As we begin our 30th anniversary year, we’re reflecting on what’s been possible through partnership with advocates like you and sharing some of the progress we’ve made together. In this newsletter, you’ll find updates on our recent work and a preview of what’s ahead.
Here’s what you can read more about in this newsletter:
- What’s Happening at Friends?: Catch up on our recent advocates webinar that explored how modern clinical trial endpoints provide efficient patient-centered methods that can support earlier assessments of treatment benefit, and the launch webinar for ProgresoparaPacientes.org, which highlighted the importance of linguistically accessible patient advocacy education for Spanish-speaking communities.
- Advocate Spotlight: Hear from Friends Advisory Advocate Misha Mehta about how she advocated for clinical research on Capitol Hill during One Voice Against Cancer’s (OVAC) Grassroots Hill Day.
- Mark Your Calendars: Register for our upcoming public meetings and advocate webinars on external control arms and cell therapies, save the date for our 19th Annual Meeting, and brows external events advocates can attend.
- Data-Driven Insights: Review insights on how the U.S. Food and Drug Administration’s (FDA) Biomarker Qualification Program (BQP) provides a pathway for use of new tools in drug development.
- Important News in Cancer Research: Hear more about the User Fee programs, such as the Prescription Drug User Fee Amendments, including how they work, why they matter, and what’s at stake for patients and innovation,
What's Happening at Friends?
Modernizing Oncology Endpoints: Pathways for Evidence and Policy
On February 19th, Friends hosted an advocates webinar as a follow-up to our February 5th Modernizing Oncology Endpoints: Pathways for Evidence and Policy public meeting. As cancer therapeutics continue to improve and patients live longer, assessing overall survival (OS) requires longer follow-up, extending the time required to generate mature evidence needed to support regulatory decision-making. Under this context, early endpoints—such as on-treatment changes in circulating tumor DNA (ctDNA), a minimally invasive blood-based biomarker, and artificial intelligence (AI)-enabled tumor assessment of early endpoints, are being evaluated for their potential to detect treatment efficacy earlier and more efficiently. Before these modern approaches can be used in clinical trials and for regulatory decision-making to speed patient access to promising therapies, rigorous evidence is needed to ensure these measures have a strong association with long-term survival outcomes. The meeting explored these modern approaches to assessing treatment benefit, why they offer more patient-centered methods for assessing treatment benefit, and the evidence needed for these novel approaches to be reliable for use in regulatory decision making.
- What ctDNA as an early endpoint could mean for patients in clinical trials, including findings from Friends ctMoniTR Project examining early on-treatment changes in ctDNA levels and their association with OS, and what validation and standardization must occur before these measures can be used more broadly in regulatory decision-making.
- How AI-enabled tumor assessment tools, as explored through Friends ai.RECIST Project, may improve the way treatment response is measured, potentially increasing consistency and reproducibility compared to conventional RECIST imaging methods, while generating the level of evidence needed to support regulatory decision-making.
- Why advocate engagement with industry and FDA matters in endpoint modernization, ensuring that emerging tools reflect outcomes meaningful to patients while upholding patient safety, scientific rigor, and transparency.
The meeting reinforced the importance of collaboration among patients, researchers, regulators, and industry to modernize evidence generation in oncology. If you missed the public meeting, read the recap or watch the meeting. If you missed our Advocates Webinar, watch the video below.
Advancing Patient Advocacy for Spanish-Speaking Communities Through Accessible Education
On March 9th, we hosted a webinar to launch ProgresoparaPacientes.org, a patient-advocacy education program for Spanish-speaking U.S. Latino and/or Hispanic communities, designed to address persistent structural barriers to participation in clinical research and regulatory engagement. Spanish-speaking advocates remain underrepresented in clinical trials and policy discussions, in part due to language inaccessibility and limited resources to regulatory science education. To help close this gap, we translated the ProgressforPatients.org course into Spanish, providing an overview of drug development and U.S. regulatory systems, including the FDA’s role, clinical trial phases, drug approval pathways, and advocacy case studies. The webinar also highlighted how advocacy organizations and communities can leverage this free resource to strengthen their advocate training pipelines and support advocates to build foundational regulatory science knowledge, facilitating more informed engagement in drug development discussions and a stronger understanding of clinical research. If you missed our webinar, watch the video below.
