Friends of Cancer Research

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://lnkd.in/eJMQHW89. #CancerResearch #HealthPolicy

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://lnkd.in/ewnsMJ5C. ▪️ Watch the full meeting on our YouTube: https://lnkd.in/e_HPVd75

As we celebrate our 30th anniversary, we are grateful for the leaders who have helped shape progress in cancer research and care. For three decades, Friends of Cancer Research has helped transform bold ideas into legislative and regulatory solutions that accelerate innovation and improve outcomes for patients. By bringing together leaders from government, academia, industry, and the patient community, we have helped shape policies that move cancer research forward and expand access to new treatments. As we look to the future, that commitment remains as strong as ever. Explore more reflections from leaders who have helped shape our journey and learn about our 30th Anniversary celebration: https://lnkd.in/e-8f4zwB. #Friends30

The FDA’s July 30 Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) met to consider data supporting an intratumoral oncolytic immunotherapy used in combination with an approved systemic therapy for patients with advanced melanoma whose disease progressed following anti-PD-1 treatment. The committee voted 10–3 that the efficacy results from the IGNYTE trial are evaluable and clinically meaningful. The discussion addressed how response should be measured for intratumoral therapies, what evidence is needed to demonstrate contribution of effect in combination regimens, and how remaining uncertainty should be considered in the context of significant unmet need when confirmatory trials are already underway. Read our latest Stakeholder Connect authored by Grace Collins to learn more about the future implications of the meeting: https://bit.ly/4pXfNjM 

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 on September 15 from 1:00PM-2:00PM ET for a public webinar to examine approaches to optimizing dosing strategies for RPTs as their use continues to expand across oncology. Expert panelists will examine fit-for-purpose strategies for administered activity escalation and dosimetry-informed development that integrates emerging clinical, dosimetry, imaging, and biological data to support regulatory decision-making. Register today: https://lnkd.in/equ6g5Hf. #cancerresearch

China's National Medical Products Administration (NMPA) has outpaced the FDA in novel oncology drug approvals over a five-year period. Streamlining early-phase drug development is critical to ensure the U.S. remains the global leader in clinical research and life-saving cancer treatments reach patients quickly and safely.   In an effort to remove friction from the drug development and clinical trial process and address growing concerns that early-stage development is shifting overseas, the U.S. Department of Health and Human Services (HHS) unveiled Operation TrialBlazer, a roadmap of reforms designed to make development more efficient and predictable for sponsors. As covered by Inside Health Policy, the roadmap outlines reforms to Institutional Review Board (IRB) processes, accelerates first-in-human trial initiations, and updates master protocol frameworks: https://lnkd.in/ejjQkBKG.   Our upcoming 2026 Annual Meeting will build on these federal modernization efforts, bringing together experts to discuss challenges surrounding early-phase drug development while prioritizing patient safety: https://lnkd.in/epkXqKqf. Sessions will focus on applying risk-based nonclinical strategies, modernizing first-in-human studies, and optimizing oncology dosing.

Oncology clinical trials are increasingly global. In 2025, 80% of patients in pivotal trials supporting FDA approvals of novel cancer drug were enrolled outside the U.S.   To understand what's driving this shift, Friends of Cancer Research surveyed eight pharmaceutical companies with global oncology programs, examining trial start-up dynamics from 2020 to 2025.   Read the latest Data-Driven Insights blog for survey insights on where U.S. sites excelled, where delays occurred, and how these insights can help identify opportunities to streamline U.S. start-up and strengthen the U.S. clinical research environment: https://lnkd.in/eHgFDet6.   #ClinicalTrials #OncologyResearch

U.S. Department of Health and Human Services (HHS) released the Operation TrialBlazer roadmap in late June, a coordinated federal initiative designed to accelerate drug development and reclaim the U.S. edge in clinical research. The roadmap tasks the FDA with a slate of reforms to make development more efficient and predictable for sponsors, including possible rulemaking to require the use of a single institutional review board for multi site studies, greater transparency around the review status of protocol amendments, an expedited Investigational New Drug pilot aimed at moving experimental drugs into first in human trials faster, and a more risk based approach to pharmacology and toxicology requirements. These changes could shave 6 to 12 months off clinical trial start-up times. With the TrialBlazer roadmap tasking the FDA to improve patient and participant access and engagement in clinical trials, the FDA's Oncology Center of Excellence announced three final guidance documents intended to increase patient participation in clinical trials of oncology drugs. Fewer than 7% of cancer patients currently receiving treatment are enrolled in clinical trials even though more than 70% say they are willing to participate. The guidance documents address performance status, washout periods and concomitant medications, and laboratory values. As each states in its preamble, unnecessarily restrictive eligibility criteria may slow subject accrual, limit patients' access to clinical trials, and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug. The documents are part of a series developed as a result of workshops with Friends of Cancer Research and the American Society of Clinical Oncology (ASCO). ▪️ Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications: https://lnkd.in/gNiHAyVA ▪️ Cancer Clinical Trial Eligibility Criteria: Performance Status: https://lnkd.in/gyE4tgbM ▪️ Cancer Clinical Trial Eligibility Criteria: Laboratory Values: https://lnkd.in/gErQcG3Z We will address several closely related topics at the Friends of Cancer Research 19th Annual Meeting, with sessions on risk-based nonclinical strategies, modernizing expectations for first in human studies, and model-inform approaches for optimizing oncology dosing, each tracking closely to the TrialBlazer roadmap. Register today: https://lnkd.in/epkXqKqf.

Patient perspectives can inform drug development in many ways, including through input during clinical trial design, participation in advisory committees, and engagement with regulators, researchers, and advocacy organizations on policy priorities. As a public service to the broader patient advocacy community, Friends of Cancer Research created ProgressforPatients.org, a free, self-guided online course covering the FDA's role, clinical trials, drug development and regulatory processes, and real-world examples of advocacy in practice. Those who complete the course will build the knowledge and skills to communicate effectively with researchers, drug developers, and regulators. More than 1,700 patient advocates and early-career professionals have taken the course, and patient advocacy organizations like Food and Drug Law Institute (FDLI), FORCE: Facing Our Risk of Cancer Empowered, GRASP and Lymphoma Research Foundation have incorporated it into their own training efforts as a ready-to-use resource. Take the free course today! Patient advocacy organizations interested in partnering may contact advocacy@focr.org to learn more. ▪️ English: https://lnkd.in/eV3sbHdJ ▪️ Spanish: https://lnkd.in/eZpEXbv5 #patientadvocacy

This is a meaningful step in efforts to make oncology clinical trials more accessible and representative. The three finalized guidance documents address eligibility criteria related to laboratory values, performance status, and washout periods and concomitant medications. These recommendations build on working group discussions and manuscripts developed through a collaboration between Friends of Cancer Research and American Society of Clinical Oncology (ASCO), and a great example of multi-stakeholder collaboration moving from evidence generation to practical policy change.