Director – Robert Meyer, MD
Robert Meyer, M.D., is the Director of the Virginia Center for Translational and Regulatory Sciences at the University of Virginia’s School of Medicine and Associate Professor of Public Health Sciences. He has expertise in drug regulation, clinical development, study design and corporate drug/biologics discovery and development. Prior to joining the faculty at UVA, Dr. Meyer was Vice President and head, Global Regulatory Strategy, Policy and Safety at Merck Research Laboratories (MRL) where he was responsible for regulatory strategy and operations, regulatory policy and intelligence, and product safety. He also participated in Merck’s Clinical Development and Safety committees. 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. Dr. Meyer joined Merck in 2007 after thirteen years at the U.S. Food and Drug Administration (FDA). His ultimate position at the FDA 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 from 2002 – 2007. 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 in the PDUFA III and IV negotiations with the Biotechnology Industry Organization (BIO) and PhRMA. While at FDA, Dr. Meyer served as an expert to the Medical Aerosols Technical Options Committee to the Montreal Protocol on the Protection of the Ozone Layer. He also served on the third expert panel for the National Heart, Lung and Blood Institute’s National Asthma Education and Prevention Program (NAEPP EPR3). Prior to joining FDA, Dr. Meyer was an academic pulmonologist and critical care specialist at the Oregon Health (and) Sciences University, where he helped launch the medical service for the Lung/Heart-Lung Transplantation program. Dr. Meyer received his MD from the University of Connecticut, where he also did his internal medicine training (along with a Chief Residency). His pulmonary and critical care training was completed at the University of Vermont.
Greg Fralish, PhD
Greg Fralish, PhD has 15 years of experience in commercial drug development, regulatory affairs, and academic basic and translational science. As Head of Translational Science, Fralish leads the Center’s activities in support of advancing innovation through managing seed funding programs, pre-IND development strategy, and start up company strategy and considerations. Fralish is cofounding CEO of the UVA start-up iTi Health, where he manages company operations and helps advance the company’s pipeline of preclinical and clinical-stage programs. Fralish previously was Program Director, Clinical and Translational Research in the Office of the Dean, UVA School of Medicine. Prior to UVA, Fralish worked at Cato Research in Research Triangle Park, N.C., where he contributed to a wide array of drug programs in managing multi-disciplinary teams tasked with commercially developing early-stage drugs and devices. In parallel to this role, Fralish also worked as Analyst for Cato BioVentures, the venture capital parent of Cato Research. Fralish was an NIH-funded post-doctoral fellow at Duke University and received his Ph.D. in Biochemistry and Molecular Biology from the University of Georgia and was certified in regulatory affairs by the Regulatory Affairs Professional Society. Fralish is Director of the Launchpad Translational Research Fund for Diabetes innovation; he serves as an Early Stage Company Mentor for SEBIO Bioinvestor Forum and as a technology transfer reviewer for the DOD Technology Development Award & Clinical Trail Award programs.