Brian E. Harvey, PhD MD is a physician and biochemist with academic research, clinical practice, U.S. FDA regulatory, bio-pharmaceutical industry and non-profit experience. He currently is Principal Consultant, at Brian E Harvey LLC, as well as a regulatory advisor at the non-profit Global Liver Institute in Washington, DC. Prior to his current activities, Harvey held positions as Vice President of U.S. Regulatory Strategy at Pfizer and Vice President of U.S. Regulatory Policy at Sanofi-Aventis, including during the period of the Genzyme merger. Harvey also held several senior roles at FDA, serving in the medical device (CDRH), biologic (CBER) and drug (CDER) Center from 1995 to 2007. As Director of CDER Division of Gastroenterology Products Office of New Drugs (OND), he headed the regulatory review teams for NDA and BLA submissions and chaired FDA meetings with regulated industry on a regular basis. As Director, he created the Inborn Errors of Metabolism Team within the GI division to focus on rare disease product approvals. 

Prior to this, he served as Deputy Director for the Office of Drug Evaluation 5 (CDER) and CBER Associate Director for Policy, Office of Therapeutics Research and Review (OTRR). Harvey graduated with honors from Middlebury College in Vermont. After college, he received his PhD in biochemistry at the University of Connecticut (Storrs), followed by his MD at UCONN Health Center (Farminigton). In his last year of medical school, he began post-doctoral research on colorectal cancer and the role of sialic acid in site-specific metastasis at Harvard University. He completed his internship and residency in internal medicine at Harvard’s Beth Israel Hospital, which included clinical rotations at Dana-Farber Cancer Institute, West Roxbury Veterans Hospital, clinical research at Brigham and Women’s Hospital and the Harvard School of Public Health. His bench research activities at Harvard resulted in several publications in peer reviewed journals. This was followed by a three year gastroenterology/hepatology fellowship at Johns Hopkins Hospital, Baltimore, MD.