Ralph E. Gaskins, MD focuses his practice on intellectual property and commercial litigation matters involving pharmaceuticals, medical and surgical devices, biotechnology, digital imaging, communications-enabled transportation systems, electronics and internet technologies. He also handles criminal and civil investigations under the Federal Food, Drug, and Cosmetic Act, the Biologics Price Competition and Innovation Act, and the Federal False Claims Act.
Ralph counsels pharmaceutical and other life science clients on compliance and enforcement issues, including FDA inspections, product seizures and injunction actions, warning letters, product recalls, and Formal Dispute Resolution proceedings within the FDA. He regularly utilizes his corporate and legal experience to assist pharmaceutical and biotechnology clients with FDA-related due diligence, Hatch-Waxman product lifecycle management strategies, prescription to OTC switch applications, and other related matters involving acquisitions or valuation determinations.
Previously, Ralph served as the founding CEO for Spectropath, an optical imaging company that licensed the global rights to novel cancer detection technologies. He was also the founding CEO for MitralSolutions and CEO of MD3Technologies, both early stage biomedical companies. He served as General Counsel for the American Cardiovascular Research Institute, a national nonprofit medical research organization.
Prior to his legal career, Ralph was an otolaryngologist (a head and neck surgeon), with a subspecialty practice in rhinology and surgery of the nose and sinuses. He was actively involved in the design and development of several products related to sinus surgery, some of which remain in commercial use after almost 30 years.