Newsletter

FasterCures Quarterly — December 2025

FasterCures

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In this Newsletter

Program Updates
Events and Convening Recaps
Latest Publications
Policy Updates
Thought Leadership
FasterCures in the Community
FasterCures in the Media
New FasterCures Team Members
Upcoming Events

 

Program Updates

ENRICH-CT Celebrates Two Years of Bringing Research Closer to Communities
Enabling Networks of Research Infrastructure for Community Health through Clinical Trials (ENRICH-CT) is a precompetitive initiative that shares best practices, supports collective action on common challenges, and builds an ecosystem of excellence to sustain the workforce, partnerships, resources, and technology needed to conduct research effectively in communities.

With over 65 participating member organizations and guidance from an executive committee, ENRICH-CT convenes bimonthly to exchange new ideas and participate in cross-sector learning on problems and solutions related to bringing research closer to communities and building the capacity to sustain the infrastructure that supports it.

ENRICH-CT’s three working groups also meet bimonthly to develop action-oriented, practical, and applicable resources. The groups are working on several aspects of easing the burden and difficulty of conducting community-based research, including: 

  • developing a framework of policy, practice, and regulatory building blocks necessary to enable more community-engaged research, highlighting existing tools and standards to articulate what is currently possible, and identifying areas in need of further alignment and action;
  • consolidating study startup and site selection processes as they pertain to newer sites, collating available tools and resources, and identifying areas of high burden that could be addressed through collective work; and
  • identifying business models that can provide sustainable support for community-serving organizations that connect communities to research; outlining the roles of research and community partners in achieving durable and successful partnerships; and building long-term capacity.

Convergence Project Aims to Improve Access to Clinical Trials
No single entity, organization, or institution can take on systemwide and sustainable change to improve access to clinical trials. The Convergence Project is a call for clinical research stakeholders to work collaboratively toward common goals and take collective action.

This summer, the Convergence Project held a virtual event, “From Barriers to Breakthroughs: Funding, Resources, and Support to Improve Clinical Trial Access and Innovation,” hosted by FasterCures in partnership with the Multi-Regional Clinical Trials Center at Brigham and Women’s Hospital of Harvard Medical School. More than 140 virtual attendees joined to hear from leaders from across the clinical trial ecosystem on the systemic barriers that limit access, including financial burdens on patients and caregivers, as well as gaps in community trust and investment.

FasterCures Vital Voices Webinar Series: Strategies for Patient Organizations to Engage with CMS
Under our Vital Voices project, FasterCures is hosting a three-part webinar series exploring how patient organizations can inform and influence the activities and state-level coverage decisions of the Centers for Medicare and Medicaid Services (CMS). Each webinar delves into a critical topic, offering real-world insights and actionable strategies for patient organizations to amplify the patient voice in CMS activities and decisions. All session video recordings and related resources are now available on our website.

  • “Strength in Numbers: Coalitions to Amplify Patient Voices in CMS Decision-Making” highlights the successes of coalition building among patient organizations in engaging with CMS.   
  • “Just the Facts: Patient Experience Data to Inform CMS Decision-Making” explores how patient organizations can effectively collect, structure, and present patient experience data to support CMS decisions.
  • Registration is now open for the final webinar, “Where the Rubber Meets the Road: Navigating State-Level Coverage and Payment Decisions,” to be held on December 8. This session will focus on best practices for patient organizations in navigating and informing state-level coverage and payment structures to improve treatment access.

FasterCures LeadersLink Application Coming Soon
FasterCures LeadersLink is an 18-month program designed to support the growth and development of emerging leaders in nonprofit, patient-driven organizations that fund or conduct biomedical research. LeadersLink aims to enhance participants' leadership abilities and professional networks, addressing their top priorities through mentorship, a capstone project, a series of gatherings, virtual collaboration, and access to Milken Institute events and networks. The theme for the 2026–2027 cohort is Advancing Research Through Strategic Industry Partnerships. Applications will be available in early January 2026. For more information, contact the LeadersLink team.

