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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Chemistry, manufacturing, and controls (CMC) is an integral aspect of cell and gene therapy (CGT) development. CGT development presents unique CMC challenges because of inherent properties such as shorter shelf life, variability in starting and ancillary materials, manufacturing complexity, logistics and cost. FDA CGT information requests (IRs) often contain more CMC related inquiries than non-CGT products. In this webcast, experts from Cardinal Health Regulatory Sciences will discuss CMC challenges and potential mitigation strategies illustrated through multiple case studies.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Yin Lai has extensive experience in the pharmaceutical industry working in biologics development. In her current role at Cardinal Health Regulatory Sciences, she focuses on providing CMC regulatory consulting and strategy in biologics and cell and gene therapy areas. Her role includes helping client in FDA meeting preparation (INTERACT, pre-IND), authoring Module 3 quality sections, preparation of information request (IR) responses and authoring of biologics master files.
Kent Amsberry specializes in regulatory strategy and CMC consulting services to clients. He has over 30 years of experience in the pharmaceutical/biopharmaceutical industry specializing in development of sterile drug products for biological and small molecules. His current focus is in regulatory strategy and submissions for cell and gene therapy products.