Brian E. Harvey, MD, Ph.D



Dr. Harvey most recently served as VP of US Regulatory for Pfizer. Previously, from 2007-2012, he was VP of US Regulatory Policy for Sanofi-Aventis, including the merger with Genzyme. Dr. Harvey was Director of the Division of Gastroenterology Products at the CDER, FDA until April of 2007. His previous positions include Deputy Director of the Office of Drug Evaluation and Acting Director of the Division of Anti-Inflammatory, Analgesic & Ophthalmologic Drug Products at the CDER, FDA, Associate Director Regulatory Policy at the Office of Therapeutics Research & Opthamology; Review at the CBER, FDA, American Political Science Association (APSA) Congressional Fellow, and Medical Officer at CDRH, FDA. Dr. Harvey has over 11 years of FDA experience in the Centers for Drugs, Biologics and Devices in both medical officer review and management positions. He has experience in drug, biologic product, medical device and combination product pre-market regulatory evaluation. His special interests include Biosimilars,  Functional GI Disorders, IBS, gastroparesis, constipation, Crohn's & Ulcerative Colitis, RA, Gout, Inborn Errors of Metabolism, Orphan Products, FDA policy development, healthcare policy and risk communication. Dr. Harvey received his PhD in biochemistry and MD from the University of Connecticut, did postdoctoral research at New England Deaconess Hospital in Boston, completed an internal medicine internship and residency at Beth Israel Hospital/Harvard, and completed a 3 year gastroenterology fellowship at Johns Hopkins Hospital.  During his time at FDA and Sanofi, he worked as a part time Medical Hospitalist at Anne Arundel Medical Center, MD.