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.

04/02/2026

Lung-MAP stands apart by matching patients to targeted therapies based on their specific biomarkers—delivering personalized treatment pathways that few trials offer. Each arm of the study provides immediate, protocol-driven access to agents targeting the molecular drivers of a patient's cancer, offering clinical responses that can be game-changing.

Prioritizing patient enrollment in Lung-MAP is critical. It's our most robust engine for generating the data needed to secure regulatory approval for these targeted therapies while offering patients with rare biomarkers—like MET exon 14 skipping or MET amplification—the best possible therapeutic options available today.

Watch Marcia Horn, President and CEO of ICAN, International Cancer Advocacy Network and chair of the MET Crusaders, discusses the importance of Lung-MAP and its three new trial arms. Visit lung-map.org to learn more.

Kelly Cuvar was diagnosed with a rare form of sarcoma in 1999. With only about 900 people affected per year, there was l...
04/01/2026

Kelly Cuvar was diagnosed with a rare form of sarcoma in 1999. With only about 900 people affected per year, there was little incentive for large-scale drug developers to invest in treatments for such a small patient population. Without the dedicated work of organizations like Friends of Cancer Research, she would not be here today.

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

Your contribution to Friends of Cancer Research will directly support our mission of accelerating cutting-edge cancer care for patients. Please consider donating today to help move this vital research forward: https://bit.ly/4uzTYZz.

Join us in one week for our "Application of External Control Arms in Oncology Drug Development" meeting!On Tuesday, Apri...
03/31/2026

Join us in one week for our "Application of External Control Arms in Oncology Drug Development" meeting!

On Tuesday, April 7, 2026, we are bringing experts from federal regulatory agencies, academia, industry, and patient advocacy to advance best practices for the use of external control arms (ECAs) in generating rigorous, reliable evidence and to explore how these approaches can strengthen regulatory decision-making and expand patient access to promising treatments.

During the meeting, we will present new findings from our multi-stakeholder pilot project examining whether independently constructed ECAs can approximate a target trial control arm across heterogeneous external datasets, including real-world data and historical clinical trial data.
Ahead of the meeting, explore the ECA Project Pilot Overview and Preliminary Findings to learn more about the project.

Attend in person in Washington, DC or virtually. Register today: https://bit.ly/3LUNS4r.

Thank you to the ECA Pilot data partners: AbbVie, American Society of Clinical Oncology, ConcertAI, Flatiron Health, Guardian Research Network, iOMEDICO, IQVIA, Medidata, Ontada Pancreatic Cancer Action Network, Tempus AI, and Verana Health.

As cancer therapies improve and patients live longer, clinical trial design is evolving, particularly around endpoint se...
03/30/2026

As cancer therapies improve and patients live longer, clinical trial design is evolving, particularly around endpoint selection. While overall survival (OS) remains the gold standard for measuring treatment efficacy, the time required to observe OS outcomes can delay regulatory approval and patient access to promising therapies.

To address this, surrogate and early endpoints, including those used as the basis of the Accelerated Approval pathway, are increasingly being explored. Our 2025 Scientific Report's "Establishing Early Endpoints for Drug Development" section focuses on both generating evidence for these endpoints and advancing pathways for their regulatory use.

Through our research, including two studies in advanced non-small cell lung cancer (aNSCLC), we evaluated circulating tumor DNA (ctDNA) as a potential early endpoint. These studies showed that reductions in ctDNA are associated with improved OS, supporting its potential to provide earlier insights into treatment benefit. While further work is needed to define its role across disease settings and ensure consistent, reliable use in clinical trials, these studies provide foundational evidence for incorporating ctDNA measurement in future studies.

In a complementary initiative, we assessed the FDA's Biomarker Qualification Program (BQP). From the program’s inception in 2016 through July 1, 2025, the BQP had accepted 61 projects, but only 8 biomarkers had been fully qualified, none as surrogate endpoints. Our analysis called for a dedicated framework to support the development of novel response biomarkers.

Read our 2025 Scientific Report to learn about our work in advancing the development and regulatory acceptance of early endpoints to support more efficient oncology drug development, accelerate evidence generation, and speed patient access to safe and effective therapies: https://friendsofcancerresearch.org/wp-content/uploads/Friends-Scientific-Report-2025.pdf.

