Marguerite Prior, Ph.D.Director, Regulatory Affairs
Dr. Marguerite Prior is a Director in the department of Regulatory Affairs at Federation Bio, where she oversees the execution and implementation of regulatory strategies across Federation Bio’s portfolio of therapeutic programs.
Dr. Prior has over seven years of experience in regulatory affairs in the pharmaceutical industry. Her experience includes working with rare disease development programs as well as FDA’s Expedited Programs for Serious Diseases and Conditions including Fast Track Designation, Accelerated Approval, Breakthrough Therapy designations, and Priority Review. Prior to joining Federation Bio, Dr. Prior worked at Intercept Pharmaceuticals, where she held various positions of increasing responsibility contributing to regulatory strategies and global marketing authorization applications for various non-viral liver diseases including Primary Biliary Cirrhosis (PBC) and Non-Alcoholic Steatohepatitis (NASH). Dr Prior also served as the Global Regulatory Lead for a rare pediatric liver indication, Biliary Atresia.
Dr. Prior has a B.Sc. in Industrial Microbiology and earned her Ph.D. in Neuroscience from University College Dublin in Ireland, while investigating therapeutic approaches to treat transmissible spongiform encephalopathies (TSEs). She completed two postdoctoral fellowships investigating therapeutic approaches in Alzheimer’s disease at the Lerner Research Institute, Cleveland Clinic and the Salk Institute for Biological Sciences. Her postdoctoral work at the Salk Institute led to the development of a small molecule neuroprotective agent that was advanced to IND enabling studies and recently completed a Phase 1 clinical study.