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eChalk Talk: CMC Bioanalytical Control for ATMPs - Challenges and Strategies
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Advanced Therapy Medicinal Products (ATMPs) are a new and rapidly growing classification of therapeutics which include such modalities as modified cell therapies (ex. CAR-T cells), mRNA-derived complexes (e.g. mRNA LNPs), and viral-vectored gene therapies (ex. AAV-based). The inherent complexity of this class of therapeutics leads to unique considerations for designing control strategies to support product development which are distinct from more traditional biologics. This webinar will provide an overview of considerations relevant to representative ATMPs in the development and lifecycle of assays for potency, purity, quantity, and identity for the product. We will then discuss case studies which demonstrate key considerations for development and phase-appropriate validation (qualification) of tests for potency, purity/impurity, quantity, and identity of ATMP drug products.
About the Speakers
Jeff Patrick, Ph.D., Senior Director of CMC Bioanalytical Operations - BioAgilytix
Jeff Patrick, Ph.D., Senior Director of CMC Bioanalytical Operations, has more than 30 years of industry expertise. Prior to joining BioAgilytix, he served as Associate Director of the CMC Group at Covance in Greenfield, IN. Dr. Patrick also spent two decades developing biologics, which included several leadership positions. He oversaw process analytical development, CMC - analytical development, early phase discovery, biomarkers, and manufacturing in addition to applying his expertise in metabolomics, proteomics, and biomarker utilization. Dr. Patrick has published more than 30 papers and reviews during his career. He earned his Ph.D. in Analytical Chemistry from Purdue University and an M.S. in Chemistry from the University of South Carolina.
Michelle Miller, Ph.D., Scientific Officer - BioAgilytix
Michelle Miller, Ph.D., has over a decade of experience working in the fields of immunology and toxicology. She has a strong background in assay development and regulated bioanalysis, previously leading a team of scientists as an Associate Director at BioAgilytix before joining the Scientific Office. Prior to her time at BioAgilytix, she worked as a study director leading GLP toxicology and immunotoxicology studies, as a lead investigator in the toxicology field applying new approach methodologies to developing high-throughput screening assays, and as a vaccine R&D scientist in the pharmaceutical industry. Dr. Miller completed her Ph.D. in Immunology at North Carolina State University’s College of Veterinary Medicine.