NDA Partners LLC, a product development consultancy to the biopharmaceutical and medical device industries, today announces it has tapped David W. Feigal, Jr., a medical doctor with a masters degree in public health, to develop and lead its medical devices and biologics practice areas. Dr. Feigal joins NDA Partners following an extended tenure with the U.S. Food and Drug Administration where he served in senior leadership positions in all three of the FDA’s medical product areas: medical devices, biologics and pharmaceuticals.

“Increasingly, innovative products blend devices and diagnostics with biologics or drugs. Due to the complexity of these unique products, the development of a streamlined regulatory and scientific path is a strategic necessity,” commented Dr. Carl Peck, NDA Partners’ chairman. “Dr. Feigal is a very skilled, knowledgeable regulatory scientist with 12 years of executive experience in three FDA product centers. He will provide invaluable insight and guidance to our clients, who otherwise would be unable to afford or attract expertise of this caliber.”

Dr. Feigal began his distinguished career in academia teaching at the University of California at both the San Diego and San Francisco campuses. He made the move to the FDA in 1992 when he was recruited to head the HIV Division in the Center for Drug Evaluation and Research. Subsequently, he served as director of the Division of Anti-Infective Drug Products, director of the Office of Drug Evaluation IV and medical deputy director of the Center for Biologics Evaluation and Research. Since 1999, Dr. Feigal has been director for the Center for Device and Radiological Health.

“There is great potential to develop therapeutics for diseases that are not common enough to create blockbuster drug markets,” said Dr. Feigal. “I have always been interested in making product development more efficient and predictable, and am looking forward to the opportunity to assist small and medium-sized pharmaceutical and device companies where many of the new therapies are being discovered. These companies have great potential to positively impact public health as well as to open new markets.”

“A paradigm shift is currently underway, where small and mid-sized medical product companies are adopting the small business model that has been successful for years in the device industry,” continued Dr. Feigal. “With the risk-based device regulations, there are often multiple paths to market, and approval strategies include creating staged market introductions from low risk to higher risk novel applications. I am excited to assist these companies in the development of strategies that reflect and advance this evolution.”

About NDA Partners
NDA Partners is a provider of strategic advisory services for mid-stage biopharmaceutical and medical device companies, providing access to a breadth of resources that small and mid-sized companies require but cannot recruit or afford to bring on staff. The company helps its clients evaluate technology and identify products in the discovery pipeline with the greatest probability for success, advises in the preparation of pre-clinical and clinical strategy plans, and provides guidance in product development program design and execution. It assists investors with product and company due diligence, development program assessments, and similar services.

Company founders include internationally recognized experts who have been instrumental in shaping the course of drug development during the past several decades. NDA Partners offers emerging companies a unique combination of drug development and regulatory expertise, strategic advice, and proven clinical development and management practices that lead to rapid, efficient and economical product development and commercialization. For more information, visit www.NDApartners.com, or call toll-free 888-823-2412.

Founders:
 Fritz Bühler, M.D., director of European Center of Pharmaceutical Medicine and former head, Worldwide Clinical R&D, Hoffman-LaRoche

 Alexander Cross, Ph.D., DSc, FRSC, formerly president and chief executive officer of Zoecon Corporation, vice president of Research at Syntex Corporation, president of Syntex Scientific Systems, and president of Syntex International Pharmaceuticals.

 Dennis Fisher, M.D., founder of the “P-Less-Than” Company, a clinical pharmacology and pharmacometrics consultancy and former professor of anesthesia and pediatrics, University of California at San Francisco

 Charles Grudzinskas, Ph.D., adjunct professor, Georgetown CDDS and former executive at G.D Searle & Co., Lederle Laboratories and NIH/NIDA

 Earle Martin, founder and former chairman and chief executive officer, PRA International (an international clinical CRO)

 Carl Peck, M.D., founder and director, Georgetown University Center for Drug Development Science and former director of FDA’s Center for Drug Evaluation & Research

 Malcolm Rowland, Ph.D., research professor of Pharmacy and former dean, School of Pharmacy and Pharmaceutical Sciences, University of Manchester and founder and former director, Medeval Ltd. (a CRO)

 David Savello, Ph.D., executive vice president of quality, regulatory and chief scientific officer at Cardinal Health and former vice president regulatory affairs, Glaxo Inc.

 George Schwartz, MBA, former chairman of Aircraft Services International Group, Inc., founder of Tioga Capital Corporation, and former senior vice president of corporate finance at Drexel Burnham Lambert

 The late Lewis Sheiner, M.D., professor of clinical pharmacology in the Departments of Laboratory Medicine and Biopharmaceutical Sciences at the University of California at San Francisco