Duke-Margolis Institute for Health Policy

Don't miss your chance to join this conversation! Tomorrow, we are gathering health policy experts and leaders across the public and private sectors to discuss the vision for accountable care reform, and chart a path toward delivering better health and better care for all: duke.is/p/3vx6

Addressing the Root Causes of Drug Shortages: Next Steps for Congress

Drug shortages have severely impacted patient care in the U.S. for decades. In our latest white paper, Duke-Margolis researchers propose next steps that Congress can take to address the root causes of the drug shortage problem + create a more reliable & resilient supply chain: duke.is/6/mduj

Institute Director Mark McClellan and Policy Analyst Sara Debab have co-authored a new Viewpoint article in JAMA Health Forum to outline steps that reduce clinician burnout by modernizing Medicare’s risk adjustment mechanism. Read their recommendations here: duke.is/w/tdna

Are We There Yet? Building a Roadmap for Home-Based Primary Care. November 18, 2025, 12-1pm ET. Duke-Margolis Institute for Health Policy. Virtual via Zoom.

A new event has been announced! Don't miss this webinar coming up on November 18, where speakers will explore opportunities to advance home-based primary care. Learn more and register here: duke.is/9/ct26

Three authors in front of the poster

@michellescotton.bsky.social @dukemargolis.bsky.social sharing our engagement project learnings with researchers and patient advocates at #PCORI25

Learn more about the current state and future of the Sentinel Initiative in our upcoming workshop, convened with the FDA. A draft agenda is now available and contains more details about the topics of discussion—you can read it and register to attend here: duke.is/z/wdhk

Individualized Therapies on the RISE. November 20, 2025, 9:30 am - 5:00 pm ET. Duke-Margolis Institute for Health Policy. Hybrid Location: National Press Club, Washington, DC, or virtual via Zoom.

A draft agenda is now available for our upcoming workshop, "Individualized Therapies on the RISE"! Co-convened with the FDA, this event will explore the regulatory considerations surrounding individualized therapies that can help treat rare diseases. Read the agenda + register here: duke.is/m/jxxj

Our next event is just around the corner! We invite you to join us in DC for a timely conversation on accountable care reform. With new technological advances, policy shifts, and the lessons learned from the last decade, the next chapter of accountable care starts now: duke.is/p/3vx6

A new hybrid workshop has been announced! Join us at the Duke in DC office on December 16 as speakers discuss ways to expand epinephrine accessibility and use, including in community settings, to reduce anaphylaxis-related morbidity and mortality. Learn more and register here: duke.is/y/x7xs

Don't miss our Open House this Friday! Join us in our Durham office to learn more about how the Institute's research and educational initiatives help engage students across campus in health policy. We're hosting this event as part of Duke's Family Weekend: duke.is/n/x6w2

In just a few weeks, we are hosting the Seventeenth Annual Sentinel Initiative Public Workshop with the FDA. Join us at the FDA's White Oak Campus in Maryland to learn more about the initiative's work so far as well as future directions. Register today: duke.is/z/wdhk

Individualized Therapies on the RISE. November 20, 2025, 9:30 am - 5:00 pm ET. Duke-Margolis Institute for Health Policy. Hybrid Location: National Press Club, Washington, DC, or virtual via Zoom.

Join us in DC for a new workshop, "Individualized Therapies on the RISE," coming up on November 20. During this event, speakers will examine the emerging science and regulatory environment for individualized medicine programs. Learn more and register here: duke.is/m/jxxj

Join us next Friday, 10/ 17, for our Open House! This event is an opportunity to meet the educators and mentors who are working with Duke students, and to learn more about how the Institute's research and educational initiatives help engage students across campus in health policy: duke.is/n/x6w2

Don't miss this upcoming event! On November 6, we are hosting the Seventeenth Annual Sentinel Initiative Public Workshop with the FDA. Each year, this event showcases the work of the Sentinel Initiative to-date, along with future-looking discussions: duke.is/z/wdhk

Accountable care—centered on personalized, coordinated, and whole-person care—is no longer the vision for the future of the American Health system: it is here, now. Join us next month for an event that will launch the new West Health Accelerator at Duke-Margolis: duke.is/p/3vx6

Don't miss the upcoming Duke Climate Collaboration Symposium! On 10/1, speakers will explore opportunities to reduce health care greenhouse gas emissions and implement reforms to mitigate the health impacts of climate change: duke.is/y/s33v

CMS Administrator Mehmet Oz and Duke-Margolis Director Mark McClellan will discuss CMS' vision and strategies during an upcoming event hosted by The Aspen Institute. Join in-person or virtually next Wednesday, September 24, to learn more! You can register to attend here: duke.is/b/49j5

The graphic features a photo of an ophthalmologist using a retinal imaging machine to examine a patient’s eyes. The accompanying text reads, “Assessing Novel Efficacy Endpoints in Ophthalmologic Rare Disease Drug and Biologics Development.” September 17, 2025, 9:30 am – 2:30 pm ET. A Hybrid Public Meeting. National Press Club, Washington, DC, or virtual via Zoom. Duke-Margolis Institute for Health Policy.”

