Scott Harris, MD
Dr. Harris’ expertise is drug development in gastroenterology and liver disease. He has served as a consultant to numerous biotechs and pharmaceutical companies for early and late-stage clinical development, regulatory strategy, product licencing (in-licensing and out-licensing), and market assessment. His role as a consultant has spanned all stages of drug development, from the pre-IND space to NDA filing, and beyond. In this capacity, he has designed and managed early and late-stage clinical trials in North America, Eastern and Western Europe, India, Bangladesh, and Australia and drug development programs in gastroparesis, idiopathic constipation, opioid induced constipation, irritable bowel syndrome, secretory diarrhea, cholera, ulcerative colitis, and Crohn’s disease. Dr. Harris was author of the Phase 3 program that resulted in the approval of Fulyzaq® (crofelemer) for HIV-associated diarrhea in 2012. The pivotal, registrational trial was the first adaptive trial methodology accepted by the FDA under Special Protocol Assessment (SPA).
He also oversaw the clinical program that lead to CE Mark approval of Zyva™ (spherical carbon adsorbent) in Europe for diarrhea-predominant IBS that same year. He has served as Chief Medical Officer (CMO) to various start-ups and biotech companies, including Avaxia Biologics, Ocera Therapeutics, and Napo Pharmaceuticals. He also acted as Interim CMO at Tranzyme Pharmaceuticals (NASDAQ:TZYM) in 2011.
He is currently on the faculty of Georgetown University School of Medicine where he directs the course on drug development in the Masters Program of the Georgetown-Howard University Center for Clinical and Translational Science, which is funded through a CTSA award from the National Institutes for Health. Dr. Harris is a graduate of Harvard College and Harvard Medical School, and holds an MS in Population Health and Administrative Medicine from the University of Wisconsin Medical School.