Mr. Simon brings over 30 years of drug development and regulatory affairs experience including involvement in the successful registration of numerous new drug applications world wide spanning the following therapeutic areas: oncology, cardiovascular, CNS, anti-infective, antiviral, dermatology and metabolism/endocrinology.
He currently serves as Senior VP of RA and QA at Threshold Pharmaceuticals. Previously he was Executive Vice President at OSI Pharmaceuticals where he was responsible for CMC, QA/QC, Regulatory Affairs, Toxicology, ADME, Medical Writing, Clinical Safety and Project Management for all drug development and post approval activities for both oncology and diabetes/obesity groups. Prior to joining OSI he was Vice President of Global Regulatory Affairs at Gilead Sciences. Before his time with Gilead he was with Bristol-Myers Squibb (BMS) where he started in the regulatory affairs department and later developed and led the CMC department, and was ultimately responsible for all CMC activities at BMS. Mr. Simon started his pharmaceutical career at SRI International as a research chemist, and then moved to Syntex.