Join us tomorrow for our next hybrid workshop! Speakers will explore novel efficacy endpoints used in interventional clinical trials for drugs and biological products intended for patients with severe vision loss. A discussion guide is now available—you can read it and register here: duke.is/6/jzzn

In our newest white paper, Duke-Margolis researchers share policy recommendations to strengthen drug supply chain security and resilience, including through the establishment of an international biopharmaceutical coalition. Read more here: duke.is/j/pevx

2025 Duke Global Mental Health Conference – Now More than Ever: Addressing the Global Imperative for Mental Health Equity

On 10/7, the Duke Center of Global Mental Health is hosting their 2025 conference, "Now More than Ever: Addressing the Global Imperative of Mental Health Equity." Registration is free and all are welcome to attend: sites.duke.edu/dukegmhconf2025/

Regulatory Opportunities to Advance Generic Drug Repurposing

📣JUST PUBLISHED: Our white paper on regulatory opportunities to advance generic drug repurposing is now available online! This paper explores the role of the regulator and policy actions it can take to support repurposing initiatives. @dukemargolis.bsky.social
healthpolicy.duke.edu/publications...

Duke-Margolis researchers have co-authored a paper in the Journal of Pharmacy & Pharmaceutical Sciences on pharmacogenomics (PGx) testing data. They noted that improving racial and genetic ancestry data, and increasing interoperability with EHRs, could make PGx data more actionable: duke.is/5/ygcs

On the RISE: Controls in Rare Disease Clinical Trials for Small and Diminishing Populations. Duke-Margolis Institute for Health Policy. September 3, 2025, 9:30 am - 4 pm ET. A hybrid public workshop. National Press Club, Washington, DC, or virtual via Zoom.

Don't miss your chance to register! Next Wednesday, September 3, we're hosting a workshop with the FDA to discuss control options in rare disease clinical trials. A final agenda and speaker bios have been posted to the event webpage—you can read them and register here: duke.is/z/mkv3

Lessons Learned from the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. September 10, 2025, 1:00 - 5:00 pm ET. A virtual public workshop. Duke-Margolis Institute for Health Policy.

Speakers have been announced for our upcoming virtual workshop! On 9/10, hear from FDA officials and health policy experts as we discuss challenges and strategies for expedited chemistry, manufacturing, and controls development. Learn more about our speakers and register here: duke.is/n/eef3

On the RISE: Controls in Rare Disease Clinical Trials for Small and Diminishing Populations. Duke-Margolis Institute for Health Policy. September 3, 2025, 9:30 am - 4 pm ET. A hybrid public workshop. National Press Club, Washington, DC, or virtual via Zoom.

Our next event is right around the corner! On 9/3, we're hosting a hybrid workshop with the FDA to explore control options for rare disease clinical trials. Though we have reached capacity for in-person registration, we invite you to join the waitlist or register to attend virtually: duke.is/z/mkv3

The graphic features a photo of an ophthalmologist using a retinal imaging machine to examine a patient’s eyes. The accompanying text reads, “Assessing Novel Efficacy Endpoints in Ophthalmologic Rare Disease Drug and Biologics Development.” September 17, 2025, 9:30 am – 2:30 pm ET. A Hybrid Public Meeting. National Press Club, Washington, DC, or virtual via Zoom. Duke-Margolis Institute for Health Policy.”

A draft agenda is now available for our workshop on 9/17, where speakers will discuss clinical trial endpoints for drugs and biological products intended for patients with severe vision loss. Join us in DC to discuss this critical topic and network with your peers: duke.is/6/jzzn

Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned. Duke-Margolis Institute for Health Policy. September 23, 2025, 9:30 am -4:00 pm ET. A hybrid public meeting. National Press Club, Washington, DC, or virtual via Zoom.

Join FDA & Duke-Margolis Sept. 23 at the National Press Club for a free, hybrid public workshop that will discuss examples in which real-world evidence was used for regulatory decision-making for medical products. Register today: duke.is/y/7nyz

Hear from Institute Director Mark McClellan at a special edition of the Virtual Value-Based Payment Summit. Mark and his fellow speakers will discuss the future of Medicare value-based care during the closing fireside chat on 9/5. Learn more and register here: valuebasedpaymentsummit.com/

Looking for practical ways to use data for impact? The breakout session “Mosaic in Motion” at #hdpalooza showcases tools and case studies that bring health data to life. See session details: buff.ly/eNJoqM4
Learn from researchers from @dukemargolis.bsky.social and more. Will we see you Sept 5?

2025 Health Datapalooza | AcademyHealth

Hear from Senior Research Director Rob Saunders at #HDPalooza on September 5 as he discusses West Health's new health data platform during the breakout session, "Mosaic in Motion: Exploring New Tools for Turning Data into Action." Learn more and register here: academyhealth.org/Datapalooza