David W Feigal, Jr is to develop and lead NDA Partners' medical devices and biologics practice areas
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 US 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 calibre." 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.
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."