Mark Stewart, Vice President, Science Policy, will be attending BioCanRx's Summit for Cancer Immunotherapy, joining the ...
03/27/2026

Mark Stewart, Vice President, Science Policy, will be attending BioCanRx's Summit for Cancer Immunotherapy, joining the panel "How Can Canada Improve Access to Immunotherapies: Learnings from International Initiatives." He and international experts, Martín Bonamino, Brazilian National Cancer Institute and Fiocruz, and S**o de Visser, Future Affordable and Sustainable Therapies (FAST), will explore how different countries are working to expand patient access to immunotherapies.

The session will cover international initiatives and emerging policy, regulatory, and development approaches aimed at translating scientific advances into treatments for patients.

Mark will share insights on Friends of Cancer Research's cell and gene therapy initiatives, which work to build alignment across the development ecosystem; identify scientific, operational, and regulatory challenges and opportunities; and help advance the next generation of cell and gene therapies to ensure these innovative treatments reach patients with serious and rare diseases.

Learn more about our cell and gene therapy work: https://friendsofcancerresearch.org/cell-gene-therapies/.

Join us on April 23, 2026, for an advocate-focused webinar on external control arms (ECAs) in oncology drug development....
03/26/2026

Join us on April 23, 2026, for an advocate-focused webinar on external control arms (ECAs) in oncology drug development. ECAs are an increasingly important approach for generating evidence, using data from prior clinical trials or real-world sources, when randomized trials are not feasible, such as in rare cancers or rapidly progressing diseases where standard-of-care options offer limited benefits.

Building on our April 7 public meeting, this free webinar will highlight key takeaways and explore what reliable ECAs mean for patients, from strengthening evidence generation to informing regulatory decision-making, and helping bring promising therapies to patients sooner.

We encourage advocates to attend both events and submit questions to be answered at the advocates webinar: https://friendsofcancerresearch.org/event/advocates-webinar-external-control-arms-in-oncology-drug-development/.

Jeff Allen, President and CEO, will join the keynote panel of the Alliance for Cancer Gene Therapy Summit, “Twenty-Five ...
03/25/2026

Jeff Allen, President and CEO, will join the keynote panel of the Alliance for Cancer Gene Therapy Summit, “Twenty-Five Years of Progress in Cancer Cell & Gene Therapy: Leadership, Strategy and the Path to Solid Tumor Success.” He, Sheila Singh, Carl June, Mark Cobbold, and Jennifer Brogdon will discuss advances made over 25 years and what it will take to deliver durable, scalable cell therapies for the future.

Jeff will share learnings from Friends of Cancer Research's cell and gene therapy initiative to address whether evidentiary expectations are diverging globally, what the FDA's draft Plausible Mechanism Framework means for developers, and whether regulatory fragmentation poses real risks to patients and scientific progress.

Learn more about our cell and gene therapy work: https://bit.ly/4syPot4.

How can sponsors make better decisions in early oncology development when the data is still incomplete?Join Mark Stewart...
03/24/2026

How can sponsors make better decisions in early oncology development when the data is still incomplete?

Join Mark Stewart, Vice President, Science Policy, on Thursday, March 26 at 12:00PM ET, for "Making the Right Decisions with Incomplete Evidence in Early-Phase Oncology Trials," a webinar hosted by MMS and Citeline. The panel will explore how sponsors can move beyond surface-level outputs and build stronger clinical narratives through disciplined statistical thinking and cross-functional alignment.

Topics include how trial design and statistical planning support early development decisions, the role of early endpoints and emerging signals in guiding programs, and how teams align clinical, statistical, and operational perspectives when evidence is still evolving.

Mark will be joined by moderator Ben Dudley, Chief Commercial Officer, MMS, and panelists Andrew Krivoshik, Chief Medical Officer, PAQ Therapeutics, and Aiden Flynn, Senior Vice President, Strategic Statistical Services, MMS.

Register for the meeting: https://discover.pharmaignite.com/data-interpretation-in-early-oncology?utm_source=lp&utm_medium=client&utm_campaign=promo.

