Dr. Ralph E. Gaskins’ practice focuses on intellectual property litigation and FDA regulatory representation and litigation.
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 FDA. His litigation practice includes matters involving criminal and/or civil investigations under the Federal Food, Drug, and Cosmetic Act, the Biologics Price Competition and Innovation Act, and the Federal False Claims Act. He also makes use of 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 related practical advice in acquisition or valuation determinations.
Prior to joining Kasowitz, Ralph served as the founding CEO for Spectropath, Inc., an optical imaging company that licensed the global rights to novel cancer detection technologies. He previously served as both Vice President of Intellectual Property and Legal Affairs and as Vice President for Clinical Affairs for CeloNova BioSciences. Ralph 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 corporate roles, Ralph practiced as a patent and regulatory attorney with two large, national law firms.
Before law school, 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 thirty years.