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In This Issue
Health Policy in Action: North Carolina State Transformation Collaborative
Policy Impact: Real-World Evidence
Team Member Welcome: Kylie Brown
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Artificial Intelligence in Health Care
Duke-Margolis researchers Christina Silcox and Valerie Parker, and Duke Health AI Evaluation & Governance Program Director Nicoleta Economou, co-authored a white paper that provides actionable guidance and recommendations for US health systems and policymakers on how to establish artificial intelligence (AI) governance within health systems that encourages incorporating these novel tools into how health care is delivered, while keeping patients safe. “AI Governance in Health Systems: Aligning Innovation, Accountability, and Trust” includes recommendations that focus on ensuring that all health systems, including those with limited resources, have access to the tools and expertise required to adhere to best practices in governance to democratize the benefits of AI advancements.
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These topics and many more were discussed at a Duke-Margolis event, “Health AI and Health Policy — Charting a Path for Patients and Progress.” The event featured thought leaders in the private and public sectors who are working to advance responsible, effective, and safe use of AI in health care. Watch the recording here.
The white paper will be discussed in further detail during the Duke-Margolis event, “From Principles to Practice: Exploring AI Governance in Health Systems.” Join us on November 18 to hear more about health system governance of AI and why this matter is critical.
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New Advisory Board Member
Bradley L. Campbell is the President and Chief Executive Officer and a member of the Board of Directors of Amicus Therapeutics, a global biotechnology company focused on developing and delivering drugs for rare diseases. He brings more than 20 years of experience in the Orphan Drug industry. Bradley joined Amicus in 2006 and was most recently the President and Chief Operating Officer responsible for the global commercialization of Galafold®. During his tenure, he also led the Business Development, Technical Operations, Market Access, Program Management, and Clinical Operations functions, among others.
Bradley currently serves on a number of Boards including Gennao Bio, the Alliance for Regenerative Medicine (ARM), and the Corporate Advisory Board for the National Tay-Sachs and Allied Diseases Association. He is a former board member of Progenics Pharmaceuticals from 2016 until its successful acquisition by Lantheus Holdings in 2020, as well as ARYA Sciences Acquisition Corp III until its successful merger with Nautilus Biotechnology, Inc. in 2021.
Prior to Amicus, Mr. Campbell spent time in various commercial and business development roles at Genzyme and Bristol-Myers Squibb and as a strategy consultant for Marakon Associates. He received a BA in Public Policy Studies from Duke University and an MBA from Harvard Business School.
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Health Policy Action Fund
To support innovative health policy scholarship and solutions for the most pressing health care challenges, Duke-Margolis has established a Health Policy Action Fund. The Fund enables Duke-Margolis to respond to emerging issues by pooling philanthropic funding to support policy analysis, development, and educational opportunities outside the scope of currently funded work. This concept creates a flywheel for rapid response and is a bridge to more traditional, sustained programmatic funding that ensures health policy is not developed in a vacuum, but rather informed by science, analysis, and representative stakeholder voices. Gifts of any amount are highly appreciated; we invite you to contribute here. To learn more about the Emerging Initiatives that would be supported by this fund, please visit this page.
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North Carolina State Transformation Collaborative (NC STC)
With support from the NC Department of Health and Human Services, Duke-Margolis recently hosted the NC STC Health Disparities Data Workgroup (HDDWG). Members discussed key challenges in the collection, sharing, and use of health disparities data, and identified practical opportunities for alignment across health-related social needs data practices as the first use-case for improving health disparities data. Key takeaways from this meeting will be used to identify action areas and alignment opportunities that will be incorporated into the Alignment Proposal for the NC STC.
More details on key HDDWG insights can be found in the recent NC STC Fall Newsletter, which also highlights a new resource: a NC STC Frequently Asked Questions document to answer key questions and illustrate the goals of the NC STC.
Subscribe to the NC STC newsletter here.
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Antimicrobial Stewardship
Senior Policy Analyst Cameron Joyce and Policy Research Associate Nicholas Harrison co-authored an issue brief to outline recommendations for incorporating diagnostic stewardship into existing antimicrobial stewardship programs and discuss strategies that federal policymakers, hospital systems, and other stakeholders can adopt. Read more here.
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Global Emergency Response and Preparedness
The Duke Global Health Innovation Center’s QuickStart Consortium has published a report to support emergency preparedness and response goals for emerging health challenges, such as the ongoing mpox outbreak. The report will be updated and shared every other week with their community—you can subscribe to their newsletter 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 U.S. Food and Drug Administration (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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2024 HCPLAN Summit
November 14, 2024 | 8:00 am – 4:30 pm ET
Location: Baltimore Convention Center, Baltimore, MD
Mark McClellan is a speaker at the Health Care Payment Learning and Action Network’s 2024 Summit and will discuss the upcoming opportunities and challenges for the transition to value-based care during a fireside chat.
Read the agenda and register here.
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Beyond Your Shot: How Treating Individuals Helps Protect Entire Communities
December 9, 2024 | 12:00 – 3:30 pm ET
Location: Virtual via Zoom
During this event, we will present our refined virus transmission reduction framework alongside proposed policy reforms to improve evidence generation on indirect benefits and population health outcomes. We also will explore how to leverage existing decision-making capacity by the FDA and the Centers for Medicare & Medicaid Services.
