by Dr. Moira Gunn In this session, Dr. Moira Gunn will provide insights on the future of precision health, encompassing precision medicine, diagnostics, cell and gene therapeutics, and the technological advancements shaping these fields in the coming decade. Moira, Gunn, Ph.D., Host, Tech Nation + BioTech Nation Radio/Podcasts, Professor and Director of Bioentrepreneurship, University of San Francisco General Session10:00 AM CDT LIMS in the Era of GenAI Ray Veeraraghavan, Executive Director - Technology, Molecular Genomics & Oncology, Quest Diagnostics General Session10:30 AM CDT Morning Coffee and Networking Take a moment to recharge with a cup of freshly brewed coffee and chat with fellow attendees, sharing thoughts and takeaways from the morning's engaging sessions. Foyer11:00 AM CDT Panel Discussion: Overcoming Challenges in the Digital Transformation of Research & Diagnostics Labs Panelists share their unique digital journeys in the transformation of their labs, their individual start and end points, the challenges along the way and what the future holds for all of us in the lab. Moderator: Arvind Ramakrishnan, Vice President of Customer Solutions - Research & Diagnostics, L7 Informatics Panelists: Ray Veeraraghavan, Executive Director - Technology, Molecular Genomics & Oncology, Quest Diagnostics David Sexton, Vice President of Digital Lab Systems, Harbinger Health Brendan Arbuckle, Chief Information Officer, The Jackson Laboratory Mike Heinz, Director of Research Operations, Genome Technology Access Center at the McDonnell Genome Institute, Washington University in St Louis Kannan Jagamoorthy, Vice President and General Manager, Americas, Zifo General Session12:00 PM CDT Lunch Join us during the lunch break for a chance to mingle, network, and recharge. As we reconvene in the afternoon, we'll delve back into captivating subjects, enriched by the connections made over lunch. Expo Hall1:00 PM CDTEstablishing Clinical Scorecards: From Biomarker Discovery to Clinical Decision Support The implementation of clinical cut-offs for diagnostic tests is standard practice. Many tests have single or multiple cut-offs to find the difference between normal and various stages of disease. These cut-offs are most often based on simplistic correlations between the measured analyte (biomarker) and observational clinical outcomes data. A classic example is blood glucose, where a value of <140mg/dl is normal and >200 mg/dl is diagnostic for diabetes, and changes in glucose levels can be correlated to treatment efficacy. However, more diagnostics are being developed that are based on multiple analytes or variables that can have complex interactions and complex correlations to clinical outcomes. An example is diagnostics based on multiple genetic mutations across multiple genes often used for diagnosis and prognosis of cancer. In addition, many multi-variant analyses often correlate with diseases using meta-analysis of clinical trials or real-world evidence from data sources like electronic medical records (EMRs). These newer multi-variant diagnostic tools are often too complex to establish simple clinical cut-points. In addition, given the often-complex relationships between multi-variant analysis and clinical outcomes, the clinician cannot reasonably be expected to translate the diagnostic result into a clinical decision. To overcome these issues, many diagnostics are using AI (machine learning or deep learning) to tease out the clinical outcome relationships and then translating the relationships into a “risk score” or a clinical decision “scorecard” that is easy to interpret. In this presentation, three different examples of diagnostic scorecards will be presented. The first is a diagnostic tool that measures the resistance of an HIV patient’s virus to different antivirals based on genetic data. This was one of the original clinical decision support tools and examples of personalized medicine. The second example is a scorecard to predict the risk of kidney failure of diabetics that combines laboratory data and EMR data into a 5-year risk score. The final example is a new point-of-care tool for evaluating oral lesions. This tool combines biomarker data, cellular morphology, and subjective analysis by pathologists to generate an objective score that can guide therapeutic decisions and monitor disease progression. Each of these examples will highlight the types of data used, the AI methodology used to interpret the data, and how the final score was validated. Timothy Alcorn, Ph.D., Managing Director, Medical Devices, Diagnostics and Health IT, Latham BioPharm Group General Session1:30 PM CDT Driving Digital Transformation in the Jackson Laboratory Scientific Services with L7|ESP The Jackson Laboratory (JAX) aims to transform our research enterprise by unifying the data ecosystem that supports our Scientific Services. L7|ESP was chosen as the LIMS application to anchor this effort, largely because of its superior flexibility, supportability, and user experience as compared to its competitors. We are now nearing completion of the second year of our rollout, at which point we will have deployed L7|ESP into production to 3 of our Scientific Services and a Research Center. We present here our experience and the lessons learned with our rollout, as well as challenges that we still need to solve. Dave Mellert, Senior Director of Research IT, The Jackson Laboratory General Session2:00 PM CDT CSI-Dx®: Metatranscriptomic Sequencing for Pathogen Detection in Synovial Fluid and Beyond, Empowered by the L7|ESP Platform Here we introduce the cutting-edge CSI-Dx® assay, a RNA-based sequencing technique designed for detecting pathogens in disease states such as Prosthetic Joint Infections (PJIs) and Sepsis. This presentation provides a concise overview of the CSI-Dx® test system and its potential applications. Discover the outcomes of a collaborative study with Zimmer Biomet involving over 320 synovial fluid samples, showcasing the clinical efficacy of CSI-Dx® and its transformative impact on pathogen detection. This collaboration highlights the assay's role in providing crucial insights into pathogen detection and the downstream potential for better understanding functional gene expression. Integral to CSI-Dx® is the L7|ESP platform, functioning as a robust Laboratory Information Management System (LIMS) and platform solution. Join us to grasp the essence of CSI-Dx's® innovation, its clinical significance through a substantial collaborative study, and the streamlined data management offered by the L7|ESP platform. Justin Wright, Co-Founder, Executive Vice President of Data Analytics, Contamination Source Identification (CSI-Dx) General Session2:30 PM CDT Digitally Native Drug Discovery – How AWS Enables Scientific R&D and Commercialization Learn how Amazon Web Services (AWS) is innovating at the intersection of science and technology with real world examples from industry leaders. AWS for Life Sciences reduces barriers to innovation by providing a curated suite of purpose-built solutions designed to help organizations develop, trial, manufacture, and commercialize therapeutics quickly and efficiently. By working to accelerate time-to-insights, increase ROI, and bring differentiated therapeutics to market faster with the most comprehensive suite of data capabilities and machine learning offerings, AWS is empowering large and small companies alike in their path to market. Eric Zimmerman, Principal Healthcare & Life Sciences BD, Venture Capital & Startups, Amazon Web Services (AWS) General SessionTherapeutics Solutions Made Simple with the L7 Manufacturing Package This presentation will explore the needs and challenges in manufacturing operations management and day to day responsibilities from an end user perspective and how L7's manufacturing package can simplify and enhance the product value streams' execution and handoffs. Interactive discussions around L7's therapeutics solution approach will be welcomed. Kevin McMahon, Associate Director, Precision Therapy Solutions, L7 Informatics Justin Paul, Senior Manager, QC Solutions, L7 Informatics Rooms 403-4043:00 PM CDT Afternoon Coffee Networking Enjoy a short afternoon break to refresh and refocus, preparing to dive back into our engaging sessions. Expo Hall3:30 PM CDT From GSheets to L7|ESP This talk will provide an overview of Nobell Foods and discuss how we are transitioning from Google-sheets based data collection to using L7|ESP. We will cover our experience during the initial implementation phase led by L7 and how we are continuing the development in-house with L7 support. Chris Rife, Senior Data Engineer, Nobell Foods General SessionBuilding Better User Experiences in LIMS via Flex View L7|ESP provides out-of-box views for immediately interacting with configured data elements in a LIMS workflow, but sometimes more is needed. In this workshop, LIMS implementers will learn how to take advantage of L7|ESP’s “Flex View” feature to provide their users with tailored views, including using out-of-box widgets, using the Generic renderer widget to provide custom views, using the “context” object to share data between widgets, and creating re-usable custom widgets. Note: this session will run for 45 minutes. Robert Zeigler, Vice President, Product Development, L7 Informatics Rooms 403-4044:00 PM CDT Your Waste Isn’t Wasted: Implementation of L7|ESP Biobot Analytics is a global leader in wastewater epidemiology, founded with the goal of transforming wastewater infrastructure into real-time public health observatories. Having worked at more than 1,000 locations across all 50 US states and several countries, Biobot uses advanced data analytics to deliver insights from wastewater to improve the health of communities around the world. Separately from their infectious disease work, Biobot also analyzes wastewater for the presence of High-Risk Substances, such as opioids, to help communities better respond to substance use and implement harm reduction programming. In order to identify which catchment areas may be at highest risk for a biomolecule or pathogen of concern (e.g., opioids, COVID, flu, monkeypox, RSV, Norovirus, etc.), a sample is collected at the wastewater treatment plant, manhole, building, etc. and sent to Biobot Analytics for chemistry and/or molecular testing. Results are released to clients, including public health officials (such as the CDC), for guidance in their responses. Biobot Analytics is implementing L7|ESP to provide chain of custody, track positive specimens during the laboratory process, and enhance workflows. Sara Beckloff, Vice President, Lab Operations, BioBot Analytics Kelly Wahl, Research Program Manager, BioBot Analytics General SessionBuilding Scalable Orchestration Workflows Chains & Performance Tuning L7|ESP In the fast-paced world of science and technology, science-supporting platforms must perform well and keep up with the pace of changes in the lab. L7|ESP provides tools for quickly modeling any variety of laboratory process. In this workshop, LIMS implementers will learn how to leverage these tools to model processes in a way that scales with data growth, user growth, and organization and process growth and change. Note: this session will run for 45 minutes. Robert Zeigler, Vice President, Product Development, L7 Informatics Rooms 403-4044:30 PM CDT Application Ontologies – Combining public ontologies with internal standards and creating FAIR data for AI and other downstream applications In this presentation, we will demonstrate the power of L7's partnership with SciBite's award winning ontology management tool, CENtree. To do this, we will cover what ontologies are, the public standards available and what the downstream use cases of these ontologies are. From there, we will explore how you can combine public ontologies with your own internal standards using CENtree thus creating what we call "application ontologies". Finally, we demonstrate the value of creating these "application ontologies" by discussing downstream use cases like an integration with L7's Enterprise Science Platform (ESP). Arvind Swaminathan, Technical Consultant, SciBite an Elsevier company General SessionL7|UNIVERSITY: Easier and Faster Learning & Adoption of L7|ESP The Product Enablement Team has been busy keeping pace with the tremendous growth of the L7|ESP platform. In this session we will highlight new L7 UNIVERSITY offerings, why one should attend the L7 University, and our exciting enablement roadmap for making learning and adopting L7|ESP easier and faster than ever before. JP Brown, Director of Product Training, L7 Informatics Expo Hall6:00 PM CDT Dinner We're thrilled to have you join us for an unforgettable dinner, embracing the vibrant flavors of Austin, TX, while enjoying the company of fellow participants. Punch Bowl Socialfriday, september 15 7:30 AM CDT Breakfast Indulge in a delightful morning and start your day in style by savoring a delicious breakfast. Foyer by Rooms 403-4049:00 AM CDTState of L7|ESP: Product Overview This session will highlight high-level features of the L7|ESP platform, focusing on what’s new for L7|ESP 3.2, including performance enhancements. This session will also set the stage for subsequent presentations on what’s new in specific parts of the application. Robert Zeigler, Vice President, Product Development, L7 Informatics Rooms 403-4049:30 AM CDTState of L7|ESP: What’s new in L7|ESP’s Foundational Applications The Enterprise Science Platform is built on a foundation of processes (Protocols, Workflows, Workflow Chains in L7|ESP) and objects (Entities, Locations, Inventory Items). This session will introduce users to enhancements made to these foundational layers in L7|ESP 3.2. Attendees will learn about enhancements made to workflow execution, including performance improvements to processing to eliminate timeout errors, enhancements made to the LIMS backlog for more consistent views, and addition of container statuses. Robert Zeigler, Vice President, Product Development, L7 Informatics Rooms 403-40410:00 AM CDTManaging Manufacturing Processes with the L7 MES App Join us as we present a review of the capabilities in the new MES app that was introduced earlier this year. Learn how easy it is to manage in-flight Sample Plans, keep an eye on Specifications as the batch progresses, and pinpoint needs with the Bill of Materials. Discover the power of highlighted data entry exceptions while reviewing process data in Quality Review, and pull everything together with the final batch reports that can speed batch release decisions. Karri Unruh, Product Owner, L7 Informatics Rooms 403-40410:30 AM CDTUnlocking Seamless Scientific Research: Bridging Notes and Applications The conundrum of efficiently organizing and tracking research notes while seamlessly integrating them with various scientific software applications has impeded progress for far too long. This presentation will dive into the numerous benefits of the L7 NOTEBOOKS app, including seamlessly connecting research notes to a growing number of scientific software applications, effortlessly crafting reusable templates, and enabling seamless collaboration within a controlled environment. Discover how L7's integrated review process fosters a culture of rigorous assessment, elevating research to new heights through collaborative refinement. Anshu Malini, Product Owner, L7 Informatics Rooms 403-40411:00 AM CDTHow to Leverage the L7|HUB to Streamline the Review Process of Scientific Digital Content Bundles? In the rapidly evolving landscape of scientific digital content production, the challenges of tracking, identifying, and efficiently gating approved content can become a bottleneck. This pressing concern demands innovative solutions that streamline the content approval process and enhance overall productivity. This presentation will unveil a strategic approach that addresses the long-standing problem of content management by seamlessly aligning approval procedures with the scientific digital content production lifecycle.The focus will be on the numerous benefits of the L7|HUB and the Bundle Review feature, resulting in minimized context switching, enhanced process control, and robust security measures to safeguard the production environment. Brandon Varela, Principal - Scientific Software Products, L7 Informatics Rooms 403-40411:30 AM CDTImplementing a successful L7|INTELLIGENCE strategy to unlock new levels of growth and innovation for your entire organization In today’s complex life sciences landscape, gaining a competitive advantage and making informed decisions are paramount to success. This presentation explores the power of L7|INTELLIGENCE. Discover the key components of a robust L7|INTELLIGENCE strategy built around L7|ESP, including data collection and integration, data warehousing and management, and analytics and reporting. Learn from real-life examples and understand the benefits of successful L7|INTELLIGENCE implementations across the industry, such as informed decision-making, competitive advantage, and operational efficiency. Walk away with best practices for implementing a successful L7|INTELLIGENCE strategy and unlock new levels of growth and innovation for your entire organization. Richard Love Sr., Director of Business Intelligence, L7 Informatics Rooms 403-40412:00 PM CDTEfficient Organization and Management of Company Resources to Stay on Track of Scientific Tasks via the Scheduling Application Efficiency within the workplace can be significantly improved when tasks are scheduled, and resources are appropriately assessed and assigned. This presentation will review the components within the Scheduling application and demonstrate how effective planning can align teams and personnel with the processes and equipment they use. Explores the Scheduling app and its sections, including Calendar, Availability, Tasks, and Resources. Isaac Rodriguez, Product Owner, L7 Informatics Rooms 403-40412:30 PM CDTClosing Session and Lunch Join us for a closing lunch, the perfect way to conclude our time together. Take a moment to connect before heading home, fueled by inspiration and connections. Waterloo Salons 4-61:00 PM CDTVoice of Customers - Therapeutics Waterloo Salons 1-3Voice of Customers - Diagnostics Waterloo Salons 4-61:00 PM CDT CReATe IVF Case Study - Track 1 - Abstract to come Speaker TBD Room TBD L7|UNIVERSE — celebrating our customers and partners in their journey to digital transformationthank you to our partners explore opportunities L7's clients + partners the latest about L7 Informatics we're hiring ### L7|LIVE SF 2023 L7|LIVE SF - Tuesday, June 13th, 2023 Digital Transformation for Life Science Leaders The L7|LIVE SF seminar will explore the ways in which digital technologies, such as unified platforms, are revolutionizing the biotech and life science industries, transforming business models, breaking down data silos, reducing turnaround times, and creating more consistent and reproducible processes. Our panel of experts will share their insights and experiences on these needed cutting-edge technologies and the trends laying the foundation for the future of life sciences. This is a great opportunity to learn about the latest developments in the field, network with industry professionals, and gain a deeper understanding of how digital transformation is shaping the future of biotech. join us in person Tuesday, June 13th Lunch (noon - 1 pm PT) Seminar (1 pm - 5 pm PT) Reception (5 pm - 7 pm PT) The St. Regis San Francisco 125 3rd St, San Francisco, CA 94103 Tuesday, June 13th Lunch (noon - 1 pm PT) Seminar (1 pm - 5 pm PT) Reception (5 pm - 7 pm PT) The St. Regis San Francisco 125 3rd St, San Francisco, CA 94103 join us virtually Tuesday, June 13th Seminar (1 pm - 5 pm PT) We understand that not everyone can join us in person for L7|LIVE SF, but we've got you covered! We are thrilled to offer this event as a hybrid experience, allowing you to participate from your office or the comfort of your home. Rest assured that you will have access to the same great content, valuable insights from industry experts, and thought-provoking discussions. We can't wait for you to be part of this transformative event! agenda 11:30 amRegistration opens Top of the elevators, Level Four​ 12:00 pm – 1:00 pm​Lunch Catered by the St. Regis SF Impressionist Room, Level Four​ 1:00 pm – 1:30 pm​ Operational Excellence with Digital Systems in Life Sciences The Life Sciences industry is rapidly evolving, and digital systems and technologies have become essential tools for driving innovation, improving patient outcomes, and accelerating drug development. However, achieving operational excellence in Life Sciences with digital systems requires a strategic approach that aligns with an organization's goals. By leveraging the latest digital technologies and best practices, organizations can optimize their processes, streamline operations, and increase productivity to gain a competitive edge. With the right approach, digital systems can enable organizations to achieve operational excellence by driving operational excellence, innovation, and success. Vasu Rangadass, Ph.D., President & CEO at L7 Informatics Conservatory, Level Four 1:30 pm – 1:45 pm​ Analytical and Process Development / Tech-Transfer Case Study Steven Barash, Vice President, Strategy & Development + Brent Wilson, Ph.D., Solutions Consultant at L7 InformaticsConservatory, Level Four 1:45 pm – 2:05 pm​ Informatics as a Service: Reimagining Scientific Computing for Modern Drug Discovery Modern drug discovery is a dynamic, collaborative process in which companies engage both internal and external resources to orchestrate their development programs. This paradigm allows companies to leverage partners for much of the scientific work, increasing scientists' efficiency and reducing costs for lab space. On the IT side, outsourcing has traditionally been limited to basic support roles with scientific tasks remaining in-house. As software and data management tasks continue to evolve, maintaining the mix of development, administration, and analytical roles is proving challenging. The pool of available informatics resources is limited and, just like lab services, not all skills are needed all the time. In this talk, we explore a new model for informatics in which the entire informatics role is handled as a service. "Informatics as a Service" provides companies with access to a range of skills at a fraction of the cost of in-sourcing, allowing companies to focus on their core mission while leveraging expert resources to handle their informatics and analysis needs. Dan Weaver, Ph.D., CEO at Boulder BioConsulting Conservatory, Level Four 2:05 pm – 2:20 pm​ Drug Discovery Case Study Brent Wilson, Ph.D. + Katherine Temple, Solutions Consultants at L7 InformaticsConservatory, Level Four 2:20 pm – 2:50 pm​ Decentralized Manufacturing Operations with Unified Platforms With the rise of Industry 4.0, manufacturers are increasingly adopting digital technologies to improve efficiency, reduce costs, and enhance quality. However, managing operations across multiple sites and geographies can be challenging, particularly when using disparate systems and technologies. The presentation covers the benefits of using a unified platform for managing decentralized manufacturing operations. By centralizing data and workflows, manufacturers can streamline operations, improve collaboration, and gain greater visibility into their supply chains, leading to increased efficiency and flexibility. Steven Barash, Vice President, Strategy & Development at L7 Informatics Conservatory, Level Four 2:50 pm – 3:05 pm​ MES Case Study Steven Barash, Vice President, Strategy & Development + Brent Wilson, Ph.D., Solutions Consultant at L7 InformaticsConservatory, Level Four 3:05 pm – 3:20 pm​ Afternoon break with pastries & coffee Hallway by Conservatory, Level Four 3:20 pm – 3.40 pm​ Highlighting Challenges and Benefits of Digitalization of Cell and Gene Therapy Laboratory Workflows through Case Studies Cell and gene therapy (CGT) is the growing focus area in the field of personalized medicine. The digitalization of CGT laboratory workflows has the potential to revolutionize the way these therapies are developed and delivered to patients. This presentation highlights some of the key benefits and challenges in the digitalization of cell and gene therapy workflows using case studies. By automating and standardizing laboratory processes, digitalization can improve the reproducibility and reliability of cell and gene therapies, leading to more consistent treatment outcomes for patients. Digitalization can also enhance the efficiency of laboratory workflows, reducing the time and cost required to develop and manufacture these therapies. This efficiency can help to accelerate the development of new treatments and improve patient access to these therapies. Furthermore, digitalization can enable the integration of data from different stages of the cell and gene therapy development process, allowing researchers and clinicians to better understand the factors that influence treatment outcomes. This integrated approach can lead to the identification of new biomarkers, the development of personalized treatment regimens, and the optimization of manufacturing processes. This digitalization offers transformative benefits, but also presents significant challenges. One of the key challenges involved in developing and manufacturing these therapies is the complexity of the laboratory workflows due to the need to handle biological materials that are often fragile and require precise control of environmental conditions. Digitalization of these workflows requires the integration of multiple technologies, including robotics, data management systems, and artificial intelligence, to enable the automation and standardization of laboratory processes. Achieving this level of integration and standardization requires significant investment in infrastructure, personnel, and training. Menhaz Husain, Senior Business System Analyst at Zifo RnD Solutions Conservatory, Level Four 3:40 pm – 3:55 pm​ LIMS Case Study Brent Wilson, Ph.D. + Katherine Temple, Solutions Consultants at L7 InformaticsConservatory, Level Four 3:55 pm – 4:15 pm​ Tag.bio: An End-to-End Data Mesh Platform for Innovation The global need to securely derive (instant) insights, have motivated (centralized) data architectures from local storage, to data lakes, data warehouses, and lake-houses. In this talk we describe Tag.bio, a next-generation end-to-end (distributed) data mesh platform consisting of vital elements: domain centricity/ownership, data-as-products with embedded (AI/machine learning) algorithms, with a federated computational layer using microservices. The platform also combines a dynamic cohort builder with analysis protocols and apps (low-code) to drive complex analysis workflows. We also introduce TagGPT, an application layer within the data mesh, that uses foundational models (GPT3.5, BLOOM, LLaMA) along with data products (such as various phases of clinical trials) to build, refine and deploy fine-tune domain-centric (private) models and apps with built-in governance. Join us for a talk on Tag.bio and learn how major pharma, non-profit organizations, and health systems are using this technology to find cures for devastating diseases, precision medicine, commercial insights/decisions, clinical trials, drug discovery, and promote collaboration (without explicitly moving data around). We show how the platform can combine clinical and genomics data products (with millions of variants and thousands of clinical parameters) using smart APIs and also connect clinical trials to RWE/RWD, adverse effects (FAERS), health economics, and outcomes. Sanjay Padhi, Ph.D., Chief Technologist and Executive Vice President at Tag.bio Conservatory, Level Four 4:15 pm – 4:45 pm​ L7|INTELLIGENCE In today's complex life sciences landscape, gaining a competitive advantage and making informed decisions are paramount for success. This presentation explores the power of L7|Intelligence. Discover the key components of a robust L7|Intelligence strategy built around ESP, including data collection and integration, data warehousing and management, analytics and reporting, and more. Learn from real-life examples of successful L7|Intelligence implementation in the industry and understand the benefits of L7|Intelligence, such as informed decision-making, competitive advantage, and operational efficiency. Walk away with best practices for implementing a successful L7|Intelligence strategy and unlock new levels of growth and innovation for your organization.Richard Love, Director of Business Intelligence at L7 InformaticsConservatory, Level Four 4:45 pm – 5:00 pm​ Closing remarks Vasu Rangadass, Ph.D., President & CEO at L7 Informatics Conservatory, Level Four 5:00 pm – 7:00 pmNetworking Reception with appetizers and cocktails Williams Room, Main Lobby L7|LIVE — digital transformation for life science leaders explore opportunities L7's clients + partners the latest about L7 Informatics we're hiring ### L7|ESP® for the Pharma Industry L7|ESP® for the Pharma IndustryReducing the Cost and Time-to-Market of Pharmaceuticalsreducing the cost and time to market of pharmaceuticals For pharma companies that are involved in small molecule, biologics, cell & gene, and other advanced therapies, L7|ESP provides an integrated data and process platform, which enables bringing drugs to market faster and reducing operational costs.a unified approach to data, process, and collaboration Pharmaceutical companies today are developing a diverse range of therapies to address complex and widespread medical conditions, from traditional small-molecule drugs to cutting-edge cell and gene therapies. While these modalities differ in their scientific approaches, teams face the same common challenges: fragmented systems, inconsistent data, and time-consuming manual tasks that slow progress and inflate costs. L7|ESP replaces disconnected tools and ad hoc workflows with a unified platform that supports the full product lifecycle. With centralized, real-time access to critical information and built-in tools for standardization and collaboration, L7|ESP helps streamline decision-making, reduce manual effort, and shorten development timelines, regardless of therapy type.a unified approach to data, process, and collaborationPharmaceutical companies today are developing a diverse range of therapies to address complex and widespread medical conditions, from traditional small-molecule drugs to cutting-edge cell and gene therapies. While these modalities differ in their scientific approaches, teams face the same common challenges: fragmented systems, inconsistent data, and time-consuming manual tasks that slow progress and inflate costs.L7|ESP replaces disconnected tools and ad hoc workflows with a unified platform that supports the full product lifecycle. With centralized, real-time access to critical information and built-in tools for standardization and collaboration, L7|ESP helps streamline decision-making, reduce manual effort, and shorten development timelines, regardless of therapy type.small molecule medicineThe pharmaceutical industry is constantly striving to discover new treatments for a wide range of diseases and medical conditions. One area of particular focus is the development of small molecule drugs, which are chemical compounds designed to interact with specific targets in the body to produce therapeutic effects. Small molecule drugs are used to treat a wide range of conditions, from common ailments like headaches and allergies to more serious conditions such as cancer and autoimmune diseases. L7|ESP's unified platform