Genomics-driven precision medicine and regenerative medicine including cell and gene therapies require a new category of “companion informatics” software that automates and synchronizes complex data and process management. This software is applicable throughout the life-cycle of these complex therapeutics as they make their way from bench to clinical trials to bedside.By connecting to disparate software systems, lab instrumentation, sequencing machines, and process equipment, L7’s Enterprise Science Platform (ESP) provides end-to-end process automation, real-time data capture, needle-to-needle chain-of-identity, actionable dashboards, and reports. ESP platform provides an integrated NGS LIMS, bio-informatics processing, AI/ML integration, sample management, inventory management, freezer management, quality management, and electronic batch records all within a regulatory compliant platform (cGMP, GAMP, CAP/CLIA, HIPAA).
This webinar will provide a first-hand look at how Gradalis, a clinical-stage immuno-oncology cell therapy company, is using the ESP platform from L7 to streamline its research, clinical, and manufacturing operations. It will showcase L7’s ESP’s implementation at Gradalis, where manual batch records and paper-based quality management with manual calculations are being replaced with the ESP automation platform.
Ernest Bognar is Gradalis’ Chief Operating Officer. Prior to Gradalis, he was General Manager of Dendreon’s manufacturing facility, which was developed to meet the anticipated clinical and commercial manufacturing needs for Provenge (sipuleucel-T) and other active immunotherapy product candidates in development.
Prior to Dendreon, Ernie served as Vice President of Manufacturing at Apptec Laboratory Services, where he managed and grew a mammalian cell-based contract manufacturing business unit. Prior to that, he was Senior Director of Commercial Manufacturing for ImClone Systems, where he managed a biopharmaceutical startup operation that produced Erbitux (cetuximab) for the treatment of colorectal cancer.
Ernie also served as Manufacturing Head at Baxter Healthcare’s Hyland-Immuno Division for the production of Recombinate (FactorVIII) and held key manufacturing positions at Cellex Biosciences, Verax, Charles River Biotech, KC Biological, and Ayerst Research Laboratories. He received his Bachelor of Science degree in in vitro cell biology from the State University of New York of Arts and Sciences at Plattsburgh and his Cell Biology Certificate from W. Alton Jones Cell Science Center.