Bob Seevers

Dr. Bob Seevers has over 40 years of experience in the pharmaceutical research and development. His experience includes serving as an FDA reviewer/team leader, clinical investigator, and working in industry. After more than a decade in Nuclear Medicine, Bob spent 8 years with FDA, followed by 16 years with Eli Lilly and Company in Quality Assurance and Regulatory Affairs. Bob has been a consultant for several years now. He has led the regulatory CMC submission strategy for drugs in preclinical development through their NDA/BLA submission and the approval process for both small and large molecules. Bob’s expertise includes cold chain shipping, stability, Nuclear Medicine, determining regulatory starting materials, radiopharmaceuticals, setting global specifications, determining product critical quality attributes, quality by design (QbD), global regulatory submissions, and interactions with regulatory agencies. His knowledge spans the therapeutic areas of Central Nervous System, Endocrine, Metabolism, Autoimmune, Oncology, and more.