In This Newsletter
Highlights from Global Conference
Recent Publications
Policy Updates
FasterCures Program Updates
FasterCures in the Community
FasterCures in the Media
Upcoming Milken Institute Events
Highlights from Global Conference
In May, the Milken Institute hosted the 27th Global Conference in Los Angeles, focused on “Shaping a Shared Future.” Kicking off the conference, the opening health plenary featured two parts. Part One was a conversation with Michael Milken and Centers for Disease Control and Prevention Director Mandy Cohen, focused on the critical need to invest in public health infrastructure, the importance of public-private partnerships, health disparities, applications for AI, and trust-building and combating misinformation for public acceptance of public health priorities. Part Two was a panel discussion moderated by Esther Krofah, EVP of MI Health, focused on prevention and innovation for a healthier tomorrow. The panel explored how prevention is key to shifting the health-care cost trajectory and improving outcomes.
FasterCures curated five public sessions. For detailed descriptions and recordings, please visit the session links below.
At Global Conference, MI Health announced several new initiatives, including FasterCures’ ENRICH-CT and Project Prevent programs. Keep reading to learn more about these programs.
For more health updates from Global Conference, read Key Trends in Health from Global Conference.
Recent Publications
Toward a National Action Plan for Achieving Diversity in Clinical Trials
Despite recent legislative efforts to improve diversity in clinical trials and many individual organizational efforts, a national plan to include diverse patients has not yet been developed. Over the course of 2023, the Clinical Trials Transformation Initiative, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, and FasterCures coordinated a series of convenings to investigate this issue and inform the publication of a National Action Plan for increasing diversity in clinical trials. This report details the actions organizations and sectors from across the enterprise can take to create a clinical trials enterprise that is diverse, equitable, inclusive, and accessible to all.
Financial Innovations for Early Warning Systems
As part of our ongoing work to advance early warning systems, FasterCures collaborated with Milken Institute Financial Innovations Labs® on a series of convenings around the globe with local and national leaders to spotlight avenues for deploying funds and utilizing partnerships to improve health threat prediction, data sharing, and international collaboration. These reports summarize the findings and recommendations from the convenings in Brazil, Indonesia, and Kenya.
Policy Updates
Comments on Draft Guidance for Medicare Drug Price Negotiation Program
FasterCures believes patients should be at the center of biomedical progress. Over the past decade, considerable advancements have been made in integrating the patient perspective throughout the health-care ecosystem. The Centers for Medicare and Medicaid Services (CMS) recognize the importance of patient-centered care and the need to provide patients with the tools and services to manage care that aligns with patients' preferences and values. In a comment letter to CMS, FasterCures provided recommendations on the Medicare Drug Price Negotiation Program (MDPNP) draft guidance. Key recommendations include:
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Adapt best practices tested and developed by the Food and Drug Administration (FDA) and evolve them to facilitate effective, meaningful, fit-for-purpose patient engagement to inform CMS's MDPNP.
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Develop official coordinating mechanisms with the FDA to integrate patients' preferences and experiences, reflected throughout the biomedical innovation ecosystem, from bench to bedside.
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Increase transparency in how the information gathered from engaging patients informs the MDPNP processes and outcomes.
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Create a designated structure of patient engagement beyond the purview of the MDPNP that is integrated into coverage decisions for innovative medical products, such as those approved by the Accelerated Approval Pathway.
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Build staff capacity to coordinate consistent patient engagement programs for the MDPNP and other emerging technologies in medical products.
Comments on the Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
FasterCures firmly believes in the importance of collecting accurate and comprehensive data on the racial and ethnic composition of the American population. In a comment letter to the FDA, we outlined recommendations to enhance inclusivity, accuracy, and effectiveness in clinical research practices, which can ultimately advance health equity and improve patient outcomes. These include:
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Expand existing question formats to accommodate more open-ended responses encompassing diverse racial and ethnic groups.
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Provide clearer guidance on when detailed racial and ethnic categorizations are appropriate in clinical trial data collection to improve accuracy in reporting.
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Address barriers inhibiting accurate data collection on race and ethnicity, ensure equitable data collection practices, and increase the integration of real-world data to inform regulatory decisions and promote diversity in drug development.
FasterCures’ Program Updates
Enabling Networks of Research Infrastructure for Community Health through Clinical Trials (ENRICH-CT)
There is an urgent need for an inclusive clinical trial infrastructure in the US. To meet this need, FasterCures launched ENRICH-CT, a multistakeholder group comprising business, government, and nonprofit leaders. ENRICH-CT will serve as a precompetitive initiative to share best practices, support collective action on common challenges, and build an ecosystem of excellence that sustains the workforce, partnerships, resourcing, and technology needed to conduct research closer to communities effectively. This video features health leaders emphasizing the need for ENRICH-CT.
Project Prevent
Project Prevent is a new program of Milken Institute Health that builds on our long-standing work in preventive health. Project Prevent aims to bring together leaders and experts across sectors—including health, finance, technology, and government—to create a blueprint for deploying targeted health prevention approaches at scale to improve health outcomes. Starting in the US and UK, it will explore innovative funding models and design pilots to improve access to preventive care. We are thrilled that GSK has joined Project Prevent as a founding partner. We look forward to working with GSK and other partners to advance tangible solutions to help expand investment in and access to preventive health care.
Welcome to the 2024–25 LeadersLink Cohort
We are pleased to introduce this year’s cohort of LeadersLink participants. Nine exceptional individuals were selected from a competitive pool of applicants. The FasterCures’ LeadersLink program aims to empower emerging leaders in patient-centered nonprofits that fund or participate in biomedical research. As part of the program, participants will address their organizational priorities, guided by assigned mentors and other experts in our network. This year’s cohort will focus on engaging diverse patients throughout the research and development process.
FasterCures in the Community
April
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On April 18, Sung Hee Choe, managing director, moderated a roundtable of senior health systems executives, investors, and health tech leaders based in South Florida at the eMerge Americas conference.
May
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On May 9, Kristin Schneeman, senior director, presented the keynote on Right Partnerships at Mayo Clinic’s Science of Community Outreach and Engagement conference.
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On May 15, Yasmeen Long, director, spoke at Ideagen Global’s “Future of…Summit."
June
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On June 3, Choe spoke on a panel, “Building Gene Therapy Platforms That Work—and Scale—Sustainably," at Endpoints at BIO in San Diego.
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On June 24, Esther Krofah, executive vice president of MI Health, spoke on the topic of best practices for diversity, equity, and fair inclusion in clinical research as part of a roundtable convened by Yale, EY, and Bioethics International on “Bioethics and Patient Centricity in Pharma.”
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On June 26, Schneeman spoke at an FDA and Digital Medicine Society workshop about using patient-generated health data to support improved trials, medical device development products, and regulatory science.
FasterCures in the Media
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FasterCures’ senior advisor, Lee Fleisher, wrote about early coverage in gene therapy in STAT.
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A summary of our Global Conference session focused on improving diversity in clinical trials appeared in STAT.
Upcoming Milken Institute Events
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September 18–20, Asia Summit in Singapore
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October 24, 2024 Global Investors’ Symposium in Mexico City
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November 13–14, Future of Health Summit in Washington, DC
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December 5–6, Middle East and Africa Summit in Abu Dhabi