is well-suited for the pharmaceutical industry's research and development of small molecule drugs. With its integrated data management system, L7|ESP allows for streamlined processing of data, enabling researchers to focus on analyzing the results rather than spending hours searching for data. L7|ESP also enables greater collaboration among researchers through its cloud-based architecture. By allowing researchers to access data and collaborate in real-time, L7|ESP facilitates quicker decision-making and ultimately, faster drug discovery and development. supporting case studyConnect with the L7 Team to find out more about the work we did with Roche. advanced therapiesThe pharmaceutical industry is at the forefront of developing novel treatments for a variety of complex diseases and medical conditions. In recent years, there has been increasing interest in developing advanced therapeutics such as cell and gene therapies, which offer the potential for more targeted and personalized treatments. Advanced therapeutics require complex data management and analysis, from preclinical research to clinical trials, in order to bring new treatments to market. L7|ESP's platform is designed to support the development of advanced therapeutics, such as cell and gene therapies. The platform's robust data management and analytics capabilities make it easier to manage the complex data associated with these novel therapies, from preclinical research to clinical trials. L7|ESP also provides automated workflows and data pipelines, which can be customized to meet the specific needs of each individual study. By automating these processes, researchers can save valuable time and focus on more complex analyses and experimental designs. supporting case studyConnect with the L7 Team to find out more about the work we did with BMS. diagnosticsThe pharmaceutical industry has long been dedicated to improving patient outcomes by developing new therapies and treatments for a wide range of diseases and medical conditions. However, as medical research has advanced, there has been an increasing focus on the development of accurate and effective diagnostic tools. Diagnostics play a critical role in disease prevention, identification, and treatment, and can help healthcare professionals make more informed decisions about patient care. L7|ESP also has a number of features that are particularly beneficial for the development of diagnostic tools. The platform's data management system allows for easy integration of diverse data types, including genomics, proteomics, and imaging data. This enables researchers to conduct more comprehensive analyses and develop more accurate diagnostic tests. In addition, L7|ESP's machine learning capabilities can be leveraged to identify biomarkers and develop predictive models. This can help researchers to identify patients at risk for certain diseases, as well as develop more effective and personalized treatment plans. supporting case studyConnect with the L7 Team to find out more about the work we did with a Top 10 big pharma company.L7|ESP packages for pharmaL7|ESP FOR PHARMA research Capabilities to support the data models and scientific experimentation to identify new compounds and molecules.INCLUDED IN PACKAGE L7|ESP PLATFORM (including L7|HUB + L7|MASTER + L7|INTELLIGENCE) L7 LIMS AGENT L7 NOTEBOOKS AGENT STANDARD DATA PRODUCT L7|ESP FOR PHARMA process development Capabilities to support the development of processes/recipes to make drugs.INCLUDED IN PACKAGE L7|ESP PLATFORM L7 LIMS AGENT L7 NOTEBOOKS AGENT PROCESS DEVELOPMENT DATA PRODUCT L7|ESP FOR PHARMA analytical development Capabilities to support the development of methods to test drugs.INCLUDED IN PACKAGE L7|ESP PLATFORM L7 LIMS AGENT L7 NOTEBOOKS AGENT ANALYTICAL DEVELOPMENT DATA PRODUCT L7|ESP FOR PHARMA clinical testing Sample management, bio-repository management and testing of clinical sample for patient trial recruitmentINCLUDED IN PACKAGE L7|ESP PLATFORM L7 LIMS AGENT STANDARD DATA PRODUCT​ L7|ESP FOR PHARMA clinical manufacturing Capabilities to support the manufacturing of drug products (end-product) and drug substances (intermediate product).INCLUDED IN PACKAGE L7|ESP PLATFORM L7 MES AGENT MANUFACTURING DATA PRODUCT L7|ESP FOR PHARMA quality control Capabilities to support the testing of drugs using analytical testing methods, including EM and stability testing.INCLUDED IN PACKAGE L7|ESP PLATFORM L7 LIMS AGENT QUALITY DATA PRODUCT L7|ESP FOR PHARMA research Capabilities to support the data models and scientific experimentation to identify new compounds and molecules.INCLUDED IN PACKAGE L7|ESP (+ L7|HUB, L7|MASTER, L7|INTELLIGENCE) L7 LIMS L7 NOTEBOOKS STANDARD DATA PRODUCT L7|ESP FOR PHARMA process development Capabilities to support the development of processes/recipes to make drugs.INCLUDED IN PACKAGE L7|ESP (+ L7|HUB, L7|MASTER, L7|INTELLIGENCE) L7 LIMS L7 NOTEBOOKS PROCESS DEVELOPMENT DATA PRODUCT L7|ESP FOR PHARMA analytical development Capabilities to support the development of methods to test drugs.INCLUDED IN PACKAGE L7|ESP (+ L7|HUB, L7|MASTER, L7|INTELLIGENCE) L7 LIMS L7 NOTEBOOKS ANALYTICAL DEVELOPMENT DATA PRODUCT L7|ESP FOR PHARMA clinical testing Sample management, bio-repository management and testing of clinical sample for patient trial recruitment.INCLUDED IN PACKAGE L7|ESP (+ L7|HUB, L7|MASTER, L7|INTELLIGENCE) L7 LIMS STANDARD DATA PRODUCT​ L7|ESP FOR PHARMA clinical manufacturing Capability to transfer-in or transfer-out recipes and methods to make and test drugs – into MSAT, TechOps, or development. INCLUDED IN PACKAGE L7|ESP (+ L7|HUB, L7|MASTER, L7|INTELLIGENCE) L7 MES L7 LIMS STANDARD DATA PRODUCT L7|ESP FOR PHARMA commercial manufacturing Capabilities to support the manufacturing of drug products (end-product) and drug substances (intermediate product).INCLUDED IN PACKAGE L7|ESP (+ L7|HUB, L7|MASTER, L7|INTELLIGENCE) L7 MES MANUFACTURING DATA PRODUCT L7|ESP FOR PHARMA quality control Capabilities to support the testing of drugs using analytical testing methods, including EM and stability testing.INCLUDED IN PACKAGE L7|ESP (+ L7|HUB, L7|MASTER, L7|INTELLIGENCE) L7 LIMS QUALITY DATA PRODUCT ready to take your data to the next level?resourcesDive deeper into the capabilities that power the L7|ESP platform and discover what’s possible with data orchestration built for life sciences.L7|ESP explainer videoL7|ESP brochure L7|HUB datasheetL7|INTELLIGENCE datasheetL7|MASTER datasheetL7 Notebooks app datasheetL7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet additional resourcesL7 Precision Research eBookL7 Precision Therapeutics eBookL7 Precision Diagnostics eBookL7 MES App DatasheetL7's clients + partnersthe latest about L7 Informatics ### L7|ESP® for the Biotech Industry L7|ESP® for the Biotech Industryovercoming common biotech challenges The biotech industry, despite its innovative advancements, faces significant operational hurdles. Fragmented data management systems create silos, making data integration and analysis cumbersome and error-prone. High costs associated with adopting advanced technologies like AI and gene editing strain financial resources, particularly for emerging companies. Additionally, navigating complex regulatory landscapes to ensure data security and compliance adds to the operational burden. These challenges not only limit efficiency but also stifle innovation. L7|ESP is designed to address these pain points, providing a unified digital platform that streamlines data integration, enhances compliance, and supports advanced analytics, empowering biotech companies to unlock their full potential.empowering scientific breakthroughs For Biotech organizations involved in developing Advanced Therapeutics, L7|ESP enables accelerated drug discovery, development, and manufacturing processes. By leveraging advanced data analytics, automation, and regulatory expertise, L7|ESP drives innovation, efficiency, and compliance, ultimately helping Biotech organizations bring life-changing therapies to market faster. challenging the status quo Relying on fragmented point solutions is stifling your biotech company's potential. It's time to rethink your technology strategy with a unified digital platform. Fragmented systems lead to inefficiencies, increased costs, and regulatory challenges, holding back your biotech innovations. The solution isn't just another tool but a transformative shift to an integrated, scalable platform. L7|ESP challenges the status quo, offering a cohesive approach that empowers you to streamline operations, enhance data integrity, and accelerate breakthroughs. It's not just about keeping up; it's about leading the way in biotech innovation.L7|ESP is the integrated solution for biotech excellence L7|ESP is a comprehensive digital platform designed to revolutionize biotech operations by seamlessly integrating data across all aspects of your organization. Unlike fragmented point solutions, L7|ESP provides a unified approach, addressing the key challenges faced by biotech companies today. What L7|ESP Offers: Unified Data Management: Break down data silos with a single platform that consolidates data from research, development, and clinical trials, ensuring seamless integration and accessibility. Scalability and Flexibility: L7|ESP grows with your organization, providing scalable solutions that adapt to your evolving needs, from small labs to large-scale operations. Enhanced Compliance: Built-in compliance features help you navigate regulatory landscapes with ease, ensuring data security and adherence to standards such as GDPR and HIPAA. Advanced Analytics and AI: Leverage powerful analytics and AI tools to derive actionable insights from your data, accelerating innovation and improving decision-making processes. Cost Efficiency: Optimize your technology investments with a platform that reduces the need for multiple point solutions, lowering overall IT costs and enhancing operational efficiency. L7|ESP isn't just another tool; it's a transformative solution designed to empower biotech companies to overcome their most pressing challenges and unlock their full potential.use case: advanced therapeuticsThe biotech industry is dedicated to developing innovative solutions to address complex medical challenges. In recent years, there has been a growing interest in developing advanced therapeutics such as cell and gene therapies, which offer the potential for more targeted and personalized treatments. Advanced therapeutics are highly complex and require a diverse range of data types to be managed and analyzed, from preclinical research to clinical trials and beyond.L7|ESP's unified platform provides a comprehensive solution for managing and analyzing the diverse data types associated with advanced therapeutics research and development. Here are a few ways that L7|ESP can help biotech organizations in this area:Streamlined Data Management L7|ESP's integrated data management system allows researchers to easily access, process, and analyze data from a wide range of sources, helping to streamline the research and development process. This can help biotech companies to bring new advanced therapeutics to market more quickly and efficiently.Collaboration and Communication Advanced therapeutics research often involves interdisciplinary teams working together to solve complex problems. L7|ESP's cloud-based architecture provides a centralized platform for data sharing and collaboration, enabling researchers to work together in real-time from anywhere in the world. This can help to facilitate communication and collaboration among team members, ultimately leading to more effective research outcomes.Advanced Analytics L7|ESP's advanced analytics capabilities allow researchers to analyze complex data sets quickly and accurately, helping to identify patterns and relationships that might otherwise be difficult to detect. This can help biotech companies to make more informed decisions about which advanced therapeutics to pursue and how to optimize their development and testing processes.L7|ESP's unified platform provides a powerful solution for managing and analyzing the complex data associated with advanced therapeutics research and development. With its streamlined data management, collaborative capabilities, and advanced analytics, L7|ESP can help biotech organizations accelerate the discovery and development of innovative advanced therapeutics.supporting case study Connect with the L7 Team to find out more about the work we did with Triumvira. resourcesDive deeper and see how L7|ESP can transform your operations:L7|ESP brochure L7|ESP explainer videoL7 Notebooks app datasheetL7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet resourcesDive deeper into the capabilities that power the L7|ESP platform and discover what’s possible with data orchestration built for life sciences.L7|ESP explainer videoL7|ESP brochure L7|HUB datasheetL7|INTELLIGENCE datasheetL7|MASTER datasheetL7 Notebooks app datasheetL7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet ready to take your data to the next level?L7's clients + partners the latest about L7 Informatics ### L7|ESP® for the Diagnostics Industry L7|ESP® for the Diagnostics Industrystreamlining workflows + improving accuracy For Diagnostics companies involved in assay development and commercialization of molecular diagnostics and companion diagnostics, L7|ESP provides a complete platform for the design and execution of complex assays from sample ingest to clinical report generation. L7|ESP supports integration to instruments and lab automation equipment. molecular diagnostics Molecular diagnostics is a rapidly evolving field that plays a crucial role in disease detection, monitoring, and personalized medicine. L7|ESP, with its powerful data management and analytics capabilities, offers valuable support to molecular diagnostics companies. Whether it's genetic testing, infectious disease screening, or precision medicine, L7|ESP enables streamlined data integration, analysis, and interpretation. With L7|ESP, molecular diagnostics companies can efficiently manage and analyze diverse data types, including genomics, proteomics, and clinical data. The platform's centralized data management system allows for seamless integration of data from multiple sources, facilitating comprehensive analysis and interpretation. This empowers researchers and healthcare professionals to make informed decisions based on accurate and reliable molecular diagnostic insights. Additionally, L7|ESP's advanced analytics tools and machine learning capabilities enable the identification of patterns, biomarkers, and predictive models. This helps improve the accuracy and efficiency of molecular diagnostics, leading to earlier disease detection, more precise treatment selection, and better patient outcomes. L7|ESP's customizable workflows and automated pipelines also streamline the diagnostic process, allowing for increased throughput and reduced turnaround time. supporting case study Connect with the L7 Team to find out more about the work we did with Quest Diagnostics. companion diagnostics Companion diagnostics are transforming the way healthcare professionals approach treatment decisions by tailoring therapies to individual patients. L7|ESP offers robust capabilities to support companion diagnostics development and implementation. By integrating clinical, genomic, and patient data, L7|ESP enables the identification of specific biomarkers and their association with therapeutic responses. L7|ESP's unified platform provides a comprehensive solution for managing and analyzing the complex data involved in companion diagnostics. By combining clinical data with genomic information, researchers and clinicians can gain insights into patient populations, identify subgroups that may respond differently to treatments, and develop targeted companion diagnostic tests. Moreover, L7|ESP's machine learning algorithms can be leveraged to develop predictive models that assist in patient stratification and treatment decision-making. This empowers healthcare professionals to select the most appropriate therapies for patients, maximizing the chances of successful treatment outcomes while minimizing potential adverse effects. L7|ESP's unified platform is a powerful tool for molecular diagnostics and companion diagnostics companies. Its data management, analytics, and machine learning capabilities enable efficient integration and analysis of diverse data types, driving advancements in disease detection, personalized medicine, and companion diagnostic development. With L7|ESP, molecular diagnostics and companion diagnostics companies can accelerate their research, improve patient care, and contribute to advancements in the field of diagnostics. supporting case study Connect with the L7 Team to find out more about the work we did with QIAGEN. resourcesDive deeper into the capabilities that power the L7|ESP platform and discover what’s possible with data orchestration built for life sciences.L7|ESP explainer videoL7|ESP brochure L7|HUB datasheetL7|INTELLIGENCE datasheetL7|MASTER datasheetL7 Notebooks app datasheetL7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet L7's clients + partners the latest about L7 Informatics ### L7|ESP® for Academic Research + NCI Designated Cancer Centers L7|ESP® for Academic Research + NCI-Designated Cancer Centersimproving patient outcomes For Academic Research and NCI Designated Cancer Centers involved in Research and Advanced Therapeutics, L7|ESP enables these organizations to focus on the clinical pathways and treatment protocols while automating and streamlining all the workflows and data capture across the clinical pathway in a regulatory-compliant platform (CAP/CLIA/cGMP/21 CFR part11 and HIPAA). L7|ESP integrates with scientific instruments, medical devices, imaging systems, EMR, ERP, lab informatics, and digital pathology systems to provide end-to-end tracking of patient treatment with complete audit and decision support capabilities.overcoming core challenges NCI-designated cancer centers and academic research are often burdened with data management challenges, including fragmented systems, limited interoperability, and scalability issues. These obstacles hinder research progress, complicate clinical workflows, and delay effective patient care. To remain at the forefront of personalized cancer research and treatment, it is crucial to adopt solutions that streamline data integration, enhance collaboration, and ensure robust data analytics. According to the NIH, effective data sharing and management are essential for accelerating cancer treatment advancements and achieving better patient outcomes. Traditional data management systems are no longer adequate—they have become liabilities. L7|ESP is designed to address these critical issues, providing a unified platform that streamlines data integration, enhances collaboration, and delivers robust analytics capabilities​.L7|ESP is the transformative platformEnhanced RESEARCH AND ACCELERATED DEVELOPMENT L7|ESP revolutionizes research and development at cancer centers by providing a robust platform for seamless data integration and real-time analysis. Researchers can access and analyze diverse datasets, including genomic, proteomic, and clinical data, fostering a comprehensive understanding of cancer biology. This integration supports collaborative research efforts, accelerates the discovery of new biomarkers, and streamlines clinical trials. By leveraging advanced analytics and machine learning tools, L7|ESP transforms raw data into actionable insights, enabling researchers to identify patterns, predict outcomes, and develop innovative therapies more efficiently. The platform's ability to manage complex data workflows ensures that research findings can be swiftly translated into clinical applications, accelerating the development of new treatments and improving patient outcomes. This holistic approach not only drives scientific breakthroughs but also enhances the overall efficiency and effectiveness of cancer research and development efforts.STREAMLINED SUPPLY CHAIN MANAGEMENT L7|ESP is a comprehensive solution for managing the entire supply chain, ensuring the smooth operation of both clinical and logistical processes. The platform efficiently manages incoming goods and raw materials, including receiving and tracking patient samples, blood samples, drug products, and inventory. L7|ESP provides real-time visibility into inventory levels, delivery schedules, and storage conditions, ensuring that all materials are handled appropriately and securely. The platform excels in managing outgoing products as well. L7|ESP ensures a clear chain of custody and chain of identity throughout the entire process so all materials and products can be traced back to their origins, maintaining integrity and compliance with regulatory standards. Additionally, L7|ESP supports clinical operations by streamlining the management of patient logistics, from sample collection to treatment delivery, enhancing the efficiency and reliability of clinical workflows. OPTIMIZED MANUFACTURING AND RIGOROUS QC L7|ESP significantly enhances the manufacturing and quality control processes at cancer centers by integrating data from various stages of production. This ensures that all data is accurately captured and accessible, facilitating better decision-making and process optimization. The platform supports the manufacturing of complex cellular therapies by providing real-time insights into production metrics, enabling timely interventions, and ensuring that products meet stringent regulatory standards. Additionally, L7|ESP’s robust quality control features monitor and manage the entire production process, ensuring that each batch adheres to the highest quality standards. By eliminating manual data entry and reducing the risk of errors, L7|ESP helps maintain high-quality standards, increases production efficiency, and ensures compliance with regulatory requirements.REGULATORY Compliance Compliance with regulatory standards is a critical concern for cancer centers and academic research institutions. L7|ESP addresses this challenge by offering robust compliance management features that ensure adherence to regulatory requirements. The platform provides comprehensive audit trails, real-time monitoring, and documentation capabilities that facilitate compliance with guidelines from agencies such as the FDA and NIH. By automating compliance processes and providing detailed reports, L7|ESP reduces the burden on staff and minimizes the risk of non-compliance. This focus on regulatory compliance ensures that cancer centers can conduct their research and clinical activities with confidence and integrity.empowering Academic Research + NCI-Designated Cancer Centers with L7|ESPL7|ESP empowers academic research and cancer centers to transform their data management practices, ensuring that they are not only data-rich but also information-efficient. Our platform provides a seamless integration of disparate systems, allowing for real-time data contextualization and workflow orchestration. By leveraging L7|ESP, they can eliminate data silos, reduce reliance on cumbersome paper records, and enhance their overall operational efficiency. Our solution supports regulatory compliance and offers advanced analytics to accelerate research and improve patient outcomes. L7|ESP stands out as the ideal choice for cancer centers looking to revolutionize their data management and research capabilities.Streamlining Data Integration​​Fragmented data systems create significant barriers to effective research, development, and manufacturing. L7|ESP resolves these issues by providing a comprehensive platform that unifies disparate data sources. This integration ensures that all relevant data—be it clinical, genomic, proteomic, or imaging—is easily accessible and interoperable across various departments and teams. By enabling real-time data updates and reducing errors associated with manual data handling, L7|ESP transforms fragmented data into a cohesive, reliable resource. Enhancing CollaborationEffective collaboration is essential for advancing cancer research and improving treatment outcomes. L7|ESP fosters a collaborative environment by providing a centralized platform where researchers, clinicians, and administrators can access and share data seamlessly. This unified approach breaks down silos, enabling teams to work together more efficiently on research projects, clinical trials, and patient care initiatives. L7|ESP's user-friendly interface makes it easy for users to collaborate, ensuring that all team members have the information they need to make informed decisions. Delivering Robust Analytics CapabilitiesThe ability to derive actionable insights from data is a critical component of modern cancer research and treatment. L7|ESP's advanced analytics capabilities empower cancer centers to analyze large, complex datasets, identify patterns, and predict outcomes. The platform leverages machine learning and artificial intelligence to transform raw data into meaningful insights. These robust analytics tools enable researchers and clinicians to develop more effective treatment plans, accelerate the discovery of new therapies, and improve patient outcomes. use case: researchResearch is a cornerstone of the healthcare industry, driving advancements in medical knowledge and patient care. L7|ESP offers comprehensive support to cancer centers and research institutions, providing a unified platform for efficient data management, analysis, and collaboration. From conducting clinical trials to studying disease patterns and exploring innovative treatment approaches, L7|ESP streamlines the research process and empowers institutions to accelerate discoveries.With L7|ESP, academic research + NCI-designated cancer centers can seamlessly integrate and organize diverse datasets from various sources, including genomics, proteomics, and clinical information. The platform's advanced analytics tools enable researchers to uncover meaningful insights, identify correlations, and discover potential biomarkers. By facilitating collaboration and data sharing among multidisciplinary research teams, L7|ESP drives collaborative breakthroughs and enhances the translation of research findings into clinical practice.L7|ESP empowers cancer centers and research institutions in their pursuit of groundbreaking discoveries. By offering a unified platform for data management, analysis, and collaboration, L7|ESP streamlines research processes and accelerates the translation of findings into clinical practice. With L7|ESP's advanced analytics tools and seamless data integration, health systems can drive interdisciplinary collaboration, uncover meaningful insights, and make significant contributions to advancing medical knowledge and improving patient care.supporting case studiesConnect with the L7 Team to find out more about the work we did with WashU, GEIC, and GTAC.supporting case studiesConnect with the L7 Team to find out more about the work we did with The Jackson Laboratory and WashU.diagnosticsDiagnostics play a crucial role in healthcare systems, enabling accurate disease detection, monitoring, and treatment decisions. L7|ESP supports health systems and diagnostic centers in optimizing diagnostic processes through efficient data management and analysis. By seamlessly integrating and analyzing data from various diagnostic modalities, L7|ESP enhances diagnostic accuracy and improves patient outcomes. L7|ESP's centralized data management system enables health systems to efficiently access and interpret diverse diagnostic data, including medical imaging, laboratory results, and patient information. The platform's advanced analytics capabilities facilitate precise disease classification, early detection, and personalized treatment selection. Additionally, L7|ESP's collaborative features streamline communication among healthcare professionals, fostering interdisciplinary collaboration and ensuring comprehensive patient care. L7|ESP enhances the capabilities of health systems and diagnostic centers, enabling accurate and efficient diagnostic practices. Through its comprehensive data management and analytics features, L7|ESP optimizes the integration and interpretation of diverse diagnostic data, improving diagnostic accuracy and patient outcomes. With L7|ESP's collaborative tools, healthcare professionals can seamlessly communicate, ensuring comprehensive patient care and fostering interdisciplinary collaboration in the pursuit of accurate diagnoses and effective treatment decisions. use case: advanced therapeuticsAcademic research + NCI-designated cancer centers play a pivotal role in the development and delivery of advanced therapeutics, revolutionizing patient treatment options. L7|ESP supports them in this field by providing robust data management and analysis capabilities. From cell and gene therapies to immunotherapies, L7|ESP facilitates the complex data handling and processing required for advanced therapeutic research and implementation.By integrating and analyzing diverse data types, such as genomics, patient outcomes, and treatment responses, L7|ESP empowers cancer centers and research institutions to identify biomarkers, predict treatment efficacy, and optimize therapeutic approaches. The platform's customizable workflows and automated pipelines enhance the efficiency of advanced therapeutic development and manufacturing, enabling health systems to accelerate the translation of research into clinical applications.L7|ESP empowers academic research + NCI-designated cancer centers to drive innovation and advancements in advanced therapeutics. By providing robust data management and analysis capabilities, L7|ESP enables health systems to integrate diverse datasets, identify biomarkers, and optimize therapeutic approaches. With L7|ESP's customizable workflows and automated pipelines, health systems can streamline the development and manufacturing of advanced therapeutics, accelerating the translation of research into clinical applications. L7|ESP plays a pivotal role in the progress of health systems, empowering them to deliver cutting-edge therapies and improve patient outcomes.supporting case studiesConnect with the L7 Team to find out more about the work we did with Dana Farber Cancer Institute.resourcesDive deeper into the capabilities that power the L7|ESP platform and discover what’s possible with data orchestration built for life sciences.L7|ESP brochure L7|HUB datasheetL7|INTELLIGENCE datasheetL7|MASTER datasheetDana-Farber at L7 LIVE Boston: DFCI Connell and O’Reilly Families CMCF webinarDana-Farber at L7 UNIVERSE: Implementation of L7 LIMS for a GMP Cellular Therapy Manufacturing Facility webinarL7 Notebooks app datasheetL7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet ready to take your data to the next level?L7's clients + partners the latest about L7 Informatics ### L7|ESP® for CDMOs L7|ESP® for CDMOsoptimizing operational efficiency + enhancing productivity For CDMOs involved in the development and manufacturing of biologics and advanced therapies, L7|ESP provides a platform for enabling “Digital Tech-Transfer”, PD, AD, Manufacturing, and Quality Control, all on a single FAIR Data + Process Platform. navigating CDMO core challenges In the dynamic world of pharmaceuticals, CDMOs play a crucial role. Yet, as the demand for rapid technology transfers and increased manufacturing capacity intensifies, CDMOs are under increasing pressure to deliver novel products swiftly and efficiently. Understanding and overcoming these challenges is not just about survival—it's about thriving in a competitive market.Designed to work with existing