In This Newsletter

Program Updates
Events and Convenings Recap
Recent Publications
Policy Updates
FasterCures in the Community
Upcoming Events

Program Updates

FasterCures Awarded FDA Funding to Advance Patient Engagement in Medtech 

FasterCures has received a Broad Agency Announcement contract from the US Food and Drug Administration (FDA) to expand patient engagement within the medtech sector. This funding will support a project that includes the development of a comprehensive framework highlighting the value of patient engagement in medtech, along with a toolkit to encourage greater patient engagement within the total product life cycle of medtech R&D activities. This project will build on FasterCures’ research to deepen the understanding of patient engagement's benefits, challenges, and opportunities in medtech R&D. For further details, please contact Raymond Puerini, director FasterCures.

Preparing the US Health System for the Future of Cancer Care

Announced at the Future of Health Summit, a new Future of Cancer Care project of FasterCures will examine how advances in cancer diagnostics may change the future of cancer care. The project will explore the implications of these advances for patients, industry, providers, and payers, as well as for the broader US health system. 

Democratizing Access to Clinical Trials

FasterCures' Enabling Networks of Research Infrastructure for Community Health through Clinical Trials (ENRICH-CT) is a multi-stakeholder coalition involving business, government, and nonprofit leaders. The initiative is launching three project working groups to address barriers to building more community-based clinical trial infrastructure: clinical services organization business models, regulatory facilitators, and new sites and investigators. As noted above, FasterCures also released a report on new players and platforms that will enable more person-centered approaches to clinical research and democratize access to trials. For more information, please contact [email protected].

Events and Convenings Recap

Highlights from the 2024 Future of Health Summit

The Milken Institute hosted its annual Future of Health Summit in Washington, DC, with programming focused on Partnering for Better Health. Kicking off the conference, the opening plenary featured three robust conversations, starting with Rob Califf, commissioner of the FDA, continuing with Mandy Cohen, CDC director, and concluding with a panel discussion focused on partnerships for a healthier tomorrow. Attendees were treated to a panel discussion with USAID Assistant Administrator for Global Health Atul Gawande and WHO Foundation CEO Anil Soni. Of equally high interest were conversations with the NIH leaders of the 21st century, featuring Monica Bertagnolli, NIH director, and former directors Elias Zerhouni and Francis Collins. 

FasterCures curated 11 public sessions during the two-day event. For detailed descriptions and recordings, you’re welcome to visit the session links below. 

• Decoding Disease: Can Genetics Unlock New Interventions?
• Drafting the Blueprint for the Next Era of Patient Engagement
• Global Collaboration to Eradicate Women’s Cancers
• How Can Clinical Trials Keep Pace with Science?
• Unlocking the Policy Agenda for NextGen Biomedical Innovation
• Why Younger People Are Getting Cancer and What We Can Do About It
• Data Sets That Address All Our Diversity
• Beyond Checkboxes: Elevating Diversity and Representativeness in Patient Engagement
• The Price of Health
• A Glimpse Ahead: The Future of R&D
• All Hands on Deck: Partnering for Prevention

UN High-Level Dialogue on AMR at the United Nations General Assembly 

Leaders from the Milken Institute and FasterCures took an active part in the 79th United Nations General Assembly, working with global changemakers to tackle some of the world’s most urgent challenges. Our experts led discussions in four critical areas: driving climate innovation, expanding global health access and investing in antimicrobial resistance (AMR) solutions, utilizing finance and innovation for a resilient Africa, and advancing strategic philanthropy.

FasterCures is at the forefront of addressing AMR, focusing on innovative funding for antibiotic development and fostering global collaboration on pandemic preparedness. Esther Krofah, executive vice president of Milken Institute Health, joined global leaders at a high-level AMR meeting to address this critical threat. Additionally, FasterCures hosted "Beyond Borders: Advancing Global Health Access in a Changing World," featuring a panel of distinguished experts focused on achieving equitable health-care access worldwide. 

Webinar: Development and Deployment of Patient-Centered Outcome Measures for Research and Care 

FasterCures’ The Research Acceleration and Innovation Network recently hosted a webinar focused on the development and deployment of patient-centered outcome measures (PCOMs) for research and care, highlighting the importance of integrating patients’ voices within the research process. Unlike traditional patient-reported outcomes, which often focus solely on symptoms, PCOMs take a broader approach by incorporating features that matter most to patients in terms of care and daily life. Speakers shared their experiences in developing PCOMs in the rare disease and obesity spaces.

Recent Publications

Community-Based Infrastructure for Inclusive Research: Democratizing Access to Research

FasterCures’ work spurred by the COVID-19 pandemic identified challenges in both the publicly and privately funded research ecosystems. Such challenges can hamper established contributors in sustaining and scaling efforts to move research opportunities closer to communities—to make an “ecosystem of excellence” out of “islands of pilots.” Our team members have highlighted solutions that could help create efficiencies, improve connectivity among research stakeholders, and serve the needs of community partners.   

Continuing the approach of previous briefs in this series, FasterCures conducted thorough research and hosted a virtual dialogue. This FasterCures brief explores strategies to democratize access to clinical research and foster more inclusive, person-centered clinical trials. 

