Frank J. Sasinowski, JD, MPH

Frank J. Sasinowski, J.D., M.P.H., M.S., assists drug companies and patient organizations in developing new medicines and has helped secure Food and Drug Administration (FDA) approval for hundreds of new drugs, including over 100 for serious, rare diseases. Frank joined the FDA in 1983 in the Center for Drugs and Biologics, where he was key to implementing both the 1983 Orphan Drug law and the 1984 Hatch-Waxman law. In 1987, he left the FDA as deputy director of the health policy staff in the commissioner’s office and joined Hyman, Phelps & McNamara.

Frank’s work has been widely recognized by patient organizations, industry, political leaders and the FDA. For example, in May 2014, both political parties asked Frank to testify at the inaugural congressional hearing on the 21st Century Cures Act. Today Frank is vice-chair of the EveryLife Foundation for Rare Diseases, a rare disease patient organization and is on the board of directors for the Alliance for Regenerative Medicine Foundation for Cell and Gene Medicine. For 16 years Frank served on the board of directors, including as chair and as vice chair, of the National Organization for Rare Disorders (NORD), which represents the 30 million Americans with rare diseases. In 2013 NORD awarded Frank its first ever Lifetime Achievement Award. In October 2012, President Obama recognized Frank’s contributions to the President’s Council of Advisors on Science and Technology (PCAST) report, “Propelling Innovation in Drug Discovery, Development and Evaluation.” Frank has also served on the board of directors, including as vice chair, of the Catholic Medical Missions Board, an over 100-year-old NGO, which last year provided over 1 billion USD of medical supplies around the globe. Frank is also on the board of the Omega Center, dedicated to exploring the vision of Teilhard de Chardin, S.J.