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In This Issue
Health Policy in Action: Cell and Gene Therapies
Upcoming Events: Medicare Accountable Care in 2025 and Beyond
People: Beth Boyer
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FDA Grant Awarded to Duke-Margolis
The U.S. Food and Drug Administration (FDA) has announced Duke-Margolis as the recipient of a cooperative agreement to support meetings (e.g., conferences, workshops, roundtables) that convene a broad range of stakeholders to explore, research, and address issues related to medical products, policy, and surveillance methods and systems. These efforts, occurring now through 2029, build on FDA-related work occurring since the Institute’s inception, helping to explore and better understand the potential of emerging and new innovations to produce scientific evidence in support of regulatory submissions.
We look forward to continuing our work with the FDA!
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New Core Faculty Members
Duke-Margolis is pleased to welcome two new members to our Core Faculty:
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Eugene Washington, MD, MPH, MSc
Dr. Eugene (Gene) Washington is Chancellor Emeritus at Duke University and is a professor of obstetrics and gynecology at the School of Medicine. Most recently, Gene was the Chancellor for Health Affairs at Duke University, where he also served as President and CEO of the Duke University Health System. His current academic work focuses on climate action to promote human health. One study he is conducting with Duke-Margolis colleagues seeks to strengthen the connection between care delivery models (particularly value-based care) and sustainability, with an aim of demonstrating that providers (individuals and health systems) can improve patient care outcomes while also reducing the impact of care on the environment.
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Jonathan Zhang, PhD
Dr. Jonathan Zhang is a health economist who joined Duke’s Sanford School of Public Policy as an assistant professor in fall 2024. He received his bachelor’s degree from the University of British Columbia and his PhD in Economics at Stanford University. Prior to coming to Duke, he completed a one-year postdoc program at Princeton and was a faculty member of McMaster University for three years. His research interests include physician behavior, especially around the opioid crisis, and policies that improve mental health and well-being. He also is affiliated with the Veterans Affairs’ Office of Mental Health and Suicide Prevention, working in clinical evaluations since 2018.
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Improving Evidence Generation from Clinical Trials
Assistant Research Director Trevan Locke, Director Mark McClellan, and Core Faculty member Adrian Hernandez co-authored a paper in Trials that noted barriers to advancing clinical trial infrastructure and offered recommendations to improve evidence generation. Read more here.
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Addressing Mental Health Care Disparities
Research Director Rachele Hendricks-Sturrup and Postdoctoral Associate Sandra Yankah co-authored a paper in Frontiers to discuss the ethical, legal, and social implications of recent advancements in biomedical research, and leveraging real-world data to reduce disparities in mental health care. Read more here.
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Celebrating 100 Years at Duke
The Chronicle published an article looking back at Duke University’s presidents from the 1970s to present day, as part of the university’s Centennial celebration. One of President Richard Brodhead’s achievements, noted in the article, was the establishment of the Duke-Margolis Center for Health Policy in 2016. Since then, we have grown our team and our scope of research significantly, our most recent university accomplishment being our elevation to Institute status in January 2024. We are honored to be part of Duke’s rich history and future!
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Medicare Accountable Care in 2025 and Beyond: Building on Successes and Finding New Opportunities
October 2, 2024 | 1:00 – 4:00 pm ET
Location: National Press Club, Washington, DC, or virtual via Zoom
Almost one decade after passage of the Medicare Access and CHIP Reauthorization Act, and numerous payment and delivery reforms implemented, accountable care is at an inflection point. As more people are covered under accountable care than ever before, the need for more advanced accountable payment arrangements continues to grow as well. In partnership with West Health, Duke-Margolis will host a hybrid event to explore how to build on successes to-date, and leverage the momentum of new administrative proposals and ongoing discussions in Congress to catalyze participation and accelerate progress.
Learn more and register here.
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Celebrating Cost-Effectiveness Analysis
October 26, 2024 | 3:00 – 7:30 pm ET
Location: Linda K. Paresky Conference Center, Boston, MA, or virtual via Zoom
The Center for the Evaluation of Value and Risk in Health at Tufts Medical Center is hosting a hybrid event, in partnership with Duke-Margolis, that will explore the history and future of cost-effectiveness analysis and explore policy implications. Deputy Director Gillian Sanders Schmidler will be co-hosting the event. Tickets are free but registration is required—learn more about the event and register here.