legacy systems, L7|ESP enhances data contextualization and consolidation under a unified platform, minimizing the need for multiple redundant systems. This innovative platform not only paves the way for future advancements but also significantly cuts legacy maintenance costs.By optimizing scientific data and process management across the entire product life cycle—from research to manufacturing—L7|ESP ensures more efficient operations, heightened transparency, and superior performance, ultimately accelerating quality and speed in process execution and fostering robust, organization-wide collaboration and visibility.Seamless CollaborationL7|ESP facilitates unmatched collaboration across all stages of drug development and manufacturing. By enabling digital integration, the platform ensures that all team members, regardless of physical location, can collaborate efficiently, share insights instantly, and make informed decisions quickly. This interconnectedness is crucial for maintaining the pace required to meet client demands and regulatory standards.Data ExchangeWith its robust data management capabilities, L7|ESP ensures a seamless and secure exchange of critical information across different phases of the product lifecycle. The platform's ability to manage and synchronize data not only streamlines workflows but also protects data integrity, enhancing the reliability of every output. This comprehensive data exchange supports CDMOs in achieving faster technology transfers and more effective scale-up processes.Visibility SolutionsL7|ESP provides comprehensive visibility across the entire product lifecycle, from initial development to final manufacturing. This visibility is critical to maintaining control over the complex processes and compliance requirements inherent in CDMO operations. By centralizing and contextualizing data, L7|ESP delivers detailed insights and traceability, empowering CDMOs to anticipate issues, optimize resources, and maintain continuous improvement in their operational practices.empowering CDMOs with L7|ESP Tailored for CDMOs, our unified platform, L7|ESP, centralizes all critical functions from development to manufacturing, production, and shipping, ensuring seamless integration and consistent data management. It harnesses the power of real-time analytics to deliver actionable insights, enabling faster and more informed decision-making that optimizes both production and quality. With automated compliance tools, L7|ESP simplifies adherence to complex regulatory standards, ensuring each product meets stringent quality requirements. Adaptable to varying project demands and scalable to accommodate growth, L7|ESP enhances efficiency and ensures high-quality outcomes, making it an essential tool in driving operational excellence and facilitating market readiness.the transformative benefits of L7|ESP for CDMOsL7|ESP stands as a catalyst for efficiency and quality in the complex environment of CDMOs. By integrating advanced technology, such as Industrial Internet of Things (IIoT), cloud connectivity, AI, and machine learning, and its data and process orchestration capabilities, L7|ESP delivers substantial benefits tailored to the needs of CDMOs:Enhanced Operational Efficiency L7|ESP optimizes the entire manufacturing process, from initial development stages to final production and shipping. Its streamlined workflows minimize manual interventions and reduce the likelihood of human error, accelerating production timelines and reducing operational costs. With L7|ESP, CDMOs can achieve higher throughput without compromising quality, making each project more profitable and time-efficient.Scalability for Future Growth As CDMOs grow and take on more complex projects, the ability to scale operations effectively becomes essential. L7|ESP is designed to scale seamlessly with your operations, accommodating increased production demands without the need for proportional increases in overhead or resources. This scalability ensures that CDMOs can expand their client base and handle larger contracts efficiently.Consistency and Quality Assurance At the heart of L7|ESP's capabilities is its ability to maintain stringent quality controls across all stages of manufacturing. The platform ensures consistent adherence to product specifications and regulatory standards, critical for CDMOs aiming to build trust with their clients. By automating quality checks and integrating real-time monitoring, L7|ESP provides a robust framework for ensuring product integrity and compliance.Data-Driven Decision Making With the integration of real-time analytics, L7|ESP turns data into one of your most valuable assets. The platform's analytics capabilities allow CDMOs to anticipate challenges, optimize resource allocation, and improve overall decision-making. This proactive approach reduces downtime and enhances the ability to respond swiftly to market demands.what customers are sayingresourcesDive deeper and see how L7|ESP can transform your operations:L7|ESP brochure CONTRACT PHARMA articleL7|ESP explainer videoL7 Notebooks app datasheetL7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet resourcesDive deeper into the capabilities that power the L7|ESP platform and discover what’s possible with data orchestration built for life sciences.L7|ESP explainer videoL7|ESP brochure L7|HUB datasheetL7|INTELLIGENCE datasheetL7|MASTER datasheetCellipont Bioservices Case StudyCONTRACT PHARMA articleL7|ESP explainer videoL7 Notebooks app datasheetL7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet small and large molecule medicine Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in the biotech industry, providing specialized services to support the development and manufacturing of small and large molecule medicines. CDMOs offer a range of services, including drug discovery, process development, analytical testing, and manufacturing. They help pharmaceutical and biotech companies to bring new drugs to market faster and more efficiently by providing specialized expertise and resources.Despite the many benefits of outsourcing to CDMOs, there are also challenges that can arise in the process. One of the biggest challenges is maintaining quality and consistency throughout the manufacturing process, particularly as the scale of manufacturing increases. CDMOs must ensure that the manufacturing process is reproducible and consistent, while also being efficient and cost-effective. With L7 Informatics' unified platform, L7|ESP, CDMOs can overcome this challenge by leveraging its robust data management and analytics capabilities. L7|ESP provides a centralized system for managing and analyzing manufacturing data, ensuring that processes are reproducible and consistent. By integrating data from various sources, including process parameters, quality control results, and equipment data, L7|ESP enables CDMOs to identify and address any deviations or anomalies in real-time, ensuring that quality standards are met throughout the manufacturing process.In addition, L7|ESP helps CDMOs in managing risk by providing comprehensive visibility and traceability across the product lifecycle. The platform's advanced tracking and audit trail features allow CDMOs to monitor and document every step of the manufacturing process, ensuring compliance with regulatory requirements. L7|ESP also enables proactive risk management through its data analytics capabilities, allowing CDMOs to identify potential risks and implement mitigation strategies in a timely manner.Furthermore, L7|ESP's flexibility and adaptability assist CDMOs in responding to changing market conditions and customer needs. The platform's customizable workflows and automation capabilities enable CDMOs to optimize and refine their manufacturing processes, enhancing efficiency and reducing costs. L7|ESP also supports seamless collaboration and communication between CDMOs and their clients, facilitating efficient tech-transfer and ensuring alignment throughout the product lifecycle.L7 Informatics' unified platform, L7|ESP, empowers CDMOs by providing an integrated and efficient system for data management, analytics, risk management, and collaboration. By leveraging L7|ESP, CDMOs can streamline their operations, ensure high-quality manufacturing, mitigate risks, and adapt to dynamic market demands, ultimately enabling them to deliver superior services and drive success in the biotech and pharmaceutical industries.supporting case studiesConnect with the L7 Team to find out more about the work we did with Cellares and Vernal Biosciences. ready to take your manufacturing processes to the next level?L7's clients + partners the latest about L7 Informatics ### L7|ESP® for Bio-Medical Research Institutions L7|ESP® for Bio-Medical Research Institutionsaccelerating scientific advancements For Bio-Medical Research Institutions involved in Research, L7|ESP enables research through seamless digitalization, enhanced collaboration, and accelerated discovery. With an integrated, science-agnostic platform, L7|ESP consolidates scientific knowledge, processes, and data in a single, comprehensive platform, resulting in streamlined workflows and expedited research outcomes. By automating critical tasks such as sample and bio-repository management, lab data collection and analysis, and instrument integration, L7|ESP ensures efficient operations and improved data-driven insights. research At Bio-Medical Research Institutions, groundbreaking discoveries and advancements in biomedical research are the driving forces behind improving human health. L7|ESP offers comprehensive support to these institutions, providing a unified platform that enhances data management, analysis, and collaboration. By leveraging L7|ESP's powerful capabilities, researchers can accelerate their research and contribute to significant breakthroughs in the field of biomedical science. L7|ESP serves as a central hub for efficient data management, allowing researchers to seamlessly integrate and analyze diverse datasets from various sources. From genomics and proteomics to clinical and experimental data, L7|ESP's unified platform streamlines the organization and accessibility of complex research data. With advanced analytics tools, researchers can uncover patterns, identify biomarkers, and gain valuable insights to advance their scientific understanding. L7|ESP also facilitates seamless collaboration among researchers, enabling interdisciplinary efforts and knowledge sharing. The platform's collaborative features allow researchers to securely share data, communicate findings, and work together on complex research projects. This collaborative environment fosters synergistic interactions and accelerates the pace of discovery. L7|ESP empowers Bio-Medical Research Institutions to push the boundaries of biomedical research. Researchers can leverage L7|ESP's capabilities to accelerate their scientific breakthroughs and contribute to advancements in understanding human health and disease. L7|ESP plays a crucial role in fueling the progress of Bio-Medical Research Institutions and propelling biomedical science forward. supporting case study Connect with the L7 Team to find out more about the work we did with JAX. resourcesDive deeper into the capabilities that power the L7|ESP platform and discover what’s possible with data orchestration built for life sciences.L7|ESP explainer videoL7|ESP brochure L7|HUB datasheetL7|INTELLIGENCE datasheetL7|MASTER datasheetL7 Notebooks app datasheetL7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet L7's clients + partners the latest about L7 Informatics ### L7|ESP® for CROs L7|ESP® for CROenabling faster clinical trial timelines For Contract Research Organizations involved in Clinical Trials, L7|ESP provides a comprehensive, integrated platform that digitalizes, automates, and fosters collaboration. With features including sample and bio-repository management, lab data collection and analysis, data visualization, and seamless instrument integration, L7|ESP streamlines workflows while offering a range of ready-to-use applications such as Notebooks, LIMS, Inventory Management, and Dashboards.clinical trialsClinical trials serve as vital stepping stones in advancing medical treatments and therapies, and Contract Research Organizations (CROs) play a crucial role in their execution. L7|ESP offers comprehensive support to CROs by providing a unified platform that streamlines data management, analysis, and collaboration throughout the clinical trial process. By leveraging the powerful capabilities of L7|ESP, CROs can enhance operational efficiency, accelerate trial timelines, and improve overall trial success rates.With L7|ESP as the backbone of clinical trial data management, CROs can seamlessly integrate and organize diverse trial data, including patient records, electronic case report forms (eCRFs), laboratory results, and imaging data. The platform's advanced analytics tools enable real-time insights into trial data, facilitating the identification of trends and potential safety or efficacy signals. L7|ESP's intuitive user interface and customizable workflows ensure efficient monitoring and management of clinical trial data, adhering to regulatory requirements and industry standards. L7|ESP also fosters seamless communication and collaboration among trial stakeholders. CROs can securely share trial data with sponsors, investigators, and regulatory authorities, facilitating efficient data review, monitoring, and reporting. L7|ESP's collaboration features enable effective communication and collaboration, enabling timely decision-making and enhancing the overall quality of clinical trial execution.L7|ESP empowers CROs to optimize their clinical trial operations and deliver high-quality results. By providing a unified platform for data management, analysis, and collaboration, L7|ESP enhances the efficiency and effectiveness of clinical trials. CROs can leverage L7|ESP's capabilities to streamline trial workflows, gain valuable insights from trial data, and foster collaboration among trial stakeholders. With L7|ESP, CROs can accelerate the development of life-changing treatments and therapies, making a significant impact on patient outcomes and advancing medical science.supporting case studyConnect with the L7 Team to find out more about the work we did with Gradalis.resourcesDive deeper into the capabilities that power the L7|ESP platform and discover what’s possible with data orchestration built for life sciences.L7|ESP explainer videoL7|ESP brochure L7|HUB datasheetL7|INTELLIGENCE datasheetL7|MASTER datasheetL7 Notebooks app datasheetL7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet L7's clients + partnersthe latest about L7 Informatics ### L7|ESP® for Ag-Bio L7|ESP® for Ag-Biodriving sustainable innovations Agricultural biotechnology (Ag-Bio) can be an important tool for addressing the causes and consequences of climate change and for achieving important societal goals such as reduced poverty, improved global food security, and reduced environmental impacts from agriculture. That’s why agricultural biotechnology is part of L7|ESP™ platform for a healthy planet and sustainable future. For Ag-Bio organizations involved in the development of advanced seeds and plant breeds, L7|ESP provides a comprehensive and unified platform that enhances visibility, digitalizes operations, and optimizes scientific research workflows. With seamless integration and automation of data and processes, L7|ESP empowers crop sciences research and development with end-to-end scientific information management, providing complete control, compliance, and synchronized collaboration across all stakeholders.​advanced ​s​eeds and ​p​lant breedsThe development of advanced seeds and plant breeds holds immense potential for enhancing agricultural productivity and sustainability. L7|ESP offers invaluable support to companies in this sector, providing a unified platform that streamlines data management, analysis, and collaboration throughout the seed breeding and development process. By leveraging the powerful capabilities of L7|ESP, Ag-Bio companies can accelerate their research and contribute to the creation of innovative plant varieties that address the evolving needs of the agricultural industry.L7|ESP serves as a comprehensive data management system for new seed and plant breed development, facilitating the integration and organization of diverse datasets. From genetic information and breeding trials to phenotypic data and environmental factors, L7|ESP's unified platform ensures efficient handling and analysis of complex data. By leveraging advanced analytics tools, researchers and breeders can uncover valuable insights, identify genetic markers, and make informed decisions in their pursuit of developing new and improved plant varieties. The platform's collaborative features allow secure data sharing, fostering interdisciplinary collaboration and enabling efficient feedback loops. By facilitating effective communication, L7|ESP accelerates the exchange of ideas and collective problem-solving, ultimately enhancing the success rate of new seed and plant breed development.Ag-Bio companies can leverage L7|ESP's capabilities to streamline workflows, gain valuable insights from complex data, and foster collaboration among breeders and researchers. With L7|ESP, Ag-Bio companies can drive innovation, develop sustainable agricultural solutions, and contribute to addressing the global challenges of food security and agricultural sustainability.supporting case studyConnect with the L7 Team to find out more about the work we did with Cibus. resourcesDive deeper into the capabilities that power the L7|ESP platform and discover what’s possible with data orchestration built for life sciences.L7|ESP explainer videoL7|ESP brochure L7|HUB datasheetL7|INTELLIGENCE datasheetL7|MASTER datasheetL7 Notebooks app datasheetL7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet L7's clients + partnersthe latest about L7 Informatics ### L7|ESP® for Life Science Tools + Media L7|ESP® for Life Science Tools + Mediacatalyzing scientific advancements For Life Science Tools/Media organizations involved in the development, manufacturing, and distribution of science tools, L7|ESP provides a comprehensive platform that can optimize their workflows, streamline processes, and enhance productivity across their operations. From research and development to manufacturing and distribution, L7|ESP enables seamless data integration, automation, and real-time collaboration. This results in accelerated time-to-market for innovative tools and media, improved quality control, and increased overall efficiency. ​science tools (instruments, equipment, reagents) The development, manufacturing, and distribution of various tools, instruments, equipment, reagents, and media used in life science research, diagnostics, and related applications play a crucial role in advancing scientific discovery, enabling researchers and scientists to study biological systems, analyze data, conduct experiments, and gain insights into the intricacies of life. L7|ESP emerges as a game-changing solution for companies operating in this industry, providing a dynamic and unified platform that revolutionizes data management, analysis, and collaboration. With L7|ESP's comprehensive capabilities, organizations can drive innovation, streamline workflows, and propel groundbreaking advancements in the realm of science tools. At the core of L7|ESP lies a powerful data management system tailored to the unique requirements of the Life Science Tools/Media industry. It seamlessly integrates and organizes the vast and diverse scientific data generated by instruments, equipment, and experiments. Researchers and scientists can effortlessly store, access, and analyze critical data, ensuring its integrity and availability for in-depth analysis. Leveraging advanced analytics tools, L7|ESP empowers organizations to extract real-time, data-driven insights, facilitating informed decision-making, process optimization, and the development of top-tier scientific tools with unparalleled quality. By uniting researchers, developers, and stakeholders on a secure and interactive platform, L7|ESP fosters a vibrant ecosystem of knowledge exchange, cross-pollination of ideas, and collective contribution to scientific breakthroughs. Through collaborative features, researchers and technicians can effortlessly collaborate, accelerating the pace of innovation and propelling the boundaries of science tools and technologies. By providing a robust data management system and fostering seamless collaboration, L7|ESP enhances productivity, accelerates discoveries, and paves the way for a future where science tools transform the world of research and enable humanity to embark on remarkable scientific journeys. supporting case study Connect with the L7 Team to find out more about the work we did with JAX.resourcesDive deeper into the capabilities that power the L7|ESP platform and discover what’s possible with data orchestration built for life sciences.L7|ESP explainer videoL7|ESP brochure L7|HUB datasheetL7|INTELLIGENCE datasheetL7|MASTER datasheetL7 Notebooks app datasheetL7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet L7's clients + partners the latest about L7 Informatics ### Contact - Industry Contact L7 Informatics L7 INFORMATICS, Inc.1219 West 6th StreetAustin, Texas 78703 USAL7 INFORMATICS, Inc.1219 West 6th StreetAustin, Texas 78703 USAL7 INFORMATICS, Inc.1219 West 6th StreetAustin, Texas 78703 USAsupport@L7informatics.com ### L7|LIVE SF 2023 - EndPoints L7|LIVE SF - Tuesday, June 13th, 2023 Digital Transformation for Life Science Leaders The L7|LIVE SF seminar will explore the ways in which digital technologies, such as unified platforms, are revolutionizing the biotech and life science industries, transforming business models, breaking down data silos, reducing turnaround times, and creating more consistent and reproducible processes. Our panel of experts will share their insights and experiences on these needed cutting-edge technologies and the trends laying the foundation for the future of life sciences. This is a great opportunity to learn about the latest developments in the field, network with industry professionals, and gain a deeper understanding of how digital transformation is shaping the future of biotech. join us in person Tuesday, June 13th Lunch (noon - 1 pm PT) Seminar (1 pm - 5 pm PT) Reception (5 pm - 7 pm PT) The St. Regis San Francisco 125 3rd St, San Francisco, CA 94103 Tuesday, June 13th Lunch (noon - 1 pm PT) Seminar (1 pm - 5 pm PT) Reception (5 pm - 7 pm PT) The St. Regis San Francisco 125 3rd St, San Francisco, CA 94103 join us virtually Tuesday, June 13th Seminar (1 pm - 5 pm PT) We understand that not everyone can join us in person for L7|LIVE SF, but we've got you covered! We are thrilled to offer this event as a hybrid experience, allowing you to participate from your office or the comfort of your home. Rest assured that you will have access to the same great content, valuable insights from industry experts, and thought-provoking discussions. We can't wait for you to be part of this transformative event! agenda 11:30 amRegistration opens Top of the elevators, Level Four​ 12:00 pm – 1:00 pm​Lunch Catered by the St. Regis SF Impressionist Room, Level Four​ 1:00 pm – 1:30 pm​ Operational Excellence with Digital Systems in Life Sciences The Life Sciences industry is rapidly evolving, and digital systems and technologies have become essential tools for driving innovation, improving patient outcomes, and accelerating drug development. However, achieving operational excellence in Life Sciences with digital systems requires a strategic approach that aligns with an organization's goals. By leveraging the latest digital technologies and best practices, organizations can optimize their processes, streamline operations, and increase productivity to gain a competitive edge. With the right approach, digital systems can enable organizations to achieve operational excellence by driving operational excellence, innovation, and success. Vasu Rangadass, Ph.D., President & CEO at L7 Informatics Conservatory, Level Four 1:30 pm – 1:45 pm​ Analytical and Process Development / Tech-Transfer Case Study Steven Barash, Vice President, Strategy & Development + Brent Wilson, Solutions Consultant at L7 InformaticsConservatory, Level Four 1:45 pm – 2:05 pm​ Informatics as a Service: Reimagining Scientific Computing for Modern Drug Discovery Modern drug discovery is a dynamic, collaborative process in which companies engage both internal and external resources to orchestrate their development programs. This paradigm allows companies to leverage partners for much of the scientific work, increasing scientists' efficiency and reducing costs for lab space. On the IT side, outsourcing has traditionally been limited to basic support roles with scientific tasks remaining in-house. As software and data management tasks continue to evolve, maintaining the mix of development, administration, and analytical roles is proving challenging. The pool of available informatics resources is limited and, just like lab services, not all skills are needed all the time. In this talk, we explore a new model for informatics in which the entire informatics role is handled as a service. "Informatics as a Service" provides companies with access to a range of skills at a fraction of the cost of in-sourcing, allowing companies to focus on their core mission while leveraging expert resources to handle their informatics and analysis needs. Dan Weaver, Ph.D., CEO at Boulder BioConsulting Conservatory, Level Four 2:05 pm – 2:20 pm​ Drug Discovery Case Study Brent Wilson + Katherine Temple, Solutions Consultants at L7 InformaticsConservatory, Level Four 2:20 pm – 2:50 pm​ Decentralized Manufacturing Operations with Unified Platforms With the rise of Industry 4.0, manufacturers are increasingly adopting digital technologies to improve efficiency, reduce costs, and enhance quality. However, managing operations across multiple sites and geographies can be challenging, particularly when using disparate systems and technologies. The presentation covers the benefits of using a unified platform for managing decentralized manufacturing operations. By centralizing data and workflows, manufacturers can streamline operations, improve collaboration, and gain greater visibility into their supply chains, leading to increased efficiency and flexibility. Steven Barash, Vice President, Strategy & Development at L7 Informatics Conservatory, Level Four 2:50 pm – 3:05 pm​ MES Case Study Steven Barash, Vice President, Strategy & Development + Brent Wilson, Solutions Consultant at L7 InformaticsConservatory, Level Four 3:05 pm – 3:20 pm​ Afternoon break with pastries & coffee Hallway by Conservatory, Level Four 3:20 pm – 3.40 pm​ Highlighting Challenges and Benefits of Digitalization of Cell and Gene Therapy Laboratory Workflows through Case Studies Cell and gene therapy (CGT) is the growing focus area in the field of personalized medicine. The digitalization of CGT laboratory workflows has the potential to revolutionize the way these therapies are developed and delivered to patients. This presentation highlights some of the key benefits and challenges in the digitalization of cell and gene therapy workflows using case studies. By automating and standardizing laboratory processes, digitalization can improve the reproducibility and reliability of cell and gene therapies, leading to more consistent treatment outcomes for patients. Digitalization can also enhance the efficiency of laboratory workflows, reducing the time and cost required to develop and manufacture these therapies. This efficiency can help to accelerate the development of new treatments and improve patient access to these therapies. Furthermore, digitalization can enable the integration of data from different stages of the cell and gene therapy development process, allowing researchers and clinicians to better understand the factors that influence treatment outcomes. This integrated approach can lead to the identification of new biomarkers, the development of personalized treatment regimens, and the optimization of manufacturing processes. This digitalization offers transformative benefits, but also presents significant challenges. One of the key challenges involved in developing and manufacturing these therapies is the complexity of the laboratory workflows due to the need to handle biological materials that are often fragile and require precise control of environmental conditions. Digitalization of these workflows requires the integration of multiple technologies, including robotics, data management systems, and artificial intelligence, to enable the automation and standardization of laboratory processes. Achieving this level of integration and standardization requires significant investment in infrastructure, personnel, and training. Menhaz Husain, Senior Business System Analyst at Zifo RnD Solutions Conservatory, Level Four 3:40 pm – 3:55 pm​ LIMS Case Study Brent Wilson + Katherine Temple, Solutions Consultants at L7 InformaticsConservatory, Level Four 3:55 pm – 4:15 pm​ Tag.bio: An End-to-End Data Mesh Platform for Innovation The global need to securely derive (instant) insights, have motivated (centralized) data architectures from local storage, to data lakes, data warehouses, and lake-houses. In this talk we describe Tag.bio, a next-generation end-to-end (distributed) data mesh platform consisting of vital elements: domain centricity/ownership, data-as-products with embedded (AI/machine learning) algorithms, with a federated computational layer using microservices. The platform also combines a dynamic cohort builder with analysis protocols and apps (low-code) to drive complex analysis workflows. We also introduce TagGPT, an application layer within the data mesh, that uses foundational models (GPT3.5, BLOOM, LLaMA) along with data products (such as various phases of clinical trials) to build, refine and deploy fine-tune domain-centric (private) models and apps with built-in governance. Join us for a talk on Tag.bio and learn how major pharma, non-profit organizations, and health systems are using this technology to find cures for devastating diseases, precision medicine, commercial insights/decisions, clinical trials, drug discovery, and promote collaboration (without explicitly moving data around). We show how the platform can combine clinical and genomics data products (with millions of variants and thousands of clinical parameters) using smart APIs and also connect clinical trials to RWE/RWD, adverse effects (FAERS), health economics, and outcomes. Sanjay Padhi, Ph.D., Chief Technologist and Executive Vice President at Tag.bio Conservatory, Level Four 4:15 pm – 4:45 pm​ L7|INTELLIGENCE In today's complex life sciences landscape, gaining a competitive advantage and making informed decisions are paramount for success. This presentation explores the power of L7|Intelligence. Discover the key components of a robust L7|Intelligence strategy built around ESP, including data collection and integration, data warehousing and management, analytics and reporting, and more. Learn from real-life examples of successful L7|Intelligence implementation in the industry and understand the benefits of L7|Intelligence, such as informed decision-making, competitive advantage, and operational efficiency. Walk away with best practices for implementing a successful L7|Intelligence strategy and unlock new levels of growth and innovation for your organization.Richard Love, Director of Business Intelligence at L7 InformaticsConservatory, Level Four 4:45 pm – 