Madison, Virginia (December 12, 2013) - Carl Peck, MD, Chairman of NDA Partners (NDAP), today announced that David Feigal, MD, a Partner in the firm, has been appointed to the Innovation in Regulatory Science Awards (IRSA) Advisory Board of the Burroughs Wellcome Fund. IRSA provides awards of up to $500,000 over five years to academic investigators who are addressing research questions that will lead to innovation in regulatory science, with ultimate translation of those results into improving the regulatory process. These awards are intended to provide support for academic researchers developing new methodologies or innovative approaches in regulatory science that will ultimately inform the regulatory decisions the Food and Drug Administration (FDA) and others make. This would necessarily draw upon the talents of individuals trained in mathematics, computer science, applied physics, medicine, engineering, toxicology, epidemiology, biostatistics, and systems pharmacology, to name a few.
Dr Feigal advises mid-stage device and biopharmaceutical companies about clinical and regulatory strategies, product development and design, and the introduction of innovative technologies. In this role he has served as the Chief Medical Officer of Topica Pharmaceuticals Inc., and is currently the CMO at ExsoMed LLC, and CytoDyn Inc.
Dr Feigal spent 12 years with the U.S. Food & Drug Administration (FDA) where he served as Head of the Center for Devices and Radiologic Health from 1999 to 2004, Head of the Center for Biologics Evaluation and Research from 1997 to 1999, and Head of the Center for Drug Evaluation and Research from 1992 to 1997. He served as a Director of the Division of Anti-Viral Drug Products from 1992 to 1996, Acting Director of the Division of Anti-Infective Drug Products from 1996 to 1997, and Director of the Office of Drug Evaluation IV from 1995 to 1997.
Dr Feigal served as the Senior Vice President and Head of Global Regulatory and Safety Surveillance at Elan Corp from 2006 to 2008 and as Vice President of Global Regulatory Affairs at Amgen, Inc from 2008 to 2010. He serves and has served on a variety of Boards including Aspect Medical Inc and Renovo Ltd.
Dr Feigal worked for 10 years within the academic and hospital settings of the University of California in San Diego, San Francisco and Davis. He has more than 30 years of experience in health policy, medical education, and healthcare regulation. Prior to leaving clinical medicine, he was a practicing Internist at UCSF and was part of the team that developed aerosolized pentamadine. Dr Feigal was a member of the World Health Organization's Global Program on AIDS and held faculty appointments at the University of California, San Francisco and the University of California, San Diego schools of medicine. He holds an MD degree from Stanford University (1976) and an MPH degree from the University of California Berkeley (1983). He earned a Bachelor's degree in Psychology from University of Minnesota in 1971.
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