Dr. Ralph E. Gaskins, Jr.

Ralph is a registered U.S. patent attorney with over 20 years of experience in Food and Drug Administration law and development of medical device-related activities and counselling pharmaceutical industries. Additionally, he has served as a design consultant to numerous manufacturers in the United States and abroad.

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As a board-certified otolaryngologist, head & neck surgeon, Ralph leverages his expertise in corporate, medical, 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, product/service strategies, and other related matters involving acquisitions or valuation determinations. Additionally, Ralph provides counsel in the pharmaceutical and life sciences industries regarding compliance and enforcement, FDA inspections, product seizures and injunction actions, warning letters, product recalls, and Formal Dispute Resolution proceedings within the FDA.

 

Ralph also provides litigation expertise primarily focused in intellectual property and commercial areas involving medical and surgical devices, pharmaceuticals, biotechnology, digital imaging, communications-enabled transportation systems, electronics, and internet technologies. Additionally, he provides counsel for clients undergoing 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.

 

He has also served as a founder and CEO for Spectropath, Inc., Lexikon Consulting, MD3Technologies, Envatec, and as the initial CEO of MitralSolutions through its first round of investor funding. During his time at MD3Technologies, Ralph negotiated the spin-off of MitralSolutions, and arranged licensing agreements for the intellectual property assets for Cartledge Medical and Advanced Cannula.

 

Ralph has served as Vice President of Intellectual Property for CeloNova BioSciences, and he was later named Vice President for Clinical Affairs. During his time at CeloNova, he created the company’s first intellectual property strategic plan, and increased the company’s portfolio of foundational patent families from nine to 25. Additionally, Ralph managed the global clinical research program, with active trials throughout Europe and the Middle East.

 

Ralph received his surgical training at the University of Colorado Affiliated Hospitals and completed his residency at the Medical College of Virginia Hospitals in otolaryngology head & neck surgery. Additionally, he serves as a Fellow of the American Rhinologic Society, Diplomat of the American Board of Otolaryngology Head & Neck Surgery, and Fellow of the American College of Surgeons.