In This Issue

Health Policy in Action: Addressing Health-Related Social Needs in North Carolina

Policy Impact: Building Supply Chain Reliability

People: Krishna Udayakumar

Monthly Highlights

2025 Duke Summer Research Showcase

Students from summer programs across Duke University presented their research projects at the annual Summer Research Showcase, which featured a range of topics such as health policy, natural sciences, engineering, medicine, and more. The event drew hundreds of fellow students, faculty, staff, and friends and family to learn more about Duke’s important student research efforts. Among the student presenters were the Duke-Margolis summer interns, who have been working on health policy research projects over the past few months with guidance from their Institute mentors. Their presentations included:

• “M-PACT: Addressing NC Rural Health Disparities and Improving Nurse Education” presented by Laura Brackett 
• “An Evaluation of the Integration Consultant Role Within a North Carolina Medicaid Pilot” presented by Priyanka Dowdell 
• “Horizon Scanning of Maternal Health Products to Inform Innovation and Introduction in Kenya, Senegal, and South Africa” presented by Kiara Ekeigwe
• “Artificial Intelligence (AI) in Healthcare Delivery: Implementation and Impact in Clinical Workflow” presented by Saira Nagda
• “Developing an Analysis Tool to Evaluate Regulatory Documents and Inform International Harmonization of Real-World Evidence (RWE) Standards Effort” presented by Ryan Pon 
• “Estimates of the 2023 Socioeconomic Benefits of Illinois’ HB40 Policy to Expand Medicaid Coverage for Abortions” presented by Lena Shadow  
• “Food is Medicine: Assessing the Impacts of Food Insecurity on Perinatal Health in NC and Relevant Policy Opportunities” presented by Rebecca Stern

Read more in the abstract book here. This event was supported by Duke University’s Undergraduate Research Support Office and the Office of Experiential Education.

Addressing Health-Related Social Needs in North Carolina

A new Duke-Margolis paper, "How Providers, Health System Leaders, and States Can Work Together to Align Disparate Policy Efforts to Address Health-Related Social Needs: Learning from North Carolina," explored efforts in NC to address health-related social needs (HRSNs) and the challenges providers, health systems, and state leaders have faced in coordinating these efforts across sectors. Published in the North Carolina Medical Journal, Institute researchers Brianna Van Stekelenburg, Katie Huber, Rebecca Whitaker, and Robert Saunders, plus former Duke-Margolis researchers Andrea Thoumi, Yolande Pokam Tchuisseu, and Will Bleser, highlighted the Healthy Opportunities Pilots program and NC Integrated Care for Kids as two key examples of cross-sector initiatives that have helped to address unmet HRSNs.

Real-World Evidence at the FDA

Duke-Margolis released two comment letters in response to the U.S. Food and Drug Administration’s (FDA) request for feedback on these topics related to real-world data and real-world evidence (RWD/E):

• Exploring alternative real-world data formats for sponsors to submit and convey critical information to the FDA. In particular, the authors recommended the Dataset-JSON format to modernize the FDA’s capabilities. Read the letter here.
• Improving clinical study data submissions involving RWD to be in greater alignment with broader health IT strategies. The authors noted the challenges and opportunities when using HL7 FHIR—read more here.

Reshaping Postpartum Care in Medicaid

Core Faculty members Jonas Swartz and Kate Bundorf co-authored a paper in JAMA Health Forum that explored insurance coverage and care utilization for postpartum individuals under Medicaid policies that extended coverage from 60 days after delivery to 12 months. The authors found that expansion led to greater access to care, which may result in better health outcomes.

Health Affairs Forefront also published an article on this topic, co-authored by Duke-Margolis researchers Brianna Van Stekelenburg, Emily Proehl, Rebecca Whitaker, and Rob Saunders. With this new extended coverage, the authors noted that states now have an opportunity to create whole-person, longitudinal systems of care that address perinatal mental health, chronic disease, and social needs. They highlighted a few policy recommendations and shared examples from states that have implemented certain policies that help fill the gaps in postpartum care. Read more here.



Policy Impact

Building Drug Supply Chain Reliability

Spectroscopy published an article on certain pharmaceutical companies’ interest in shifting drug manufacturing and investment to the United States and referenced a Duke-Margolis white paper, “Building a Resilient and Secure Pharmaceutical Supply Chain: The Role of Geographic Diversification,” which notes that reshoring alone won’t solve all supply chain issues. The authors called for policymakers to advance international regulatory harmonization, coordinate target products, and scale production with new partners in existing markets to help improve global supply chain reliability.

Improving Health Care Data Infrastructure

The Evidence Base wrote an article that reported on a recent Duke-Margolis white paper, "Building a Holistic Patient View for Patient-Focused Evidence: A Policy Framework for High Quality Source Data Collection, Curation, and Linkage," where authors lay out a policy framework for supporting a patient-focused learning health system. Read The Evidence Base's thoughts on the paper here.