5:00 pm​ Closing remarks Vasu Rangadass, Ph.D., President & CEO at L7 Informatics Conservatory, Level Four 5:00 pm – 7:00 pmNetworking Reception with appetizers and cocktails Williams Room, Main Lobby L7|LIVE — digital transformation for life science leaders explore opportunities L7's clients + partners the latest about L7 Informatics we're hiring ### L7|LIVE San Francisco L7|LIVE SF - Tuesday, June 13th, 2023 Digital Transformation for Life Science Leaders The L7|LIVE SF seminar will explore the ways in which digital technologies, such as unified platforms, are revolutionizing the biotech and life science industries, transforming business models, breaking down data silos, reducing turnaround times, and creating more consistent and reproducible processes. Our panel of experts will share their insights and experiences on these needed cutting-edge technologies and the trends laying the foundation for the future of life sciences. This is a great opportunity to learn about the latest developments in the field, network with industry professionals, and gain a deeper understanding of how digital transformation is shaping the future of biotech. join us in person Tuesday, June 13th Lunch (noon - 1 pm PT) Seminar (1 pm - 5 pm PT) Reception (5 pm - 7 pm PT) The St. Regis San Francisco 125 3rd St, San Francisco, CA 94103Tuesday, June 13th Lunch (noon - 1 pm PT) Seminar (1 pm - 5 pm PT) Reception (5 pm - 7 pm PT) The St. Regis San Francisco 125 3rd St, San Francisco, CA 94103join us virtually Tuesday, June 13th Seminar (1 pm - 5 pm PT) We understand that not everyone can join us in person for L7|LIVE SF, but we've got you covered! We are thrilled to offer this event as a hybrid experience, allowing you to participate from your office or the comfort of your home. Rest assured that you will have access to the same great content, valuable insights from industry experts, and thought-provoking discussions. We can't wait for you to be part of this transformative event!agenda 11:30 amRegistration opens Top of the elevators, Level Four​ 12:00 pm – 1:00 pm​Lunch Catered by the St. Regis SF Impressionist Room, Level Four​ 1:00 pm – 1:30 pm​ Operational Excellence with Digital Systems in Life Sciences The Life Sciences industry is rapidly evolving, and digital systems and technologies have become essential tools for driving innovation, improving patient outcomes, and accelerating drug development. However, achieving operational excellence in Life Sciences with digital systems requires a strategic approach that aligns with an organization's goals. By leveraging the latest digital technologies and best practices, organizations can optimize their processes, streamline operations, and increase productivity to gain a competitive edge. With the right approach, digital systems can enable organizations to achieve operational excellence by driving operational excellence, innovation, and success. Vasu Rangadass, Ph.D., President & CEO at L7 Informatics Conservatory, Level Four 1:30 pm – 1:45 pm​ Analytical and Process Development / Tech-Transfer Case Study Steven Barash, Vice President, Strategy & Development + Brent Wilson, Solutions Consultant at L7 InformaticsConservatory, Level Four 1:45 pm – 2:05 pm​ Informatics as a Service: Reimagining Scientific Computing for Modern Drug Discovery Modern drug discovery is a dynamic, collaborative process in which companies engage both internal and external resources to orchestrate their development programs. This paradigm allows companies to leverage partners for much of the scientific work, increasing scientists' efficiency and reducing costs for lab space. On the IT side, outsourcing has traditionally been limited to basic support roles with scientific tasks remaining in-house. As software and data management tasks continue to evolve, maintaining the mix of development, administration, and analytical roles is proving challenging. The pool of available informatics resources is limited and, just like lab services, not all skills are needed all the time. In this talk, we explore a new model for informatics in which the entire informatics role is handled as a service. "Informatics as a Service" provides companies with access to a range of skills at a fraction of the cost of in-sourcing, allowing companies to focus on their core mission while leveraging expert resources to handle their informatics and analysis needs. Dan Weaver, Ph.D., CEO at Boulder BioConsulting Conservatory, Level Four 2:05 pm – 2:20 pm​ Drug Discovery Case Study Brent Wilson + Katherine Temple, Solutions Consultants at L7 InformaticsConservatory, Level Four 2:20 pm – 2:50 pm​ Decentralized Manufacturing Operations with Unified Platforms With the rise of Industry 4.0, manufacturers are increasingly adopting digital technologies to improve efficiency, reduce costs, and enhance quality. However, managing operations across multiple sites and geographies can be challenging, particularly when using disparate systems and technologies. The presentation covers the benefits of using a unified platform for managing decentralized manufacturing operations. By centralizing data and workflows, manufacturers can streamline operations, improve collaboration, and gain greater visibility into their supply chains, leading to increased efficiency and flexibility. Steven Barash, Vice President, Strategy & Development at L7 Informatics Conservatory, Level Four 2:50 pm – 3:05 pm​ MES Case Study Steven Barash, Vice President, Strategy & Development + Brent Wilson, Solutions Consultant at L7 InformaticsConservatory, Level Four 3:05 pm – 3:20 pm​ Afternoon break with pastries & coffee Hallway by Conservatory, Level Four 3:20 pm – 3.40 pm​ Highlighting Challenges and Benefits of Digitalization of Cell and Gene Therapy Laboratory Workflows through Case Studies Cell and gene therapy (CGT) is the growing focus area in the field of personalized medicine. The digitalization of CGT laboratory workflows has the potential to revolutionize the way these therapies are developed and delivered to patients. This presentation highlights some of the key benefits and challenges in the digitalization of cell and gene therapy workflows using case studies. By automating and standardizing laboratory processes, digitalization can improve the reproducibility and reliability of cell and gene therapies, leading to more consistent treatment outcomes for patients. Digitalization can also enhance the efficiency of laboratory workflows, reducing the time and cost required to develop and manufacture these therapies. This efficiency can help to accelerate the development of new treatments and improve patient access to these therapies. Furthermore, digitalization can enable the integration of data from different stages of the cell and gene therapy development process, allowing researchers and clinicians to better understand the factors that influence treatment outcomes. This integrated approach can lead to the identification of new biomarkers, the development of personalized treatment regimens, and the optimization of manufacturing processes. This digitalization offers transformative benefits, but also presents significant challenges. One of the key challenges involved in developing and manufacturing these therapies is the complexity of the laboratory workflows due to the need to handle biological materials that are often fragile and require precise control of environmental conditions. Digitalization of these workflows requires the integration of multiple technologies, including robotics, data management systems, and artificial intelligence, to enable the automation and standardization of laboratory processes. Achieving this level of integration and standardization requires significant investment in infrastructure, personnel, and training. Menhaz Husain, Senior Business System Analyst at Zifo RnD Solutions Conservatory, Level Four 3:40 pm – 3:55 pm​ LIMS Case Study Brent Wilson + Katherine Temple, Solutions Consultants at L7 InformaticsConservatory, Level Four 3:55 pm – 4:15 pm​ Tag.bio: An End-to-End Data Mesh Platform for Innovation The global need to securely derive (instant) insights, have motivated (centralized) data architectures from local storage, to data lakes, data warehouses, and lake-houses. In this talk we describe Tag.bio, a next-generation end-to-end (distributed) data mesh platform consisting of vital elements: domain centricity/ownership, data-as-products with embedded (AI/machine learning) algorithms, with a federated computational layer using microservices. The platform also combines a dynamic cohort builder with analysis protocols and apps (low-code) to drive complex analysis workflows. We also introduce TagGPT, an application layer within the data mesh, that uses foundational models (GPT3.5, BLOOM, LLaMA) along with data products (such as various phases of clinical trials) to build, refine and deploy fine-tune domain-centric (private) models and apps with built-in governance. Join us for a talk on Tag.bio and learn how major pharma, non-profit organizations, and health systems are using this technology to find cures for devastating diseases, precision medicine, commercial insights/decisions, clinical trials, drug discovery, and promote collaboration (without explicitly moving data around). We show how the platform can combine clinical and genomics data products (with millions of variants and thousands of clinical parameters) using smart APIs and also connect clinical trials to RWE/RWD, adverse effects (FAERS), health economics, and outcomes. Sanjay Padhi, Ph.D., Chief Technologist and Executive Vice President at Tag.bio Conservatory, Level Four 4:15 pm – 4:45 pm​ L7|INTELLIGENCE In today's complex life sciences landscape, gaining a competitive advantage and making informed decisions are paramount for success. This presentation explores the power of L7|Intelligence. Discover the key components of a robust L7|Intelligence strategy built around ESP, including data collection and integration, data warehousing and management, analytics and reporting, and more. Learn from real-life examples of successful L7|Intelligence implementation in the industry and understand the benefits of L7|Intelligence, such as informed decision-making, competitive advantage, and operational efficiency. Walk away with best practices for implementing a successful L7|Intelligence strategy and unlock new levels of growth and innovation for your organization.Richard Love, Director of Business Intelligence at L7 InformaticsConservatory, Level Four 4:45 pm – 5:00 pm​ Closing remarks Vasu Rangadass, Ph.D., President & CEO at L7 Informatics Conservatory, Level Four 5:00 pm – 7:00 pmNetworking Reception with appetizers and cocktails Williams Room, Main Lobby L7|LIVE — digital transformation for life science leaders explore opportunities L7's clients + partners the latest about L7 Informatics we're hiring ### L7 Universe 2023 streamline, automate, and optimize operationsL7 UNIVERSE 2023:Embrace the ExtraordinaryJoin us for an exceptional opportunity to learn from world-leading companies across Life Sciences and Healthcare and how they are using L7|ESP™ to streamline, automate, and optimize their operations, such as The Jackson Laboratory, Quest Diagnostics, Dana-Farber Cancer Institute, Cellares, Harbinger Health, QIAGEN, Rutgers Cancer Institute of New Jersey, Vernal Biosciences, Nobell Foods, Think Bioscience, Gradalis, ATCC, Biobot Analytics, Benson Hill, Cibus, GeneDx, Genome Technology Access Center at the McDonnell Genome Institute in Washington University in St. Louis, Contamination Source Identification, and more!L7|UNIVERSE 2023 Leading Life-Sciences and Healthcare companies are streamlining, automating, and optimizing operations with L7 Informatics. Come to L7|UNIVERSE 2023 to learn how! We are thrilled and excited as we reflect on the incredible success of our recent roadshow of L7|LIVE events and our inaugural L7 UNIVERSE event last year. And now, we have even more exciting news to share with you. Introducing L7 UNIVERSE 2023—a bigger, better, and more captivating event coming to our hometown of Austin. We are planning an agenda that is jam-packed with dynamic speakers and engaging panel discussions. We cordially invite you to be a part of this remarkable gathering, where you can connect with peers, gain insights into industry innovations, and explore creative approaches. L7 UNIVERSE 2023 promises to be an enriching experience for everyone involved. It's a chance to learn from experts, exchange ideas with like-minded individuals, and have some well-deserved fun. We sincerely hope you can join us for this exceptional event.dates + venueSeptember 12-15, 2023 Location: Austin Marriott Downtown304 E Cesar Chavez St,Austin, TX 78701agenda at-a-glanceTuesday, September 12, 2023Evening: Welcome Reception Wednesday, September 13, 2023Full Day: General Sessions, Breakout Sessions, Exhibit Hall, L7 Awards & Dinner Event Thursday, September 14, 2023Full Day: General Sessions, Breakout Sessions, Exhibit Hall, L7 Dinner Event Friday, September 15, 2023Morning: Special Sessions (TBA)what will happen at L7 UNIVERSE?Business + Product + Partners Track Industry / Market Trends L7 Strategy + Roadmap Performance Enhancement + Performance Optimization L7 Customer Presentations L7 Partner Presentations L7 Excellence and Transformative Awards Operations + Science + Technology Track Training Opportunities Implementation and adoption of L7|ESP Preview and Advise on New Products Technical Sessions what attendees said about UNIVERSE 2022:L7 UNIVERSE — celebrating our customers and partners in their journey to digital transformationexplore opportunitiesL7's clients + partnersthe latest about L7 Informaticswe're hiring ### L7 LIVE SF 2023 Registration Page L7|LIVE SF Registrationexcited for you to be our guest at L7|LIVE SF! Please enter your information in the form below to RSVP and confirm your presence on Tuesday, June 13th, 2023. RSVP now agenda 11:30 amRegistration opens Top of the elevators, Level Four​ 12:00 pm – 1:00 pm​Lunch with Keynote by ... Impressionist, Level Four​ 1:00 pm – 1:30 pm​​Welcome remarks + intro to L7 – Vasu Rangadass Conservatory, Level Four 1:30 pm – 2:15 pm​Guest Speaker 1 Conservatory, Level Four 2:15 pm – 3:00 pm​Guest Speaker 2 Conservatory, Level Four 3:00 pm – 3:15 pm​Afternoon break (coffee & pastries) Hallway by Conservatory, Level Four 3:15 pm – 4:00 pm​L7|ESP demo Conservatory, Level Four 4:00 pm – 4:45 pm​Guest speaker 3 Conservatory, Level Four 4:45 pm – 5:00 pm​Closing remarks – Vasu Rangadass Conservatory, Level Four 5:00 pm – 7:00 pmHappy Hour Reception with appetizers and cocktails Williams Room, Main Lobby L7|LIVE — digital transformation for life science leaders explore opportunities L7's clients + partners the latest about L7 Informatics we're hiring ### L7 LIVE SF 2023 L7|LIVE SF - Tuesday, June 13th, 2023Digital Transformationfor Life Science Leaders The L7|LIVE SF seminar will explore the ways in which digital technologies, such as unified platforms, are revolutionizing the biotech and life science industries, transforming business models, breaking down data silos, reducing turnaround times, and creating more consistent and reproducible processes. Our panel of experts will share their insights and experiences on these needed cutting-edge technologies and the trends laying the foundation for the future of life sciences. This is a great opportunity to learn about the latest developments in the field, network with industry professionals, and gain a deeper understanding of how digital transformation is shaping the future of biotech. date + venueTuesday, June 13th Seminar (noon - 5 pm PT) Reception (5 pm - 7 pm PT) The St. Regis San Francisco 125 3rd St San Francisco, CA 94103pack your bagsWe are very excited to offer registered guests who attend L7|LIVE SF on June 13th an exclusive gift set, which includes an L7-branded Patagonia Black Hole® Duffel Bag 40L in Pitch Blue, a notebook, and a pen. Don't wait to confirm your attendance and secure your spot!agenda11:30 amRegistration opensTop of the elevators, Level Four​12:00 pm – 1:00 pm​Lunch Catered by the St. Regis SFImpressionist Room, Level Four​1:00 pm – 1:30 pm​Operational Excellence with Digital Systems in Life Sciences The Life Sciences industry is rapidly evolving, and digital systems and technologies have become essential tools for driving innovation, improving patient outcomes, and accelerating drug development. However, achieving operational excellence in Life Sciences with digital systems requires a strategic approach that aligns with an organization's goals. By leveraging the latest digital technologies and best practices, organizations can optimize their processes, streamline operations, and increase productivity to gain a competitive edge. With the right approach, digital systems can enable organizations to achieve operational excellence by driving operational excellence, innovation, and success.Vasu Rangadass, Ph.D., President & CEO at L7 InformaticsConservatory, Level Four1:30 pm – 1:45 pm​Analytical and Process Development / Tech-Transfer Case StudySteven Barash, Vice President, Strategy & Development + Brent Wilson, Ph.D., Solutions Consultant at L7 InformaticsConservatory, Level Four1:45 pm – 2:05 pm​Informatics as a Service: Reimagining Scientific Computing for Modern Drug DiscoveryModern drug discovery is a dynamic, collaborative process in which companies engage both internal and external resources to orchestrate their development programs. This paradigm allows companies to leverage partners for much of the scientific work, increasing scientists' efficiency and reducing costs for lab space. On the IT side, outsourcing has traditionally been limited to basic support roles with scientific tasks remaining in-house. As software and data management tasks continue to evolve, maintaining the mix of development, administration, and analytical roles is proving challenging. The pool of available informatics resources is limited and, just like lab services, not all skills are needed all the time. In this talk, we explore a new model for informatics in which the entire informatics role is handled as a service. "Informatics as a Service" provides companies with access to a range of skills at a fraction of the cost of in-sourcing, allowing companies to focus on their core mission while leveraging expert resources to handle their informatics and analysis needs.Dan Weaver, Ph.D., CEO at Boulder BioConsultingConservatory, Level Four2:05 pm – 2:20 pm​Drug Discovery Case StudyBrent Wilson, Ph.D. + Katherine Temple, Solutions Consultants at L7 InformaticsConservatory, Level Four2:20 pm – 2:50 pm​Decentralized Manufacturing Operations with Unified PlatformsWith the rise of Industry 4.0, manufacturers are increasingly adopting digital technologies to improve efficiency, reduce costs, and enhance quality. However, managing operations across multiple sites and geographies can be challenging, particularly when using disparate systems and technologies. The presentation covers the benefits of using a unified platform for managing decentralized manufacturing operations. By centralizing data and workflows, manufacturers can streamline operations, improve collaboration, and gain greater visibility into their supply chains, leading to increased efficiency and flexibility.Steven Barash, Vice President, Strategy & Development at L7 InformaticsConservatory, Level Four2:50 pm – 3:05 pm​MES Case StudySteven Barash, Vice President, Strategy & Development + Brent Wilson, Ph.D., Solutions Consultant at L7 InformaticsConservatory, Level Four3:05 pm – 3:20 pm​Afternoon break with pastries & coffeeHallway by Conservatory, Level Four3:20 pm – 3.40 pm​Highlighting Challenges and Benefits of Digitalization of Cell and Gene Therapy Laboratory Workflows through Case StudiesCell and gene therapy (CGT) is the growing focus area in the field of personalized medicine. The digitalization of CGT laboratory workflows has the potential to revolutionize the way these therapies are developed and delivered to patients. This presentation highlights some of the key benefits and challenges in the digitalization of cell and gene therapy workflows using case studies. By automating and standardizing laboratory processes, digitalization can improve the reproducibility and reliability of cell and gene therapies, leading to more consistent treatment outcomes for patients. Digitalization can also enhance the efficiency of laboratory workflows, reducing the time and cost required to develop and manufacture these therapies. This efficiency can help to accelerate the development of new treatments and improve patient access to these therapies. Furthermore, digitalization can enable the integration of data from different stages of the cell and gene therapy development process, allowing researchers and clinicians to better understand the factors that influence treatment outcomes. This integrated approach can lead to the identification of new biomarkers, the development of personalized treatment regimens, and the optimization of manufacturing processes. This digitalization offers transformative benefits, but also presents significant challenges. One of the key challenges involved in developing and manufacturing these therapies is the complexity of the laboratory workflows due to the need to handle biological materials that are often fragile and require precise control of environmental conditions. Digitalization of these workflows requires the integration of multiple technologies, including robotics, data management systems, and artificial intelligence, to enable the automation and standardization of laboratory processes. Achieving this level of integration and standardization requires significant investment in infrastructure, personnel, and training.Mehnaz Husain, Senior Business System Analyst at Zifo RnD SolutionsConservatory, Level Four3:40 pm – 3:55 pm​LIMS Case StudyBrent Wilson, Ph.D. + Katherine Temple, Solutions Consultants at L7 InformaticsConservatory, Level Four3:55 pm – 4:15 pm​Tag.bio: An End-to-End Data Mesh Platform for InnovationThe global need to securely derive (instant) insights have motivated (centralized) data architectures from local storage, to data lakes, data warehouses, and lake-houses. In this talk we describe Tag.bio, a next-generation end-to-end (distributed) data mesh platform consisting of vital elements: domain centricity/ownership, data-as-products with embedded (AI/machine learning) algorithms, with a federated computational layer using microservices. The platform also combines a dynamic cohort builder with analysis protocols and apps (low-code) to drive complex analysis workflows. We also introduce TagGPT, an application layer within the data mesh, that uses foundational models (GPT3.5, BLOOM, LLaMA) along with data products (such as various phases of clinical trials) to build, refine and deploy fine-tune domain-centric (private) models and apps with built-in governance. Join us for a talk on Tag.bio and learn how major pharma, non-profit organizations, and health systems are using this technology to find cures for devastating diseases, precision medicine, commercial insights/decisions, clinical trials, drug discovery, and promote collaboration (without explicitly moving data around). We show how the platform can combine clinical and genomics data products (with millions of variants and thousands of clinical parameters) using smart APIs and also connect clinical trials to RWE/RWD, adverse effects (FAERS), health economics, and outcomes.Sanjay Padhi, Ph.D., Chief Technologist and Executive Vice President at Tag.bioConservatory, Level Four4:15 pm – 4:45 pm​L7|INTELLIGENCEIn today's complex life sciences landscape, gaining a competitive advantage and making informed decisions are paramount for success. This presentation explores the power of L7|Intelligence. Discover the key components of a robust L7|Intelligence strategy built around ESP, including data collection and integration, data warehousing and management, analytics and reporting, and more. Learn from real-life examples of successful L7|Intelligence implementation in the industry and understand the benefits of L7|Intelligence, such as informed decision-making, competitive advantage, and operational efficiency. Walk away with best practices for implementing a successful L7|Intelligence strategy and unlock new levels of growth and innovation for your organization.Richard Love, Director of Business Intelligence at L7 InformaticsConservatory, Level Four4:45 pm – 5:00 pm​Closing remarksVasu Rangadass, Ph.D., President & CEO at L7 InformaticsConservatory, Level Four5:00 pm – 7:00 pmNetworking Reception with appetizers and cocktailsWilliams Room, Main LobbyL7|LIVE — digital transformation for life science leadersexplore opportunitiesL7's clients + partnersthe latest about L7 Informaticswe're hiring ### Boulder BioConsulting Partner L7 | Partner Resources webinars + presentations case studies datasheets white papers videos ebooks analyst reports latest news resources by verticalPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTUREPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTURE ### 2023 BEBPA US Bioassay Conference Virtual Booth BEBPA 2023 US Bioassay Conference – March 14-16, 2023 welcome to our virtual booth!together we can help improve the quality of life L7 Informatics reimagines data intelligence for modern life sciences and healthcare organizations. Beyond simple data management, L7 provides tools that optimize the flow of information between process and people, unlocking innovation at every stage of the clinical, research, and manufacturing value chains. Our comprehensive operating environment and software stack bring flexible, secure, and collaborative data intelligence to your entire operation. From regulatory compliance and workflow orchestration to customized applications and integrations, our end-to-end transformation engine helps organizations solve the challenges of today and realize the opportunities of tomorrow.L7 at a glanceL7 culture At L7, we aspire to do great things. L7's innovation is fueled by an interdisciplinary team of scientists, engineers, and operations-research experts. L7'ers are passionate about our technology with a desire to make a positive impact on improving the speed, efficiency, and progression of healthcare and life sciences organizations around the world. L7 is growing fast, and we are looking for potential colleagues that are as inspired and motivated as we are!explore opportunitiesdata+intelligence for the scientific enterprise L7 | ESP is designed to unlock innovation at every stage of the clinical, research, and manufacturing value chain. From data and workflow orchestration – to custom apps and integrations, L7 | ESP is an end-to-end transformation engine to help solve the challenges of today and realize the opportunities of tomorrow.L7's clients + partnersthe latest about L7 Informaticswe're hiring ### L7 University L7 UNIVERSITY L7 UNIVERSITY offers a growing catalog of live and on-demand training options carefully designed to give new and experienced users the skills and knowledge they need to leverage the power and extensibility of L7|ESP.L7 UNIVERSITYL7|ESP MasterClassesEarn your certification in these immersive, hands-on courses. Develop the knowledge and skills needed to master code-level application engineering within L7|ESP. Through real-world examples and hands-on exercises, you will leave able to build and test the components necessary to extend the power of L7|ESP and tailor it for your organization’s business needs. Format: Live, Virtual
Duration: 5 DaysDevelop the knowledge and skills needed to build no-code, custom L7|ESP implementations specific to your organization’s needs. Given real-world scenarios, you will learn how to rapidly model and build the components of scientific business processes using the building blocks in L7|ESP. Format: Live, Virtual
