Friends of Cancer Research

Friends of Cancer Research Friends of Cancer Research powers advances in science and policy that speed life-saving treatments to patients.

Mission
Friends of Cancer Research powers advances in science and policy that speed life-saving treatments to patients. About Us
Friends of Cancer Research aims to accelerate cutting edge cancer care that both extends and improves quality of life for patients. To accomplish this, we leverage groundbreaking collaborations, generate scientific evidence, and integrate patient input to shape public policy. How we work at Friends of Cancer Research:
We identify problems standing in the way of the best science reaching patients. We generate the evidence necessary to understand a problem. We create policy solutions to address and overcome that problem.

Our recent meeting, Modernizing Oncology Endpoints: Pathways for Evidence and Policy, brought together experts from indu...
02/20/2026

Our recent meeting, Modernizing Oncology Endpoints: Pathways for Evidence and Policy, brought together experts from industry, academia, regulatory agencies, and patient advocacy organizations to discuss the current landscape and application of early endpoints, including their potential to improve trial efficiency, their role in drug development, and regulatory and policy considerations.

Read the full recap on our blog (https://bit.ly/3MdMHgM) and watch the full meeting on YouTube (https://bit.ly/4andgYP).

02/17/2026

At the Friends of Cancer Research Modernizing Oncology Endpoints meeting, panelists discussed the use of artificial intelligence (AI)-enabled tools in imaging and radiology, addressing questions around standardization and harmonization around novel technologies, patient and clinician acceptance, and pathways to regulatory approval. Friends of Cancer Research Advisory Advocate Lia Ridout emphasized that patients would prefer maintaining human involvement in AI-assisted imaging to ensure patient trust and confidence.

Building on these conversations, we invite patient advocates and caregivers to join our free Advocates Webinar on Thursday, February 19 at 12pm ET. This session will reinforce key takeaways from the meeting, address remaining questions, and translate our ctMoniTR and ai.RECIST projects into advocate-focused insights.

Register today: https://friendsofcancerresearch.org/event/advocates-webinar-modernizing-oncology-endpoints/.

02/17/2026

The FDA recently responded to our analysis of the Biomarker Qualification Program published in DIA's Therapeutic Innovation & Regulatory Science, which evaluated use of the program over the past eight years and identified areas for targeted enhancements.

We appreciate the FDA’s thoughtful response and acknowledgement of the need for collaboration to advance biomarker qualification and drug development innovation and look forward to collaborating on these issues.

Read the FDA's response (https://link.springer.com/article/10.1007/s43441-025-00911-x) and our analysis (https://link.springer.com/article/10.1007/s43441-025-00889-6) in Therapeutic Innovation & Regulatory Science.

External control arms (ECAs) leverage existing data sources, such as prior clinical trials and real-world data, to serve...
02/16/2026

External control arms (ECAs) leverage existing data sources, such as prior clinical trials and real-world data, to serve as comparators for evaluating new therapies, particularly when traditional randomized trials are impractical. As oncology drug development evolves, ECAs are increasingly considered to support regulatory decision-making. Yet important questions remain around methodological rigor, data quality, and fitness-for-purpose.

Join us for our upcoming meeting, “Application of External Control Arms in Oncology Drug Development,” to hear insights from our ECA research partnership, and to explore best practices for generating reliable, decision-grade evidence.

This meeting will highlight:
▪️New findings from independently constructed ECAs applying a shared, prespecified analytic framework.
▪️Methodological lessons in constructing ECAs across data partners, including data capture, eligibility operationalization, and analytic alignment.
▪️Regulatory and policy considerations for assessing fitness-for-purpose and evidence validity.
▪️Implications for future oncology trial design and for expanding patient access to innovative treatments.

View the agenda and register now to secure your spot: https://bit.ly/3LUNS4r.

AI-enabled tools in radiology may improve how we assess tumor changes in clinical trials by automating lesion detection ...
02/13/2026

AI-enabled tools in radiology may improve how we assess tumor changes in clinical trials by automating lesion detection and capturing characteristics beyond tumor size—like texture, volume, and growth patterns. These advances could lead to more precise endpoints that better predict patient outcomes, potentially shortening trials and accelerating access to effective therapies.

