Brian Harvey

Brian E Harvey LLC

Brian Harvey is a prominent figure in the fields of medicine, biochemistry, and regulatory affairs, currently serving as an Entrepreneur In Residence at Yale University since September 2018. He also operates as the Principal Consultant at his own firm, Brian E Harvey LLC, which he founded in June 2015. His consultancy focuses on regulatory and clinical strategy for pharmaceuticals, biotechnology, medical devices, and combination products, providing expertise to navigate U.S. FDA regulations and global markets.1 2

Education and Early Career

Brian Harvey's academic background is extensive. He graduated with a BA in Biology and Chemistry from Middlebury College (1980) and went on to earn a PhD in Biochemistry from the University of Connecticut (1985). He completed his MD at the University of Connecticut School of Medicine (1989) and pursued further training through a Clinical Fellowship in Internal Medicine at Harvard Medical School (1992) and a Gastroenterology Fellowship at Johns Hopkins Hospital (1995) .1 2

Professional Experience

Harvey's career spans various roles in both clinical practice and regulatory affairs:

Chief Regulatory Advisor at HighTide Therapeutics (2019-2020)
Executive Vice President of Scientific and Regulatory Affairs at the Global Liver Institute (2015-2020)
Vice President of U.S. Regulatory Strategy at Pfizer (2012-2015)
Vice President of U.S. Regulatory Policy at Sanofi-Aventis (2007-2012)
Significant roles at the U.S. FDA from 1995 to 2007, including Director of the Division of Gastroenterology Products where he led teams for drug approvals related to gastrointestinal diseases.1 2 3

Contributions and Research

Throughout his career, Harvey has been involved in both regulatory policy development and clinical research. He has contributed to various initiatives aimed at improving drug approval processes for rare diseases and has been active in academic research, particularly during his time at Harvard, where he published several peer-reviewed articles on colorectal cancer.2 3

Current Focus

At Yale University, Harvey continues to leverage his extensive experience to foster innovation within the biotech sector while mentoring emerging entrepreneurs in health-related fields.1 2