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 po

licy. 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.

09/04/2026

For 30 years, Friends of Cancer Research has brought together patients, scientists, policymakers, industry, and government to advance cancer care and change how we think about the role of regulatory policy.

Sudip Parikh, CEO of AAAS - The American Association for the Advancement of Science, began his relationship with Friends of Cancer Research over 20 years ago, during his time on the Hill. From that rare vantage point on Congress and the scientific community, he highlights how we have helped patients and scientists alike recognize the profound impact regulatory policy has on their lives.

That patient-centered focus has remained at the heart of our mission. By building trusted relationships across FDA, industry, biotech, academia, government, and the patient community, Friends of Cancer Research brings people together to identify challenges and develop solutions.

Learn more about our 30th Anniversary celebration and the impact we have made together: https://bit.ly/3UxqSfR.

Watch the video on our YouTube: https://bit.ly/4wZEDS5.

Jeff Allen, President & CEO, is keynoting the 2026 Technology Showcase, hosted by the National Cancer Institute and Fred...
09/03/2026

Jeff Allen, President & CEO, is keynoting the 2026 Technology Showcase, hosted by the National Cancer Institute and Frederick National Laboratory for Cancer Research on September 9, 2026.

He will address factors that have allowed innovative cancer research and treatments to progress in oncology, from advances in understanding disease biology to sustained investment and a robust clinical research infrastructure. However, with substantial challenges, such as rising incidences and cancers with no curative drug therapy, Jeff will also discuss the power of collaboration and leveraging science to shape policy as essential components to accelerate progress in cancer treatment.

The annual Technology Showcase highlights why collaboration across government, academia and industry matters. The event itself is a successful collaboration, co-sponsored by Frederick National Laboratory for Cancer Research, National Cancer Institute (NCI), Frederick County Office of Economic Development, The City of Frederick: Department of Economic Development, TEDCO, Federal Laboratory Consortium.

Register today: https://frederick.cancer.gov/events/2026-technology-showcase.

Just released! Our white paper, “Optimizing Dosing for Radiopharmaceutical Therapies,” outlines a fit-for-purpose approa...
09/01/2026

Just released! Our white paper, “Optimizing Dosing for Radiopharmaceutical Therapies,” outlines a fit-for-purpose approach to administered activity escalation and dosage optimization for radiopharmaceutical therapies (RPTs): https://bit.ly/45kai5b.

As RPT development accelerates, there is a growing need for dose-escalation and optimization approaches that better reflect the distinct characteristics of these therapies. The white paper outlines three core principles that guide this approach:

▪️ Generate RPT-specific evidence through escalation. Experience from external beam radiation therapy can inform starting assumptions, but escalation should characterize RPT-specific relationships between administered activity, absorbed dose, clinical activity, and toxicity.
▪️ Anchor decisions in the totality of evidence. Dosage optimization should integrate emerging clinical, dosimetry, imaging, and biological evidence, rather than relying on fixed reference points.
▪️ Keep evidence generation practical and patient centered. Development strategies should generate evidence to support dosage selection while minimizing unnecessary burden on patients, particularly in early-phase studies.

During the September 15th webinar, expert panelists will build on these recommendations, discussing how the field can approach administered activity escalation, what evidence is needed to support dosage selection, and what sponsors can do now to advance RPT dosage optimization.

Register today: https://bit.ly/3RbsQRR.

08/31/2026

Friends of Cancer Research submitted comments to the FDA on its draft guidance on leveraging prior knowledge in the development of human gene therapy products incorporating genome editing.

The guidance outlines how public and platform knowledge may be scientifically leveraged across CMC, nonclinical, and clinical development to reduce unnecessary new data generation and support more efficient product development. Our comments support this direction and offer targeted considerations to strengthen practical and consistent implementation, including establishing a structured framework for leveraging prior knowledge, tailoring additional evidence generation to remaining uncertainty, and clarifying how prior knowledge can inform clinical development and regulatory decision-making across programs and submissions.

Identifying strategies to leverage prior knowledge has been part of our work for several years. At our 2023 multi-stakeholder meeting on next-generation cellular therapies, moderator Jonathan Jazayeri helped frame a central challenge: while not all next-generation assets carry the same risk, iterative product changes can effectively send sponsors back to square one in the clinic. That discussion helped shape a risk-based framework, later published in Cytotherapy, to determine when existing evidence may be sufficient and when additional data are needed based on remaining uncertainty. We are pleased to see these principles reflected in the FDA's approach to leveraging prior knowledge in this draft guidance.

We appreciate the FDA's consideration of our comments and look forward to continued engagement to advance practical approaches that support efficient and responsible development of next-generation cell and gene therapies.

▪️Read our full comments: https://bit.ly/4ikxoAf
▪️Read our 2024 publication in Cytotherapy: https://bit.ly/3SniJK0

Mark Stewart, Vice President, Science Policy, will be on the panel "Bringing CAR-T and TCE Care Closer to Home," hosted ...
08/28/2026

Mark Stewart, Vice President, Science Policy, will be on the panel "Bringing CAR-T and TCE Care Closer to Home," hosted by Digital Medicine Society (DiMe) and Ametris on September 1, 2026, at 11AM ET.

He will join Stéphane Champiat, Enrique Gomez Radilla, Kelsey Miller, Michael Pettinati, Hussein Ezzeldin, Julie Jouguelet, and Juliane Liese as they explore what it will take to move CAR-T/TCE care and CRS monitoring closer to patients rather than concentrated at major academic centers. Mark will discuss how growing clinical experience is helping to clarify key patient access barriers and identify where regulatory flexibility and emerging technologies may safely help bring CAR-T and TCE care closer to patients.

Register today: https://zoom.us/webinar/register/WN_zBBTHLn6SbC6ee61emwQOg #/registration!