Our latest blog breaks down our white paper, "Leveraging AI-Enabled Tumor Assessment Tools on Radiological Images to Evaluate Treatment Effect and Support Clinical Trial Endpoints in Solid Tumors," featured at last week's Modernizing Oncology Endpoints meeting. This blog is perfect for patient advocates preparing for our upcoming Advocates Webinar on early endpoints.

Read the full blog: https://bit.ly/4aDfTqC.

Patient Advocates! Join us for our Advocates Webinar: Modernizing Oncology Endpoints on Thursday, February 19, 2026, at ...
02/10/2026

Patient Advocates! Join us for our Advocates Webinar: Modernizing Oncology Endpoints on Thursday, February 19, 2026, at 12pm ET. This free virtual session will build on conversations from our public meeting, Modernizing Oncology Endpoints: Pathways for Evidence and Policy, exploring two emerging tools in cancer drug development—circulating tumor DNA (ctDNA) and artificial intelligence (AI)-enabled tumor assessment—in an accessible format. Advocates are encouraged to submit questions to get answers to their most pressing questions.

To get the most out of the webinar, we recommend first reading the white paper on AI-enabled tumor assessments tools: https://bit.ly/4qQSlEE.

Register today:https://bit.ly/4qbiUUp!

Today, Jeff Allen, President and CEO of Friends of Cancer Research, will join leaders across drug development at the Fou...
02/09/2026

Today, Jeff Allen, President and CEO of Friends of Cancer Research, will join leaders across drug development at the Foundation for the National Institutes of Health (FNIH)'s Biomarker Consortium Symposium to celebrate 20 years of biomarker advancement. Jeff will present on collaborative opportunities to advance AI-enabled drug development tools, highlighting our Digital PATH and ai.RECIST projects.

These initiatives aim to promote consistency among AI tools in diagnostics and address the need for regulatory policy to advance a new generation of technologies, ultimately improving clinical trials, speeding drug development, and ensuring patient safety.

Learn more about the Digital PATH Project (https://friendsofcancerresearch.org/digital-pathology/) and ai.RECIST Project (https://friendsofcancerresearch.org/ai-recist/).

Thank you to everyone who attended our “Modernizing Oncology Endpoints: Pathways for Evidence and Policy” meeting. Our s...
02/06/2026

Thank you to everyone who attended our “Modernizing Oncology Endpoints: Pathways for Evidence and Policy” meeting. Our speakers provided insights on ctDNA and AI-enabled tumor assessments as early endpoints, exploring their potential function in oncology clinical trials and drug development, as well as regulatory and policy implications of integrating novel measurement tools and endpoints into clinical development programs. We hope you enjoyed the discussions and we look forward to seeing you at our next meeting.

◾ You can access the meeting on-demand on our YouTube channel: https://bit.ly/4andgYP.
◾ Read the white paper on AI-enabled tumor assessment tools on our website: https://bit.ly/4qQSlEE.
◾ Visit our events page to register for future public meetings: https://bit.ly/3LDUe80.

02/03/2026

Last chance to register! Join us Thursday in Washington, DC or virtually for our "Modernizing Oncology Endpoints: Pathways for Evidence and Policy" meeting. This free event will examine the current landscape and application of evolving early endpoints and how they may improve trial efficiency and inform regulatory decision-making. Panels include:

"ctDNA: Lessons Learned and Future Directions" will provide an overview of new results from the ctMoniTR Project, examine how ctDNA may function as an early endpoint in oncology trials, and discuss evidence needs for its integration into drug development.
◾ Nevine Zariffa, NMD Group, LLC
◾ Jonathan Baden, Bristol Myers Squibb
◾ Deng Shibing, Pfizer
◾ Minetta Liu, Natera
◾ Paz Vellanki, FDA

