About me
Andrew P. Byrnes, PhD, is the Director of the Division of Gene Therapy 1 at FDA’s Center for Biologics Evaluation and Research. The Division of Gene Therapy 1 reviews manufacturing of gene therapy vectors, microbial vectors, cancer vaccines, oncolytic viruses, in vivo genome editing products, and other products. Dr. Byrnes has a background in virology and gene therapy, with over 25 years of experience at FDA in CMC review and regulatory policy for cellular and gene therapy products.