Friends of Cancer Research submitted comments to the FDA in response to its Request for Information on the proposed Expe...
08/27/2026

Friends of Cancer Research submitted comments to the FDA in response to its Request for Information on the proposed Expedited Investigational New Drug (IND) Pilot Program.

The proposed pilot would explore approaches to reduce the time and complexity of initiating first-in-human studies, including improving IND submission quality, introducing rolling review of IND components, and allowing IRB review and site contracting to occur in parallel with IND development.

Our comments support the FDA's efforts and offer targeted considerations across key components of the pilot, including how Qualified Research Institution designation can provide distinct value, how t rolling review should be evaluated to ensure it produces meaningful efficiencies without introducing additional burden or rework, and how pilot success should ultimately be defined across the full pathway to first-in-human study initiation.

Friends of Cancer Research remains committed to approaches that support more efficient entry into first-in-human studies. Our 19th Annual Meeting on November 10, 2026, will explore these issues further, including a session on modernizing expectations for first-in-human studies, examining opportunities for fit-for-purpose regulatory expectations that support efficient development while maintaining patient safety.

We appreciate the FDA's consideration of our comments and look forward to continued efforts to strengthen early clinical development in the U.S.

▪️Read our full comments: https://bit.ly/4gqZbwA.
▪️Register for the Annual Meeting: https://bit.ly/464kdfT.

08/26/2026

Breakthroughs in cancer research do not happen in isolation. They require collaboration across disciplines, institutions, and sectors to turn scientific discoveries into real-world impact for patients.

For three decades, Friends of Cancer Research have served as a trusted convener—bringing together the regulators, researchers, patient advocates, and industry leaders needed to advance science-based solutions that improve cancer care.

As we look ahead to the next 30 years, we remain committed to fostering collaboration and advancing groundbreaking science.

Explore more reflections from leaders who have helped shape our journey and learn about our 30th Anniversary celebration: https://friendsofcancerresearch.org/30th/.

A new landscape assessment by Friends of Cancer Research evaluating early circulating tumor DNA (ctDNA) dynamics in adva...
08/25/2026

A new landscape assessment by Friends of Cancer Research evaluating early circulating tumor DNA (ctDNA) dynamics in advanced solid tumor studies was published in JCO Oncology Advances.

The analysis synthesized data from 162 advanced solid tumor studies evaluating on-treatment reductions in ctDNA levels within the first 15 weeks of therapy, and their associations with overall survival (OS) and/or progression-free survival (PFS). Among the 76 studies that assessed the association between ctDNA dynamics and OS, all but one reported a significant association with improved OS, independent of cancer type, treatment modality, assay platform, or molecular response (MR) definitions.

While the evidence underscores the promise of ctDNA as an early indicator of treatment benefit, the landscape assessment also highlights key gaps limiting regulatory interpretation and use, including variability in sampling schedules, MR thresholds, and assay methods, that must be addressed to advance ctDNA toward regulatory qualification as an early endpoint.

Read the full publication in JCO Journals: https://bit.ly/4xY5A9o.

Learn more about Friends of Cancer Research's ctMoniTR Project, which works to build the evidence needed to support ctDNA as an early endpoint for drug development and regulatory decision-making: https://bit.ly/49vyIM0.

While radiopharmaceutical therapies (RPTs) offer significant therapeutic potential, determining appropriate dosing remai...
08/21/2026

While radiopharmaceutical therapies (RPTs) offer significant therapeutic potential, determining appropriate dosing remains complex as existing development approaches may not fully account for their unique exposure patterns, toxicity timing, and treatment regimens.

Join Friends of Cancer Research’s public webinar on September 15, 2026, from 1:00PM – 2:00PM ET, examining approaches to optimize dosing strategies for RPTs as their use continues to expand across oncology. Expert panelists Eileen Sneeden, Vicki Jardine, Shefali Kakar, Phillip Kuo, Mira A. Patel, and Dan Pryma will explore fit-for-purpose strategies for administered activity escalation and dosimetry-informed development that integrate emerging clinical, dosimetry, imaging, and biological data to support regulatory decision-making.

Register today: https://bit.ly/3RbsQRR!

The U.S. has long been a global leader in biomedical innovation and reducing barriers that slow the development of new t...
08/20/2026

The U.S. has long been a global leader in biomedical innovation and reducing barriers that slow the development of new therapies is required for sustaining that leadership. This is particularly important in oncology, rare diseases, and advanced modalities such as cell and gene therapies, where scientific, operational, manufacturing, and commercial uncertainties can add complexity at multiple stages of development.

Friends of Cancer Research submitted comments to the Senate Finance Committee in response to a request for information from Ranking Member Wyden (D-OR) on policies to strengthen U.S. biopharmaceutical competitiveness.

Our recommendations focused on reducing avoidable barriers throughout drug development, including identifying opportunities to:
▪️ Reduce duplicative trial startup processes and site activation delays
▪️ Build regulatory readiness into federally supported research so evidence can more readily support regulatory decision-making
▪️ Create clearer pathways and stronger infrastructure for complex, high-risk first-in-human development
▪️ Address manufacturing and CMC challenges before they become barriers to clinical development
▪️ Help academic, nonprofit, and other researchers more efficiently move promising therapies from discovery to clinical testing.

Together, these recommendations aim to support innovative approaches in drug development while supporting FDA’s rigorous standards.

As Congress, regulatory agencies, academia, and industry consider how to support U.S. biomedical innovation, we look forward to serving as a resource and partner in advancing policies that ensure targeted investments translate into meaningful new therapies for patients

Read our full comments: https://bit.ly/4gHFW2X.

Address

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

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Friday 9am - 5pm
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(202) 944-6700

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