Former FDA Regulatory Scientist Joins Pearl Pathways
Pearl Pathways has hired Robert Seevers as senior advisor to serve biopharmaceutical companies. He has more than 40 years of experience in pharmaceutical research and development for both large and small molecules. His expertise includes CMC regulatory, cold chain shipping, setting global specifications, quality by design (QbD), global regulatory submissions, and interactions with global regulatory agencies. His knowledge spans all major therapeutic areas with specific expertise in CNS, Endocrine, Metabolism, Autoimmune, Oncology, Radiopharmaceuticals, and drug delivery systems. Seevers’ robust clinical research experience includes acting as a primary investigator, vice-chair of an Institutional Review Board, FDA reviewer/team leader and medical writer.
His career includes eight years at the United States Food and Drug Administration. There he served as a team leader responsible for managing a team of reviewers for the evaluation of CMC sections of INDs, NDAs and BLAs. Prior to joining Pearl Pathways, Seevers spent 16 years with Eli Lilly and Co. in Regulatory Affairs, where he led the regulatory CMC submission strategy for drugs in preclinical development through their NDA/MAA submission and the approval process for both small and large molecules.
He is a member of the United States Pharmacopeia Packaging, Storing, and Distribution Expert Committee, acts as a stability consultant for the World Health Organization, speaks regularly at nation and international life science conferences, and continues to be an active writer of industry publications.