Frank J. Sasinowski
Frank J. Sasinowski, M.S., M.P.H., J.D., assists sponsors and patient organizations in developing new medicines and has helped secure FDA approval for hundreds of new drugs, including more than 45 new molecular entities, often for serious and/or rare diseases. Mr. Sasinowski 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 this firm.
In its March 2012 issue, the Drug Information Journal published Mr. Sasinowski'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 officials as well.
In December 2014, Frank was appointed an Adjunct Professor of Neurology at the University of Rochester Medical Center.
Mr. Sasinowski's work has been widely recognized by industry and political leaders, as well as notable organizations. For example, Mr. Sasinowski was asked by both political parties to testify at the May 2014 inaugural hearing of Congress 21st Century Cures Initiative. In May 2013, the National Organization for Rare Disorders (NORD), which represents the 30 million Americans with rare diseases, awarded Mr. Sasinowski its first ever NORD Lifetime Achievement Award. In 2000, Mr. Sasinowski was elected to NORD's Board of Directors, where he has served as Chair and as Vice Chair, and where he remains on the Board until 2016. In October 2012, President Obama recognized Mr. Sasinowski's contributions to the President's Council of Advisors on Science and Technology (PCAST) report, "Propelling Innovation in Drug Discovery, Development and Evaluation."
Based on his extensive experience with FDA, from both the agency and client side, Mr. Sasinowski possesses a detailed 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. Mr. Sasinowski has been Chair of the Food and Nutrition Section of the American Public Health Association (APHA) and has taught health law at American University. Mr. Sasinowski has also served on the Board of Directors of the United States Pharmacopeia (USP).
Awards & Recognition
• 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
• LMG Life Sciences, Life Science Stars, 2013 - 2015
• NORD, Inaugural Lifetime Achievement Award, 2013
• NORD, Humanitarian Award, 2000
• FDA, Award of Merit, 1985 - 1986
Board of Directors, Chair, Vice Chair, NORD (2000 - 2016)
Board of Directors, Every Life Foundation (2016 – current)
Board of Directors, United States Pharmacopeia (USP)
Board of Directors, Chair, Omega Center (2017- current)
Board of Directors, Shalem Institute for Spiritual Formation (2012 - 2016)
Board of Directors, Vice Chair, Catholic Medical Mission Board (2002 - 2009)
Charter Member, Advisory Council of Global Camps Africa (2011 - current)
Guest Lecturer, Georgetown University Center of Excellence in Regulatory Science and Innovation (CERSI)(2015)
Volunteer Chaplain, Northern Virginia Mental Health Institute (2009 - 2015)
Chair, Food and Nutrition Section, American Public Health Association (1979 - 1981)
Member of American Academy of Neurology (AAN)
Member of American Society for Experimental NeuroTherapeutics (ASENT)
Articles / Publications
• Meet the Attorney, HD Insights: A Huntington disease research periodical, vol. 11, Spring 2015 Edition,
June 1, 2015
• Quantum of Effectiveness Evidence in FDA's Approval of Orphan Drugs: Update, July 2010 to June 2014, Therapeutic Innovation & Regulatory Science,
April 27, 2015
• Exploring the FDA's Flexibility With Novel Orphan Therapies, Neurological Rare Disease Special Report, Supplement to Neurology Reviews,
February 1, 2015
• Quantum of Effectiveness Evidence in FDA's Approval of Orphan Drugs: Cataloging FDA's Flexibility in Regulating Therapies for Persons with Rare,
see more speaking engagements
• ASENT 19th Annual Meeting, Regulatory Innovations in Neurological Disorder Therapies, including Spinraza and Exondys 51, March 15-17, 2017
• Webinar: 21st Century Cures Act - Pharmaceutical and Biologic Product Development Provisions, January 12, 2017
• 24th Annual Adler Symposium on Alzheimer’s Research at Salk Institute, February 3, 2015
• NORD Rare Diseases, Exploring FDA's Flexibility with Novel Orphan Therapies, October 21, 2014
• 21st Century Cures: House Energy and Commerce Committee invited testimony, May 20, 2014
• A Spark Points the Way Forward on Gene Therapy,
October 12, 2017
• Regenerative Medicine Advanced Therapy: FDA’s Newest Expedited Program Evolves to Keep Pace with Recommendations,
September 27, 2017
• Accelerating Accelerated Approval & Other Drug Development Signals from FDA’s Approval of 1st Therapy for Chagas,
September 13, 2017