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| Sydney Gilman, PhD, Gene Logic |
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| Dr. Sydney Gilman has over twenty years of experience in positions of increasing responsibility in Pharmaceutical industries. He has extensive expertise in regulatory affairs within the Center for Drug Evaluation and Research and has had collaborative interactions with the pain and CNS divisions. Dr. Gilman has a broad range of regulatory/QA knowledge and experience on global pharmaceutical development that encompasses investigational development through marketed products over the last five years in industry, as well as extensive knowledge of ICH guidelines and FDA guidance documents and EMEA guidances, which are relevant to global pharmaceuticals. He served as a Chemistry Reviewer at the FDA for 6 years and spent fifteen years preparing Chemistry, Manufacturing and Control Sections of Global Regulatory Dossiers (IND, NDA, BLA, and MAA), as well as post-approval supplements (NDA and BLA) and variations (MM). Currently as Vice President, Regulatory Affairs at Gene Logic Inc. in Gaithersburg, Maryland, Dr. Gilman is responsible for providing comprehensive regulatory guidance, regulatory document preparation and strategic planning to pharmaceutical, biotechnology and academic organizations in support of their drug development programs. Dr. Gilman holds a Ph.D. in Organic Chemistry from the University of Pittsburgh, Pennsylvania and a B.S. in Chemistry from Loyola College in Baltimore, MD.
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