Advocate Spotlight
Misha Mehta, Friends Advisory Advocate, recently participated in One Voice Against Cancer (OVAC) Advocacy Day where she met with members of Congress to advocate for sustained funding for the National Institutes of Health (NIH), National Cancer Institute (NCI), and Centers for Disease Control and Prevention (CDC). Below she shared why investment in clinical research is important to her and how her advocacy makes an impact.
“Through my work and lived experience, I have seen firsthand how decreased federal research funding, particularly tightening paylines, instability in multi-year grants, and especially the defunding of critical cooperative groups like the Pediatric Brain Tumor Consortium (PBTC), directly undermines cancer research, with disproportionate consequences for childhood cancer. When funding becomes uncertain, discovery slows, promising lines of investigation are interrupted, and investigators struggle to sustain the long-term, collaborative science required to translate breakthroughs into real options for children. When infrastructure like PBTC is defunded, the impact is even more devastating: early-phase trials stall, national collaboration fragments, and children with aggressive and rare brain tumors lose access to experimental therapies that may represent their only hope. For these families, sustained federal investment is not abstract, it is, quite literally, the difference between life and death. I am honored to bring both this perspective and my personal experience as a bereaved mother to meetings with Members of Congress, and to advocate alongside Friends for sustained and increased investment in the NIH, NCI, and CDC.” — Misha Mehta
Mark Your Calendars
Please register for our upcoming events at the links below.
⬇️ = Reduced Advocate Registration | 🟩 = Free | 🔷 = Friends Event
| 🟩🔷 April 7, 2026 | Application of External Control Arms in Oncology Drug Development |
| ⬇️ April 17 – 22, 2026 | AACR Annual Meeting 2026 |
| 🟩🔷 April 23, 2026 | Advocates Webinar: External Control Arms in Oncology Drug Development |
| 🟩🔷 May 6, 2026 | Unlocking Next-Generation Therapies |
| ⬇️ May 29 – June 2, 2026 | 2026 ASCO Annual Meeting |
| 🟩🔷 June 11, 2026 | Advocates Webinar: Unlocking Next-Generation Therapies |
| ⬇️ June 14 – 18, 2026 | Drug Information Association (DIA) 2026 Global Annual Meeting |
| ⬇️ June 22 – 25, 2026 | BIO International Convention |
| 🟩🔷 November 10, 2026 | Friends of Cancer Research Annual Meeting 2026 |
| 🟩🔷 November 17, 2026 | Advocates Webinar: Annual Meeting 2026 |
Data-Driven Insights
New biomarkers have the potential to modernize clinical research by enabling new, patient-centered approaches across clinical trial design and evaluation. The FDA’s Biomarker Qualification Program (BQP) provides a pathway for evaluating and validating these tools. Once qualified, biomarkers may be used to support drug development and regulatory decision-making. In our recent manuscript, we assessed the performance of the BQP and found that it has not delivered as much real-world benefit as intended. We offered practical suggestions for how the FDA can improve the program to make it easier to approve biomarkers that could help make clinical trials faster and more effective.
To learn more, read our Data-Driven Insight Blog “The Biomarker Qualification Program: Takeaways and Recommendations” authored by Friends Science Policy Fellow Elena Levi-D’Ancona.
Important News in Cancer Research
User Fee programs provide critical funding to advance regulatory modernization at the FDA. Negotiations for the eighth reauthorization of the Prescription Drug User Fee Act (PDUFA) are underway, with PDUFA VIII set to be reauthorized in 2027. These discussions explore potential enhancements for PDUFA, including proposals that could help advance novel endpoints, use of real-world data in regulatory decision making, and other priority areas. In the video below, Ryan Hohman, Friends’ Vice President of Public Affairs, breaks down what PDUFA is and what it means for the FDA and patients.
Resources
ProgressforPatients.org and ProgresoparaPacientes.org
Interested in learning more about drug development and how the FDA functions?
ProgressforPatients.org and ProgresoparaPacientes.org are online advocacy education programs and communities working to help patients, advocates, and caregivers acquire the necessary tools to effectively communicate with drug researchers, drug developers, and regulators.