Speakers

David Young, Pharm.D., Ph.D. - Dr. Young is President of Research and Development at Processa Pharmaceuticals, Inc. (NASDAQ: PCSA). Dr. Young founded the company in 2017, has served on the Board of Directors since 2017, and served as Chief Executive Officer from 2017 until August 7, 2023. Dr. Young has over 30 years of pharmaceutical research, drug development, and corporate experience. Prior to Processa, from 2006 to 2009, Dr. Young served as an independent Director on the Questcor Board of Directors. In 2009, Dr. Young joined the Questcor executive management team as Chief Scientific Officer (CSO) and obtained FDA approval for Acthar in the Orphan indication of Infantile Spasms (IS), worked with FDA on modernizing the label, and led all aspects of the approval including the Advisory Committee Meeting that voted to approve the NDA for IS. During the eight years that Dr. Young was involved with Questcor as an independent director and as its CSO, Questcor transitioned to an orphan drug specialty pharmaceutical company, moving from near bankruptcy in 2007 to the ultimate sale of the company for approximately $5.6 billion in 2014. While serving on Questcor’s Board of Directors, Dr. Young was Executive Director & President, U.S. Operations of AGI Therapeutics plc. Dr. Young has also served as the Executive Vice President of the Strategic Drug Development Division of ICON plc, an international CRO, and was the Founder and CEO of GloboMax LLC, a CRO specializing in FDA drug development, purchased by ICON plc in 2003. Prior to forming GloboMax, Dr. Young was a Tenured Associate Professor at the School of Pharmacy, University of Maryland at Baltimore (UMAB), where he led a group of 30 faculty, scientists, postdocs, graduate students, and technicians in evaluating the biological properties of drugs and drug delivery systems in animals and humans. Dr. Young is an expert in small molecule and protein non-clinical and clinical drug development. He has served on FDA Advisory Committees, was Co-Principal Investigator on an FDA-funded Clinical Pharmacology contract, was responsible for the analytical, clinical studies, and pharmacokinetic evaluation of all oral products manufactured in the UMAB-FDA contract which led to the Scale-up and Post-Approval Changes (SUPAC) and in-vitro in-vivo correlation (IVIVC) FDA Guidance, taught FDA reviewers as part of the UMAB-FDA contract for five years, has served on National Institutes of Health (NIH) grant review committees, and was Co-Principal Investigator on a National Cancer Institute contract to evaluate new oncology drugs. Dr. Young has met with the FDA over 100 times on more than 50 drug products and has been a key team member on more than 30 FDA approvals for indications across the FDA. Dr. Young has more than 150 presentations-authored publications-book chapters, including formal presentations to the FDA, FDA Advisory Committees, and numerous invited presentations. Dr. Young received his B.S. in Physiology from the University of California at Berkeley, his M.S. in Medical Physics from the University of Wisconsin at Madison, and his Pharm.D. - Ph.D. with emphasis in Pharmacokinetics and Pharmaceutical Sciences from the University of Southern California.