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Health AI and Health Policy — Charting a Path for Patients and Progress
October 28, 2024 | 3:00 – 5:00 pm ET
Location: Fuqua School of Business, Durham, NC, or virtual via Zoom
During this critical time in the evolution of artificial intelligence (AI), Duke-Margolis and Duke Health AI are hosting a hybrid event to explore the future of AI in health care, with a focus on balancing the need for innovation with safety and real-world clinical impact. Experts will discuss how AI is poised to transform health care delivery, while also discussing strategies for evaluating clinical outcomes and ensuring equitable care for patients. A key panel will dive into the role of government policy in democratizing the safe and equitable implementation of health AI. Attendees also will hear about efforts nationally and at Duke to advance health AI.
Learn more and register here.
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Opportunities to Improve Dose-Finding and Optimization for Rare Disease Drug Development
October 29, 2024 | 10:00 am – 3:30 pm ET
Location: Virtual via Zoom
Join Duke-Margolis and the FDA for a one-day virtual workshop that will explore effective strategies for dose-finding and optimization in rare diseases, including considerations for pediatric populations, opportunities to enhance early-phase trial design, and potential applications for real-world data.
Learn more and register here.
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Sixteenth Annual Sentinel Initiative Public Workshop
November 7, 2024 | 9:00 am – 4:15 pm ET
Location: National Press Club, Washington, DC, or virtual via Zoom
The Sentinel Initiative was launched in response to the FDA Act of 2007 (FDAAA) and Congressional mandate that FDA develop a national electronic system to track the safety of regulated medical products. Since its inception, the Sentinel Initiative has continued to refine and expand its data infrastructure capabilities. During this hybrid workshop hosted under a cooperative agreement with the FDA, attendees will learn more about the Sentinel Initiative's recent achievements as well as upcoming opportunities for the Sentinel System and BEST System.
Learn more and register here.
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The Second Annual Future of Prescription Drug Promotion and Digital Marketing Meeting
The pace at which new marketing technologies, trends, and venues are proliferating in the digital marketing space presents challenges and opportunities for regulators of prescription drug advertising and promotion. This second annual virtual workshop, convened under a cooperative agreement with the FDA, explored how recent and emerging trends in this space might impact public health. A range of experts explored new formats and strategies that have emerged since the September 2023 convening and expanded on discussions from the prior convening.
Watch the recording here.
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Policy Research Associate Beth Boyer participated in the University of Chicago Market Shaping Accelerator’s open innovation competition and was awarded $155,000 in prize funding to further support her and her team’s research in drug repurposing. Congratulations, Beth! | |
Health Policy Certificate student and former intern Anna Tharakan (’25) co-authored a paper in Health Affairs Scholar to explore the accessibility of Diabetes Self-Management Education and Support programs in the United States. Read more here. | |
Research Director Will Bleser presented at Modern Healthcare’s Health Equity Conference to discuss the future of the CMS Innovation Center’s ACO REACH program. Modern Healthcare then published an article about the event that quoted Will—read it here. | |
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Mark McClellan spoke at the Physician-Focused Payment Model Technical Advisory Committee’s latest meeting to discuss how to maximize participation in population-based total cost of care models. A recording and transcript are available here.
Mark also spoke at the Johns Hopkins School of Nursing’s event, “Advancing Value-Based Care: A Bipartisan Dialogue on Health Equity and Innovation” alongside other former administrators of the Centers for Medicare & Medicaid Services.
Mark was featured in a video from the Milken Institute’s FasterCures to introduce their new initiative, “Enabling Networks of Research Infrastructure for Community Health through Clinical Trials.” Watch it here.
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Margolis Scholar Freya Gulamali spent her summer as a fellow with the American Association for the Advancement of Science and covered science for The News & Observer. Her most recent article covers pharmacy benefit managers and their impact on independent pharmacies, and you can read more of her work here. | |
The Telegraph quoted Core Faculty member Gavin Yamey in an article that reported on the World Health Organization’s call for wealthy countries to surrender some of their stockpiled smallpox vaccines to those in immediate need. Read more here. | |
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Core Faculty member David Ridley was quoted in an AP News article that reported on the FDA’s backlog of factory inspections and the impact on drug quality. Read more here.
David also presented his research to the Congressional Budget Office as part of a discussion about how FDA accelerated drug approvals speed up price reductions.
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Core Faculty member Nathan Boucher wrote an editorial in of the Journal of American Geriatrics Society that discussed home- and community-based health care services and the importance of listening to caregivers’ lived experience to drive improvements in care. Read more here.
Nathan also was awarded a $100,000 grant from the Veterans Administration’s National Center of Homelessness among Veterans (NCHAV) to research opportunities to improve services for veterans and address critical needs in the community. He is a Research Affiliate of NCHAV.
Nathan wrote a commentary in NC Newsline that stressed the importance of supporting parents’ and caregivers’ well-being in order to promote good outcomes for children. Read more here.
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Opportunities at the Duke-Margolis Institute for Health Policy | |
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. | | | | |
