Our Leadership Team
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Seth DePuy, Ph.D.
Director, Regulatory & Product Strategy
Dr. Seth DePuy is a scientist and mentor with over 10 years of research experience in both academia and industry and over 5 years of experience in drug development and regulatory affairs for a broad range of therapeutic areas and unique drug products and/or dosage forms. Dr. DePuy is accomplished in performing thorough background research and assessing scientific and regulatory information to develop/support regulatory strategy and produce quality on-time deliverables to all stakeholders.
Dr. DePuy’s key experience includes (but is not limited to) regulatory strategy and support of US FDA meetings, IND applications and maintenance, expedited programs and designation applications, and NDA submissions. He possesses significant expertise in 505(b)(2) drug development and the unique strategies required for this development pathway.