Madison, Virginia (May 29, 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 a 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 (CDDS) at the UCSF and was Guest Medical Reviewer, Division of Cardio-Renal Products and Guest Researcher, Office of Clinical Pharmacology and Biopharmaceutics, FDA CDER.
In-Jin (Theo) Jang, MD, PhD - Dr Jang is a professor in the Department of Clinical Pharmacology at the Seoul National University College of Medicine and Director of the Department of Pharmacology at the Seoul National University Hospital.
According to Dr Peck, "Our new Premier Experts strengthen our position as one of the premier strategy consulting firms in the world in the area of medical product development. We are pleased with the extraordinary depth of expertise and accomplishment that they will bring to bear on the solutions we provide for our clients."
About NDA Partners
NDAP is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms and investment funds. The highly experienced Principals and Premier Experts of NDA Partners include two former FDA Center Directors and an extensive international team of former pharmaceutical and medical device industry senior executives and regulators. Services include expert consulting, product development planning, regulatory strategy, advisory boards, product assessments and due diligence, litigation and patent support, and associated support projects.
Earle Martin, General Manager