David Young | President, Research & Development and Founder
Processa Pharmaceuticals, Inc.

David Young, President, Research & Development and Founder, Processa Pharmaceuticals, Inc.

Dr. Young has over 40 years of pharmaceutical research, drug development, and corporate experience. He was Founder of Processa Pharmaceuticals, Inc. and served as CEO from 2017-2023 before becoming President of R&D. Dr. Young was a Board Member and Chief Scientific Officer at Questcor Pharmaceuticals from 2006-2014 and was responsible for working with the FDA on modernizing the Acthar Gel label and in obtaining approval in Infantile Spasms. During the eight years that he was involved with Questcor, Questcor transitioned to an orphan drug specialty pharmaceutical company. Dr. Young has held several other leadership roles in Biotech companies and CROs since 1997. Before forming the CRO GloboMax, Dr. Young, as a Tenured Associate Professor at the University of Maryland, worked with FDA to develop the concept of Regulatory Science as a Co-Principal Investigator on an FDA clinical pharmacology contract and as the clinical pharmacologist on the UMAB-FDA contract to develop the FDA SUPAC and the IVIVC FDA Guidances as well as teach FDA reviewers. Dr. Young is an expert in Clinical Drug Development and Regulatory Science, having met with FDA more than 100 times on more than 50 drug indications. Dr. Young has also been a key team member on more than 30 FDA-approved indications across the divisions of FDA. Dr. Young has  B.S. in physiology, a M.S. in medical physics, a PharmD, and a PhD.    

Appearances:



Day 2 - World Orphan Drug Congress USA 2025 @ 14:00

Presentation: Applying Principles of FDA’s Project Optimus to Oncology and Non-Oncology Rare Diseases

last published: 24/Apr/25 11:35 GMT

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