Duration: 4 Days Deep-dive, hands-on modules intended for Users, Super Users and Developers.Learn to use and extend L7|ESP's growing list of applicationsLearn to install, configure and use L7|HUB Standard Content.L7 UNIVERSITYL7|ESP Self-Directed TrainingLearn L7|ESP at your own pace anytime, anywhere. ### Mphasis Partner L7 | Partner Resourceswebinars + presentations case studies white papers videos ebooks analyst reports latest news resources by verticalPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTUREPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTURE ### L7 UNIVERSE 2022 Agenda Agenda2022 agenda Please check back regularly as we continue to add more details around our sessions and confirmed speakers. Sessions and topics are subject to change.monday, november 145:00 PM CDTWelcome Reception P6 at The LINEtuesday, november 159:00 AM CDTOpening Keynote: Unified Platforms for Health and Science L7|ESP is rapidly becoming a key component of Digital Transformation in science + health organizations. The talk will cover the fundamental concepts of the L7|ESP unified platform and its evolution over the past few years and the roadmap moving forward. Vasu Rangadass, Ph.D., President and CEO, L7 Informatics Waller D9:30 AM CDTUnified Platforms, Digitalization of CGT Platforms, Lab of the Future "Lab of the Future" (LoF) has recently become a popular topic for modernizing laboratories. While performing upgrades to laboratory informatics systems and adopting "hyped" technologies such as IoT, AI/ML, AR/VR and blockchain may support modernization on the surface, many existing LoF strategies run the risks of only delivering incremental value. Your LoF strategies, especially for CG&T initiatives, need to have a deeper impact to survive executive scrutiny and must put an augmented data analytics strategy at the center. A LoF strategy must also enable a digital twin for the lab at multiple levels- with impacts on lab assets, personnel, and systems. As businesses transform, all aspects of business, including the laboratory need to support digital optimization and transformation. In this session, we review the meaning of digitalization, the technologies important for achieving LoF, and outline strategic steps for ensuring your "LoF" strategy will be aligned to deliver true value in the Digital Era. Michael Shanler, Distinguished VP Analyst, Gartner Waller D10:00 AM CDTMorning Coffee and Networking Foyer10:30 AM CDTScaling Precision Diagnostics - Lessons from the Trenches Almost a decade into genomics going mainstream, the community still feels challenged in basic areas surrounding EHR connectivity, clinical phenotypes, data provenance, data governance, state management, integrations, assimilation of newer technology platforms, scalability and speed to market. We will look at some of the challenges and learnings to understand what it takes to succeed in this age of precision medicine. Ray Veeraraghavan, Executive Director - Advanced Diagnostics Technology, US, Quest Diagnostics Waller D11:00 AM CDTPanel Discussion: Digital Transformation in Manufacturing Due to the explosive growth in the Cell and Gene Therapy market and increased demand for manufacturing capacity, significant bottlenecks have become both realized and felt by the drug sponsors and their manufacturers. With an expected CGT market growth of 40% per annum and new regulatory pathways accelerating drug commercialization, the CGT industry must adapt to the changing climate and demand and embrace digital solutions within their operations. This panel comprised of industry experts focuses on those bottlenecks manufacturing bottlenecks and where investment in next-generation digital tools and technologies are warranted to overcome the manufacturing hurdles to bring CGT products to the clinic. Moderator: Steven Barash, VP Strategy & Development, L7 Informatics Panelists: Michael Shanler, Distinguished VP Analyst, Gartner Trent Carrier, Ph.D, MBA, Chief Operating Officer, L7 Informatics Waller D12:00 PM CDTLunch Foyer1:10 PM CDTStarting the Digital Journey on the Right Foot Industries and its leaders are progressing towards digital transformation which is an integral requirement and that includes the Lifesciences industry as well. The scope of digital transformation in the Lifesciences industry can be expanded based on an organization's position on the digital maturity ladder. Digital convergence is a milestone on this journey towards digital maturity and this can be achieved by way of digital thinking. However, looking at the current state of transformation, there are various gaps that need to be addressed including those in data management, the various missteps in architecture including data and systems, which impacts the results. This can explain how digital thinking comes together, the major factors to look for in digital journey, and how they are all interlinked to create and establish the transformation. In this webinar, we give an insight into what Zifo has learned so far in its digital journey, as well as the industry trends that are in place and how they help with this digital journey. It also glances over a few minimal digital use cases which illustrate how the digital journey translates into systems. Following this, is an overview of Zifo as an organization and its business prospects in terms of expertise and value proposition. Mary Bradley, Ph.D., Head of Consulting, Zifo Waller D1:30 PM CDTNeedle-to-Needle Cell and Gene Therapy Gradalis is a clinical-stage biotechnology company whose mission is to develop a more effective treatment for cancer, using the patient’s immune system to target the entire complement of tumor neoantigens. The product life cycle begins with the collection of tumor tissue from the patient during standard of care cytoreductive surgery. Tissue is sent to Gradalis for product manufacture, testing, storage, verification of patient protocol eligibility, and product disposition. After release, verified product is distributed to and administered to the patient. Gradalis is further developing L7|ESP to provide patient identifiers that facilitate reporting of chain of identity and chain of custody from initial patient scheduling, through tissue collection and manufacturing, and during product shipments. Ernest Bognar, Chief Operating Officer, Gradalis Waller D2:00 PM CDTFrom Paper to Digital: Overcoming Challenges in Transitioning to a BioManufacturing Lab of the Future The American Type Culture Collection (ATCC) is the world's largest biological materials repository, and has provided the life sciences research community with critical reagents and biomaterials since 1925. In 2020, ATCC made the commitment to begin the journey towards a 100% digital, zero-paper biomanufacturing organization – a critical and transformative step in maintaining our industry leadership position as a standards setting organization. In this presentation, we will present our approach to beginning this journey and the progress we have made thus far. We will present some of the unique technical and infrastructure challenges our organization faces, our solutions to those challenges, and what challenges remain. Lastly, we will present our overall vision for our digital biology roadmap, and why digitalization of laboratories and manufacturing goes beyond improvements in quality, process, and throughput – but also creates new opportunities for commercial entities that were previously unreachable. Jonathan Jacobs, Ph.D., Senior Director of Bioinformatics, ATCC Waller D2:30 PM CDTDriving Commercial Launch Success with Digital Transformation Leveraging in-market launch and transition experience, Jeff highlights key factors and components to having a CGT-centric digital platform. This session serves to demonstrate key success indicators of digital transformation, highlight other commercial launch enablers and explain what differentiates market leaders in digital transformation Jeffrey Lacey, Senior Manager, Life Sciences, Deloitte Waller D3:00 PM CDTAfternoon Coffee Networking Foyer3:30 PM CDTImproving Assisted Reproduction Outcomes - State of the ART Preimplantation and Fertility Genetic Testing As demand for fertility treatments, including Assisted Reproductive Technologies (ART) grow, there is increasing interest in fertility and pre-implantation genetic testing (PGT) as an approach to improve treatment success. In vitro fertilization coupled with diagnosing of hereditary diseases in embryos (PGT-M) emerges as a treatment option for genetic disorders that are progressively identified though implementation and wider adoption of carrier screening. CReATe Fertility Centre is internationally renowned for its specialized fertility services and personalized fertility treatment powered by CReATe Reproductive Genetics, a leader in developing and providing fertility and preimplantation genetic testing to improve patient management and increase success in ART. A steady 30% year-over-year growth in samples processed, over 20% increase in patients tested, diversification of genetic tests (eg. embryo testing PGT-A, PGT-M, PGT-SR, PGT-HLA, unsuccessful pregnancies - products of conception, patient fertility work up), and platforms used (eg Next Generation Sequencing-NGS, Long read sequencing, SNP arrays etc), maintaining high laboratory and regulatory standards highlighted the need for digitalization and effective operation support system. L7 ESP has enabled to integrate the clinical information from CReATe Electronic Medical Record (EMR) system, develop customized LIMS to support the end-to-end workflows of high throughput laboratory operations with multiple technology platforms, adopt automation of NGS for PGT, manage high dimensional data and reporting in a complex clinical setting. L7|ESP's powerful audit trail and provenance history capabilities were essential in processing samples and in managing sample storage, inventory, and automating a multitude of important tasks from bar code printing to clinical report generation. Interactive development and implantation of L7|ESP LIMS and database system will prime the CReATe Reproductive genetics laboratory to handle and manage high throughput and growing activities. Svetlana Madjunkova MD, PhD, Member, Board of Directors, Canadian Fertility and Andrology Society (CFAS), Member, Board of Directors, Preimplantation Genetic Diagnosis International Society (PGDIS), Adjunct Faculty, Department of Laboratory Medicine and Pathobiology, Temerty Faculty of Medicine, University of Toronto, Executive Director, CReATe Reproductive Genetics, Toronto, Canada Waller D4:00 PM CDTEnabling the Life Sciences Value Chain: People - Data - Process - L7 Informatics A complex life sciences environment demands a resilient value chain and transformed business model that break down data silos, reduce turnaround times, and place patients at the center of your operations. With an industry-wide connected value chain, data is readily available and accessible, which enables informed decision-making and quick reactions to disruptions in the supply chain. This also contributes to data integrity and on-time delivery of quality products. At the L7 Universe, GVW is present to discuss its approach towards a lifesciences value chain data backbone of the future by integrating People, Data Process, and L7 Informatics, delivering better business and patient outcomes. Louis Hendriks, Founder and CEO, Global Value Web (GVW) Waller D4:15 PM CDTOf Mice and Men: the Story of the Jackson Laboratory Quantori will describe the collaborative work done with the Jackson Laboratory to develop and refine their laboratory technology infrastructure environments. The presentation will also share a high-level approach taken to implement L7|ESP to streamline operations and comply with evolving requirements for both commercial and research operations. Arun Nayar, Global Head, R&D Informatics, Quantori Waller D4:30 PM CDTL7 Roadmap Learn more about what is in L7's most recent release as well as where we are going over the next year. Robert Ziegler, VP Product Development, L7 Informatics Patrick Rose, Director of Product Management, L7 Informatics Waller D6:00 PM CDTDinner The Roosevelt Roomwednesday, november 169:00 AM CDTPanel Discussion: How do You Quantify Digital Success? For companies grounded in the physical world, measuring the return on investment in digital is critical to pacing investment, but key performance indicators vary depending on the use case. In this panel, we’ll hear L7 customers discuss their approaches to quantifying success for their organizations across a range of initiatives including customer-facing digital solutions, digital customer experience, digitization of business operations and digital ways of working together. Moderator: Surekha Trivedi, VP Data Analytics & Strategy, Danaher Panelists: Brendan Arbuckle, Sr. Director, Research IT, The Jackson Laboratory Ray Veeraraghavan, Executive Director - Advanced Diagnostics Technology, US, Quest Diagnostics Jonathan Jacobs, Ph.D., Senior Director of Bioinformatics, ATCC Waller D10:00 AM CDTMorning Coffee and Networking Foyer10:30 AM CDTTranslating Your Scientific Workflows into a Modern Digitalized Platform with Experienced Advocacy With the many different functions within the lab, the ability to get the most out of your solution is critical. Leveraging powerful solutions such as L7 ESP will provide the flexibility to fill any gaps and improve your overall process. Partnering with experienced professionals such as the team at Astrix avoids the need to learn how to be effective with an implementation. Even more valuable is the breadth of expertise, not only with your L7 implementation but across all the current market offerings. From this discussion we will look to cover:• Ways to translate and improve your existing processes into the L7 ESP workflow capabilities• How to properly augment your team for successful deployments• Leveraging the proper guidance to prevent or correct the most common oversights Adam Ryba, Director, LIS Delivery, Astrix Waller D10:50 AM CDTHow L7|ESP Has Enabled QIAGEN Laboratory Digitalization L7|ESP is a powerful platform with features that accelerate the development of customized content, which supports a broad range of customer needs. L7|ESP streamlines lab-process execution and analysis pipelines, integrates with laboratory instrumentation, and provides a full chain-of-custody and audit trail from sample to report. L7|ESP also offers a role-based approval system and electronic signatures which are critical to meet Quality Assurance requirements. Vikas Gupta, Associate Director, Global Bioinformatics and Software Development Lead at QIAGEN Waller D11:10 AM CDTUsing Innovative Microbial Genomic Techniques to Detect Pathogens Associated with Prosthetic Joint Infection Prosthetic joint infections impart a large healthcare and personal burden, and their incidence has been increasing in the United States. Contamination Source Identification® (CSI) is working together with premier orthopedic institutions, including the Rothman Institute and Zimmer Biomet, to develop its own assay, CSI-Dx®, using proprietary RNA-targeted genomic sample preparation and bioinformatics annotation (RAPID-Dx®) techniques to detect PJIs. In a pilot study, CSI’s technology revealed distinct microbial communities between primary, aseptic, and infected synovial fluid samples using its own proprietary RNA sequencing assay. CSI-Dx® also identified pathogenic taxa in synovial fluid suspected to be infected in which current culture-based diagnostics failed. Justin Wright, Co-Founder, Executive Vice President of Data Analytics, CSI-Dx / Wright Labs Waller D11:30 AM CDTESP in a High Throughput Diagnostic Genetics LabA start to implementation at GeneDx | sema4 Like many companies, GeneDx | sema4 has struggled to find or develop a single LIMS platform that can handle the volume, complexity, and change that is inherent in production life sciences. Third-party LIMS systems have been especially difficult to adopt due to lack of system performance at scale or copious amounts of customization that relied on vendor development. We endeavor to make L7|ESP the global solution that will manage and track all workflows within our high throughput and complex laboratory. Our efforts to make L7|ESP the sole LIMS platform started with a Whole Genome Next Generation Sequencing workflow and ramped up to manage our entire DNA Extraction process. These processes need to handle plates of samples simultaneously and ease user workload by eliminating the burden of manually registering each sample. The methods highlight the ability work at scale with multiple technology platforms and also display the ability to handle exceptions to the high-volume pipeline in order to fully track the laboratory process. Come explore how these two laboratory workflows are established for our high throughout genetics lab and the customizations that have made them successful. We’ll explore the makeup of these workflows and the custom APIs, protocol actions, pipelines, and applets that drive these processes. Additionally, we’ll discuss some insights into L7|ESP that we think could make the platform stronger for the high throughput environment and potentially help your own workflows. Chad Walters, Associate Director of Informatics, Gene-Dx | Sema4 Waller D12:00 PM CDTLunch Foyer1:00 PM CDTMphasis’ FHIR Based Interoperability Exchange Mphasis, an applied technology company, has created an Interoperability exchange for connecting various entities in the healthcare and life sciences sector with different transaction standards so as to make systems/products/applications/instruments interoperable. The exchange can read different transaction formats like HL7, HIPAA X12, FHIR and creating a FHIR based lake. This not only provides a plug n play FHIR data interface to any system including L7 Informatics, but can also be used for patient/provider(HCP) experience or analytics. Himanshu Gupta, Healthcare & Life Sciences Solutions Lead, Mphasis Waller D1:15 PM CDTMining Microbial Signatures Platform for New Diagnostics and Therapeutics Targets Using an advanced metagenomics pipeline and advanced AI capabilities can revolutionize how biomarkers/drug targets are identified and validated in the clinic (Accuracy & Speed). BiotaX has developed a novel platform to identify & validate new microbial signatures that can be used as a noninvasive, early-stage diagnosis. BiotaX initial focus was on early-stage diagnosis of Colorectal Cancer & Pancreatic Cancer and companion diagnostic for immunotherapy checkpoint blockade treatments. Shay Hilel, CEO, Biotax Labs LTD Waller D1:30 PM CDTUnified Single-Cell Data Management with TileDB Datasets generated by profiling single cells are growing rapidly in volume. The formats commonly used to distribute these data are not optimized for large volumes of data and cannot leverage cost effective cloud storage. Furthermore, choice of format is often determined by the language or analysis framework, creating silos of data that are difficult to share. To address these challenges, we have partnered with the Chan Zuckerberg Initiative to develop SOMA: a unified and open source solution for single-cell data. With TileDB-backed SOMA datasets, researchers can rapidly query and slice subsets of the data for analysis directly from the cloud and without downloading the entire dataset. We will demonstrate how the SOMA R and Python packages integrate directly with popular single-cell analysis frameworks like Seurat and Scanpy. And with TileDB Cloud researchers have a unified data management and analytics platform that provides data governance, simple sharing, and a serverless compute environment for scalable single-cell analysis. Aaron Wolen, Principal Software Engineer, TileDB Waller D1:45 PM CDTL7 & Tag.bio - A Data Mesh Architecture for Your L7 Data Assets L7 and Tag.bio have partnered up to provide a data mesh architecture for L7 data assets. Data mesh / data fabric are the terms of art for the concept of turning data sources into interoperable, extensible data products. Tag.bio has developed a comprehensive data mesh platform that couples FAIR data principles with a robust governance layer. By deploying L7 data assets into a data mesh architecture, organizations can augment the usability and functionality of their data. Tom Covington, CEO, Tag.bio Waller D2:00 PM CDTProcess Development using ELN on L7|ESP Platform L7|ESP is changing the software landscape at Triumvira, helping to bring data from research, process dev, and, ultimately, manufacturing. Come here how they are going to start with the ELN and sample registration, to change the way they work. Arnaud Deladeriere, Director of Process Development, Triumvira Patrick Rose, Director of Product Management, L7 Informatics Waller D2:15 PM CDTCustomer Success Overview & Highlights The success of our customers is top of mind for us. At L7 no one owns the customer, but someone always owns the moment. From our teams for Implementation, Customer Success, and Support, we strive daily to provide our customers with a consistent, predictable experience. Hear from Paul Wallace, Tom Ermlich, and Evan Payne on why 2023 is the year of Customer Success. Paul Wallace, VP Customer Operations, L7 Informatics Tom Ermlich, Sr. Practice Director, Professional Services, L7 Informatics Evan Payne, Director of Customer Success, L7 Informatics Waller D2:45 PM CDTL7 Masterclasses: What it's About, and Who Should Attend 2022 has been a big year for L7 University. J.P. Brown will introduce the L7 University team, share our growing portfolio of offerings, and present how you can access them at our new University website. He will wrap up with a preview of offerings planned for 2023. JP Brown, Director of Product Training, L7 Informatics Waller D3:00 PM CDTAfternoon Coffee Networking Foyer3:30 PM CDTL7 Product Session: Upcoming Applications - Moving Your Processes, and Workflows with the L7|HUB Brandon Varela, Scientific Technologist, Bioinformatics Applications, L7 Informatics - Learning How to Make the Most of Your Data with L7|INTELLIGENCE Patrick Rose, Director of Product Management, L7 Informatics - Scheduling Your Work in L7|ESP Megan Zimerman, Product Manager, L7 Informatics - Using the Manufacturing Execution System (MES) with L7|ESP Karri Unruh, Director of Product Management, L7 Informatics - Using the Notebook Application in L7|ESP Patrick Rose, Director of Product Management, L7 Informatics Waller D6:30 PM CDTDinner Zanzibarthank you to our partnersL7|UNIVERSE — celebrating our customers and partners in their journey to digital transformation explore opportunities L7's clients + partners the latest about L7 Informatics we're hiring ### ZiFo Partner gated L7 | Partner Resources ZiFo Partner gatedwebinars + presentations case studies white papers videos ebooks analyst reports latest news resources by verticalPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTUREPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTURE ### L7 UNIVERSE 2022 Executive Conference | November 15-16, 2022L7's inaugural annual executive conference We're looking forward to 2 days of dedicated executive and user tracks, filled with various sessions! We'll kick off the festivities on Monday evening with a welcome reception, have a full day Tuesday and Wednesday, and will round out the event with a Customer Celebration Dinner on Wednesday night.dates + venue Tue. Nov. 15th - Wed. Nov. 16th Location: Austin Marriott Downtown304 E Cesar Chavez St,Austin, TX 78701what will happen at L7|UNIVERSE? Business + Product + Partners Track Industry / Market Trends L7 Strategy + Roadmap L7 Customer Presentations L7 Partner Presentations L7 Excellence and Transformative Awards Operations + Science + Technology Track Training Opportunities Implementation and adoption of L7|ESP Preview and Advise on New Products Technical Sessions L7|UNIVERSE — celebrating our customers and partners in their journey to digital transformation explore opportunities L7's clients + partners the latest about L7 Informatics we're hiring ### 2022 BEBPA Europe Bioassay Conference Virtual Booth BEBPA 2022 EUROPE Bioassay Conference September 27-29, 2022 - Welcome to our virtual booth!together we can help improve the quality of life L7 Informatics reimagines data intelligence for modern life sciences and healthcare organizations. Beyond simple data management, L7 provides tools that optimize the flow of information between process and people, unlocking innovation at every stage of the clinical, research, and manufacturing value chains. Our comprehensive operating environment and software stack bring flexible, secure, and collaborative data intelligence to your entire operation. From regulatory compliance and workflow orchestration to customized applications and integrations, our end-to-end transformation engine helps organizations solve the challenges of today and realize the opportunities of tomorrow.L7 at a glanceL7 culture At L7, we aspire to do great things. L7's innovation is fueled by an interdisciplinary team of scientists, engineers, and operations-research experts. L7'ers are passionate about our technology with a desire to make a positive impact on improving the speed, efficiency, and progression of healthcare and life sciences organizations around the world. L7 is growing fast, and we are looking for potential colleagues that are as inspired and motivated as we are!explore opportunitiesdata+intelligence for the scientific enterprise L7 | ESP is designed to unlock innovation at every stage of the clinical, research, and manufacturing value chain. From data and workflow orchestration – to custom apps and integrations, L7 | ESP is an end-to-end transformation engine to help solve the challenges of today and realize the opportunities of tomorrow.L7's clients + partnersthe latest about L7 Informaticswe're hiring ### Microsoft L7 | Partner Resourceswebinars + presentations case studies datasheets white papers videos ebooks analyst reports latest news resources by verticalPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTUREPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTURE ### Contact Us Contact L7 InformaticsL7 INFORMATICS, Inc.1219 West 6th StreetAustin, Texas 78703 USAL7 INFORMATICS, Inc.1219 West 6th StreetAustin, Texas 78703 USAL7 INFORMATICS, Inc.1219 West 6th StreetAustin, Texas 78703 USAsupport@L7informatics.com ### Partners eBooks L7 | eBooks ### eBooks L7 | eBooks ### GVW L7 | Partner Resourcesresources by typePresentationscase studieswhite papersL7|ESPeBooksvideosnewsanalyst reportsresources by verticalPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTUREPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTURE ### 2022 BEBPA Bioassay Conference Virtual Booth BEBPA 2022 US Bioassay Conference – March 21-24, 2022 welcome to our virtual booth!together we can help improve the quality of life L7 Informatics reimagines data intelligence for modern life sciences and healthcare organizations. Beyond simple data management, L7 provides tools that optimize the flow of information between process and people, unlocking innovation at every stage of the clinical, research, and manufacturing value chains. Our comprehensive operating environment and software stack bring flexible, secure, and collaborative data intelligence to your entire operation. From regulatory compliance and workflow orchestration to customized applications and integrations, our end-to-end transformation engine helps organizations solve the challenges of today and realize the opportunities of tomorrow.L7 at a glanceL7 culture At L7, we aspire to do great things. L7's innovation is fueled by an interdisciplinary team of scientists, engineers, and operations-research experts. L7'ers are passionate about our technology with a desire to make a positive impact on improving the speed, efficiency, and progression of healthcare and life sciences organizations around the world. L7 is growing fast, and we are looking for potential colleagues that are as inspired and motivated as we are!explore opportunitiesdata+intelligence for the scientific enterprise L7 | ESP is designed to unlock innovation at every stage of the clinical, research, and manufacturing value chain. From data and workflow orchestration – to custom apps and integrations, L7 | ESP is an end-to-end transformation engine to help solve the challenges of today and realize the opportunities of tomorrow.L7's clients + partnersthe latest about L7 Informaticswe're hiring ### Standard Apps L7 | Standard AppsAssets Assets app in L7|ESP is used to manage a specialized class of entities call Assets that are used in the execution of laboratory and manufacturing operations. Assets can be of many types (e.g. instruments, equipment, tools and clean rooms) and in regulatory environments put into workflows (processed) for calibration and cleaning as documented in the asset management standard operating procedures.Dashboards & Reports The Dashboards app provides high-level operational metrics (reagents to re-order, sample turnaround times, resource bottlenecks) to summarize and display what is happening in the labs and clean rooms. The Reports app compliments the metrics displayed on the Dashboards app. The Reports app allows you to view this data in L7|ESP an organized manner. Reports can be customized for each customer. The Reports tab shows the full list of Reports via List, Group or Card view.Data The Data app gives you complete access to all data files registered in L7|ESP. Each file can be a standalone file or be associated with one or more Entities, experiments and batch records.Entities Entities app in L7|ESP is used to create business objects in a lab or clean room that are tracked as they progress through various Workflows (e.g., samples, orders, patients, specimens, assets, inventory etc.). L7|ESP allows users to create a two-level hierarchy of business objects – entity class and entity type (e.g. an Asset class can have Asset types such as Instruments, Pipettes etc.) The Entities app displays a list of all Entities in L7|ESP and allows you to register new Entities and submit Entities to a Workflow. Click on entity to access details and associated details (i.e., Entity Name (ID), Entity Class, Sample Type, Tag(s), Description, Owner, Created, Updated, and Barcode).Ingest The Ingest app offers an easy mechanism for importing and loading Samples and other Entities into ESP in bulk and annotating the Entities with metadata, which helps users with existing datasets adopt ESP. Allowable formats to Ingest include: txt, csv, xlsx, and JSON (JSON data must be structured in a format suitable for parsing into a tabular file).Projects The Projects app has three tabs: the Projects tab displays details of all Projects, the Experiments tab displays details of all Experiments (or batches) grouped by Project, and the Planner tab is a tool used to view and manage a Workflow Chain plan, focusing on the visualization of Experiment (batch) dates and durations along their lifespans.Samples Samples app is used to manage a specialized class of L7|ESP entity, the Sample – which is used to model the various types of biological starting material and extracted materials such as blood, tissue, urine, libraries, DNA, RNA, protein etc. The Samples app displays the chain of identity between the parent and child samples as well as the data (experimental and master) associated with each samples and its entire audit history.Search The L7|ESP Search app can be used to securely search globally across all the data stored in ESP, and displays Search History and your Recent Activity.L7 servicesWhen you become a customer, you'll be granted full access to L7 | University, an incredibly rich library of proprietary content and training resources. ### Digital+Science L7 | Digital+Science modern tools for digitalization and transformation across the scientific enterprise and extended value chain​digitalization + transformation Digitalization and Transformation are no longer buzzwords - but a business imperative. L7 enables you to meet evolving scientific and business needs with the tools to create, share and reuse your own data & process models, execute multi-party workflows with value-chain partners, with the data-integrity and provenance to support increasing intelligence.L7 | MASTER L7 | MASTER (aka Builders) is a low-code authoring tool that enables your citizen-developers, scientists, and process engineers to design and develop new data and process models + variants.​L7 | HUB L7 | HUB is your repository of portable, standardized content—including workflows, data models, and analytics packages—organized in a searchable storefront.​L7 | INTELLIGENCE To deliver on the promise of precision healthcare and life sciences, L7 enables the mining of data to generate prospective and predictive Intelligence and models.​TRENDING​ What processes are we running?​ High-level​ Summarize performance over time​ Track performance metrics​ Align to strategic goals OPERATIONAL​ Are our processes under control?​ More detailed than trending reports​ Monitor and analyze activities in a given business area​ Exception alerting based on real-time data​ Monitor progress towards a target​ Designed to be viewed multiple times throughout the day​ Can lead to direct action, further analysis, and improvement ANALYTICAL​ Where do we need to improve our process?