Seevers brings over 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.
Seevers’ career includes eight years at the United States Food and Drug Administration (FDA). At FDA, Seevers 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 Company 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.
As senior advisor at Pearl Pathways, Seevers is responsible for the development of the regulatory strategy for early through late-stage regulatory filings of both large and small molecules, interactions with global regulatory agencies, leading cross-functional CMC development teams, and helping clients identify product development vendors (e.g. CROs, CMOs, contract laboratories). He will serve on Pearl IRB, an AAHRPP accredited Independent Review Board.
Seevers is a member of the United States Pharmacopeia Packaging, Storing, and Distribution Expert Committee; acts as a Stability Consultant for the World Health Organization (WHO); speaks regularly at nation and international life science conferences; and continues to be an active writer of industry publications.
Pearl Pathways President and CEO DIana Caldwell shares, “Our clients will benefit from Robert’s unique life science portfolio as an ex-FDA regulator coupled with extensive leadership experience within the biopharmaceutical industry. His dual-sided industry experience will be invaluable for our clients to navigate a variety of regulatory compliance challenges in both large multi-national companies and small startups. He brings expert technical knowledge; we are thrilled to have Robert join our team.”
Pearl Pathways is a sponsor of VisionTech Partners/VisionTech Angels, Indiana’s most active angel investing group with chapters in Bloomington, Fort Wayne, Greater Lafayette, Indianapolis and a physician-led chapter called AngelBOM.
Contact: Waylon Wright