Brian E. Harvey, MD, PhD

Senior Regulatory Lead

Dr. Brian Harvey has extensive industry, regulatory and clinical expertise in gastrointestinal and liver diseases. He previously was Vice President of U.S. Regulatory Strategy at Pfizer (2012-2015) and Vice President of U.S. Regulatory Policy at Sanofi Aventis (2007-2012). Prior to joining industry, Dr. Harvey worked at the U.S. Food & Drug Administration, most recently as director of FDA’s Division of Gastroenterology Products. Dr. Harvey led the regulatory review for NDA and BLA submissions of major breakthrough drugs for the treatment of IBD in adults and children, including adalimumab (Humira®), infliximab (Remicade®), and mesalamine (Lialda®). He is currently Senior Vice President of Regulatory and Scientific Affairs at the Global Liver Institute, a non-profit organization focused on improving the lives of patients with liver diseases.

Dr. Harvey graduated with honors from Middlebury College in Vermont. He earned his Ph.D. in lipid biochemistry and M.D. degree at the University of Connecticut. Prior to joining the FDA, he conducted post-doctoral research at Harvard Medical School, followed by his internal medicine internship and residency at Boston’s Beth Israel Hospital and a three-year gastroenterology fellowship at the Johns Hopkins Hospital in Baltimore, MD. Throughout his FDA career, Dr. Harvey remained a practicing clinician at the Anne Arundel Medical Center in Maryland.