Imperatives for United States Clinical Research Leadership and Coordination

Morgan Hanger is the executive director of the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between Duke University and the US Food and Drug Administration. She brings extensive experience in convening diverse stakeholders to tackle complex challenges in evidence generation and is deeply committed to data ethics and transparency. Hanger has held leadership roles at health technology companies focused on improving patient experiences—streamlining specialty product access, simplifying Medicare plan selection, and advancing learning through data sharing.
As vice president at PatientsLikeMe, she led initiatives to integrate patient-generated health data into life sciences and regulatory settings, developing tools to enhance clinical trial design and support decentralized trials. Prior to that, she advised biotech and pharmaceutical organizations on research strategies at Avalere Health. Hanger also contributed to health outcomes research at Memorial Sloan Kettering Cancer Center, with a focus on equity and cost in oncology, and conducted policy analysis at the Congressional Budget Office on federally supported comparative effectiveness research. Hanger holds a bachelor’s degree in politics, summa cum laude, from New York University and a master’s degree in public policy from the University of California, Berkeley.

Julie L. Gerberding is president and chief executive officer of the Foundation for the National Institutes of Health, a nonprofit organization that builds public-private-patient partnerships supporting the mission of the NIH. She co-chairs the CSIS Bipartisan Alliance on Global Health Security and is a globally recognized expert in infectious diseases, whose career spans multiple sectors, including senior leadership roles in academia as a tenured faculty member at the University of California, San Francisco (UCSF). She directed the US Centers for Disease Control and Prevention from 2002 to 2009 and previously served as president, Merck Vaccines and as executive vice president and chief patient officer at Merck & Co., Inc. Her board service includes McKesson, Mayo Clinic, Case Western Reserve University, and several biotech and nonprofit organizations. Gerberding is a member of the National Academy of Medicine and holds adjunct faculty positions at UCSF and Case Western Reserve University.

Susan C. Winckler is chief executive officer of the Reagan-Udall Foundation for the FDA, the nonprofit 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, a health-care strategy firm founded by Gov. Michael O. Leavitt, former secretary of the US Department of Health and Human Services. She directly advised C-suite executives on public policy and 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 (APhA). Winckler earned a bachelor’s degree from the University of Iowa College of Pharmacy and a law degree, magna cum laude, from Georgetown University Law Center. She is an APhA Fellow, a member of the Purgo Scientific board, and served as an elected member (2015–2020, 2020–2025) and chair (2018–2025) of the United States Pharmacopeial Convention Board of Trustees. In 2023, she received the FDA Distinguished Alumni Award and, separately, was awarded the Osterhaus Medal for Lifetime Achievement by the University of Iowa College of Pharmacy.