Management team member Brian E. Harvey has past ti
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Posted On: 07/31/2018 7:53:12 PM
Management team member Brian E. Harvey has past ties to Pfizer:
From AMBS website
Brian E. Harvey, MD, PhD
Chief Regulatory Advisor
Dr. Harvey recently served as Vice President of U.S Regulatory Strategy at Pfizer, where he led U.S. FDA regulatory interactions across all Pfizer business units and was a member of the CEO's Senior Leadership Council (SLC). He led the Pfizer efforts on the PhRMA Regulatory Affairs Coordinating Committee (RACC). In addition, he was responsible for supervisory oversight of U.S. Regulatory Policy & Intelligence functions and the U.S. Advertising & Promotion activities. He played an early role in PDUFA VI Preparation, the PhRMA Steering Committee and the 21st Century Cures initiatives.
Prior to his time at Pfizer, Dr. Harvey served as Vice President of Regulatory Policy at Sanofi, where he was the head Liaison with U.S. Food and Drug Administration (FDA), served on the International Biologics and Biotechnology Taskforce and Biologics Key Issues Team, was on the Biotechnology Industry Organization (BIO) Regulatory Affairs Committee (RAC). He was the Signatory authority for Sanofi written comments to the FDA docket and was a Member of the Sanofi Policy Development Committee.
Prior to Sanofi, Dr. Harvey spent 11 years with FDA in increasing positions of responsibility across the organization including Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH). From 2000 to 2001, Dr. Harvey served as an American Political Science Association (APSA) Congressional Fellow on behalf of FDA. Dr. Harvey received his PhD, then MD from the University of Connecticut.
His Internal Medicine Internship and Residency at Beth Israel Hospital/Harvard was followed by a 3-year Gastroenterology/Hepatology Fellowship at Johns Hopkins Hospital prior to joining FDA.
From AMBS website
Brian E. Harvey, MD, PhD
Chief Regulatory Advisor
Dr. Harvey recently served as Vice President of U.S Regulatory Strategy at Pfizer, where he led U.S. FDA regulatory interactions across all Pfizer business units and was a member of the CEO's Senior Leadership Council (SLC). He led the Pfizer efforts on the PhRMA Regulatory Affairs Coordinating Committee (RACC). In addition, he was responsible for supervisory oversight of U.S. Regulatory Policy & Intelligence functions and the U.S. Advertising & Promotion activities. He played an early role in PDUFA VI Preparation, the PhRMA Steering Committee and the 21st Century Cures initiatives.
Prior to his time at Pfizer, Dr. Harvey served as Vice President of Regulatory Policy at Sanofi, where he was the head Liaison with U.S. Food and Drug Administration (FDA), served on the International Biologics and Biotechnology Taskforce and Biologics Key Issues Team, was on the Biotechnology Industry Organization (BIO) Regulatory Affairs Committee (RAC). He was the Signatory authority for Sanofi written comments to the FDA docket and was a Member of the Sanofi Policy Development Committee.
Prior to Sanofi, Dr. Harvey spent 11 years with FDA in increasing positions of responsibility across the organization including Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH). From 2000 to 2001, Dr. Harvey served as an American Political Science Association (APSA) Congressional Fellow on behalf of FDA. Dr. Harvey received his PhD, then MD from the University of Connecticut.
His Internal Medicine Internship and Residency at Beth Israel Hospital/Harvard was followed by a 3-year Gastroenterology/Hepatology Fellowship at Johns Hopkins Hospital prior to joining FDA.
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