E. Mitchell Seymour, PhD, RAC University of Michigan, Ann Arbor, MI, USA
Dr. Seymour is research faculty at the University of Michigan Medical School and also serves in Michigan Institute for Clinical and Health Research. This unit serves the FDA regulatory needs of faculty sponsor-investigators, including FDA meeting preparation and engagement, Investigational New Drug (IND) and Investigational New Device (IDE) submissions, clinical hold responses, IND/IDE lifecycle maintenance, and investigator education. He also serves on the University of Michigan Health System’s Institutional Review Board, and is a lecturer at Eastern Michigan University in their Masters of Science program in Clinical Research Administration. As a consultant, Dr. Seymour provides regulatory affairs services for industry and academia that include regulatory writing, regulatory strategy, regulatory intelligence, and regulatory due diligence. As a life scientist, he has over 20 years of experience in basic science and clinical research in industrial and academic settings. His principal interest are in repurposing/repositioning of approved drugs for either innovative clinical care or for-profit through the 505(b)(2) marketing pathway. Dr. Seymour earned his BS in Biology from the University of Notre Dame and his PhD in Biochemical and Molecular Nutrition from Michigan State University. He also earned the US Regulatory Affairs Certified (RAC) credential from the Regulatory Affairs Professional Society.