TRAIN eNews is delivered directly to organizations that take part in The Research Acceleration and Innovation Network (TRAIN). TRAIN is an affinity network of foundations interested in taking a more strategic and entrepreneurial approach—what some refer to as “venture philanthropy”—to their role as funders of medical research. TRAIN convenes dozens of forward-thinking foundations to learn from each other and share their novel solutions with the rest of the medical research system. To learn more about becoming a TRAIN organization, visit the TRAIN application page.

In This Issue

News from FasterCures
TRAIN Organization Updates
News You Can Use

News from FasterCures

Attend the Milken Institute’s Future of Health Summit

Join us for the 2024 Milken Institute’s Future of Health Summit on November 13-14 in Washington, DC. The Future of Health Summit brings together a dynamic community of changemakers, all working toward creating our shared vision of lasting impact. The summit focuses on advancing key areas such as biomedical research and technological innovation, rare disease research, patient engagement, and a wide range of other health and biomedical topics. As a TRAIN member, each organization receives one invitation to attend. If you have not received an invite and would like to attend, please reach out to [email protected]. 

Upcoming TRAIN Webinar on Drug Repurposing

TRAIN is hosting a webinar this December, focused on strategies and financing options for drug repurposing. Presenters will discuss the challenges and opportunities in pursuing drug repurposing and explore what the future may look like in light of shifting innovations, policies, and incentives. Invitations will be sent to all TRAIN members in the coming weeks.  

New FasterCures Report Examines Patient Engagement in Medtech 

In October, FasterCures released a new report entitled Defining and Demonstrating the Value of Patient Engagement in Medtech Research and Product Development. The report explores key barriers, innovative solutions, and the value of integrating patient engagement activities into device, diagnostic, and digital health (collectively known as medtech) product development. Read the report and learn more about medtech company and patient-organization opportunities for engaging patients in the medtech R&D space.  

Refer Patient Organizations to Join TRAIN

We are looking to expand the TRAIN network and are actively seeking new organizations to join our community. If you know of any research-focused patient organizations that would benefit from TRAIN programming, resources, and convenings, please encourage them to apply. Your recommendation could help bring in a valuable partner that strengthens our network and could help advance biomedical research in other disease areas.

Policy Update

Comment Letter for Cures 2.0

FasterCures has been deeply involved in the 21st Century Cures Act from its early development through its enactment and implementation. We have collaborated closely with federal agencies, such as the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), and provided our recommendations for advancing the next phase in a comment letter for Cures 2.0. 

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

In a comment letter to the FDA, FasterCures provided recommendations on ways to improve the composition of the committees and clarify the public perceptions of them. Our recommendations include having one patient and one patient advocate as permanent voting members, establishing scientifically validated questions to collect patient experiences and perspectives, and providing clear rationales to the public and the scientific community as to how the committee recommendations are considered and why the FDA decided to accept or reject committee recommendations. 

TRAIN Organization Updates

FDA Promotes Use of Parkinson's Biomarker in Clinical Trials

The US Food and Drug Administration issued a letter of support encouraging drug developers to incorporate Parkinson’s disease biomarkers in research and clinical trials. In the letter, the FDA emphasized that its support stems from significant evidence made possible through the Michael J. Fox Foundation for Parkinson’s Research landmark study, the Parkinson’s Progression Markers Initiative. 

Multiple Myeloma Research Foundation (MMRF) Founder Discusses Her New Book and Her Fight with Cancer

MMRF Founder Kathy Giusti recently spoke with Stat News about her new book, in which she shares insights on becoming an empowered patient advocate, the inspiration behind founding MMRF from her personal cancer journey, and her transformative impact on the development of myeloma treatments.

TRAIN Organizations Partner with 23andMe for Lung Cancer Genetics Study 

TRAIN organizations, along with the GO2 Foundation for Lung Cancer, Lung Cancer Research Foundation, and LUNGevity are partnering with 23andMe and other lung cancer research advocacy groups for The Lung Cancer Genetics Study. This study is designed to develop an open-source database combining genetic and patient-reported data to improve lung cancer detection, treatment, and prevention. The initiative addresses the critical need for more comprehensive lung cancer research, which is essential to advance early detection, treatment options, and overall survival outcomes.

News You Can Use

FDA Requests Comments on Draft Guidance for Collecting and Submitting Patient Preference Information in Device Development

The FDA has released an updated version of the draft guidance titled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle” of device development and is requesting comments on the new version. The guidance provides recommendations for sponsors and other stakeholders on collecting and submitting patient preference information. Comments are due for submission to the FDA by December 5, 2024. If you plan to submit comments, please reach out to FasterCures at [email protected] to let us know the topics or issues you raised with the FDA. 

Chan Zuckerberg Initiative Announces New “Rare as One” Grantees

The Chan Zuckerberg Initiative has selected 31 new Cycle 3 grantees of the Rare As One (RAO) program. The RAO Program offers five-year grants for patient-led rare disease advocacy organizations to build scientific research capacity. Each cycle has a specific disease focus. Cycle 3 focuses on three disease categories: channelopathies, ciliopathies, and inborn errors of metabolism. Since 2020, FasterCures has provided mentors from TRAIN to support RAO grantees and plans to reach out in Q1 of 2025 to recruit additional mentors from the TRAIN community.

The Reagan-Udall Foundation Launches Framework to Improve Diversity in Data Collection

The Reagan-Udall Foundation for the FDA has introduced a new resource for health-care organizations looking to improve diversity in their data collection. The RAISE Action Framework, created through the “Real-world Accelerator to Improve the Standard of Collection and Curation of Race and Ethnicity,” or RAISE project, is designed to support efforts to improve the collection, management, and sharing of race and ethnicity data in health-care settings. 

NCATS Provides Insights to Advance Equity in Preclinical Research and Therapeutic Development

At a recent meeting of the National Center for Advancing Translational Science (NCATS) Advisory Council, Sharie Haugabook, PhD, acting head of scientific project management in the Therapeutic Development Branch at NCATS, described how equity can be considered in preclinical therapeutics development. Haugabook’s presentation begins at 1:08:00 in this NCATS recording.