Madison, VA (PRWEB) June 07, 2013
Carl Peck, MD, Chairman of NDA Partners LLC (NDAP), today announced the addition of three senior industry executives to its roster of Premier Expert consultants. NDAP’s Premier Experts are top tier consultants whose expertise and professional stature allow them to bring extraordinary value to NDAP clients that face complex and challenging issues in the development, regulatory approval and commercialization of medical products. NDAP’s Premier Experts provide expert consulting in product development and regulatory strategies, expert reports and testimony in litigation disputes, and due diligence in investment decisions. As participants on NDA Partners project teams, they collaborate with the Partners and other Premier Experts to design and implement critical solutions needed to advance products through the development, regulatory and commercialization process.
Kathryn Stein, PhD – Dr Stein is a former Director of the Division of Monoclonal Antibodies (DMA) at the US Food & Drug Administration (FDA). She was lead or co-author on all of the guidance documents published by the FDA specific for monoclonal antibodies, a co-author of the FDA guidance on comparability and led the committee and co-authored the draft FDA-USDA Guidance for Industry on Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants. During Dr. Stein’s tenure as Director of DMA, 15 of the first 17 monoclonal antibodies were approved. She has 11 years of post-FDA industry experience in product development, regulatory affairs and biologics manufacturing.
Howard Lee, MD, PhD - Dr Lee is a Professor and head of the Clinical Trials Center, Seoul National University Hospital, Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine. He has formerly held positions as Associate Director for Research and Director of the Center for Drug Development Science (CD
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