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Mr. Simon is Executive Vice President, Pharmaceutical Development and Manufacturing of OSI. Before joining OSI in 2002, Mr. Simon served as Vice President Global Regulatory Affairs for Gilead Sciences from 1999 - 2001. Prior to joining Gilead he was Vice President Worldwide Regulatory Affairs at Bristol-Myers Squibb. There he was responsible for all CMC regulatory activities worldwide for both marketed products and new drug registration. From 1987-1997, Mr. Simon held various other regulatory affairs positions at Bristol Myers Squibb. He was responsible for the filings of numerous US IND’s, NDA’s, AADA’s and SNDA’s as well as a variety of international dossiers. During his career in regulatory affairs, he has created an electronic CMC dossier system capable of providing the CMC sections of worldwide registrational dossiers simultaneously. In addition, he successfully prepared and negotiated the approval of the CMC section of the only NDA that required an environmental impact statement. Among other achievements, Mr. Simon established a novel communications procedure with the FDA to help expedite the review and approval of the CMC sections of NDA’s that are the subject of important new therapies. Mr. Simon holds a Bachelors degree in Chemistry from California State University and has had Executive Management training from Levinson Institute and Columbia University. He was also the co-founder of the Regulatory Science Section of the American Association of Pharmaceutical Scientists (AAPS). | 