Brian Harvey, MD, PhD

Brian E. Harvey, MD, PhD is a physician and biochemist with academic, clinical practice, U.S. FDA regulatory, bio-pharmaceutical industry and non-profit experience. Since 2015, he has been Principal Consultant at Brian E Harvey LLC, providing regulatory strategy advice on the development of biologics, drugs and medical devices for U.S. FDA and around the world ( Dr. Harvey has been named an Entrepreneur-in-Residence (EIR) at The Office of Cooperative Research, Yale University (, where he works with the Blavatnik Fellows in Life Science Entrepreneurship and advises on regulatory issues to help ready molecules from the Yale laboratories for introduction to the FDA Pre-IND meeting process and ultimately human clinical trials.  In addition, he volunteers as the Executive Vice President, Science and Regulatory at the non-profit Global Liver Institute ( based in Washington, DC. Prior to his current activities, Dr. 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.

Dr. 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).

Brian graduated with honors from Middlebury College in Vermont. After college, he received his PhD in biochemistry, followed by his MD at the University of Connecticut. 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 resulted in several publications in peer reviewed journals. This was followed by three year gastroenterology fellowship at Johns Hopkins Hospital, Baltimore, MD, which included hepatology training and a member of the Liver Transplant Service.