Upcoming Events

On the RISE: Controls in Rare Disease Clinical Trials for Small and Diminishing Populations



September 3, 2025 | 9:30 am – 4:00 pm ET

Location: National Press Club, Washington, DC (or Virtual via Zoom)

Conducting clinical trials in rare disease populations continues to pose many unique challenges, especially for small and diminishing populations, despite the existence of regulatory guidance on how to perform controls in rare disease trials and an increase in approvals for drugs and biologics to treat patients with rare diseases. This hybrid public workshop, co-convened by Duke-Margolis and the FDA Rare Disease Innovation Hub under a cooperative agreement with the FDA, will explore considerations when choosing a control, discuss existing and innovative control options internal and external to the trial, and identify how these controls can be used to generate evidence that supports regulatory decision-making.

Learn more and register here.

Lessons Learned from the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program



September 10, 2025 | 1:00 – 5:00 pm ET

Location: Virtual via Zoom

Duke-Margolis is hosting a virtual workshop in collaboration with the FDA that will delve into the challenges and strategies for expedited chemistry, manufacturing, and controls (CMC) development. The meeting will feature perspectives from both industry leaders and FDA regulators, who will discuss best practices and lessons learned from the CMC Development and Readiness Pilot program.

Learn more and register here.

Assessing Novel Efficacy Endpoints in Ophthalmologic Rare Disease Drug and Biologics Development



September 17, 2025 | 9:30 am – 2:30 pm ET

Location: National Press Club, Washington, DC (or Virtual via Zoom)

Under a cooperative agreement with the FDA, Duke-Margolis is convening a public workshop focused on novel efficacy endpoints used in interventional clinical trials for drugs and biological products intended for patients with severe vision loss. In particular, the workshop will focus on full-field stimulus threshold testing and ellipsoid zone data. Researchers, clinicians, and others will discuss evidence and data that may support the use of these tools in regulatory decision-making, and will explore current limitations and potential strategies to advance the use and implementation of these tools.

Learn more and register here.

Past Events

The State of Real-World Evidence Policy 2025

This annual meeting, convened with the Duke-Margolis Real-World Evidence Collaborative, explored the latest developments in the real-world data and real-world evidence (RWD/E) landscape. This year, panelists discussed a few timely topics:

• Opportunities to harmonize, collaborate, and make progress globally in the RWD/E community
• How to cultivate research into routine care and advance pre- and post-market evidence generation
• Uses of RWD/E to support pricing, coverage, and payment
• Ways that RWE can support regulatory decision-making, using recent use cases to illustrate lessons learned

A recording will be uploaded to the event webpage and our YouTube channel in the coming days.

As the final deliverable for a Duke University Bass Connections project, "Equitable Access to Monoclonal Antibodies for Low- and Middle-Income Countries,” team leader and Duke-Margolis Policy Research Associate Beth Boyer co-authored a paper with the student team members. The paper investigated disparities in access to monoclonal antibody treatments among populations in South Africa and India and noted common barriers, such as fragmented health care systems, budget constraints, lack of national coordination, and insufficient diagnostic infrastructure. Read the paper here.

Kate Bundorf co-authored a paper in Health Affairs Scholar to study certain telehealth payment parity legislation passed during the COVID-19 pandemic, which the authors found led to increased telehealth visits and total outpatient visits. Read more here.

Research Director Rachele Hendricks-Sturrup presented at an ISPOR event, “Global Standards, Real-World Impact: The Role of HARPER,” which explored the relevance of the HARPER protocol template for RWE studies and explored how international stakeholders might better harmonize their study standards.

AP News quoted Core Faculty member Matt Maciejewski in an article discussing pricing, coverage, and access to obesity treatments. Despite the lowering cost for these drugs, coverage and access remains challenging. Read more here.

Assistant Research Director Frank McStay spoke at the Centers for Medicare & Medicaid Services’ 2025 Quality Conference during a session focused on the history and future of the Health Care Payment and Learning Action Network. Looking to the future, Frank and his fellow speakers advised streamlining quality measurement and advancing value-based care through public-private partnerships.

Core Faculty member Krishna Udayakumar was interviewed by Al Jazeera to discuss the global HIV/AIDS response and the impact of U.S. funding cuts as the largest donor to this international effort. Krishna noted that  to combat the disruption from these cuts, HIV/AIDS programming could be integrated into stronger health systems. Watch the video interview here.

Core Faculty member David Ridley was quoted in an article from CP24 that described Canada’s reliance on the United States for drug manufacturer inspections and the backlog that has slowed down the supply chain. David noted that cuts to the FDA have exacerbated the problem and stressed the importance of these inspections to ensure consumers receive safe products.

The Journal of Medical Internet Research published a paper, co-authored by Core Faculty members Caroline Sloan and Peter Ubel, that examined the impact of specific medical conditions on crowdfunding success. The authors found that certain conditions did impact funding amounts but the socioeconomic status of a campaign’s location also had an impact on fundraising.

Team Member Welcome

Veronica Marshall-Kirk joins Duke-Margolis as a Policy Research Assistant on the Health Care Transformation team. She will support projects in multiple portfolios, including rapid learning, North Carolina innovation and Medicaid transformation, and national Medicare accountable care policy. Veronica recently graduated from the University of North Carolina in Chapel Hill with a BSPH in Health Policy & Management from the Gillings School of Global Public Health. She was also a Program Assistant for the Department of Health Policy & Management’s Bachelor program. She was an intern at Duke-Margolis during the summer of 2024, when she worked with the Health Care Transformation team on research regarding North Carolina’s Healthy Opportunities Pilots program. 

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.