Date: 2016-03-04
Type of information: Nomination
Compound:
Company: Amarantus BioScience (USA – CA)
Therapeutic area: Rare diseases - Regenerative medicine
Type agreement: nomination
Action mechanism:
Disease:
Details: * On March 4, 2016, Amarantus BioScience announced that it has appointed Brian E. Harvey, MD PhD to its strategic advisory board. Dr. Harvey will assist the company's management team in developing and executing its strategy to accelerate FDA regulatory approval for its orphan drug portfolio of products. 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 the 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 Liaison with the 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 the FDA in increasing positions of responsibility across various divisions 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 the FDA. Dr. Harvey received his PhD, then MD from the University of Connecticut.
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