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.

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.

For 30 years, Friends of Cancer Research has convened leaders from federal health and regulatory agencies, academia, ind...
08/17/2026

For 30 years, Friends of Cancer Research has convened leaders from federal health and regulatory agencies, academia, industry, and patient advocacy groups to identify problems standing in the way of the best science reaching patients, generate the evidence necessary to understand them, and create policy solutions to address them.

Our work includes research partnerships advancing diagnostics harmonization, early endpoints, and real-world evidence; policy initiatives, such as addressing barriers to cell and gene therapy development and improving clinical trial eligibility criteria; and interactive dashboards exploring trends in oncology drug approvals. We also bring advocates directly into our research and policy work through our Advisory Advocates program and free advocacy education courses.

Whether you want to read our latest research, register for an upcoming free public meeting, or get updates in cancer research and policy, there is always a way to stay connected.

➡️Sign up for our email list: https://focr.app.neoncrm.com/forms/subscription-preferences-form
➡️Follow us on Twitter/X: https://x.com/CancerResrch
➡️Follow us on LinkedIn: https://www.linkedin.com/company/friends-of-cancer-research/

A new analysis from Friends of Cancer Research, published in Health Affairs [tag] Scholar, examines how first-in-class c...
08/14/2026

A new analysis from Friends of Cancer Research, published in Health Affairs [tag] Scholar, examines how first-in-class cancer therapies were approved by the U.S. and China from 2020 to 2025.

During this time, China’s National Medical Products Administration (NMPA) approved more novel oncology drugs than the FDA, with its approval volume exceeding the FDA's in each year from 2023 to 2025. But approval volume tells only part of the story. Among 167 novel oncology drugs approved by both agencies during the study period, 36 were global first-in-class, or drugs representing a novel mechanism-target pair not previously approved by either agency. The FDA approved 30 of these first; the NMPA approved 6.

First-in-class oncology approvals remained concentrated at the FDA during the study period, reinforcing the U.S.' role in the early availability of first-in-class therapies. However, this advantage may be narrowing at earlier stages of development as China's pipeline of first-in-class candidates has grown rapidly in recent years.

Sustaining this advantage will require continued investment in regulatory capacity and pathway clarity in the U.S., as well as attention to the structural factors, including faster clinical trial initiation and enrollment, that have contributed to China's growing output of novel therapeutics.

Read the full publication: https://bit.ly/4hn33R2.

Friends of Cancer Research works to modernize regulatory frameworks and advance policies that enable efficient developme...
08/12/2026

Friends of Cancer Research works to modernize regulatory frameworks and advance policies that enable efficient development of safe and effective therapies. Our priorities focus on strengthening the scientific and regulatory infrastructure needed to support innovation, improve clinical trial efficiency, and accelerate patient access to new treatments.

Our work spans legislative priorities, including advancing qualification of drug development tools, enabling responsible use of artificial intelligence (AI), and supporting efficient development of cell and gene therapies, alongside regulatory priorities such as advancing drug development, inclusive clinical research, diagnostic harmonization and development, and innovative trial designs.

We also actively monitor the regulatory landscape, submitting public comments on issues including AI benchmarks in care, patient-centered dose optimization, and regulatory improvements for liquid biopsies.

Explore our full policy priorities: https://friendsofcancerresearch.org/policy-portfolio/.

08/10/2026

What does it take to move a biomarker from an exploratory measure to an approval endpoint?

At our recent meeting, Modernizing Oncology Endpoints, that question was addressed:
▪️The ctMoniTR Project showed that reductions in ctDNA relative to baseline are consistently associated with improved overall survival. There are open questions about collection timing, molecular response thresholds, assay performance, and what the FDA would need to see to accept ctDNA as an early endpoint for regulatory decision-making.
▪️For AI-enabled tumor assessment tools, transparent training data, defined reference standards, and harmonized public reference datasets may help make validation scalable rather than repeated program by program.
▪️An update to traditional validation may be necessary, including a modular qualification approach that separates analytic method validation from disease-specific clinical validation.

Dr. Richard Pazdur, former Director of FDA's Oncology Center of Excellence, made the point that evidence to support the use of a novel endpoint depends on its context of use, and that these measures need to be embedded in prospective trials to understand their relationship to survival. Sponsors often already collect the data, but they often do not prespecify the use of the data. As he noted, an earlier signal of progression can inform whether a patient continues therapy or stops, a decision that matters more as maintenance regimens lengthen.

None of this happens without evidence and generating that evidence is expensive and slow. But the difference between a decade of one-off pilots and a decade of accumulated regulatory learning is whether the frameworks are built to reuse what has already been established.

▪️Read the meeting recap: https://friendsofcancerresearch.org/blog/meeting-recap-endpoints-meeting-2026/.
▪️Watch the full meeting on our YouTube: https://www.youtube.com/live/3Wy4H4jlNcY?si=E8Uo078cHFdTcpmc

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1800 M Street NW
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20036

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

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