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
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 5
wednesday, september 13
Breakfast
Join us and set the tone for a fantastic day ahead with a mouthwatering breakfast
Expo Hall
Welcome
Steven Barash, Vice President of Strategy & Development, L7 Informatics
General Session
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 Session
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 Session
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.
Foyer
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 Session
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 Hall
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 Session
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 Session
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 Session
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 Session
Afternoon Coffee Networking
It’s time for a quick afternoon breather – a chance to relax and recharge before we continue our afternoon agenda.
Foyer
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 Session
“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 Session
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 Session
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 Hotel
thursday, september 14
Breakfast
Join us for a delicious breakfast as we prepare to tackle the day ahead.
Expo Hall
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 Session
LIMS in the Era of GenAI
Ray Veeraraghavan, Executive Director – Technology, Molecular Genomics & Oncology, Quest Diagnostics
General Session
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.
Foyer
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 Session
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 Hall
1:00 PM CDT
Establishing 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 Session
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 Session
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 Session
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 Session
Therapeutics 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 403-404
Afternoon Coffee Networking
Enjoy a short afternoon break to refresh and refocus, preparing to dive back into our engaging sessions.
Expo Hall
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 Session
Building 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.
Rooms 403-404
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 Session
Building Scalable Orchestration Workflows Chains & Performance Tuning L7|ESP
Note: this session will run for 45 minutes.
Rooms 403-404
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 Session
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 Social
friday, september 15
Breakfast
Indulge in a delightful morning and start your day in style by savoring a delicious breakfast.
Foyer by Rooms 403-404
9:00 AM CDT
State 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.
Rooms 403-404
9:30 AM CDT
State 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.
Rooms 403-404
10:00 AM CDT
Managing 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.
Rooms 403-404
10:30 AM CDT
Unlocking 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.
Rooms 403-404
11:00 AM CDT
How 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.
Rooms 403-404
11:30 AM CDT
Implementing 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.
Rooms 403-404
12:00 PM CDT
Efficient 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.
Product Owner
Rooms 403-404
12:30 PM CDT
Closing 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 4-6