Brian Harvey, MD, PhD
EVP of Global Liver Institute, USA
Dr. Brian Harvey is a physician and biochemist with academic research, clinical practice, US FDA regulatory, bio-pharmaceutical industry, and non-profit experience. He is currently the Executive Vice President, Scientific and Regulatory Affairs, at the non-profit Global Liver Institute based in Washington, DC, and also serves as a regulatory consultant. Other volunteer activities include work as a Veterinary Husband and Assistant with World Vets, including a week-long Equine mission in Nicaragua, where he and the team cared for over 400 horses.
Previously, Dr. Harvey held positions as Vice President of US Regulatory Strategy at Pfizer and Vice President of US Regulatory Policy at Sanofi-Aventis, including during 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. 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). In 2000-2001, Dr. Harvey represented FDA as an American Political Science Association (APSA) Congressional Fellow and worked with the health staffs of the Senate Finance, Health Education Labor & Pensions (HELP), and Judiciary Committees. During his entire federal service, he also worked as a medical hospitalist, caring for patients on evenings, weekends, and holidays at Anne Arundel Medical Center in Annapolis, MD, as an “Outside Activity” (HHS-520 Approved).
Brian graduated with honors from Middlebury College in Vermont. He completed his PhD in biochemistry and then enrolled into the MD program 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 and West Roxbury Veterans Hospital, as well as 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. He then pursued a three-year gastroenterology fellowship at Johns Hopkins Hospital, Baltimore, MD, which included hepatology training and being a member of the Liver Transplant Service.