FasterCures Patient Engagement Web Page Offers Tools for Integrating Patient Perspectives in Biomedical Research
Ensuring that patients are at the center of the biomedical research ecosystem is a top priority for FasterCures. Our capacity-building programs aim to strengthen patient foundations and nonprofit organizations, enabling them to support, advance, or conduct research that can lead to new therapies. The newly launched Practice of Engagement web page serves as a hub showcasing our work and featuring reports, webinar recordings, and other resources designed to support meaningful patient engagement.

Transforming the Future of Women’s Health 
The Milken Institute Women’s Health Network is a global collaborative of diverse leaders and experts committed to breaking down silos and advancing research, innovation, and investment to improve women’s health. The Network—chaired by Dr. Jill Biden, former First Lady of the United States—has expanded its membership to over 100 participating organizations and is guided by a 14-member steering committee. Find more information.


Events and Convening Recaps

Future of Health Summit 2025
The annual Milken Institute Future of Health Summit took place November 4–6 in Washington, DC. Centered on the theme, In Service of Better Health, the Summit convened leaders from diverse sectors around the globe to confront the toughest health challenges by matching human, financial, and scientific resources with the most innovative ideas to drive better health outcomes for all. All public session recordings are available for online viewing.

FasterCures curated five public and five private sessions, as well as an Advisory Board meeting. For detailed descriptions and recordings of FasterCures’ public sessions, visit the session links below. 
Caption: “Access Reimagined” plenary speakers, from left to right: Neil Lindsay, Amazon Health Services; AmirAli Talasaz, Guardant Health; Sarah Owermohle, CNN; Deborah Glasser, Sanofi; Daniel Knecht, EmblemHealth; Sung Hee Choe, Milken Institute Health

Public session recordings include:

Private session topics and descriptions include:

Future of Health Summit 2025 Power of Ideas Essays Collection
Ahead of the 2025 Milken Institute Future of Health Summit, we released a new collection of Power of Ideas essays exploring how cross-sector collaborations can advance patient engagement, longevity, caregiving, and more.


Asia Summit 2025
The 12th Milken Institute Asia Summit took place from October 1–3 in Singapore. Under the theme Progress with Purpose: Collaboration Amid Complexity, the Summit convened bold thought leaders at the forefront of the world’s most impactful megatrends. Together, we aimed to catalyze strategic partnerships and scale initiatives to accelerate progress toward a brighter future. Across discussions and roundtables, we brought together individuals transforming business, finance, government, health care, technology, and philanthropy to advance shared interests, deepen collaboration, improve health and well-being, and enhance competitiveness, sustainability, and resilience.

Watch the session, “Will AI Deliver on the Promise of Better, Faster, Cheaper Health Care?” moderated by Sung Hee Choe, managing director, FasterCures. The session examined the potential and progress of artificial intelligence (AI) to transform biomedical research and clinical practice.

 

Latest Publications

How Blood-based Liquid Biopsies Are Shaping the Future of Cancer Care
A Pivotal Role: Liquid Biopsies in the Future of Cancer Care, the first installment of a two-part series, explores how innovation in liquid biopsies is poised to shape the future of cancer care over the next five years. The report focuses on blood-based tests and their potential to deliver faster results, reduce the physical and emotional toll of repeated biopsies and scans, lower treatment costs, expand access to screening for cancers that often go undetected until later stages, and pave the way for increasingly personalized care. This work builds on FasterCures’ efforts to define and measure the ideal performance of the biomedical ecosystem in addressing patient needs and advancing better outcomes.

Bridging Gaps in Clinical Trials: Strategies for Increasing Access and Representation
Despite the high spending on health care in the United States, health outcomes continue to lag across many diseases and populations. In recent years, limited access to clinical trials and insufficient infrastructure to effectively recruit populations disproportionately affected by the burden of disease have become major concerns for researchers and clinical trial sponsors. In September 2025, FasterCures published Bridging Gaps in Clinical Trials: Strategies for Increasing Access and Representation. The report highlights current practices and insights from organizations actively engaged in a range of efforts to build collective knowledge and to serve as a resource for stakeholders working to expand access and representation in clinical trials across disease areas, geographies, and populations, all within an evolving research environment.

Improving and Sustaining Health Through Prevention Across Medicare 
Preventable illnesses are a leading cause of death worldwide, with noncommunicable diseases like cardiovascular disease, diabetes, and obesity now accounting for most premature deaths. These conditions are driven by a lack of access to healthy foods, physical inactivity, and inadequate screening. The Milken Institute’s Project Prevent is an initiative that aims to foster collaboration with leaders and experts from various sectors to create a blueprint for scaling health prevention.  