Defining and Demonstrating the Value of Patient Engagement in Medtech Research and Product Development

Patient engagement (PE) has grown steadily in pharmaceutical R&D, yet PE in medtech has lagged due to unique barriers. This FasterCures report explores why PE has been slower to evolve in medtech compared to the pharmaceutical sector. Issues raised include the key barriers facing PE in medtech R&D, the benefits and value of PE, and the opportunities to enhance PE in medtech. The report also offers recommendations for improving patient involvement throughout the medtech development process.

Prescription for Biomedical Innovation: Recommendations for the New Administration 

Fired up by a mission to accelerate scientific advancements that save lives, FasterCures has been a driving force in shaping national priorities to advance biomedical innovation and remove barriers that delay patient access to breakthrough therapies. 

This FasterCures report delineates our expertise as advocates and facilitators, cultivated through extensive research, projects, and collaboration with experts across our stakeholder network. We aim to support the new administration in addressing emerging health challenges and prioritizing policies that will advance biomedical research and health-care innovation for the future.

Journal Articles

• Esther Krofah, executive vice president, Milken Institute Health, was one of the authors of an article in Health Affairs that calls for a coordinated, national strategy and details actionable steps to address the longstanding gaps in representation within US clinical trials. 
• Sung Hee Choe, managing director, FasterCures, was a co-author of an article focused on a novel financing mechanism for antiviral drug development, featured in the Milken Institute Review.

Policy Updates

Request for Information on Next-Generation Cures Bill

In the past decade, significant strides have been made to integrate patient perspectives into biomedical research, driven by legislation like the Cures Act, which has fostered innovation in R&D and improved patient access to lifesaving medical products. FasterCures has played a key role in supporting the Cures Act and now offers recommendations for the upcoming Cures 2.0 to further enhance patient-centered biomedical progress. Key recommendations include:

1. Legislative support for community-based clinical research, coordinated nationally by a proposed Office of the National Clinical Trial and Research Coordinator.
2. Enhanced collaboration between the FDA and Centers for Medicaid and Medicare Services (CMS) to streamline access to FDA-approved innovations.
3. Systematic patient engagement in product development and approval.
4. Alignment of evidentiary standards between the FDA and CMS for timely patient access.
5. Preservation of the Affordable Care Act's preventive service mandate and reimbursement mechanisms to encourage preventive care.
6. Continued funding for innovative research to close biomedical innovation gaps.

Comments on Optimizing the FDA’s Use of and Processes for Advisory Committees

The FDA relies on external experts through Advisory Committees to gain diverse perspectives for evaluating complex medical products. FasterCures values the FDA's efforts to refine this advisory process and offers the following recommendations to enhance it:

1. Include a patient and a patient advocate as permanent voting members on each committee, except in meetings unrelated to patient concerns.
2. Use structured, scientifically validated questions to gather patient experiences, enhancing the FDA’s evaluation of medical products.
3. Continue using voting with scaled questions, ensuring that patient representatives participate.
4. Provide clear, public explanations on how committee recommendations influence FDA decisions.
5. Communicate the role and importance of advisory committees through social media in accessible language.

Comments on the Diversity Action Plans to Improve Enrolment of Participants from Underrepresented Populations in Clinical Studies

FasterCures commends the FDA's recent advancements in promoting diversity in clinical studies through updated guidance on the Diversity Action Plan (DAP), mandated by the Food and Drug Omnibus Reform Act. This guidance encourages clinical studies to consider demographic and additional diversity factors to address health inequities, such as geographic location, gender identity, socioeconomic status, and health conditions.

FasterCures supports this initiative and suggests further recommendations for the FDA:

1. Keep inclusive language on social and environmental factors affecting safety and efficacy.
2. Clarify support for sponsors facing challenges meeting DAP enrollment goals.
3. Emphasize ongoing community engagement to build trust and partnerships.
4. Streamline regulations across FDA centers to improve recruitment, retention, and data collection from underrepresented communities.

FasterCures in the Community

September 

• On September 5, Mark Williams, associate director, spoke on a panel titled “Modernizing Incentive Structures: A Roadmap to Strengthen Antimicrobial Development” at the World AMR Congress & Disease Prevention and Control Summit.
• On September 6, June Cha, policy director, spoke on a panel about precision equity at the Precision Medicine Summit.
• On September 26, Raymond Puerini, director, led an interactive workshop on building research partnerships. 

October

• On October 14, Hadly Clark, director, spoke on a panel at PLEN’s Health Policy Seminar.
• On October 15, Puerini spoke on a panel about patient engagement in medtech development at The Medtech Conference.
• On October 15, Sung Hee Choe, managing director, spoke on a panel, “Realizing the Promise of Gene Therapy: Exploring Health System Challenges,” at the World Health Summit in Berlin.
• On October 22, Kristin Schneeman, senior director, spoke on a panel, “Bringing Research to Patients to Be More Inclusive," at NORD's Breakthrough Summit. 

November

• On November 15, Amanda Wagner Gee, associate director, spoke on a panel about improving access to clinical trials at the Decentralized Trials and Research Alliance Annual Meeting.
• On November 20, Schneeman spoke at the Patient-Focused Medicines Development meeting on "Leveraging PE Intelligence to Drive Systemic Change in Healthcare."

Upcoming Events

• December 5–6, 2024, Middle East and Africa Summit in Abu Dhabi 
• March 24, 2025, Global Investors’ Symposium in Hong Kong
• May 4–7, 2025, Global Conference in Los Angeles