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John recently retired from the FDA after 20 years of service. His most recent responsibilities were as Director, Division of Pre-Marketing Assessment II & Manufacturing Science in the Office of New Drug Quality Assessment. Some of his major achievements have been the review, inspection and approval of Gleevec, a new class of oncology drug in 45 days, which required collaborative and innovative approaches to working with a pharmaceutical manufacturer. He has also been involved with the review and approval of the first major combination products Mylotarg (a monoclonal antibody with a cytotoxic agent) and the Cypher drug eluting stent (a drug-device combo). He has served in the Office of New Drug Chemistry, Office of Generic Drugs, Division of Cardio-Renal Drug Products and the Division of Biopharmaceutics. His current areas of interest include PAT and Combination Products. He has over 125 publications and presentations in the areas of analytical methodology to evaluate drugs in vitro and in vivo. Prior to FDA, he was on the faculty at the University of Pittsburgh, School of Pharmacy and the University of Kansas, School of Pharmacy, Center for Biomedical Research. He holds degrees from Temple University and the University of Pittsburgh. | 