In This Issue

Health Policy in Action: Supporting Global Health Policy

Upcoming Events: Improving Anaphylaxis Outcomes

People: Rebecca Whitaker

Drug Repurposing

The current U.S. drug development system will never realize the full potential of generics, but the Food and Drug Administration (FDA) can help fix this, argues Janet Woodcock, former FDA Principal Deputy Commissioner of Food and Drugs, and Duke-Margolis researchers Beth Boyer and Mia Williams. Read the commentary in BioCentury here.

Earlier this month, Beth and Mia co-authored a white paper with the University of Chicago Market Shaping Accelerator that proposed a pull funding model to create stronger incentives for developing and adopting repurposed generic drugs. Read more here.

North Carolina Health Reform

Duke-Margolis researchers Katie Huber, Brianna Van Stekelenburg, Alida Austin, and Rebecca Whitaker, as well as former intern Rebecca Stern (’25), co-authored an article in the North Carolina Medical Journal that discussed the history of bipartisan support for NC Medicaid, highlighted examples of impact and lessons learned, and offered key considerations for the path forward. Read more here.

Home-Based Primary Care

Policy Research Assistant Montgomery Smith and Assistant Research Director Frank McStay co-authored a paper in the Journal of the American Medical Directors Association that studied feedback on the potential development of a home-based primary care practice recognition program. The authors gathered perspectives from clinicians and practice leaders, payers, health system leaders, and quality of care stakeholders, who were in favor of developing a program but urged that the process should involve ongoing stakeholder input.

Medicare Accountable Care Organizations in 2024



Duke-Margolis researchers Audrey Ford, Kylie Brown, Mark McClellan, and Frank McStay, and Visiting Fellow David Muhlestein, co-authored an article in Health Affairs Forefront that analyzed the results of the 2024 data from the Medicare Shared Savings Program. The authors found that participation in accountable care organizations (ACOs) has increased and suggested that the Centers for Medicare & Medicaid Services support policies that balance ACO participation incentives and net savings for Medicare. Read more here.

Supporting Global Health Policy



The Duke Global Health Innovation Center has launched the ALIGN Consortium, an initiative that aims to create more accountable, resilient health systems and to “generate insights, tools, and resources that can be used by stakeholders around the world.” Their foundational working paper, co-authored by Beth Boyer, Core Faculty member Krishna Udayakumar, and other members of the Consortium, explored how countries might decide which innovations to prioritize and how to finance and implement them.

Funding for Global Health

Core Faculty members Osondu Ogbuoji and Gavin Yamey co-authored a paper in PLoS Medicine that examined how middle-income countries might successfully transition away from international health aid. They noted that effective leadership, domestic resources, and realignment to new sources of domestic funding are three key factors. Read more here.

Policy Impact

Communications for Climate and Sustainability co-authored an article that summarized the recent Duke Climate Collaboration Symposium focused on health reform and climate change. A campus-wide event co-hosted by Duke-Margolis and the Duke University School of Medicine, the event convened leaders across disciplines to explore how the health care landscapes can adapt and lead in the face of a changing climate. Read the article here and watch the event recording here.



Upcoming Events

Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine

December 16, 2025 | 9:00 am – 4:30 pm ET



Location: Duke in DC Office (or Virtual via Zoom)

This hybrid public workshop, co-convened with the FDA, will initiate a discussion on expanding epinephrine accessibility and use, including in community settings, to reduce anaphylaxis-related morbidity and mortality. 

Key topics attendees will hear more about: 



• Allergic diseases, anaphylaxis, and treatment of anaphylaxis in the community setting
• Regulatory pathways for epinephrine products, including considerations for prescription and nonprescription development
• Current accessibility to epinephrine for treating anaphylaxis 
• Opportunities to enhance access to and use of epinephrine 

Learn more and register here.

Past Events

Are We There Yet? Building the Roadmap for Home-Based Primary Care

November 18, 2025 | 12:00 – 1:00 pm ET



The population of homebound individuals—those who cannot easily leave their homes without assistance—is growing. This webinar explored opportunities to advance home-based primary care (HBPC). Attendees learned more about the impact of HBPC in improving health outcomes and strategies for how Medicare can leverage HBPC to enhance value and outcomes for homebound beneficiaries.



Watch the recording here.

Individualized Therapies on the RISE

November 20, 2025 | 9:00 am – 5:00 pm ET



This public workshop, co-convened by the Duke-Margolis Institute for Health Policy and the Rare Disease Innovation Hub at the FDA, examined the emerging science and regulatory environment for individualized medicine programs, including nonclinical data recommendations, clinical assessments, regulatory submission structure, and additional information necessary to support the development, evaluation, and potential commercialization of these treatments. Regulatory Focus covered the event and Agency IQ's latest issue also covered the event.



Watch the recording here.

The American Heart Association (AHA) is launching a new initiative, Target: Aortic Stenosis™, to drive awareness of and access to clinical trials, particularly as an opportunity for those with aortic stenosis to receive earlier treatment. Core Faculty member Sreekanth Vemalupalli is involved in this initiative as a volunteer member of its Scientific Advisory Group and was quoted in the AHA’s press release on the initiative.

POLITICO quoted Research Director Rebecca Whitaker in an article on North Carolina’s Healthy Opportunities Pilots, a program designed to address non-medical drivers of health and improve long-term health outcomes. The article discussed the impact of the program, both on individuals and communities. Read more here.

Core Faculty member Nathan Boucher was quoted in an article from Public News Service that discussed changes to Medicaid’s work reporting requirements, which could disproportionately affect people with mental health conditions. Nathan warned that not only individuals could be impacted by this change, but also hospitals.

Research Director Brian Canter spoke at the Milken Institute’s Future of Health Summit 2025, “Toward a New Regulatory Framework for Clinical Research.” He explored the challenges of integrating different data systems and stakeholders to better coordinate information flow, and many of his main points were informed by a recent Duke-Margolis white paper.

Christina Silcox joined the 2025 Behavioral Health Tech Conference, where she spoke about digital health policies surrounding AI tools for mental health. A summary of the discussion was posted here.



Christina was also a panelist at the 2025 Executive Health Care Conference and spoke about AI governance within health systems. Learn more about the event here.

Health Evolution has released a summary of their 2025 Summit, which quoted speakers including Director Mark McClellan and Advisory Board member Esther Krofah as they discussed how health care leaders can build a more sustainable future.

Senior Policy Analyst Rachel Bonesteel was interviewed for Health Affairs This Week, a podcast series. In this episode, “Keeping ACO Models Accountable,” Rachel discussed her recent article on how ACO REACH enabled ACOs to in an advanced, global-risk, population-based payment model. Listen to the podcast here.

Core Faculty member Jessie Tenenbaum, also President Elect of the American College of Medical Informatics (ACMI), inducted the 2025 Fellows into the society during their Annual Symposium. ACMI is a group that recognizes individuals who have made "significant and sustained contributions to the field of biomedical informatics."

Do you want to be part of health policy in action? Do you want to work on the leading health policy issues confronting cities, states, the nation, and the globe? The Duke-Margolis team is a dynamic, high impact national leader in leveraging policy to ensure high quality, affordable care for all. Multiple positions are currently available with new ones added frequently. Click here to view all of our career opportunities.