Frank J. Sasinowski Director 202-737-4287
Frank J. Sasinowski

Overview

 

Frank J. Sasinowski, M.S., M.P.H., J.D., by assisting sponsors and patient organizations in developing new medicines has helped secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities, often for serious and rare diseases.  Frank was involved in 6 of the most recent 7 drugs FDA approved by way of its accelerated approval process.  Frank is involved in many cell and gene therapies and aided significantly on the first approved systemic gene therapy, Zolgensma.

Frank joined FDA in 1983 as regulatory counsel 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.

In its March 2012 issue, the Drug Information Journal published Frank’s seminal analysis on therapies for rare disorders: “Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs: Cataloguing FDA’s Flexibility in Regulating Therapies for Persons with Rare Disorders.”  Other papers on Accelerated Approval and Orphan Drugs are cited by FDA, industry and academia as well.

Since 2014, Frank has been an Adjunct Professor of Neurology at the University of Rochester School of Medicine. His work has been widely recognized by industry and political leaders. For example, Frank was asked by both political parties to testify at the May 2014 inaugural congressional hearing on the 21st Century Cures law. In August 2018 Frank was appointed to the Board of Directors for the Alliance for Regenerative Medicine (ARM) Foundation for Cell and Gene Medicine. In May 2013, the National Organization for Rare Disorders (NORD) awarded Frank its first ever Lifetime Achievement Award. In 2000, Frank was elected to NORD’s Board of Directors, where he served as Chair and as Vice Chair & was on its Board until 2016. In 2017 Frank joined the Board of the Everylife Foundation for Rare Diseases where he currently is its Vice Chair. 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 is a founding Board member of the IndoUSrare patient organization, representing those in India and in the US with rare conditions.  Frank has also served on the Board of Directors of the United States Pharmacopeia (USP).

Based on extensive FDA experience from many perspectives, from within the Agency, from the sponsor perspective & as a voice of the patient, Frank possesses a nuanced & deep understanding of the regulatory process. He regularly shares his insight on drug development issues with physicians, scientists, and regulators, and has served on the boards of several biotechnology companies. Frank has also been Chair of the Food and Nutrition Section of the American Public Health Association (APHA) and has taught health law at American University.

Education & Admissions

Education

J.D., Georgetown University Law Center

M.S., Nutritional Sciences, University of California at Berkeley

M.P.H., University of California at Berkeley

B.S., Biological Sciences and Genetics, Cornell University

Honors & Awards

  • The International Who’s Who of Business Lawyers
    Life Sciences 2014 – 2016
  • Academic Appointments Adjunct Professor of Neurology
    University of Rochester School of Medicine 2014 – present
  • DC Super Lawyer
    2013 – 2016
  • Life Science Stars
    LMG Life Sciences 2013 – 2015
  • Inaugural Lifetime Achievement Award
    NORD 2013
  • Humanitarian Award
    NORD 2000
  • Award of Merit
    FDA 1985 – 1986

Speaking Engagements

  • University Hospital, Krakow, Poland and Jagiellonian University Medical College First Educational Conference: Rare Diseases from the perspective of the Polish healthcare system, “Lessons from the US rare disease program: 1. some to copy, 2. some to avoid and 3. some waiting for Poland to bring to the world”, September 11, 2019
  • FDA Mitochondrial Disease Workshop, “Clinical Trial Design Considerations in Rare Disease Studies”, September 8, 2019
  • Everylife Foundation Annual Scientific Workshop, “Quantum of Effectiveness Evidence Needed for Rare Diseases:  time for explicit statement of FDA flexibility authority”, September 5, 2019
  • Everylife Foundation Scientific Symposium, “FDA’s Regulation of Proposals for Improving Orphan Drugs”, September 13, 2018
  • ASENT Dinner Symposium, March 8, 2018
  • 14th Annual Meeting of The International Society of Central Nervous System Clinical trials Methodology (ISCTM), February 21, 2018
  • Congressional Rare Disease Caucus briefing on 21st Century Cures Act, March 2, 2017 
  • ASENT 19th Annual Meeting, “Regulatory Innovations in Neurological Disorder Therapies, including
    Spinraza and Exondys 51”, March 15-17, 2017
Education

J.D., Georgetown University Law Center

M.S., Nutritional Sciences, University of California at Berkeley

M.P.H., University of California at Berkeley

B.S., Biological Sciences and Genetics, Cornell University

Practice Areas
Industries
FDA Regulatory Categories