Andrew Byrnes

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 over 20 years of experience at FDA in CMC review and regulatory policy for cellular and gene therapy products. Dr. Byrnes has a background in virology and gene therapy, and his laboratory at FDA studies gene therapy with adenovirus vectors.