Susan Winckler | Chief Executive Officer
Reagan Udall Foundation for the F.D.A.

Susan Winckler, Chief Executive Officer, Reagan Udall Foundation for the F.D.A.

Susan C. Winckler is CEO of the Reagan-Udall Foundation for the Food and Drug Administration; the non-profit organization created by Congress to advance the mission of the FDA. Prior to accepting the Foundation post in May of 2020, Winckler served as President of Leavitt Partners Solutions, a healthcare strategy firm founded by Gov. Michael O. Leavitt, former Secretary of the U.S. Department of Health and Human Services. She directly advised C-suite executives on public policy/regulation, business strategy, investments, and other matters. A pharmacist and attorney by training, she was, earlier, CEO of the Food & Drug Law Institute. As Chief of Staff for the FDA (2007-2009), Winckler managed the Commissioner’s Office, served both Republican and Democratic commissioners as their senior-most staff adviser, analyzed complex policy challenges, and represented FDA with myriad government entities and external stakeholders. Her earlier career service included more than a decade at the American Pharmacists Association. Ms. Winckler earned a bachelor's degree from the University of Iowa College of Pharmacy and her law degree magna cum laude from Georgetown University Law Center. She is an APhA Fellow, an elected member (2015-2020, 2020-2025) and Chair (2018- present) of the United States Pharmacopeial Convention (USP) Board of Trustees, and a member of the Purgo Scientific, LLC board. In 2023, she received the Distinguished Alumni Award of the Food and Drug Administration Alumni Association and, separately, was awarded the Osterhaus Medal for Lifetime Achievement by the Univ. of Iowa College of Pharmacy.

Appearances:



Day 1- World Orphan Drug Congress USA 2025 @ 09:45

Keynote: Vision 2030: Charting a bright future for rare medicine

Discussion to focus on immediate outcomes of Rare Disease Innovation Hub as a new model of collaboration between CDER and CBER. While the extent to which this initiative will translate into influencing policy or decision making is unknown, it has the potential significance on the scale of Patient Focused Drug Development 2.0 – representing an opportunity for a systematic approach to prioritize and streamline rare disease drug development. with. Discussion sub-topics:

  • Vision for Rare Disease Innovation Hub and advice for the RD community
  • Impacts to endpoint assessments, trial design, patient recruitment and development efficiency
last published: 24/Apr/25 11:35 GMT

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