​ Analyze large volumes of data​ Investigate trends, predict outcomes, and discover insights​ Drill-down and ad-hoc querying​ Monitor process-capability or method-variability to facilitate root-cause analysis L7 | EXCHANGE L7 | EXCHANGE enables disconnected teams and partner organizations to securely orchestrate multi-party workflows–involving apps, processes, and legacy systems unique to each group.L7|ESP is an adaptable and customizable platform that streamlines process execution, provides a complete chain of custody from sample to report, and enables management of complex workflows. Simon Hughes, Associate Director, CDx Assay Development, QIAGENL7|ESP provides a single platform to assure both control and compliance, while providing a seamless transfer of clinical operations to manufacturing operations. Ernie Bognar, Chief Operations Officer, Gradalis, Inc. ### Deloitte Technology Fast 500 2021, 2022, 2023 & 2024 Deloitte Technology Fast 500L7 made the FAST 500 winners list again! We're proud to celebrate four consecutive years on the Deloitte Technology Fast 500™, a recognition that highlights L7's sustained innovation and growth in the life sciences sector. This year’s honor underscores the transformative power of our unifying platform, L7|ESP®, which continues to help organizations transcend traditional data silos, drive operational efficiency, and unlock the potential of AI-ready, contextualized data—laying the foundation for true AI capabilities in life sciences. This achievement is a testament to the trust and collaboration of our customers and partners, as well as our unwavering commitment to advancing life sciences with solutions that enable smarter, faster, and more flexible decision-making.L7 joins the FAST 500 winner’s circle again In its third consecutive year on the Deloitte Technology Fast 500™, L7 Informatics celebrates its significant revenue growth of 2047%. This achievement underscores the company's innovative approach and dedication to delivering value to the life sciences sector. Led by CEO Dr. Vasu Rangadass, L7 Informatics has been instrumental in helping innovative life science organizations optimize their operations, transcending traditional data silos. The company's unified platform, L7|ESP™, offers unprecedented flexibility and has quickly become an industry standard, driving both cost efficiency and productivity. This recognition reflects not only past accomplishments but also the company's ongoing commitment to transformation, innovation, and a prosperous future.our journey L7 Informatics’s chief executive officer, Vasu Rangadass, Ph.D., credits the increasing awareness for the need for a unifying platform like L7|ESP® that integrates data across various departments (R&D, clinical, manufacturing, etc.) while seamlessly providing process orchestration and data contextualization. Vasu Rangadass, Ph.D.CEOIt’s imperative that we break down these digital silos produced by legacy point solutions by adding a platform that unifies data into knowledge graphs, offers holistic control of the scientific workflow orchestration (including instrument integration), and applies data contextualization so these companies can now unlock the power of AI without human intervention. ### Astrix Partner Resource Page L7 | Partner Resourceswebinars + presentations case studies datasheets white papers videos ebooks analyst reports latest news resources by verticalPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTUREPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTURElet's work together ### 2021 BEBPA Bioassay Conference Virtual Booth L7 | ESP™BEBPA 2021 EUR Bioassay Conference (Sept. 20-23, 2021)Welcome to our virtual booth!who we are L7 Informatics is a leader in enterprise-scale digital transformation and automation of scientific processes in the life sciences and healthcare. L7's mission is to revolutionize scientific process and data management to accelerate precision health across life sciences, healthcare, and nutrition value chains. Our end-to-end solutions and services yield efficiencies that enable researchers to make new genomics discoveries, precision therapeutics manufacturers to create higher fidelity therapies, health systems to provide superior diagnostics and standard of care, and precision agriculture to meet tomorrow's nutrition needs through improvements to crops and livestock. Our platform, L7|ESP, is a unified and composable platform with a single data fabric that reduces the total cost of operations while enabling digital transformation. This FDA regulatory compliant platform comes with several pre-built best-in-class apps: ELN, LIMS, Sample Management, Inventory, Analysis, EBR (Electronic Batch Record), Dashboards, Data, Intelligence, EM (Environmental Monitoring), Builders, Search, etc. L7|ESP's REST API library and Python SDK enable flexibility and extensibility to meet customer-specific requirements. We are continuously adding new applications with each release. Our approach breaks down barriers by providing streamlined processes and better data management across all functionalities. We integrate L7 solutions with external, in-house, and open-source tools to create a seamless workflow. We develop and deliver customized, end-to-end solutions that integrate seamlessly and scale with your entity for future growth by working closely with our customers and partners. presenting L7|ESP: precision solutions for science + health Precision health is bringing biology to the forefront of scientific discovery and human health. Yet, today’s data silos and outdated and disjointed systems delay progress, increase costs, and put patients at risk. Realizing the incredible potential of precision health requires a new, digitally-enabled approach to how science gets done. ​what makes L7|ESP an ideal operating system for your lab? L7 is the premier FDA compliant operating platform for science in the precision era. Unlike traditional LIMS, ELNs, and other data management systems built for a single purpose, L7’s integrated software solutions tailor workflows for your specific needs, enabling rapid assessment of lab operations or treatment protocols while automating data analysis, visualization, and reporting. L7’s solutions and services are built for today’s complex and constantly evolving precision lab and clinical environments. Rather than a one-size-fits all approach, L7 overlays and connects legacy systems and provides access to hundreds of pre-built apps and connectors alongside a continuously growing content library. Limitlessly customizable and composable, L7 even allows users to build their own solutions using our low-code development tool, L7|Master.executive teammanagement teamL7's clients + partnerswe're hiringthe latest about L7 Informatics ### Book a Demo L7 | Book a Demorequest a demo now Fill out the form and we'll reach out to you to show you a demo of L7|ESP ### Customers L7 CustomersL7|ESP is an adaptable and customizable platform that streamlines process execution, provides a complete chain of custody from sample to report, and enables management of complex workflows. Simon Hughes, Associate Director, CDx Assay Development, QIAGENL7|ESP provides a single platform to assure both control and compliance, while providing a seamless transfer of clinical operations to manufacturing operations. Ernie Bognar, Chief Operations Officer, Gradalis, Inc. ### SLO L7 Informatics Product SupportVisibility CTOs, Manufacturing and CMC leaders can use ESP to gain visibility to assess operational performance, long term planning needs, and state of regulatory compliance and business goals.Integration Heads of supply chain, clinical operations, and process development benefit from ESP’s data integration across the full therapeutic value chain to understand cycle times, delivery performance, capacity bottlenecks, and resource allocations.Collaboration Directors of quality control, manufacturing, and process development use ESP to quickly streamline data exchange across functions, improving the access to data across teams to improve team performance and deliver on critical milestones.outstanding support L7 Informatics Product Support provides expert technical assistance worldwide through highly experienced professionals committed to customer satisfaction. Our highly skilled support team has a comprehensive knowledge of our different products. L7 Informatics Product Support is available in Support Plans outlined below:Included with license for no additional cost. Basic provides access to L7's knowledge base.Available for an additional fee, Daily Care provides access to our customer support team via our ticketing system and when needed includes live virtual access to support engineers during normal business hours 7a – 7p CST Monday through Friday.Available for an additional fee, Daily Care provides access to our customer support team via our ticketing system and when needed includes live virtual access to support engineers 7x24x365.Configure, extend and customize your implementation(s) of L7|ESP with the help of direct access to L7 engineers who are familiar with your use cases, personnel, and goals for the L7|ESP platform. Available for an additional fee.understanding L7 Informatics product support severities The severity level is a measure of the relative impact of the technical issue on your systems or business. Accurately defining the severity ensures a timely response and helps L7 Informatics Support to better understand the nature of your issue. Response and resolution times may be different based on your Support Terms with L7 Informatics – please refer to your License Agreement for more details. L7 Informatics will make reasonable efforts to adhere to the response and resolution times for issues within the scope of its own software. The following definitions of Severity should be used when opening support tickets: Critical production issue that severely impacts your use of L7|ESP™. The situation halts your business operations, and no procedural workaround exists.Major functionality is impacted, or significant performance degradation is experienced with L7|ESP. The situation is causing a high impact to portions of your business operations and no reasonable workaround exists.There is a partial, non-critical loss of use of the service with a medium-to-low impact on your business, but your business continues to function. A short-term workaround is available, but not scalable.Inquiry regarding routine technical issues.product support plans solution sheet L7 ESP for precision therapeutics ### Partners White Papers L7 | White Papers, Publications and Articles ### Partners Case Studies L7 | Customer and Partner Case Studies ### ZiFo Partner L7 | Partner Resourceswebinars + presentations case studies white papers videos ebooks analyst reports latest news resources by verticalPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTUREPRECISION THERAPEUTICSPRECISION MEDICINEPRECISION DIAGNOSTICSPRECISION RESEARCHPRECISION AGRICULTURE ### Partner Webinars L7 | Webinars and Industry Presentations ### Partners L7 Partnerspartnering with L7 L7 employs a collaborative partnering model that focuses on both our customer’s success as well as our partners’. This approach enables L7’s partners to increase the value L7’s Enterprise Science Platform (ESP) provides to our customers. Through this diverse partner network our customers can access end-to-end integrated solutions and extensive professional service offerings.implementation/strategic partners Having the right L7|ESP implementation partner by your side will allow your business to achieve its full potential and ensure positive outcomes. An L7|ESP implementation partner will design, configure, and implement the right solution for your laboratories, that meet your exacting requirements, eliminates business bottlenecks, and turns your data into intelligence. So whether it is the configuration of L7|ESP, app and instrument integrations, or ongoing development and support, our certified partners ensure your team uses its L7|ESP platform to its fullest potential.technology partners L7’s technology partners play a pivotal role in our customer’s success. They provide a way for our customers’ organization to implement and optimize L7|ESP with its various technical systems with the help of related IT infrastructure and/or expanded functionality within the L7|ESP platform via enhanced integrated solutions. Our partners can help with seamless cooperation between L7|ESP and other IT systems to avoid hassles transitioning from old to new technology. In combination with our implementation partners and the L7|ESP platform, L7 Informatics can take you from implementations of the past to Lab of the Future today!OEM partners L7’s OEM (value-added) partnerships allow our partners to leverage the power of L7|ESP, a fully integrated enterprise platform, to enhance the value of their solution(s). Our partners work with L7's technical team to integrate L7|ESP into their solutions whether it is a focused point solution, instrument or robotics system, or a turn-key laboratory. Our partners then market and sell the enabled technology, bringing a new digital infrastructure to their customers that unlocks the power of true data intelligence.become a L7 partner We take pride in maintaining partnerships with corporations that share our excitement for transforming unstructured information into the building blocks of scientific discovery and business growth. Does this resonate with you? Interested in becoming part of our partner ecosystem? Let’s talk!This joint development effort with L7 will create a smartPOD cleanroom infrastructure . We firmly believe that automating processes in this way is essential to improving quality and reducing costs in pharmaceutical manufacturing. Maik Jornitz, President and CEO, G-CON ManufacturingWe’re very excited about our partnership with L7 because they appreciate and align their product and commercialization strategy with the market landscape of precision medicine and multi-omics opportunities. Trent Norris, Senior Program Manager, Microsoft GenomicsL7 is reshaping the way companies should think about laboratory information management systems and we’re pleased that they chose to do it on Azure and with the Microsoft Genomics service. Trent Norris, Senior Program Manager, Microsoft GenomicsL7|ESP has a unique offering in the marketplace and is dedicated to breaking down silos within life sciences. Rob Greenwood, CEO, SciBiteWe are excited to partner with L7 Informatics and continue to fuel discoveries with the power of data. Rob Greenwood, CEO, SciBite ### CDMO L7 | Contract Development and Manufacturing Organizationsdata+intelligence for CDMO L7|ESP offers an end-to-end solution for the regulatory compliant automation of biologics manufacturing and quality control operations, from original source samples to final drug products, digitally transforming the information technology landscape. Siloed multi-vendor IT systems make it challenging to create an integrated and validated environment for biologics manufacturing with processes involving a mixture of paper, software systems, instruments, environmental monitoring systems, and bioprocess equipment. L7|ESP is a unique software package that provides an integrated data platform for the digital transformation of the sample to drug process with features including QC LIMS, Environmental Monitoring, Electronic Batch Records (EBR), MES, CPV, inventory, sample management, equipment integration, analytics/statistical processing, and business intelligence dashboards.L7 CDMO workflow business benefits VELOCITY​ accelerate sample-to-drug ​ EFFICIENCY​ easy to implement and user-driven no rip and replace of existing systems ​ COMPLIANCE​ CFR part11/GCP/GMP solution capabilities INTEGRITY​ single data and process automation platform integrated and validated environment strengthen the understanding between process, product, and patient outcomes ​ COLLABORATION​ better collaboration between all stakeholders ​ CONNECTIVITY​ software environmental monitoring bio-process equipment quality control instrumentation solution packagesL7 PRECISION THERAPEUTICS lab digitalize lab operations Design, execute, and report quality control laboratory operations to a GMP QC level. Capture quality and business decisions. L7 BUSINESS APPS Environmental Monitoring (EM) Inventory Validation Locations Scheduling StabilityTracking Logistics L7 STANDARD APPS Projects Entities Data Samples Search Ingest Dashboards Reports Knowledge Graph L7 PRECISION SOLUTION CONTENT Connectors - Software Connectors - Instrument Standard Methods Reports Role and Access Profiles Standard Entity Types L7 PREMIUM APPL7 | LIMS The LIMS app allows you to accept Entities (Samples and otherbusiness objects such as Assets and Inventory) and direct themthrough a Workflow and Workflow Chains. You can also view Entitieswaiting to be processed (the queue), as well as create and fill outsample worksheets.L7 PRECISION THERAPEUTICS manufacturing design and execute controlled manufacturing processes Capture, report, and store all operations data and results to a cGMP compliant level. Capture quality and business decisions. L7 BUSINESS APPS Inventory Personnel Validation Locations Scheduling Planning Assets Tracking and Logistics L7 STANDARD APPS Projects Entities Data Samples Search Ingest Dashboards Reports Knowledge Graph L7 PRECISION SOLUTION CONTENT Connectors - Software Connectors - Instrument Standard Unit Operations Reports Role and Access Profiles Standard Entity Types L7 PREMIUM APP L7 | MANUFACTURING EXECUTION SYSTEM (MES) Equipment integration, automated calculations, inventory consumptionand asset usage. Full support for part 11 compliant signatures and PDFgeneration of batch records after completion.L7 PRECISION THERAPEUTICS supply track cell lines from source to storage Generate repeatable controlled processes to fully track cell lines from source, to expansion, to fill and storage. L7 BUSINESS APPS Inventory Personnel Validation Locations Scheduling Planning Assets Tracking and Logistics L7 STANDARD APPS Projects Entities Data Samples Search Ingest Dashboards Reports Knowledge Graph L7 PRECISION SOLUTION CONTENT Connectors - Software Connectors - Instrument Standard Unit Operations Reports Role and Access Profiles Standard Entity Types L7 PREMIUM APP L7 | MANUFACTURING EXECUTION SYSTEM (MES) Equipment integration, automated calculations, inventory consumptionand asset usage. Full support for part 11 compliant signatures and PDFgeneration of batch records after completion.L7 PRECISION THERAPEUTICS clinical replace paper-based planning and tracking Organize and schedule patients, sites, studies and regulatory submissions. L7 BUSINESS APPS Tracking and Logistics L7 STANDARD APPS Identity and Access Mgmt (IAM) Security L7 PRECISION SOLUTION CONTENT Connectors - Software L7 PREMIUM APPL7 | CLINICAL OPERATIONS Clinical Operations app in L7|ESP is used to manage clinicaloperations for autologous cell-based therapies. The app manages thevein-to-vein chain of Identity and chain of custody and provides eraltime visibility to manufacturing slots to all the clinical trial sites as wellas integration to logistics providers.L7 PRECISION THERAPEUTICS development analytical and process development Design, execute, and report development studies in preparation for transfer to GMP operations. Capture quality and business decisions. L7 BUSINESS APPS Inventory Design of Experiment (DOE) Validation Locations Assets Stability L7 STANDARD APPS Projects Entities Data Samples Search Ingest Dashboards Reports Knowledge Graph L7 PRECISION SOLUTION CONTENT Connectors - Software Connectors - Instrument Standard Methods Standard Unit Operations L7 PREMIUM APPL7 | ELECTRONIC LAB NOTEBOOK (ELN) Capture data while executing unstructured experiments for research and protocol / method / assay development.L7 PRECISION THERAPEUTICS drug discovery correlate findings from research to potential targets Extend findings from research and correlate with disease mechanisms and potential targets to disrupt or correct using biologics or C> methods. L7 BUSINESS APPS Inventory Design of Experiment (DOE) Locations L7 STANDARD APPS Entities Data Samples Search Ingest Knowledge Graph L7 PRECISION SOLUTION CONTENT Connectors - Instrument Standard Methods L7 PREMIUM APPL7 | ELECTRONIC LAB NOTEBOOK (ELN) Capture data while executing unstructured experiments for research and protocol/method/assay development.L7 PRECISION THERAPEUTICS research explore disease pathways + tools and techniques for investigation Capture experiments and collaborate on tasks across research groups. L7 BUSINESS APPS Design of Experiment (DOE) Locations L7 STANDARD APPS Entities Data Samples Search Ingest Knowledge Graph L7 PRECISION SOLUTION CONTENT Connectors - Instrument Standard Methods L7 PREMIUM APPL7 | ELECTRONIC LAB NOTEBOOK (ELN) Capture data while executing unstructured experiments for research and protocol/method/assay development.L7 in the newsL7 servicesWhen you become a customer, you'll be granted full access to L7 | University, an incredibly rich library of proprietary content and training resources.L7|ESP is an adaptable and customizable platform that streamlines process execution, provides a complete chain of custody from sample to report, and enables management of complex workflows. Simon Hughes, Associate Director, CDx Assay Development, QIAGENL7|ESP provides a single platform to assure both control and compliance, while providing a seamless transfer of clinical operations to manufacturing operations. Ernie Bognar, Chief Operations Officer, Gradalis, Inc.solution data sheetL7|ESP FOR PRECISION THERAPEUTICS Precision medicine and new classes of biological treatments, including cell and gene therapies, require a new category of companion informatics that automate and synchronize complete manufacturing, quality management, and treatment processes. read key benefitsL7|ESP provides a single data and process automation platform for all therapy-related information in a regulatory compliant way that supports better collaboration between all the stakeholders.L7|ESP links disparate systems with connectors to existing systems, apps to view the same data from one system, and interfaces with analytics tools.L7|ESP is easy to implement and user-driven, with no rip and replace existing systems. It has an integrated suite of applications such as LIMS, EBR, etc. that provides complete data provenance from tissue collection to shipping, including manufacturing, QC, and packaging.value proposition L7|ESP can serve as a data slipstream for manufacturing, process, and QC data thereby improving quality, reducing redundancies, and enhancing visibility across stakeholders, thereby strengthening the understanding between process, product, and clinical outcomes.clientsclientsresourcesL7 INFORMATICS AND GRADALIS readL7 INFORMATICS AT WORLD VACCINE & IMMUNOTHERAPY CONGRESS watchWEBINAR: COMPANION INFORMATICS’ TO AUTOMATE IMMUNOTHERAPY MANUFACTURING & TREATMENT watchL7 in the newsG-CON MANUFACTURING AND L7 INFORMATICS ANNOUNCE A COLLABORATION TO DEVELOP ESP G-CON SMARTPOD, THE FIRST-OF-ITS-KIND INTEGRATED CLEANROOM SOFTWARE PLATFORM readCOGNATE BIOSERVICES, THE LEADING BIOLOGICS CDMO, SELECTS L7 INFORMATICS TO IMPLEMENT L7|ESP FOR INTEGRATED MANUFACTURING AND LAB OPERATIONS readGRADALIS DEPLOYS L7’S ENTERPRISE SCIENCE PLATFORM FOR NEXT-GENERATION LIFE SCIENCE COMPANIES IN RECORD TIME TO SUPPORT MISSION-CRITICAL IMMUNOTHERAPY MANUFACTURING AND CLINICAL TRIAL PROCESSES readL7 INFORMATICS RECOGNIZED AS A COOL VENDOR IN THE MAY 2020 COOL VENDORS IN LIFE SCIENCES REPORT BY GARTNER readget in touch Let’s work together to solve your workflow challenges. ### L7 Informatics Gartner Recognition & Analyst Mentions L7 Recognized by Gartner® for Innovation in Life SciencesL7 was identified in THIRTY-ONE Gartner reports, INCLUDING HYPE CYCLES AND MARKET GUIDES: Gartner, "Hype Cycle for Life Science Manufacturing" Hybrid Execution System, 2025, ID G00832373, 16 July 2025 Gartner, "Hype Cycle for Life Science Manufacturing" Cell and Gene Therapy Platform, 2025, ID G00832373, 16 July 2025 Gartner, "Hype Cycle for Life Science Manufacturing" Laboratory Informatics Suites, 2025, ID G00832373, 16 July 2025 Gartner, "Hype Cycle for Life Science R&D" Cell and Gene Therapy Platform, 2025, ID G00832966, 7 July 2025 Gartner, "Hype Cycle for Life Science R&D" Workbench for Genomics Research, 2025, ID G00832966, 7 July 2025 Gartner, "Hype Cycle for Life Science R&D" Laboratory Informatics Suites, 2025, ID G00832966, 7 July 2025 Gartner, Market Guide for Laboratory Information Management Systems, 2025, ID G00757034, Analysts Michael Shanler, Reuben Harwood, Lynn Rice, 16 April 2025 Gartner, Market Guide for Electronic Laboratory Notebooks, 2025, Analysts Michael Shanler, Reuben Harwood, Lynn Rice, 5 May 2025 Gartner, "Hype Cycle for Life Science Manufacturing, Quality and Supply Chain", 2024, ID G00814456, 13 August 2024 Gartner "Hype Cycle for Life Science Discovery Research", 2024, ID G00814161, 13 August 2024 Gartner "Hype Cycle for Life Science Commercial Operations", 2024, ID G00812983, 13 August 2024 Gartner, "Hype Cycle for Life Science Clinical Development", 2023, Analyst Jeff Smith, 20 July 2023. Gartner, "Hype Cycle for Life Science Commercial Operations", 2023, Analyst Animesh Gandhi, 19 July 2023. Gartner, "Hype Cycle for Digital Care Delivery Including Virtual Care", 2023, Analysts Sharon Hakkennes, Veronica Walk, 16 July 2023. Gartner, "Hype Cycle for Healthcare Providers", 2023, Analysts Andrew Meyer, Roger Benn, 16 July 2023. Gartner, "Life Science CIO’s Strategy for Delivering Cell and Gene Therapy Capabilities", 2023, Analysts Michael Shanler, Jessica Hong, 20 March 2023. Gartner, "Hype Cycle for Consumer Engagement and Experience in Healthcare and Life Sciences", 2022, Analyst Kate McCarthy, 27 July 2022. Gartner, "Hype Cycle for Life Science Manufacturing, Quality and Supply Chain" 2022, Analysts Michael Shanler, Rick Franzosa, Maria Nieradka, Rohan Sinha, 26 July 2022. Gartner, "Hype Cycle for Life Science Clinical Development", 2022, Analysts Jeff Smith, Rohan Sinha, 26 July 2022. Gartner, "Hype Cycle for Life Science Discovery Research", 2022, Analysts Michael Shanler, Reuben Harwood, 26 July 2022. Gartner, "Hype Cycle for Healthcare Providers", 2022, Analysts Andrew Meyer, Mike Jones, 18 July 2022. Gartner, "Hype Cycle for Life Science Commercial Operations", 2022, Analyst Animesh Gandhi, 18 July 2022. Gartner, "Hype Cycle for Digital Care Delivery Including Virtual Care", 2022, Analysts Sharon Hakkennes, Veronica Walk, 9 July 2022. Gartner, “Hype Cycle for Digital Care Delivery Including Virtual Care”, 2021, Analysts Sharon Hakkennes and Mike Jones, 13 July 2021. Gartner, “Hype Cycle for Healthcare Providers”, 2021, Analysts Mike Jones and Sachin Dev, 12 July 2021. Gartner, “Hype Cycle for Consumer Engagement With Healthcare and Wellness, 2020, Analysts Mark Gilbert, Jeff Cribbs, 13 August 2020. Gartner, “Hype Cycle for Life Science Research and Development 2020,” Analysts Jeff Smith, Michael Shanler, 13 August 2020. Gartner, “Hype Cycle for Life Science Manufacturing, Quality & Supply Chain, 2020, Analysts Michael Shanler, Stephen Meyer, Andrew Stevens, 12 August 2020. Gartner, “Hype Cycle for Digital Care Delivery Including Telemedicine & Virtual Care, 2020, Analysts Sharon Hakkennes, Laura Craft, Mike Jones, 10 August 2020. Gartner, “Hype Cycle for Life Science Commercial Operations, 2020, Analysts Animesh Gandhi, Michael Shanler, 6 August 2020. Gartner, “Hype Cycle for Healthcare Providers, 2020, Analysts Laura Craft, Mike Jones, 5 August 2020. Gartner, 2025 Market Guide for Laboratory Information Management Systems. Figure 2: The Evolution of Lab InformaticsL7 is honored to be RECOGNIZED as a Sample Vendor in Gartner® Hype Cycle™ for Life Science Manufacturing, Quality, and Supply Chain, 2024! According to Gartner, “Supply chains continue to be disrupted, and as CIO, you must work with quality, operations and supply chain leaders to sustain flexible production capabilities and build resiliency while supporting IT modernization projects. CEOs will increase pressure on IT leaders and business professionals to reduce costs and build efficiencies at scale with technology-centric approaches in the year ahead."¹ Read more Gartner insights on how CIOs can use this Hype Cycle to identify the emerging technologies and innovations available to life science manufacturing organizations in order to build and deliver the quality products and services their CEOs expect. ¹ Source: Gartner, Hype Cycle for Life Science Manufacturing, Quality and Supply Chain, 2024, published 13 August 2024 - ID G00814456, by Michael Shanler, Maria Nieradka. DOWNLOAD RESEARCH L7 is one of only five companies recognized in the Cool Vendors in Life Sciences report that technology leaders should watch to help accelerate life science business results. According to the report, “life science companies are increasingly looking to technology-based innovation to drive R&D pipelines, digital capabilities, novel therapies and new commercial engagement models. CIOs should consider these new, disruptive vendors that are poised to help accelerate life science business results.” The GARTNER COOL VENDOR badge is a trademark and service mark of Gartner, Inc. and/or its affiliates and is used herein with permission. All rights reserved. Gartner does not endorse any vendor, product or service depicted in its research publications and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s Research & Advisory organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose. Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, express or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose. GARTNER is a registered trademark and service mark of Gartner, Inc. and HYPE CYCLE is a registered trademark of Gartner, Inc. and/or its affiliates in the U.S. and internationally and are used herein with permission. All rights reserved.The GARTNER COOL VENDOR badge is a trademark and service mark of Gartner, Inc. and/or its affiliates and is used herein with permission. All rights reserved. Gartner does not endorse any vendor, product or service depicted in its research publications and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s Research & Advisory organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose. Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, express or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose. GARTNER is a registered trademark and service mark of Gartner, Inc. and HYPE CYCLE is a registered trademark of Gartner, Inc. and/or its affiliates in the U.S. and internationally and are used herein with permission. All rights reserved. ### Terms of Use L7 | Terms of UseIntroduction The following Website Terms of Use and Acceptable Use Policy govern your use of our website and hosted services that we (L7 Informatics, Inc.) may provide to you. The Terms of Use apply to your use of our website and the Acceptable Use Policy applies to your use of any Hosted Services. L7 may revise these terms at any time and will update the “Last Updated” date at the bottom of this page when it does so. It is your responsibility to check this page and take notice of any changes. These terms do not permit you to use of any products or services (including hosting services) that may be offered by L7 or any products or services that may be offered by third parties from or in connection with the Website or otherwise, which are subject to their own terms and conditions. You must accept any terms and conditions relating to products and services as a condition to receiving such products or services. Website Terms of Use General These Website Terms of Use (“Website Terms”) govern your access to and use of our website located at https://l7informatics.com (the “Website”). By accessing, browsing, using and interacting with this Website, you agree that you have read, understood, and accept the Website Terms. Please read them carefully and let us know if you have any questions. If you do not agree with any of the terms herein, do not use the Website. Use of the Website You may only use this Website for its intended purpose and solely in accordance with these Website Terms. In addition, you may not restrict or inhibit any other person from using or enjoying the Website. The Website may contain links to other Internet websites and third-party resources, and we may employ third party technologies in connection with our Website that require you to accept such third party’s terms. L7 is not responsible for either the availability of these outside resources or their content, including for any products or services you may obtain by contacting any person or entity as a result of use of the Website or the features hereof. L7 may, but is not obligated to, monitor your use of the Website Intellectual Property The content of this Website is protected by law, including without limitation United States copyright law, trademark law, and applicable international treaties. You are granted permission to display the materials on this Website solely for your own personal, non-commercial use. You may not remove any legends placed thereon. You may not “mirror” any content contained within this Website without our express prior written consent. Except as stated herein, none of the content may be reproduced, distributed, published, displayed, downloaded, or transmitted in any form by any means without our prior written consent, or the consent of the applicable copyright owner. L7 does not grant you any licenses, express or implied, to the intellectual property of L7 or its licensors, except as expressly stated in these Website Terms. Transmission of Content Any material, information or ideas that you transmit to or post to or through this Website by any means will be treated as non-confidential and non-proprietary, despite any legends to the contrary, and may be used by L7 and its designees for any purpose whatsoever. Notwithstanding the foregoing, all personal information provided by you will be handled in accordance with L7’s Privacy Policy (https://l7informatics.com/privacy/). You agree to the terms of such Privacy Policy by providing your personal information to L7. International Use This Website is controlled and operated by L7 from within the United States. L7 makes no representations that materials contained within the Website are appropriate or available for use in other locations, and access to the Website from locations where such activity is illegal is prohibited. Those who choose to use the Website from other locations do so on their own initiative and are solely responsible for compliance with all applicable laws. U.S. Government Restricted Rights The content of this Website is provided with “RESTRICTED RIGHTS.” Use, duplication, or disclosure by the United States Government is subject to restrictions as set forth in applicable laws and regulations. Limitation of Liability THE WEBSITE AND ITS CONTENT ARE PROVIDED TO YOU STRICTLY ON AN “AS IS” BASIS. ALL CONDITIONS, REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT OF THIRD PARTY RIGHTS, ARE HEREBY DISCLAIMED TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW. IN NO EVENT SHALL L7 BE LIABLE TO YOU OR ANY THIRD PARTY FOR ANY INDIRECT, CONSEQUENTIAL, EXEMPLARY, INCIDENTAL, SPECIAL OR PUNITIVE DAMAGES, INCLUDING LOST PROFIT DAMAGES ARISING FROM YOUR USE OF THE WEBSITE OR ITS CONTENT, EVEN IF L7 HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED IN THESE WEBSITE TERMS, L7’S AGGREGATE LIABILITY TO YOU FOR ANY CAUSE WHATSOEVER AND REGARDLESS OF THE FORM OF THE ACTION, WILL AT ALL TIMES BE LIMITED TO $50.00. SOME JURISDICTIONS DO NOT ALLOW THE LIMITATION OR EXCLUSION OF LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATIONS OR EXCLUSIONS MAY NOT APPLY TO YOU. Term and Termination These Terms are effective as of the date of your first access or use of the Website, and shall remain in effect for the duration of your access or use. Your right to use the Website shall automatically terminate upon your breach of these Website Terms. General The laws of the State of Texas, excluding its conflict of law principles, govern these Website Terms and your use of the Website. Any suit to enforce these Terms shall be brought exclusively in the state or federal courts sitting in Travis County, Texas and you hereby consent to the jurisdiction of such courts and waive any venue objection. These Website Terms may not be modified, supplemented, qualified, or interpreted by any trade usage or prior course of dealing not made a part of these Terms. “L7” and all associated logos displayed within the Website are our trademarks (unless otherwise noted). The invalidity or unenforceability of any provision of these Website Terms shall not affect the validity of these Website Terms as a whole and any such provision should be enforced by authorities, and reconstructed if need be, to apply to the maximum extent allowable under applicable law. The failure by either party to enforce at any time any of the provisions of these Website Terms, to exercise any election or option provided herein, or to require at any time the performance of the other of any of the provisions herein will not in any way be construed as a waiver of such provisions. Reasonable attorneys' fees and costs will be awarded to the prevailing party in the event of litigation involving the enforcement or interpretation of these Website Terms. The section headings used herein are for convenience only and shall not be given any legal import. Contacting Us All questions, comments, feedback and other communications regarding the Website or products and services offered by L7 should be directed to info@l7informatics.com Acceptable Use Policy for Hosted Services This Acceptable Use Policy (“AUP”) sets out the terms and conditions under which authorized users may submit Customer Data into hosted environments. This AUP is legally binding on all users of hosted services purchased through L7 (“Hosted Services”). We provide Hosted Services pursuant to separate hosting terms and conditions and this AUP applies in addition to any such terms and conditions. Prohibited Uses You may use the Hosted Services only for lawful purposes, in accordance with the terms of this AUP and in accordance with the applicable agreement under which governs your access to and use of the Hosted Services. You may not use the Hosted Services: • in any way that breaches or promotes the breach of any applicable local, national, or international law or regulation;• in any way that is unlawful, fraudulent, or misleading;• to sell or advertise the sale or purchase of any goods or services;• for the purpose of harming or attempting to harm minors in any way;• in any way that violates third-party rights;• to knowingly or recklessly upload, share, or transmit any data or material that contains viruses, spyware, adware, Trojan horses, worms, corrupt files, or other similar computer code designed to adversely affect the operation of the Hosting Services, L7 software or products or any computer software, hardware or networks;• in any way that seeks to circumvent, disable, or otherwise compromise the security of the Hosted Services, any user account or any password; or• to upload, send, or distribute unsolicited messaging, including SMS, emails or comments. Complying with this Policy L7 is under no obligation to monitor, review, filter, or remove any Customer Data from the Hosted Services. L7 reserves the right, in its sole discretion, to determine whether or not you have abided by the spirit and principles of this AUP and will take whatever action it deems appropriate under the circumstances, including but not limited to: • immediate suspension of your right to upload Customer Data to the Hosted Services;• immediate removal of any Customer Data uploaded by you to the Hosted Services;• taking legal action against you or the entity you represent; or• disclosure of relevant information to law enforcement authorities. (Last updated: March 10, 2020) ### Video Library L7 | Videos ### Privacy Policy Privacy Policy(Effective – January 1, 2019)L7 Informatics, Inc. (“L7,” “our,” “us,” or “we“) respects your privacy. We created this Privacy Policy to let you know what information we collect and how we use it, as well as our information sharing and protection practices. This Privacy Policy applies to your use of the website https://l7informatics.com (the “Website”) as well as any email, text and other electronic communications between you and L7. This Privacy Policy does not apply to:Information we collect offline or by any other means (such as through other websites or services we may offer); andInformation collected by our affiliates or any other third parties, which may have their own privacy policies. Please note that this Privacy Policy does not cover Personal Information that we receive through customer usage of our products and services, which is covered under the applicable customer agreement. Please read this Privacy Policy carefully and save it. If you do not agree with it, you should not access the Website. By accessing the Website or by submitting electronic communications to us, you consent to the practices prescribed in this Privacy Policy. What information does L7 collect? Personal Information. When we refer to “Personal Information” in this Privacy Policy, we mean any information by which you may be personally identified or contacted, whether online or offline. When you fill out any forms located on the Website, we may collect certain Personal Information from you, such as your first and last name, job title, company, home or other physical address, email address, phone number, or other contact information, whether at work or at home, and, if you elect to apply for a job via the email provided on the Website, your employment history and the other content of your cover letter and resume. It is always your choice whether or not to provide Personal Information. If you choose not to provide requested Personal Information, you may not be able to participate in certain activities or use certain features of the Website. Technical Information. We may also collect and use technical data and related information, such as information about your device, system and application software, peripherals and other data related to your interactions with the Website (“Technical Information”). We may automatically collect Technical Information through technologies like cookies, flash cookies, web beacons and log files. The information we collect from these technologies may include your IP address, the time and duration of your visit, device type, operating system, browser information and the page you request. L7 does not consider this information to be Personal Information. While we will not use this Technical Information in a way that associates the information with you, we may use and aggregate this information. We use third party analytics tools, such as Google Analytics and HubSpot to analyze the data we collect using these means. We may receive the kind of data described in this section from our marketing partner, HubSpot. They may use cookies and other online technologies to collect this data. We do not control their data collection practices and you should review their privacy policies available at https://legal.hubspot.com/privacy-policy. We will use the data our marketing partners provide to us in accordance with this Privacy Policy. How does L7 use this Information? Except as described in this Privacy Policy or in our End User License Agreement, Personal Information, and Technical Information (collectively, “Information”) that you provide or that we collect will be kept confidential and used to support your relationship with L7. We may use your Information, including your Personal Information, as follows: To provide software updates, product support, product enhancements and other services to you related to the Website. To improve user experience on the Website and monitor system performance To improve, market or promote L7’s products and services. To communicate with you, including about your account. To alert you to product upgrades, special offers, updated information and other new products and services offered by L7 or its third party partners. To respond to your inquiries, questions, and/or other requests, including for recruiting and human resources purposes. To display advertisements, including advertisements from third parties. For any other purpose we may describe when you provide the Information. We may also use your Information for any other purpose with your consent. Information We Share Except as described in this Privacy Policy, L7 does not share, rent or sell your Personal Information with third parties. L7 or its agents, vendors or contractors may disclose Information, including your Personal Information, to third parties in the following circumstances: To our agents, vendors or contractors that we use to support the internal operations of our business including the Website and who are required to keep the Information confidential and use it only for the purposes for which we disclose it to them. If required to do so by law, comply with legal process or to comply with a governmental or regulatory request; To protect and defend the rights or property of L7 or its agents or contractors; To enforce our End User License Agreement or other L7 agreements; To act in urgent circumstances to protect the personal safety of others; and As part of a transaction or potential transaction where L7 merges with another organization, files for bankruptcy, or sells its assets or capital stock. Security of Your InformationWe maintain physical, technical, and procedural safeguards designed to protect the Information. These safeguards include storing your Information on computer servers in a controlled, secure environment. Despite the actions and precautions we take, no data transmissions over the Internet can be guaranteed to be 100% secure. Consequently, we cannot ensure or warrant the security of the Information and you acknowledge and agree that you transmit it to us at your own risk. Third-Party Websites, Services and TechnologiesWe may provide links to third-party websites on the Website or in other communications to you. These links may appear as a specific domain name or URL or may be activated by clicking on an advertisement or other icon or graphic. Please be aware that other websites and services, including the websites of third parties that you connect with through the Website, may collect personally information from you. We cannot control and are not responsible for the information collection practices of any third-party websites, services or applications. We encourage you to carefully review their terms of use, privacy policies, and any other legal notifications before using or providing information through such websites, services or applications. International TransfersInformation collected from you may be stored and processed in the United States or any other country in which L7 or its affiliates, subsidiaries, agents or contractors maintain facilities. If you are accessing the Website from the European Union or other regions with laws governing data collection and use, please note that you are agreeing to the transfer of your data to the United States and processing globally. By providing your Information, you consent to any transfer and processing in accordance with this Privacy Policy. Children’s PrivacyThe Website is not intended for children under the age of 13. We do not knowingly collect Information from children under 13. If you believe that we may have collected Information from a child under the age of 13, please contact us at info@l7informatics.com. Information Choices and ChangesWe would like to make certain commercial offers available to you from time to time. As such, you consent to receive commercial messages (whether by phone, email, text or push notifications) from us or our third party partners, and acknowledge and agree that your primary phone numbers and email addresses and other information may be used for the purpose of initiating commercial messages. We will allow you to opt-out of receiving commercial messages, but in order to stop receiving any messages from us whatsoever, you will need to terminate your account. Depending on your browser, you may be able to remove and reject cookies from our Website by changing your browser settings. The default setting of many browsers is set to accept cookies until you change your settings. Please note that if you disable or refuse cookies, certain features of the Website may become inaccessible or may not function properly. Changes to this Privacy PolicyThis is our entire Privacy Policy and it replaces any earlier version. We may change this Privacy Policy by posting a new version on the Website, and it is your responsibility to review this Privacy Policy periodically. If we make material changes to our practices regarding the collection, use and sharing of your Personal Information, we will notify you via e-mail to the email address you provide to us and/or through a notice on the Website home page.When we do change the Privacy Policy, we will also revise the “effective” date. Your continued use of the Website after such date constitutes your agreement to this Privacy Policy and any updates. Contacting L7For questions or comments regarding this Privacy Policy or Cookie Consent, please contact Joshua Boyles, L7's Data Compliance Officer, at compliance@L7informatics.com. ### Webinars L7 | Webinars and Industry Presentations ### Book A Meeting Book A Meetingthe L7 team is looking forward to connecting with you ### Careers Careers @ L7 Informaticsexplore opportunitiescore valuesAt L7, we collaborate, innovate, excel, and grow.L7 culture At L7, we aspire to do great things. L7's innovation is fueled by an interdisciplinary team of scientists, engineers, and operations-research experts. L7'ers are passionate about our technology with a desire to make a positive impact on improving the speed, efficiency, and progression of healthcare and life sciences organizations around the world. L7 is growing fast, and we are looking for potential colleagues that are as inspired and motivated as we are! ### Events L7 | Events The L7 team is looking forward to connecting with industry peers at the following eventsupcoming events past events ### News L7 | Newsarchives ### Resources L7 Resource Centerwebinars + presentations datasheets case studies white papers videos ebooks L7 UNIVERSITY L7 UNIVERSITY offers a growing catalog of instructor-led and self-directed training options carefully designed to give new and experienced users the skills and knowledge they need to leverage the power and extensibility of L7|ESP.analyst reports L7|CHATS ### White Papers L7 | White Papers, Publications and Articles ### Case Studies L7 | Customer and Partner Case Studies ### Connectors L7 | Standard ConnectorsThe L7|ESP data and workflow orchestration system automates, optimizes, and executes tasks providing a holistic approach to scientific process and business management. To rapidly enable this, efficient interfacing with your lab instruments is of utmost importance. L7 Informatics has a dedicated team building Standard Methods and Connectors that integrate with all your relevant instruments. Currently available Methods and Instruments Connectors are supporting applications across a broad range including sequencing, PCR, label printing, quantification of nucleic acids and proteins, automated nucleic acid extraction, imaging, liquid handling, and more. These Methods and Connectors are readily available via the collaboration and deployment portal L7|HUB®. Example List of Prebuilt Methods and Connectors Domain / Application Example Methods/Connectors Label Design/Printing BarTender (various commercial printers) Liquid Handling BioMek i7 (Beckman Coulter), Twister I (Caliper) Microbial Detection System BACT/Alert 3D (Biomerieux) PCR Verti Thermal Cycler, StepOne Realtime PCR, QuantStudio 12k Flex (Thermo Fisher Scientific), LightCycler 480 (Roche) Plate Reader SpectraMax GA 3500 (Molecular Devices) Synergy LX (Biotek) Quantification of Nucleic Acids and Proteins Qubit, Nanodrop spectrophotometer (Thermo Fisher Scientific) Sequencing MiSeq, HiSeq, NextSeq 500/550 (Illumina) Nanopore sequencing (Oxford Nanopore) Sequel IIe System (PacBio) Spatial Omics Vector Polaris (Akoya Bioscience) Don't see your specific Method/Connector? Contact us to get the complete list.L7|ESP includes a wide and growing range of Standard Connectors with extensible and standard-integration capabilities to connect your internal and external systems, instruments, and assets. Agilent Bioanalyzer 2100 Tapestation 2200,4200 Microplate Labeler Akoya Bioscience Vector Polaris APC UPS/SMX3000RMHV2U Applied Technology 7900 HT Beckman Coulter Ampure BioMek i7 Bio-Rad Gel Doc XR + Imager Biolog Plate Renderer Biomerieux BACT/Alert 3D BioStore III Cryo -190C Biotek Synergy LX (fluorimeter) Bulldog BioShake XP Caliper Twister II (liquid handler) Cardinal Health Timer/ C6510-7 Thermometer CH240056, CH2971-6, CH2212-2 Cellomter Vision Clean AirSystems 24" ISO 5 Combination Cole-Parmer Techometer Covaris LE220 Ultrasonicator Datamax-O'Neil M-420 Mark II printer Dynmo Label Printer 1750283 Eppendorf Cetrifuge 5424, 5430R, 5804R SmartBlock 1.5mL Thermomixer ESCO Class II, BSC/AC2-4S9-NS Illumina MiSeq HiSeq NextSeq 500, 550 NovaSeq 6000 iSeq PacBio PacBio RSII, Sequel Julabo Water Bath Lascar Electronics Lonza FlashGel Media Jet Printer MJ 9410 MilliQ Integral Water Purification System Molecular Devices SpectraMax (GA3500) Olympus IX83 Oxford Nanopore Sequence Perkin Elmer LabChipGX Promega Maxwell CSC Maxwell RSC Protein Simple ELLA QIAGEN EZ1 Advanced XL Quant Studio 12k Flex/Dx RAININ RFID reader and pipettes Rees EMS Roche LightCycler 480 SATO Plastic Tag Printer TXPSX5 Sage Pippin Savant DNA 120 Scientific Industries Vortex Mixer Digital Vortex-Genie 2 Scotsman Ice Maker/AFE424A-1A Siemens HDMI Solair 5100 Particle Counter StepOne Plus SynergyLx Microplate reader Thermo Fisher Scientific Veriti Thermal Cycler 3500, 3500 XL Fragment Analyzer Genetic Analyzer Qubit - 1.0, 2.0, 3.0, 4.0 QuantStudio 12k Flex StepOne Realtime PCR Nanodrop spectrophotometer Trinean DropSense Unico Rock-IT! Tube Mixer USA Scientific Vortex Mixer ViaFreeze Duo CRY VWR Total Range Thermometer Traceable Stopwatch Mini Centrifuge Vortex Mixer Zebra Zebra Printer 410\420 instrumentsSequencers Illumina HiSeq, NextSeq, NovaSeq, MiSeq Panels, WES, WGS, RNAseq ThermoFisher ION PGM, ION Proton, Ion S5, ABI 37xx Cancer panels, RNAseq PacBio RS II, Sequel QC BioAnalyzer, NanoDrop, DropSense, Qubit, qPCR Other VWR SpectraMax M2 microplate/cuvette reader Fisher Microvolume spectrometer (8 channel NanoDrop) Aglient Fragment Analyzer Fisher GPS Series Lab Refrigerator, 45CF CHROMA REF Fisher Revco DxF -40C and -80C Ultra-Low Temperature Freezers Fisher VisionMate Wireless Barcode Readers Roche LightCycler Beckman BioMek liquid handler Sanger Sequencing ABI Fragment Analyzer Fragment Analysis softwareSequencers LIMS platforms (e.g. ClarityLIMS, MiniLIMS, STARLIMS) Informatics platforms (e.g. CLCbio, Galaxy, DNAnexus, Fabric) External operations systems Billing and ordering systems Inventory and document control Electronic Medical Records (EMRs) Compute Platforms Job Schedulers (LSF, Slurm, OGE/SGE, PBS) Clouds (Bluemix, Amazon, Azure etc.) ### Content L7 | Standard Content L7|ESP is populated with a growing library of standard contentworkflowsOUT-OF-THE-BOX WORKFLOW SUPPORT Illumina HiSeq/NovaSeq/MiSeq sequencing gDNA library preparation Exome capture, multiplexed DNA extraction from tissue, blood or FFPE RNA isolation from tissue, blood or FFPE RNA-seq library preparation PacBio RS II sequencing PacBio Genome library preparation PacBio Amplicon library preparation Kapa Quant Library Concentration User-prepared libraries for Illumina sequencing data modelsEXTENSIVE SET OF DATA MODELS SUPPORTING VARIOUS BUSINESS PROCESSES IN LIFE SCIENCES AND HEALTH CARE Translational oncology sample management models Gene expression studies Inventory (reagent and supply management models) Sample storage and sample ingest and tracking models Phenotype and Genotype models for oncology and rare-diseases Plant and animal genomics models analyticsRICH COLLECTION OF BIO-INFORMATICS, AI, MACHINE LEARNING AND STATISTICAL SOFTWARE PACKAGES A standard, platform independent, relocatable package structure enables easy search, usage & deployment Versioned binary releases of all tools aid in validation and reproducibility Vendor optimized versions of specific tools ensure high performance on cutting edge hardware Inclusion of all supporting libraries ensures tools “just work” A single source of provenance for all tools streamlines certification processes (e.g., FDA,CLIA) ### L7 Apps L7 AppsL7 LIMS L7 LIMS provides an effective and clear solution to streamline today’s complex laboratory operations which is incompatible with the paper and Excel paradigms. L7 LIMS is part of the L7|ESP Unified Platform with Workflow Orchestration and Data Contextualization, where samples are recorded, experiments are executed, inventory is tracked, and where protocols and workflows reside in the same database as L7 Notebooks, inventory data, scheduling tools, and a myriad of other applications. The system uses existing workflow orchestration chain configurations to automate task orchestration. L7 Environmental Monitoring (EM) an L7 LIMS add-on app L7 EM is designed to streamline the planning and execution of comprehensive environmental monitoring programs, essential for ensuring product quality, safety, and operational consistency. Users can efficiently capture and track critical environmental quality control metrics—including cleanroom surfaces, air, water, personnel, and complete facility monitoring—at both room and building levels. Fully integrated within the L7|ESP Unified Platform, L7 EM ensures seamless data connectivity and compliance, enabling proactive contamination control, process stability, and adherence to regulatory standards across biotech operations.L7 Stability an L7 LIMS add-on app L7 Stability is a comprehensive solution designed to define, manage, and execute stability programs with precision and flexibility. Users can create detailed stability plans, monitoring specifications, and storage strategies without the need to define sample information upfront, allowing for dynamic test planning. Seamlessly integrated within the L7|ESP Unified Platform, L7 Stability optimizes stability testing workflows while maintaining compliance and operational efficiency.L7 Biorepository an L7 LIMS add-on app L7 Biorepository is an adaptable solution designed to streamline the registration, receipt, and transfer of samples with precision and efficiency. Users can manually or bulk register samples based on order requests, ensuring flexibility in sample management workflows. Upon arrival at the laboratory, barcode scanners enable seamless sample verification, ensuring that order details align with received shipments. Fully integrated with the L7|ESP Unified Platform, L7 Biorepository facilitates the smooth routing of verified samples for further processing within L7 LIMS, enhancing operational efficiency and accuracy in sample handling.L7 Manufacturing Execution System (MES) L7 MES is a versatile digital solution used for the electronic data capture of batches while addressing traditional bottlenecks in regulated environments. Compliant with 21 CFR Part 11, L7 MES allows users to rapidly configure Master Batch Records and Drug Product recipes while benefiting from configurable electronic signatures, sample plan management, and label reconciliation. The low-code/no-code environment enables quick builds and updates without the need for IT intervention. Fully integrated to the L7|ESP unified platform, L7 MES seamlessly integrates with various applications for streamlined operations, offering real-time quality reviews with compliant electronic signatures. Its cloud-native architecture ensures high availability and scalability.L7 Notebooks L7 Notebooks is a secure and collaborative digital solution that facilitates the creation of notebook templates, libraries, and protocol execution. As part of the L7|ESP Unified Platform, it seamlessly connects entries to data sources for efficient operations. Offering rapid configuration and reusable templates, L7 Notebooks enhances productivity and precision in lab processes. L7 Notebooks offers role-based access and robust data security for cross-departmental collaboration, while its low-code/no-code environment allows for swift adaptation to market needs. L7 Notebooks supports seamless integration with various apps for holistic research plan execution and real-time data reporting.L7 Scheduling L7 Scheduling is a dynamic solution that is fully integrated within the L7|ESP Unified Platform. It automates the linking of entries to 'schedulable' data sources and synchronizes with MES and LIMS applications. Designed to handle real-world supply chain complexities, L7 Scheduling ensures compliance with 21 CFR Part 11 and optimizes resource utilization by coordinating instrument run times, staff schedules, and workflows. L7 Scheduling supports year-round operations at full capacity, providing real-time task monitoring and effective resource capacity planning for streamlined and cost-efficient operations.L7 Inventory (included in L7|ESP) L7 Inventory is designed to manage and maintain a comprehensive range of inventory items, from consumables to kit components and stock reagents. By utilizing L7 Builders, users can customize data models to set threshold and reorder levels, ensuring timely alerts and minimizing operational disruptions due to material shortages. Fully integrated with the L7|ESP Unified Platform, L7 Inventory enables seamless tracking of item usage across processes while synchronizing inventory data with sample processing within L7 LIMS.L7 Assets (included in L7|ESP) L7 Assets is a centralized solution for managing Containers, Equipment, and Kits within the L7|ESP Unified Platform. Building on the capabilities of L7 Location (designed to optimize the organization and tracking of samples, inventory items, and other data models), L7 Assets introduces new data models and configurations through L7|Master. Starting in ESP v3.5, users can define Equipment Types with customizable maintenance schedules to reduce downtime and ensure manufacturing readiness. Kit modeling supports streamlined batch manufacturing by allowing users to define kit components and print kit summaries for lab use or integration with QMS systems. Fully integrated with L7 LIMS, L7 MES, and L7 Notebooks, L7 Assets enables synchronized orchestration across critical resources, providing greater operational control, traceability, and compliance in modern laboratory and manufacturing environments.L7 Stability Stability app in L7|ESP is used for the automated scheduling of stability studies of manufactured batches of drug products and drug substances.L7 Environmental Monitoring (EM) EM app in L7|ESP is used for executing environmental monitoring and testing of clean room surfaces, air monitoring and personnel monitoring. EM provides scheduling capability as well as integration to LIMS app to support all the testing.Clinical Operations Clinical Operations app in L7|ESP is used to manage clinical operations for autologous cell-based therapies. The app manages the vein-to-vein chain of Identity and chain of custody and provides real time visibility to manufacturing slots to all the clinical trial sites as well as integration to logistics providers. The app can be used post FDA approval for tracking the chain of identity and chain of custody. ### L7|ESP® Enterprise Science Platform L7 | Enterprise Science Platform (L7|ESP®) a unified platform that contextualizes data and eliminates business silos via process orchestrationpowering the life science digital revolution Built by scientists for the life sciences community - relentlessly focusing on serving our customers in research, development, manufacturing, and diagnostics with the overall goal of better clinical and operational outcomes for the life sciences industry.data+intelligence for the scientific enterprise L7 | ESP is designed to unlock innovation at every stage of the clinical, research, and manufacturing value chain. From data and workflow orchestration – to custom apps and integrations, L7 | ESP is an end-to-end transformation engine to help solve the challenges of today and realize the opportunities of tomorrow.Our L7|ESP orchestration platform, along with FAIRification of process and data, improves business intelligence via data integration and contextualization, increases business velocity, and reduces costs.L7 | ESP guiding principlespurpose-built for the life sciences, based on industry 4.0 principlesThe L7|ESP platform is developed based on the best practices of Industry 4.0, which has revolutionized how life sciences companies conduct their research and manage the production and distribution of their products. Incorporating technologies such as the Industrial Internet of Things (IIoT), cloud connectivity, AI, and machine learning, L7|ESP integrates these tools into the core drug discovery and manufacturing processes. By leveraging Industry 4.0 principles, L7|ESP enhances process connectivity and efficiency, helping to speed up drug development and improve production. This integration not only increases operations efficiency but also relieves team members from repetitive tasks, allowing them to focus on higher-value work and collaborate more effectively with advanced technologies. L7|ESP is a comprehensive solution that facilitates the digitalization of data and scientific processes in life sciences organizations. It optimizes workflow orchestration and data management, improves task automation and execution, and can be expanded with tools for real-time analytics and insights, ensuring a maximum return on IT investments.L7|ESP platform componentsL7 enables you to meet evolving scientific and business needs with the tools to create, share, and reuse your own data and process models, and execute multi-party workflows with value chain partners, with the data integrity and provenance to support increased intelligence.L7|MASTER® L7|MASTER is a low code/no code authoring tool that enables the creation of any scientific data and process model as a single digital standard.