Mr. Weiss is Global Project Leader for Auven Therapeutics’ ophthalmology programs. Mr. Weiss joined Auven Therapeutics in April 2011 with over 30 years of pharmaceutical industry experience, most recently in drug development program management. He is a clinical biostatistician by academic training with recent therapeutic experience in ophthalmology and solid organ transplantation. He has been a frequent participant in regulatory meetings with FDA and EMA. Prior to joining the company, Mr. Weiss was Senior Vice President of Lux Biosciences, a development stage biotechnology company specializing in immune-mediated ophthalmic diseases, where he planned and led a landmark clinical development program of a systemic immunosuppressive agent for the treatment of non-infectious posterior uveitis, from project inception through NDA and MAA submissions and post submission regulatory interactions. While at Lux, Mr. Weiss also led development activities for a novel topical agent for the treatment of Dry Eye Syndrome, from formulations development, CMC upscaling and toxicology through IND filing and the successful conduct of a first-in-man study. Mr. Weiss was one of the founders of Lux Biosciences and was instrumental in raising a $49 million Series A venture round and in the in-licensing of two clinical stage projects. Prior to Lux, he served as Senior Director, Program Management for Enzon, Inc., where he led US development activities for a transplant immunosuppressant licensed from a European pharmaceutical company. Earlier, Mr. Weiss had a 20 year career at Berlex Laboratories (now Bayer Healthcare) where he served as Director of Biostatistics and as Head of Drug Development Information Systems.
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