Frank J. Sasinowski, M.S., M.P.H., J.D.

Frank Sasinowski, J.D., M.P.H., M.S. had more than 20 years of board experience at prestigious institutions, including the Alliance for Regenerative Medicine (ARM) Foundation for Cell and Gene Medicine, National Organization for Rare Disorders (NORD), EveryLife Foundation for Rare Diseases, the IndoUSrare patient organization, the United States Pharmacopiea (USP) and various notable biotechnology companies. Currently, he serves a Director of Hyman, Phelps & McNamara, P.C., and an Adjunct Professor of Neurology at the University of Rochester School of Medicine.

After joining the U.S. Food and Drug Administration (FDA) in 1983 as regulatory counsel in the Center for Drugs and Biologics, Sasinowski became a key player in the implementation of foundational legislation such as the 1983 Orphan Drug Act and 1984 Hatch-Waxman Act. He worked with the FDA for nearly half a decade before leaving his position as the Deputy Director of health policy in the Commissioner’s office and joining Hyman, Phelps & McNamara, P.C. Sasinowski used his experience working in the drug regulatory process to help secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities – often for serious and rare diseases. Sasinowski has been widely recognized for his expertise by the life sciences sector, patient advocacy organizations and notable world leaders, including former President Barack Obama, who recognized his contributions to the President’s Council of Advisors on Science and Technology (PCAST) report in 2012. He is the recipient of numerous awards, including NORD’s first-ever Lifetime Achievement Award, as well as the FDA’s Award of Merit and NORD’s Humanitarian Award, where he was honored for his work benefiting the rare disease community. Most recently, Sasinowski received Pope Francis’ 2021 Pontifical Hero Award for Inspiration as recognition for his leadership, advocacy and unwavering dedication to patients living with rare disease.