The Project Prevent Collaborative launched in February 2025 as a platform for stakeholders, funders, and implementation partners to identify opportunities for statewide or national expansions. On September 15, the Collaborative convened virtually and was joined by special guests from the CMS Innovation Center (CMMI), who emphasized integrating preventive health care into daily life rather than reserving it for annual visits. Priorities include evidence-based interventions in nutrition and physical activity, as well as incorporating prevention into future CMMI models, targeting areas where the health system has historically underperformed.   

The Collaborative also convened a private session of 50 stakeholders at the Future of Health Summit and announced the release of Improving and Sustaining Health Through Prevention Across Medicare. Despite broad no-cost coverage of preventive services under Medicare and Medicaid, the use of preventive screening and disease management services remains low, especially in rural areas and among beneficiaries with multiple chronic conditions. The report outlines recommendations that leverage the array of existing CMS tools to make prevention the default experience, not the exception.

A Policy Roadmap to Preserve US Leadership in Biomedical Research and Innovation  
As other nations invest and expand their life sciences capabilities, the United States faces systemic challenges that threaten progress. FasterCures has engaged leaders across the public, private, and philanthropic sectors to drive a bold path forward—one that maintains US leadership in the life sciences and delivers better health for all. The latest report, The Future of US Biomedical Research and Innovation: Recommendations for Action, presents six sets of policy recommendations as a starting point for dialogue and action.

FasterCures’ Access Point Brief Highlights Trends in Clinical Trials Transformation
Access Point highlights how innovations in clinical trial conduct are addressing dual challenges of access and operational efficiency, showcasing a future of streamlined, cost-effective clinical research that better serves both patients and sponsors. The first issue, Access Point: Trends in Clinical Trials Transformation, explores four key themes: trial trends, the power of big data, connections to care, and industry and regulatory priorities.

The Supply of Clinical Trial Sites: Openings, Closings, and Longevity
Clinical trial sites—involving one or more physical locations—are essential to conducting pharmaceutical studies, and participants must typically travel to these sites for part of the trial. Despite their vital role, little is known about their overall life cycle and supply on a macro level. FasterCures’ report, The Supply of Clinical Trial Sites: Openings, Closings, and Longevity, provides the first detailed look at the macro-level dynamics of the supply of clinical trial sites. It also examines which site and trial characteristics correlate with longer site longevity.

Opportunities for Local Mammography Deployment
There is strong evidence that limited access to screening is at least partly responsible for missed breast cancer diagnoses. While some areas have a high density of mammography resources—and correspondingly high screening and detection rates—other areas have far fewer resources and, in turn, lower detection rates. Our new report assesses and compares the availability, capacity, and performance of screening mammography across US counties.

 

Policy Updates

FasterCures Provides Recommendations to the FDA’s Reauthorization of the Prescription Drug User Fee Act
FasterCures submitted a response to the FDA’s Request for Comments on the Reauthorization of the Prescription Drug User Fee Act (PDUFA) VIII. With science advancing rapidly and health care delivered across increasingly diverse settings, PDUFA VIII presents an opportunity to align user-fee commitments with targeted resourcing and clear performance goals. The resulting operational improvements will ripple outward across the biomedical innovation ecosystem.

Summary of Recommendations:

  1. Make Regulatory Priority for Increasing Community Proximity of Clinical Trials and Research
  2. Enforce Community-Based Research Infrastructure with Practical and Streamlined Regulations and Support
  3. Build Data Connectivity and Accountability: From Community Sites to Regulatory and Coverage Decisions
  4. Elevate Patient Expertise as Core Evidence Input for Advisory Committee Meetings
  5. Ensure Continuity of Patient Voice Beyond Approval

FasterCures Outlines Recommendations to HHS to Reduce Burdens on Conducting Clinical Research
FasterCures submitted a comment letter on the “Ensuring Lawful Regulation and Unleashing Innovation to Make America Healthy Again.” Currently, research oversight is dispersed across various agencies and entities within the Department of Health and Human Services (HHS), each with distinct missions and limited coordination. As a result, interpretations and enforcement of oversight requirements are often inconsistent. Actions HHS can take to address this inefficiency include:

  1. Align regulatory requirements and interpretations across oversight entities.
  2. Use risk-based oversight to distinguish between low- and high-risk clinical research and inspections.
  3. Streamline data collection policies and oversight, reconciling practice and regulation.
  4. Prioritize decentralized trials and remote monitoring.
  5. Expand clinical research participation to local health-care providers and nontraditional stakeholders.
  6. Prioritize master contracts and legal agreements.
  7. Expand CMS incentives for research engagement.