​L7|HUB® L7|HUB is your repository of portable, standardized content—including workflows, data models, and analytics packages—organized in a searchable storefront.​L7|INTELLIGENCE® To deliver on the promise of precision healthcare and life sciences, L7 enables the mining of data to generate prospective and predictive Intelligence and models.​TRENDING​ What processes are we running?​ High-level​ Summarize performance over time​ Track performance metrics​ Align to strategic goals OPERATIONAL​ Are our processes under control?​ More detailed than trending reports​ Monitor and analyze activities in a given business area​ Exception alerting based on real-time data​ Monitor progress towards a target​ Designed to be viewed multiple times throughout the day​ Can lead to direct action, further analysis, and improvement ANALYTICAL​ Where do we need to improve our process?​ Analyze large volumes of data​ Investigate trends, predict outcomes, and discover insights​ Drill-down and ad-hoc querying​ Monitor process-capability or method-variability to facilitate root-cause analysis L7|EXCHANGE L7|EXCHANGE will enable disconnected teams and partner organizations to securely orchestrate multi-party workflows–involving apps, processes, and legacy systems unique to each group. Estimated release date: end 2025-early 2026what we deliver with L7|ESPL7 Informatics' L7|ESP platform is a state-of-the-art solution for life science organizations seeking to digitalize their data and scientific processes, ensuring an optimal return on IT investments. This unified platform enhances workflow orchestration and data contextualization, addressing both current and future organizational needs. L7|ESP not only automates and optimizes task execution but also offers a comprehensive approach to managing scientific and business processes. Additionally, it supports expansion with advanced trending and charting tools, providing real-time operational and scientific insights for enhanced decision-making.an architecture for digitalization, resulting in shortened product lifecyclesThe L7|ESP platform integrates all standard data information management systems, including L7 Notebooks, L7 LIMS, L7 MES, and L7 Scheduling, as well as other resources such as Instrument Connectors, Location, Custody of Chain, and more. Designed to also work with existing legacy systems, L7|ESP enhances data contextualization and consolidation under a unified platform, minimizing the need for multiple redundant systems. This innovative platform not only paves the way for future advancements but also significantly cuts legacy maintenance costs.BUSINESS APPS L7|ESP integrates all common data information management systems, such as L7 Notebooks, L7 LIMS, L7 MES, L7 Scheduling, and more!Designed to work with existing legacy systems, L7|ESP enhances data contextualization and consolidation under a unified platform, minimizing the need for multiple redundant systems. This innovative platform not only paves the way for future advancements but also significantly cuts legacy maintenance costs.By optimizing scientific data and process management across the entire product life cycle—from research to manufacturing—L7|ESP ensures more efficient operations, heightened transparency, and superior performance, ultimately accelerating quality and speed in process execution and fostering robust, organization-wide collaboration and visibility.L7|ESP Knowledge Graph: a powerful visualization toolUnlike traditional point solutions, any data model and process model can be configured in L7|ESP to contextualize recorded data at the point of execution where it is then stored in a Knowledge Graph structure. This Knowledge Graph models complex relationships and genealogies among entities (such as people, equipment, places, processes, activities, actions,..etc) and allows L7|ESP to create a semantic layer that integrates with our PostgreSQL database. This integration creates a contextualized enterprise data fabric that allows cross-functional teams to ask complex queries. This enables insights to span departments and enhance decision-making and analysis, all while future-proofing your data for AI and machine learning projects. L7 | ESP platform services + apis L7|ESP provides an array of 'building-block' Services + APIs to enable extensibility and customization to meet evolving needs.L7|ESP and beyond: a world built on data+intelligence for the scientific enterpriseL7 enables you to meet evolving scientific and business needs with the tools to create, share and reuse your own data & process models, execute multi-party workflows with value-chain partners, with the data-integrity and provenance to support increasing intelligence.L7 | ESP standard apps L7|ESP includes a suite of best-in-class apps for common, core capabilities SEARCH Securely search globally across all the data stored in L7ESP.DASHBOARDS High-level operational metrics of what's happening in the labs and clean rooms.DATA Complete access to all data files.SAMPLES Manage samples and display chain of identityPROJECTS Display details of all projects, experiments and manage workflow chain plans.ASSETS Manage assets used in the execution of laboratory and manufacturing operations.REPORTS View metrics displayed on the Dashboards app in an organized mannerENTITIES Track business objects in a lab or clean room as they progress through various workflows.INGEST Easy mechanism for importing and loading samples and other entities.SEARCH Securely search globally across all the data stored in L7ESP.ASSETS Manage assets used in the execution of laboratory and manufacturing operations.DASHBOARDS High-level operational metrics of what's happening in the labs and clean rooms.REPORTS View metrics displayed on the Dashboards app in an organized mannerDATA Complete access to all data files.ENTITIES Track business objects in a lab or clean room as they progress through various workflows.SAMPLES Manage samples and display chain of identityINGEST Easy mechanism for importing and loading samples and other entities.PROJECTS Display details of all projects, experiments and manage workflow chain plans.L7 | ESP standard contentL7|ESP is populated with a growing library of standard content DATA MODELS ENTITIES WORKFLOWS PROTOCOLS PIPELINESMETHODS CONNECTORS REPORTS DASHBOARDSL7 | ESP platform services + apis L7|ESP provides an array of Services + APIs to enable extensibility and customization to meet evolving needs.SECURITY FILE REGISTRY CLOUD EXECUTEREGULATORY SAMPLE SERVICE EXPERIMENT SERVICE PROTOCOL SERVICEINSTRUMENT CONTROL ANALYSIS SERVICE SAMPLE REGISTRY CLUSTER EXECUTEINSTRUMENT MONITORING AUDIT SERVICE PROJECT SERVICE WORKFLOW SERVICEPIPELINE SERVICE REPORTING SERVICE USER SERVICEL7 | ESP standard connectorsL7|ESP includes a wide range of standard connectors SEQUENCING INSTRUMENT WET LAB SOFTWARE IOT DEVICE ENVIRONMENTAL MONITORINGLOGISTICS BIOPROCESS EQUIPMENT AI/MACHINE LEARNING BIO-INFORMATICS STATISTICAL PROCESSINGL7 | ESP standard connectors L7|ESP includes a wide range of standard connectorsresourcesDive deeper and see how L7|ESP can transform your operations:L7|ESP brochure L7|ESP blog postL7|ESP explainer videoL7 Notebooks app datasheetL7 LIMS app datasheet L7 MES app datasheet L7 scheduling app datasheet L7 servicesWhen you become a customer, you'll be granted full access to L7 | University, an incredibly rich library of proprietary content and training resources.L7|ESP is an adaptable and customizable platform that streamlines process execution, provides a complete chain of custody from sample to report, and enables management of complex workflows. Simon Hughes, Associate Director, CDx Assay Development, QIAGENL7|ESP provides a single platform to assure both control and compliance, while providing a seamless transfer of clinical operations to manufacturing operations. Ernie Bognar, Chief Operations Officer, Gradalis, Inc. ready to take your data to the next level? ### Contact Contact L7 Informatics L7 INFORMATICS, Inc.1219 West 6th StreetAustin, Texas 78703 USAL7 INFORMATICS, Inc.1219 West 6th StreetAustin, Texas 78703 USAL7 INFORMATICS, Inc.1219 West 6th StreetAustin, Texas 78703 USAsupport@L7informatics.com ### Blog L7 | CHATS ### About Us About L7 Informaticstogether we can help improve quality of life L7 Informatics reimagines data intelligence for modern life sciences and healthcare organizations. Beyond simple data management, L7 provides tools that optimize the flow of information between process and people, unlocking innovation at every stage of the clinical, research, and manufacturing value chains. Our comprehensive operating environment and software stack bring flexible, secure, and collaborative data intelligence to your entire operation. From regulatory compliance and workflow orchestration to customized applications and integrations, our end-to-end transformation engine helps organizations solve the challenges of today and realize the opportunities of tomorrow.L7 at a glanceL7 culture At L7, we aspire to do great things. L7's innovation is fueled by an interdisciplinary team of scientists, engineers, and operations-research experts. L7'ers are passionate about our technology with a desire to make a positive impact on improving the speed, efficiency, and progression of healthcare and life sciences organizations around the world. L7 is growing fast, and we are looking for potential colleagues that are as inspired and motivated as we are!executive teammanagement teamL7|CHATS latest news more ways to engage with L7 ### Services L7 ServicesL7 UNIVERSITY L7 UNIVERSITY offers a growing catalog of live and on-demand training options carefully designed to give new and experienced users the skills and knowledge they need to leverage the power and extensibility of L7|ESP.assessment Our Life Sciences Operations Assessment (LOA) service provides an independent review of your operational efficiencies and finds areas of opportunity for improvement. The LOA process involves on-site interviews with all of your key stakeholders and evaluates their roles and their pain points. Once we’ve completed the LOA and presented our results, we can work with you to tailor an L7|ESP solution.blueprinting The blueprinting process (and associated artifacts) aims to create a clear, comprehensive design that aligns business objectives with technical solutions. It helps ensure that all stakeholders have a shared understanding of the project’s goals, design, and implementation. This process helps identify potential challenges early, streamlines implementation, and facilitates efficient resource allocation, ultimately leading to more successful project outcomes.PROCESS FLOW DIAGRAM Business process mapping ( lab manufacturing, clinical operations, etc... )​SYSTEM ARCHITECTURE DIAGRAM Where does L7|ESP fit into the customer’s ecosystem of systems and instruments, equipment and other software systems)​ENTITY RELATIONSHIP DIAGRAM Where and how do data move from process / workflow and how are they manipulated each step of the wayimplementation L7 Informatics identified a need to define a reliable & repeatable implementation methodology given our fast-growing services portfolio. The Implementation team has collated a wealth of best practices and lessons learned to build a Software Development Life Cycle (SDLC) methodology specifically for use during customer implementations.BENEFITS OF THE SDLC (AND ASSOCIATED ARTIFACTS) INCLUDE:Well defined roles and responsibilities across project team member typesMore repeatable outcomes via robust templates & work instructionsGreater regulatory compliance to clinical & software validation requirementsGreater confidence and reference-ability with L7’s growing customer basecomplianceAs the leading data intelligence software for life sciences and healthcare, we recognize the need for documenting the qualification of software to meet regulatory and certifying body requirements.COMPREHENSIVE L7|ESP PLATFORM COMPLIANCE To help you establish and maintain software that is compliant with regulatory and certifying body requirements, the L7|ESP platform is developed and tested in accordance with prevailing software standards including GAMP5 and CFR Part 11. We provide documented release notes and testing summaries with each L7|ESP platform release.REDUCING CUSTOMER’S QUALIFICATION BURDEN Each L7 services implementation follows an established SDLC which includes well-documented verification of customer-specific configurations. The customer-specific User Requirements, design documentation, Verification Test Matrix, and Summary Reports that are created within an L7 implementation are provided so you can leverage this work for validation activities — greatly reducing the burden of performing IQ/OQ/PQ by your CSV team.Online knowledge-base articles email supportEmail and voice/video support during normal business hoursEmail and voice/video access to our customer support team 7x24x365.supportL7 Informatics Product Support provides expert technical assistance worldwide through highly experienced professionals committed to customer satisfaction. Our highly skilled support team has a comprehensive knowledge of our different products.build+maintain L7 is here to help customers find the correct level of support from developer assistance to a comprehensive customer success offering. L7 build and maintain services are available via the following two options:LEVEL 1 ​Expert assistance from our developers to yours to help further your L7|ESP development after initial implementation, including sanity checks, best practice recommendations, and work-around suggestions.LEVEL 2 ​Let L7 continue to build on and add value to your existing L7|ESP implementation by providing ongoing development to meet your growing and changing business needs.hostingL7 INFORMATICS IS CLOUD AGNOSTIC Compute (servers, storage and network) Managed and supported operating systems, database platforms and web services Life Science-experienced quality oversight for operations and support Audit and governmental regulatory defense on your behalf Qualified and auditable infrastructure Managed security Operational SOPs Delivered qualification of customer systems, databases, network Control where data resides Managed backups Disaster recovery Anti-virus, monitoring and response HOW L7|ESP IS HOSTED IN A VALIDATED CLOUD ### Solutions L7 | Precision SolutionsL7|ESP is tailored for a variety of industriesFoster collaboration and expedite genomic research in academic, industry, clinical, and agricultural environments. Our integrated, agnostic platform manages scientific processes and data in one place, yielding better data access and faster discoveries.Get total visibility over your operations while integrating and automating workflows. L7|ESP can help increase your sample throughput and quality assurance in your diagnostic results. Plus, our platform provides reliable documentation for regulatory review.Bring therapeutics to market faster. By automating processes and managing data from various stages of development and manufacturing, you can easily access data and necessary documentation for regulatory submission, operational efficiency, and audits.choose your journey Whether you’re using our complete solution or complementing your existing tools, L7|ESP can work for you.get in touch Let’s work together to solve your workflow challenges. ### Home Eliminate Data Silos with One Digital Platform. ▹ Orchestrate + Automate Processes. Unify Data. ▹ Cut Lead-Times. Reduce Operational Costs. ▹ Accelerate Science with AI-Ready Data. L7 IS A DELOITTE FAST 500 COMPANY We've been listed in the Deloitte Fast 500 annual ranking of fastest-growing companies for the 4th consecutive year - what an honor! platform L7|ESP is a unifying platform designed to eliminate silos and transform life sciences organizations through data contextualization and process orchestration. With built-in best-of-breed apps, including LIMS, ELN, MES, Scheduling, Inventory, Knowledge Graphs, and seamless integration with third-party tools and lab instruments, L7|ESP serves as a single source of truth. This centralized model delivers harmonized, AI-ready data, enabling real-time intelligence and empowering precision medicine breakthroughs.data silos are costing you more than you think Data silos aren’t just slowing you down—they’re silently draining your time, your budget, and your competitive edge.Most life sciences organizations are built on fragmented systems, each with its own language, logic, and limits. The result? Disconnected workflows, unstructured data, and innovation stuck in first gear. Life sciences enterprises are built on fragmented systems, each with its own data model and semantics. This results in data silos and disconnected workflows that slow innovation and drive up costs—delaying life-saving therapies. But in the AI era, the stakes are even higher. AI can’t deliver value without high-quality, contextualized, and harmonized data. Without it, GenAI risks hallucinating, and Agentic AI fails to provide reliable predictions. The AI-chasm is real. If your data isn’t AI-ready, the promise of AI remains an expensive illusion. To accelerate discovery, reduce costs, and bridge the AI chasm, enterprises must break free from silos—now. AI won't help you—unless you fix your data first Everyone’s racing to implement AI—but without the right data foundation, most efforts fall flat. At the same time, drug development is taking longer and costing more than ever before. Disconnected systems, fragmented workflows, and inaccessible data are delaying therapies, driving up costs, and keeping companies from reaching AI's full potential. 10 years On average, that’s how long it takes to deliver new treatments, with inefficiencies dragging out every phase.* $2.3B+ The cost of bringing a new drug to market is soaring, putting strain on R&D and manufacturing.** <25% AI-readiness Most companies aren’t yet in a position to leverage AI at scale.* unify, contextualize, orchestrate—L7|ESP powers AI-driven science AI is only as powerful as the data behind it. But in life sciences, silos, inconsistent ontologies, and fragmented systems create an AI chasm—blocking the path to real value. That’s where L7|ESP comes in. Our composable platform contextualizes data at the source, automates end-to-end processes, and standardizes workflows across research, development, and manufacturing—eliminating silos and laying the groundwork for real AI readiness. L7|ESP isn’t just a platform—it’s your digital backbone. With modular components like L7|MASTER, L7|HUB, L7|ESP CORE, and L7|INTELLIGENCE, it powers AI-ready data, seamless orchestration, and cross-functional collaboration at every stage of your digital journey. And the best part? L7|ESP layers over your existing systems—no disruptive rip-and-replace required. why digital-first life sciences teams trust L7|ESP platform L7|ESP is a unifying platform designed to eliminate silos and transform life sciences organizations through data contextualization and process orchestration. With built-in best-of-breed apps, including LIMS, ELN, MES, Scheduling, Inventory, Knowledge Graphs, and seamless integration with third-party tools and lab instruments, L7|ESP serves as a single source of truth. This centralized model delivers harmonized, AI-ready data, enabling real-time intelligence and empowering precision medicine breakthroughs.platform The L7|ESP unifying platform is the backbone of digital transformation in life sciences, enabling seamless workflow orchestration, AI-ready data contextualization, and cross-functional collaboration. Designed to support every stage of the Digitalization Lifecycle, our platform components—L7|MASTER, L7|HUB, L7|ESP CORE, and L7|INTELLIGENCE—work together to unify scientific and operational processes. Whether you need to standardize data models, integrate disparate systems, or extract real-time insights, L7|ESP empowers life sciences organizations to break silos, accelerate innovation, and scale with confidence.the power of the L7|ESP unifying platform The L7|ESP unifying platform is the backbone of digital transformation in life sciences, enabling seamless workflow orchestration, AI-ready data contextualization, and cross-functional collaboration. Designed to support every stage of the digitalization lifecycle, our platform components—L7|MASTER, L7|HUB, L7|ESP CORE, and L7|INTELLIGENCE—work together to unify scientific and operational processes.L7|ESP connects and orchestrates lab and manufacturing workflows, eliminating silos and ensuring AI-ready data at the source. Seamless integration – Works with instruments, equipment, and legacy systems. Data contextualization – Captures data at the point of generation, eliminating complex downstream transformations. Reduced IT overhead – Minimizes manual intervention and simplifies data management. Real-time insights – Transforms raw data into actionable intelligence without degradation over time. Adaptable in any IT landscape – Supports both legacy-heavy (brownfield) and newly established (greenfield) environments. More than a data lake – A fully ​u​nifying platform with built-in LIMS, ELN, MES, Scheduling apps​, and more. L7|ESP is GLP, GCP, and GMP-ready, ensuring data integrity, traceability, and AI readiness by structuring information at the point of execution. Complete audit trail – Captures instruments, reagents, media, and personnel for every experiment or process. Automatic data contextualization – Eliminates the need for complex ETL pipelines and siloed storage. AI-ready foundation – Organizes data for seamless AI/ML training, including LLMs. Enhanced regulatory compliance – Simplifies audits, submissions, and root cause analysis. Single source of truth – Ensures structured, intact, and contextualized data for improved decision-making. L7|ESP streamlines internal and external tech transfers, accelerating time-to-market for drug products, biologics, and diagnostics. Seamless digital transfers – Eliminates process variations and the need to revert to paper. Unified data + processes – Ensures consistency across research, development, clinical trials, and commercialization. gxP-compliant – Maintains data integrity and harmonization throughout the product lifecycle. CRO/CDMO-ready – Enables smooth collaboration with external partners. Faster scale-up + commercialization – Reduces delays and inefficiencies in tech transfer. L7|ESP simplifies IT ecosystems, reducing costs and freeing resources for innovation. Eliminates redundancies – Orchestrates interactions across legacy systems, instruments, and equipment. Reduces IT complexity – Streamlines architecture to optimize resource allocation. Future-proof framework – Supports both monolithic and next-gen solutions. Phased system transitions – Enables seamless onboarding and retirement of technologies. Unlocks AI + ML potential – Frees budgets for transformative technologies like Gen​ AI​, machine learning, and Agentic AI. L7|ESP unifies research, lab, and manufacturing operations, eliminating inefficiencies and enhancing visibility ​b​y answering questions such as ‘What is the utilization of my lab resources?​”, “When will my test be completed?​”, or “What is delaying my batch release?​” End-to-end integration – Connects ELN, LIMS, MES, and Scheduling in a single platform. Optimized workflows – Replaces paper-based processes to improve efficiency. Material + capacity management – Ensures better resource utilization. Real-time operational insights – Provides answers to critical questions on test timelines, batch delays, and resource allocation. Smarter decision-making – Enhances visibility across Research, Development, and Manufacturing. L7|ESP connects and orchestrates lab and manufacturing workflows, eliminating silos and ensuring AI-ready data at the source. Seamless integration – Works with instruments, equipment, and legacy systems. Data contextualization – Captures data at the point of generation, eliminating complex downstream transformations. Reduced IT overhead – Minimizes manual intervention and simplifies data management. Real-time insights – Transforms raw data into actionable intelligence without degradation over time. Adaptable in any IT landscape – Supports both legacy-heavy (brownfield) and newly established (greenfield) environments. More than a data lake – A fully ​u​nifying platform with built-in LIMS, ELN, MES, Scheduling apps​, and more. L7|ESP ensures data integrity, traceability, and AI readiness by structuring information at the point of execution. Complete audit trail – Captures instruments, reagents, media, and personnel for every experiment or process. Automatic data contextualization – Eliminates the need for complex ETL pipelines and siloed storage. AI-ready foundation – Organizes data for seamless AI/ML training, including LLMs. Enhanced regulatory compliance – Simplifies audits, submissions, and root cause analysis. Single source of truth – Ensures structured, intact, and contextualized data for improved decision-making. L7|ESP streamlines internal and external tech transfers, accelerating time-to-market for drug products, biologics, and diagnostics. Seamless digital transfers – Eliminates process variations and the need to revert to paper. Unified data + processes – Ensures consistency across research, development, clinical trials, and commercialization. gxP-compliant – Maintains data integrity and harmonization throughout the product lifecycle. CRO/CDMO-ready – Enables smooth collaboration with external partners. Faster scale-up + commercialization – Reduces delays and inefficiencies in tech transfer. L7|ESP simplifies IT ecosystems, reducing costs and freeing resources for innovation. Eliminates redundancies – Orchestrates interactions across legacy systems, instruments, and equipment. Reduces IT complexity – Streamlines architecture to optimize resource allocation. Future-proof framework – Supports both monolithic and next-gen solutions. Phased system transitions – Enables seamless onboarding and retirement of technologies. Unlocks AI + ML potential – Frees budgets for transformative technologies like Gen​ AI​, machine learning, and Agentic AI. L7|ESP unifies research, lab, and manufacturing operations, eliminating inefficiencies and enhancing visibility ​b​y answering questions such as ‘What is the utilization of my lab resources?​”, “When will my test be completed?​”, or “What is delaying my batch release?​” End-to-end integration – Connects ELN, LIMS, MES, and Scheduling in a single platform. Optimized workflows – Replaces paper-based processes to improve efficiency. Material + capacity management – Ensures better resource utilization. Real-time operational insights – Provides answers to critical questions on test timelines, batch delays, and resource allocation. Smarter decision-making – Enhances visibility across Research, Development, and Manufacturing. why do scientific enterprises choose L7?L7|ESP is an adaptable and customizable platform that streamlines process execution, provides a complete chain of custody from sample to report, and enables management of complex workflows. Simon Hughes, Associate Director, CDx Assay Development, QIAGENL7|ESP provides a single platform to assure both control and compliance, while providing a seamless transfer of clinical operations to manufacturing operations. Ernie Bognar, Chief Operations Officer, Gradalis, Inc.L7 | CHATS meet us at latest newsrecent case studies ## Events ### Cell and Gene Meeting on the Mesa 2025 ### Biomanufacturing World Summit 2025 ### European Biomanufacturing Summit 2025 ### Lab of the Future Europe 2025 ### Cell Therapy at Scale: Digitalizing Manufacturing for Compliance and Efficiency ### ZIFO SIEE 2025 ### SAP Cell and Gene Therapy Consortium 2025 ### Stellix Aspire 2025 ### Pistoia Life Science Informatics Forum 2025 ### xTelliGent One: AI in GxP 2025 Summit ### Future Labs Live Europe 2025 ### Pharma Manufacturing World Summit 2025 ### Bio-IT 2025 ### Lab of the Future USA 2025 ### PMWC Silicon Valley 2025 ### Advanced Therapies Week 2025 ### Industry Webinar with SciBite ### Industry Webinar with DMark ### Biomanufacturing World Summit 2024 ### BiotechX Europe 2024 ### Cell and Gene on the Mesa 2024 ### Lab of the Future Congress Europe 2024 ### Future Labs Live Europe 2024 ### Pharma Manufacturing World Summit 2024 ### Bio-IT World Conference & Expo 2024 ### Cell & Gene Meeting on the Mediterranean 2024 ### Zifo Scientific Informatics Experience Exchange 2024 ### SmartLab Exchange USA 2024 ### Lab of the Future USA 2024 ### SmartLab Exchange Europe 2024 ### SLAS 2024 ### Advanced Therapies Week (Phacilitate) ### BMWS 2023 ### Plant Genomics & Gene Editing Congress 2023 ### ISPE Annual Meeting & Expo 2023 ### Future Labs Live USA 2023 ### Bio-IT World Europe 2023 ### Cell and Gene on the Mesa 2023 ### Lab of the Future Europe 2023 ### Pharma MES 2023 ### L7 UNIVERSE 2023 ### ASHG Annual Meeting 2023 ### L7 LIVE San Francisco ### BiotechX Europe 2023 ### AGBT Health 2023 ### ASCO Annual 2023 ### Future Labs, Automation and Technology Summit 2023 ### Future Labs Live 2023 ### Zifo Scientific Informatics Experience Exchange ### Advanced Therapies Xchange East Coast 2023 ### Reuters Pharma USA 2023 ### L7|LIVE BOSTON ### BioProcess International US West ### Unified Platform for Life Sciences Value Chain Webinar ### PAG 30 2023 ### Advanced Therapies Week ### PMWC Silicon Valley 2023 ### 2023 BEBPA US Bioassay Conference ### Lab of the Future Congress USA ### Lab of the Future Digital Dialogues ### Cell and Gene Meeting on the Med ### BioIT World Conference and Expo ### ​ASGCT 2023 ### Reuters Pharma Awards USA 2022 ### BioTechX ### Fall 2022 Meeting in the Millyard ### Lab of the Future Europe 2022 ### AGBT Precision Health 2022 ### Fierce Biotech Summit ### Cell and gene on the Mesa ### Bio-IT World ### AGBT Ag ### Spring 2022 Meeting in the Millyard ### ASGCT 2022 ### ISCT 2022 ### Cell & Gene Meeting on the Med ### BEBPA 2022 US Bioassay Conference ### Lab of the Future USA ### Molecular & Precision Med Tri-Conference ### PMWC Silicon Valley 2022 ### Advanced Therapies Week - Phacilitate ### PAG XXIX ### Biotech Week Boston ### Future Labs Live ## Customers ### SAP ### Microsoft ### CTMC ### Alpine Bio ### Boulder BioConsulting ### ZÆTHER ### Karchem Consulting ### Cellipont Bioservices ### Think BioScience ### Cellares ### Vernal Biosciences ### Harbinger Health ### Mphasis ### SciBite ### Global Value Web ### D-Mark Biosciences ### Waters ### Deloitte ### ZiFo RnD ### Quest Diagnostics ### Wright Labs ### GESC ### CReATe Fertility Center ### CSI-Dx ### Agri-Food Canada ### Cibus ### GeneDx ### Dana Farber Cancer Institute ### Gradalis ### GTAC ### QIAGEN ### ATCC ### The Jackson Laboratory