Amy McCord

Dr. Amy McCord has over 15 years of experience in biotech and pharma, specializing in regulatory affairs/CMC for complex biologics. Dr. McCord currently sits as Director, Global Regulatory Affairs, CMC within the Cell Therapy group at Takeda Pharmaceuticals, where she directs global CMC regulatory strategy for clinical and pre-clinical cell therapy programs and provides risk-based guidance in the areas of CMC submission content and strategy. Prior to Takeda, Amy worked as a consultant with DS Informatics and Cardinal Health Regulatory Sciences, where she directed and supported CMC and regulatory strategy for multiple products including recombinant proteins, mAbs, cell therapies, gene therapies, and small molecules. Dr. McCord has worked with a range of clients, from small biotech to large pharma, to direct and support both clinical trial applications and marketing applications.

Dr. McCord earned her B.S. in Microbiology and Cell Science from the University of Florida and her Ph.D. in Microbiology from the University of South Florida, and conducted her post-doctoral fellowship at Moffitt Cancer Center with a focus on drug discovery and cancer biology.