Thought Leadership

Maintaining Trust Between Clinical Researchers and Communities Requires Commitment and Candor
The ENRICH-CT Creating Sustainable Business Models for Community-Serving Organizations working group published an article highlighting the need to preserve and strengthen trust between communities and the clinical research enterprise amid shifting funding priorities. The piece features insights from leaders, including Silas Buchanan of Our Health Community and Gladys Maestre, MD, PhD, of the University of Texas Rio Grande Valley, who emphasize the importance of transparency, sustained partnerships, and inclusive research practices. It also outlines current funding opportunities and collaborative efforts across industry, philanthropy, and health systems aimed at advancing equitable access to clinical research and ensuring that innovation benefits all communities.

A Patient-Centered Pathway for Biomedical Innovation and Access
The Food and Drug Administration (FDA) approval and CMS coverage frameworks continue to rely on population averages that often obscure what patients value most—symptom relief, functional independence, manageable side effects, and protection from overwhelming out-of-pocket costs. In an article published in Health Affairs, FasterCures Director June Cha recommends ways to better align FDA and CMS evidence requirements, including incorporating patient priorities into every stage of value assessment, creating a shared, interoperable data platform, and pursuing parallel engagement that treats patient-generated evidence as essential for both approval and reimbursement.

 

FasterCures in the Community

  • Director Raymond Puerini presented the FasterCures’ Research Partnership Maturity Model at the Global Liver Institute's Strategies and Synergies in Rare Liver Diseases Summit.
  • Cha spoke on a panel, “Future Outlook for Regulatory Science: Advancing Regional and Global Impact,” at the 2025 Critical Path Institute® Global Impact Conference.
  • Director Lisa Lewis gave keynote remarks at the Project Increasing Minority Participation and Awareness in Clinical Trials 2.0 Symposium, “Transforming Clinical Trials Towards Health Equity,” during the 123rd National Medical Association Annual Convention and Scientific Assembly. 
     

FasterCures in the Media

New FasterCures Team Members

FasterCures welcomed three new team members this fall.

Manvit Adusumilli, Associate
Manvit Adusumilli primarily supports the team’s projects, including those involving clinical trials, disease prevention, and research infrastructure. Previously, he contributed to innovative community and public health efforts, including community health worker and mobile clinic programs. He also conducted community-engaged participatory research in Chiapas, Mexico, and South Bend, IN, exploring effective and sustainable methods to increase access to care. After graduating, Adusumilli joined the AmeriCorps National Health Corps program in Chicago to care for vulnerable communities and families. He received a BS in neuroscience and behavior and global affairs from the University of Notre Dame.

Isaiah Dennings, Associate
Isaiah Dennings supports research activities for diverse projects. A native of Colorado Springs, Dennings began his career as an intern in the Colorado General Assembly. For the past two years, he has specialized in science policy research and analysis, supporting reports for the National Academies of Sciences, Engineering, and Medicine and the National Security Commission on Emerging Biotechnology. Dennings holds a bachelor of arts in political science and a minor in biomedical sciences from Colorado State University, as well as a master of science in biomedical science policy and advocacy from Georgetown University. He is based in Washington, DC.

Michelle McNabb, Senior Associate
Michelle McNabb supports FasterCures in developing and executing communication strategies to amplify their efforts across digital platforms. McNabb has experience in health communications, digital content strategy, and community outreach across federal, state, and local government agencies. She is dedicated to making health information accessible through clear and engaging messaging. Before joining FasterCures, McNabb served as an analyst supporting the National Institutes of Health. In this role, she led strategic communications and stakeholder engagement efforts to support organizational goals. McNabb holds a BS in biology and an MPH in community health promotion.

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