"AI-Enabled Tumor Assessments: Opportunities and Challenges for Incorporation into Clinical Trials" will discuss insights from our ai.RECIST Project and evaluate opportunities to incorporate AI-enabled tumor assessment tools into clinical trials, including how automated imaging tools could support more efficient trial operations and the development of novel endpoints.
◾ Ariel Bourla, Johnson & Johnson
◾ Felix Baldauf-Lenschen, Altis Labs
◾ Lauren K Brady, Genmab
◾ Nathaniel Braman, Picture Health
◾ Lia Ridout, Friends of Cancer Research Advisory Advocate
◾ Larry Schwartz, Memorial Sloan Kettering Cancer Center
◾ Alain Silk, Tempus AI

"Modernizing Regulatory Frameworks: Future Policies & Priorities" will explore regulatory and policy implications of integrating novel measurement tools and endpoints into clinical development programs and examine opportunities to advance frameworks that support their use.
◾ Jeff Allen, Friends of Cancer Research
◾ Tala Fakhouri, Parexel
◾ Michael C. Montalto, PhD, Amgen
◾ John Stone, BGR Group
◾ Lowell M. Zeta, FDA

Visit our website to register, explore panel topics, and read the meeting white paper: https://friendsofcancerresearch.org/event/modernizing-oncology-endpoints-pathways-for-evidence-and-policy/.

01/29/2026

Every five years, the FDA enters a new user fee cycle — a process that plays a central role in how efficiently and rigorously medical products are reviewed.

User fee programs like PDUFA supplement congressional funding to support FDA’s expert reviewers, modern tools, and predictable review timelines — without compromising scientific standards.

In this short explainer video, Ryan Hohman of Friends of Cancer Research breaks down how FDA user fees work, why they matter, and what’s at stake for patients and innovation.

Join us in 9 days for our public "Modernizing Oncology Endpoints: Pathways for Evidence and Policy" meeting!On Thursday,...
01/27/2026

Join us in 9 days for our public "Modernizing Oncology Endpoints: Pathways for Evidence and Policy" meeting!

On Thursday, February 5, 2026, we will convene stakeholders across federal health and regulatory agencies, academic research, industry, and patient advocates to discuss the current landscape and application of evolving early endpoints—including ctDNA and artificial intelligence (AI)-enabled tumor assessments—and explore how they may improve trial efficiency and inform regulatory decision-making.

Prepare for the discussion by reading our white paper, "Leveraging AI-Enabled Tumor Assessment Tools on Radiological Images to Evaluate Treatment Effect and Support Clinical Trial Endpoints in Solid Tumors:" https://bit.ly/4qQSlEE. This paper examines:

• Limitations of current imaging endpoints like RECIST
• Emerging AI-driven approaches for more precise tumor assessment
• A proposed framework for validating and integrating novel AI-imaging endpoints into clinical trials and regulatory pathways

Register today for in-person attendance in Washington, DC or virtual participation: https://friendsofcancerresearch.org/event/modernizing-oncology-endpoints-pathways-for-evidence-and-policy/.

As science advances, policy and regulatory frameworks must evolve alongside it. At our public meeting, Modernizing Oncol...
01/26/2026

As science advances, policy and regulatory frameworks must evolve alongside it. At our public meeting, Modernizing Oncology Endpoints: Pathways for Evidence and Policy, leaders across government, research, advocacy and industry will examine how novel measurement tools and endpoints are reshaping clinical development and the implications of those advances on the future of public policy.

During session 3, Modernizing Regulatory Frameworks, a panel of policy experts will explore how regulatory frameworks can adapt to support innovation in the development, validation and use of modern oncology endpoints, while maintaining rigor, consistency, and public trust. The discussion will highlight opportunities to advance policies that enable efficient evidence generation that can keep pace with emerging science.

For policymakers, this conversation is timely, practical, and an essential session to attend to ensure regulatory systems remain appropriate for regulatory use in an evolving research landscape.

Join the discussion by registering for the February 5th meeting: https://friendsofcancerresearch.org/event/modernizing-oncology-endpoints-pathways-for-evidence-and-policy/.

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1800 M Street NW
Washington D.C., DC
20036

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Tuesday 9am - 5pm
Wednesday 9am - 5pm
Thursday 9am - 5pm
Friday 9am - 5pm
Saturday 9am - 5pm
Sunday 9am - 5pm

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(202) 944-6700

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