Chemistry, manufacturing, and controls (CMC) is an integral aspect of cell and gene therapy development. Cell and gene therapy development presents unique CMC challenges because of inherent properties such as shorter shelf life, variability in starting and ancillary materials, manufacturing and logistical complexities, and cost. FDA cell and gene therapy information requests often contain more CMC related inquiries than traditional products. In this webinar, experts from Cardinal Health Regulatory Sciences discuss CMC challenges and potential mitigation strategies illustrated through multiple case studies. Cell and gene therapy developers, research scientists, regulatory and legal professionals are all encouraged to attend.

Featured Speakers

Yin Lai, PhD, MSc, RAC

Director/Principal Scientist,
CMC, Cardinal Health Regulatory Sciences

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 the cell and gene therapy area. Her role includes helping clients 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, PhD, RAC

Director/Principal Scientist
CMC, Cardinal Health Regulatory Sciences

Kent Amsberry, PhD, RAC is a Director in Cardinal Health Regulatory Sciences specializing in regulatory strategy and Chemistry, Manufacturing and Controls (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.