This event builds on a public meeting hosted in November 2023 and the initial framework also released last year.
Learn more about the 2024 meeting and register here.
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Mortality and Antipsychotic Use in Dementia-Related Behavioral Disorders
December 10, 2024 | 12:00 – 4:00 pm ET
Location: Virtual via Zoom
Duke-Margolis and the FDA will convene a workshop to review data regarding risks associated with the use of medications in the antipsychotic class in older adults with behavioral and psychiatric symptoms associated with dementia. Workshop attendees will hear reflections on available evidence and further considerations related to the assessment of risks associated with the use of antipsychotics within this patient population.
Learn more and register here.
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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 a 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. Duke-Margolis and West Health hosted 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.
Watch the recording 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
This FDA convening explored 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.
Watch the recording here.
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The Daily Tarheel quoted Research Directors Will Bleser and Rebecca Whitaker in an article that reported on the North Carolina Department of Health and Human Services’ 2024 Health Disparities Analysis Report. Read the article here. | |
Deputy Director Gillian Sanders Schmidler co-hosted an event, held in partnership between Duke-Margolis and the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, to explore the history and future of cost-effectiveness analysis and explore policy implications. | |
Core Faculty member Gavin Yamey co-authored an op-ed in Time that explores the future of public health, considering the upcoming election and the visions each presidential candidate offers. Read more here. | |
Research Director Christina Silcox was quoted in an article from Managed Healthcare Executive, “How AI is Changing Healthcare.” Christina noted the potential of AI to improve treatment speed and efficiency—read more here. | |
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Research Director Rachele Hendricks-Sturrup co-authored a few publications:
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Journal of Comparative Effectiveness Research: The paper provides a tool to assist in identifying the most suitable analytical approach for answering a comparative effectiveness research question.
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JAMA Network Open: The authors report on key findings from an emulation of the KEYNOTE-189 RCT using a commercially available electronic health record (EHR) data source.
Rachele also presented at these events:
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American Academy of Actuaries 2024 Annual Meeting: Rachele discussed ethical, legal, and social implications in the use of social determinants of health and genetic Z codes in actuarial practice and mental health care settings.
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NORD Breakthrough Summit: Rachele moderated a panel to discuss how advances in science and technology can be best applied and used to advance innovative clinical trials.
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DIA Real-World Evidence Conference: Rachele moderated a panel and discussed alignment of RWE standards, considerations, and definitions among regulators globally.
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Core Faculty member Mina Silberberg co-authored recent publications, including:
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The Gerontologist: Research explored attitudes and insights of patients and primary care clinic personnel relative to routine hearing screening in primary care for older adults.
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The Journal of Clinical Translational Science: Authors developed the Social, Environmental, and Equity Drivers Health Atlas, a platform to make data for social drivers of health more widely accessible.
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Senior Policy Analyst Montgomery Smith was a speaker at the American Academy of Home Care Medicine’s 2024 Annual Meeting, and discussed policy and payment considerations for home-based primary care recognition and opportunities to support transformation. This panel featured a joint initiative across the four co-grantees of a broader project supported by The John A. Hartford Foundation exploring policies to scale home-based primary care. | |
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Mark McClellan wrote a report in NEJM Catalyst that described the findings of a NEJM Catalyst Insights Council survey, where respondants expressed concern for health care affordability and access.
Mark also was quoted in two articles:
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Inside Health Policy discussed price negotiation under the Inflation Reduction Act. Read more here.
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Biocentury’s op-ed highlighted that the FDA should be protected from politics to be most effective. Read more here.
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Research Associate Samantha Repka was quoted in Spotlight Delaware’s article to report on the state’s opioid settlement funding and what lawmakers might do with those funds. A team of Duke-Margolis researchers, including Sam, have been working on a project to address this issue in partnership with Elevance Health Foundation and Third Horizons. | |
Core Faculty member Nathan Boucher co-authored an article in the Journal of Applied Gerontology to explore direct service worker training and credentialing in North Carolina, and offer recommendations for change. Read more here. | |
Research Associate Brianna Van Stekelenburg was a panelist for the Duke School of Medicine Health Policy Interest Group that addressed key health policy issues under discussion ahead of the 2024 presidential election. The health policy panel was organized by Duke-Margolis Scholar Becca Sullenger (’26). | |
Core Faculty member Courtney Van Houtven co-authored a commentary, "Expanding In-Home Care Coverage is a Needed Evolution of Medicare," published by The Brookings Institution—read more here. | |
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Kylie Brown joins Duke-Margolis as a Policy Analyst on the Health Care Transformation team. She primarily supports the Institute's work in new rapid assessment, learning, and diffusion under West Health. Prior to Duke-Margolis, Kylie was a Policy Intern at the Georgia Center for Oncology Research and Education, as well as a Student Health Policy Analyst and Interprofessional Health Challenge Team Advisor at Emory University. She has conducted health policy research and analysis on many topics, including school nutrition funding in North Carolina, vaccine safety, physician supervision requirements in NC, and more. She earned her BA in Biology and Public Policy at the University of North Carolina in Chapel Hill and recently graduated from Emory University with her MPH.
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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. | |
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Interesting Project? Funding Opportunities? News and Events?
Awards and Honors? Policy Impact? Op Eds?
We're looking for ways to highlight your accomplishments and share information.
Email submissions to dukemargolis@duke.edu.
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