Friends of Cancer Research and the Parker Institute for Cancer Immunotherapy are hosting a public meeting on Wednesday, ...
03/23/2026

Friends of Cancer Research and the Parker Institute for Cancer Immunotherapy are hosting a public meeting on Wednesday, May 6, 2026, to explore opportunities to advance next-generation therapies, including innovative approaches in cell therapy development.

Academic, regulatory, industry, and patient experts will explore practical considerations for investigational new drug (IND) readiness and early-phase trial design, phase-appropriate data generation and comparability strategies, and longer-term structural opportunities to reinforce the cell therapy ecosystem.

Join us in person or virtually: https://friendsofcancerresearch.org/event/unlocking-next-generation-therapies-2/.

Generating reliable evidence about new cancer therapies can be particularly challenging in certain clinical settings, su...
03/20/2026

Generating reliable evidence about new cancer therapies can be particularly challenging in certain clinical settings, such as when patient populations are small, effective treatment options remain limited, or traditional trial designs are difficult to implement efficiently.

External control arms (ECAs), constructed from existing data sources, such as prior clinical trials or real-world data, are being explored as a complementary approach for evaluating new therapies. However, the central challenge of ECAs lies in establishing credibility, ensuring the quality of the underlying data, alignment between the external data source and the target trial population, and the rigor of the analytic methods employed.

The Friends of Cancer Research ECA Pilot Project is examining these questions by evaluating how independently constructed ECAs perform relative to a target clinical trial, while identifying key methodological and operational considerations for their use in oncology drug development. When high-quality data are paired with rigorous methodology, ECAs may provide credible evidence to inform regulatory decision-making.

Speakers at our upcoming April 7, 2026, public meeting, "Application of External Control Arms in Oncology Drug Development," will share perspectives on lessons from the Pilot and discuss how ECAs can be responsibly integrated into oncology drug development.

Register today to join the conversation: https://bit.ly/3LUNS4r. Swipe to read insights from Amy Abernethy, Ruthie Davi, Brad Karalius, and Elizabeth Garrett-Mayer.

03/19/2026

Thirty years young and still no time for cake.

Ellen Sigal founded Friends of Cancer Research in 1996 because patients deserved better.

Three decades later, the mission hasn't changed. And neither has the urgency.

Happy 30th to us. Now back to work!

Want to join us? Donate Today: https://bit.ly/4uzTYZz!

03/18/2026

Combination therapies are becoming increasingly common in oncology drug development, offering the potential for improved outcomes and earlier access to promising treatments. However, introducing multiple drugs into a regimen can also increase the risk of toxicity, making it critical to demonstrate the contribution of effect (COE) of each component.

At our 2025 Annual Meeting, Elad Sharon, Clinical & Translational Director of the Immunotherapy Toxicity Program at Dana-Farber Cancer Institute, discussed a key challenge in combination trial design: generating the clinical evidence needed to demonstrate therapy inefficacy while ensuring patients are not unnecessarily exposed to agents that add toxicity without meaningful benefit. Establishing this evidence is essential when developing combination therapies, where patients may be exposed to additional agents—and potential toxicity—without clear added value.

While factorial designs remain the gold standard, alternative approaches—including adaptive designs, 3-arm and 2-arm trials, and trials that include descriptive comparisons—may provide sufficient COE evidence when a full factorial design is not feasible. The key is ensuring these approaches are scientifically sound, agreed upon with regulators before trials begin, and supported by the totality of evidence.

Building on draft guidance from the U.S. Food and Drug Administration on establishing clinical evidence for COE in novel oncology combinations, Friends of Cancer Research released a white paper exploring design considerations for registrational trials evaluating COE in oncology combination therapies: https://bit.ly/3LcLaqf.

Address

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

Opening Hours

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

Telephone

(202) 944-6700

Alerts

Be the first to know and let us send you an email when Friends of Cancer Research posts news and promotions. Your email address will not be used for any other purpose, and you can unsubscribe at any time.

Share

Share on Facebook Share on Twitter Share on LinkedIn
Share on Pinterest Share on Reddit Share via Email
Share on WhatsApp Share on Instagram Share on Telegram