Duke-Robert J. Margolis, MD, Institute for Health Policy

08/04/2026

On August 10, CSIS Renewing American Innovation program and Duke University are hosting a half-day hybrid symposium of expert panels on the global importance of the North Carolina Research Triangle region for biotechnology innovation and biopharmaceutical manufacturing and workforce development. Institute Director Mark McClellan and Core Faculty member David Ridley will be speaking at this event. Learn more and register here: https://duke.is/b/f3zv

The North Carolina Research Triangle is a world-class innovation hub for biopharmaceuticals, supported by a robust research university system. This innovation ecosystem is a national security asset for U.S. global innovation competitiveness in life sciences.

07/30/2026

A draft agenda is available for the upcoming virtual workshop, "Statistical Considerations for Digitally-Derived Endpoints in Clinical Trials," which we are convening under a cooperative agreement with the U.S. Food and Drug Administration. Sessions will include:

- Regulatory Efforts to Advance the Use of Digitally-Derived Endpoints for Product Development and Review
- Continuous Glucose Monitoring Technical Specification as a Model for Regulatory Submissions, Device Evaluation, and Analytical Best Practices
- Statistical and Measurement Considerations in Developing Digitally-Derived Endpoints for Regulatory Review
- Addressing Statistical Challenges to Analyzing Digitally-Derived Endpoints
- Future Considerations for Digitally-Derived Endpoints

Learn more and register here: https://duke.is/4/7rtf

07/29/2026

Margolis Scholar alum Sydney Grube (MBA '26) spoke about her Bass Connections project, "Advancing Community-Based Models of Health and Social Care in North Carolina," in a profile published on the program website. Bass Connections is a Duke University-wide academic program that supports collaborative, interdisciplinary research at Duke. Project teams span a number of themes, including the Duke-Margolis-led theme on Health Policy & Innovation that Sydney's project was part of. Read the profile here: https://duke.is/m/4h39

“[Participating in Bass Connections] gave me a lot of practice approaching people with openness, transparency and curiosity and managing a project while staying flexible

07/21/2026

On August 27, the FDA is hosting a public workshop, convened by the Duke-Margolis Institute for Health Policy under a cooperative agreement with the FDA, to discuss statistical considerations for digitally-derived endpoints in drug and biological product clinical trials. Learn more about FDA’s efforts to advance the use of digital health technologies in drug and biological product development and regulatory review, discover opportunities to support the broader use of clinically meaningful, digitally-derived endpoints in clinical trials, and hear practical insights into the development and review of digitally-derived endpoints: https://duke.is/4/7rtf

07/17/2026

Our next event is coming up soon! Join us on July 27 for our annual State of Real-World Evidence Policy convening, where experts will consider how real-world evidence and real-world data can routinely inform regulatory and coverage decisions, integrate research into patient care, and foster greater harmonization across the health policy ecosystem. See who's speaking and register to attend here: https://duke.is/2/ynaf

07/15/2026

Drop by the Duke Summer Research Showcase on Friday, July 24, 2026, from 10:00 am - 12:00 pm at Bostock Library, The Edge, to support over 130 student researchers—including our wonderful Summer Experience interns—who are presenting posters about their Duke-sponsored summer research.

07/10/2026

Join us next week for our hybrid workshop at Convene in Washington, DC, as we examine opportunities to improve how biomarker evidence supports regulatory decision-making in individual product submissions. Learn more about our speakers and topics of discussion, read our preliminary policy roadmap, and register here: https://duke.is/2/7sb2

07/01/2026

Drawing on our previously released Health Policy Core Competency Framework, we have created a new framework of Real-World Evidence (RWE) Policy Core Competencies. RWE is a complex and cross-cutting topic that touches many areas of science policy, practice, and education. Together, the competencies reflect a versatile, interdisciplinary skillset that will prepare tomorrow’s RWE policy leaders to solve today’s—and tomorrow’s—toughest RWE policy challenges with evidence, innovation, and impact. Read more here: https://duke.is/4/scwe

06/30/2026

Join us for a new virtual workshop on September 1! Duke-Margolis and the U.S. Food and Drug Administration's Quantitative Medicine Center of Excellence are co-convening this event to inform the establishment of the Quantitative Medicine Innovation Network (QMIN). The QMIN will bring together academic institutions, industry sponsors, contract research organizations, regulators, and patient advocates in a sustained, cross-sector collaboration to advance the science and regulatory application of quantitative medicine with the goal of fundamentally transforming drug development and clinical care. Learn more and register here: https://duke.is/8/4p56

06/23/2026

Influenza is a persistent public health challenge with significant morbidity, mortality, and economic costs. The seasonal influenza vaccine remains the best intervention to reduce disease burden, and numerous opportunities exist to improve the influenza vaccine development process. Duke-Margolis has released a new policy brief that outlines short- and long-term policy priorities to modernize seasonal influenza vaccine development, which you can read here: https://duke.is/2/4va5