Robert Meyer, M.D.

Bob MeyerRobert Meyer, M.D., is the Director of the Virginia Center for Translational and Regulatory Sciences at the University of Virginia’s School of Medicine, as well as being an Associate Professor of Public Health Sciences. In this position, he is heading a group developing a regulatory science educational track, as well as providing regulatory and translational knowledge resources to University and external entities who seek regulatory strategic adivce. He is on the Board of Directors for the Reagan-Udall Foundation for the FDA, as well as being a Medical Science Trustee for the United States Pharmacopeia Board of Trustees (previously servicing at USP on the expert panel making recommendations on the Medicare Model Guidelines) and a member of the Benefit-Risk Advisory Council for FasterCures. Prior to joining the faculty at UVA in 2013, Dr. Meyer was Vice President and head, Global Regulatory Strategy, Policy and Safety at Merck Research Laboratories (MRL), where he was responsible for leading an organization of over 1000 individuals in the oversight of all regulatory strategy and operations, global regulatory policy and intelligence, and global product safety and pharmacovigilance. At Merck, Dr. Meyer served on the Early and Late Stage Development Review Committees, the Safety Review Committee, the Corporate Responsibility Committee and chaired the Development Policy Committee. Externally, Dr. Meyer chaired the Regulatory Affairs Coordinating Committee for Pharmaceutical Research and Manufacturers of America (PhRMA) from 2012-13, and served as a key PhRMA negotiator on PDUFA V.

Prior to Merck, Dr. Meyer worked for the U.S. Food and Drug Administration (FDA) from 1994-2007. In his last 5 years at the FDA, Dr. Meyer was as the Director for the Office of Drug Evaluation II (ODEII) within Center for Drug Evaluation and Research (CDER), with responsibilities for pulmonary and allergy, metabolic and endocrine, and analgesics, anesthetics and rheumatologic drug products. Dr. Meyer was involved in several CDER initiatives, amongst them chairing the development of the Pre-Market Risk Assessment guidance. Additionally, he participated with the FDA negotiation team for PDUFA III and IV. While at FDA and again after returning to academia, Dr. Meyer is a technical expert on the Medical Aerosols Technical Options Committee to the Montreal Protocol on the Protection of the Ozone Layer, work for which he was recognized by both United Nations Environmental Programme and the US EPA. Prior to joining FDA, Dr. Meyer was a pulmonologist and critical care faculty member of the Oregon Health [and] Sciences University, where he helped create the medical service for the Lung/Heart-Lung Transplantation service. Dr. Meyer received his medical degree from the University of Connecticut School Of Medicine, Pulmonary and Critical Care fellowship at the University of Vermont and his bachelor’s degree in natural science from Lehigh University.