Also known as: drscottharris
My expertise is drug development in gastroenterology and digestive disorders. I have 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. My role as a consultant has spanned all stages of drug development, from pre-IND to post-NDA. In this capacity, I have designed and managed early and late-stage clinical trials and drug development programs in gastroparesis, idiopathic constipation, opioid induced constipation, irritable bowel syndrome, secretory diarrhea, cholera, ulcerative colitis, and Crohn's disease. I was author of the Phase program that resulted in the approval of Fulyzaq (crofelemer) for HIV-associated diarrhea in . The pivotal, registrational trial was the first adaptive trial methodology accepted by the FDA under Special Protocol Assessment (SPA). I have served as Chief Medical Officer (CMO) to Avaxia Biologics, Ocera Therapeutics, and Napo Pharmaceuticals. I also acted as Interim CMO at Tranzyme Pharmaceuticals (NASDAQTZYM) , where I provided medical support for its IPO in and facilitated its merger with Ocera Therapeutics in . I am currently on the faculty of Georgetown University School of Medicine where I direct 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. Specialties Gastroenterology, biotechnology, drug development, and translational medicine. My main therapeutic areas are gastroenterology and liver disease.
Scott Harris lives in Davenport, Florida. Companies in which he has a work history include Busch Gardens, Royal Caribbean, Customer Service, Florida Dance Thearer and Holiday Inn Club Vacations.
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