Friends of Cancer Research

Building upon our Real-World Evidence Portfolio, Friends of Cancer Research’s Control Arm (ECA) Pilot Project will identify and refine best practices for using historical clinical trial data and real-world data to construct rigorous ECAs or augment single arm trials. After completing foundational work, project scoping and design, with our project partners, we are excited to announce the launch of phase 3, pilot execution. For patients with rare or hard-to-treat conditions where traditional randomized controlled trials may not be feasible, ECAs provide a potential tool for generating evidence relevant to new treatments, ensuring those with urgent medical needs gain access to life-saving options sooner. Learn more about our ECA Pilot Project and how it benefits patients, potentially providing them with innovative treatments quickly and safely: https://lnkd.in/eDsUWrhA.  #realworldevidence #cancertreatment 

Our Annual Meeting brings together leaders from federal health and regulatory agencies, academic research, industry, and patient advocacy to address the most current topics in oncology drug development and policy. Explore the breadth of our work and access full video recordings from our Annual Meetings: https://lnkd.in/ehUAUu7Y. Dive into our previous white papers and panel discussions on topics such as modernizing clinical trial eligibility criteria, advancing Breakthrough Therapy Designation and other expedited development pathways, and establishing a roadmap for ctDNA as an early endpoint. Don't miss this year's meeting as we discuss trial designs for rare cancer, combination drug contribution of effect, and control arm selection for multi-regional clinical trials. Register today: https://lnkd.in/e3tdCbyY. #FriendsAM25 #cancerresearch

This year’s Ellen V. Sigal Advocacy Award went to Peter Marks for his steadfast commitment to advancing public health through scientific integrity and regulatory excellence, and the Marlene A. Malek Public Service Award was awarded to Mark McClellan for his exceptional leadership and enduring contributions to public health. Watch Dr. Marks (youtu.be/5ZmoVliIMjE) and Dr. McClellan’s award videos (https://lnkd.in/e6Z4kXjA) on our YouTube channel.

Want to learn more about how Friends of Cancer Research powers advances in science and policy that speed life-saving treatments to patients?   By aggregating and analyzing data from clinical trials, diagnostic testing, and routine patient care, our research generates the evidence needed to support innovative approaches in oncology. These insights help align stakeholders and inform evidence-based policies that modernize regulatory frameworks, advance cell and gene therapies, broaden clinical trial eligibility, and improve patient outcomes.   Explore how we bring science and policy together to drive progress for patients: https://lnkd.in/e-8kpvYB.   #CancerResearch #HealthPolicy

Mark Stewart, Vice President, Science Policy, will be speaking at the Hanson Wade’s 15th World Clinical Biomarkers & Companion Diagnostics Summit, presenting findings from Friends of Cancer Research’s Digital PATH project, which evaluated AI-based HER2 scoring tools in breast cancer. He will also join discussions on the role of AI-enabled H&E-based molecular profiling in diagnosis and collaborative strategies to advance precision medicine. These sessions will focus on how innovative tools and partnerships can build regulatory confidence, accelerate drug–diagnostic development, and ultimately bring new treatments to patients faster. #worldcdx #cancerresearch

New research led by Friends of Cancer Research shows that reductions in circulating tumor DNA (ctDNA) levels after treatment are associated with improved overall survival (OS) in patients with advanced non-small cell lung cancer (aNSCLC) treated with immunotherapy or chemotherapy. The analysis focused on different early ctDNA timepoints and definitions of molecular response (MR). Read the full publication: https://lnkd.in/evV74SFP. The aggregate analysis, published in the Journal for ImmunoTherapy of Cancer, analyzed data from four randomized clinical trials involving 918 patients treated with anti-PD(L)1 therapy (with or without chemotherapy) or chemotherapy alone. In patients receiving immunotherapy, ctDNA reductions at two early timepoints (i.e., up to 7 weeks and 7-13 weeks after treatment initiation) showed significant associations with improved OS across all MR thresholds (i.e., 50% decrease, 90% decrease, and 100% clearance). Among those treated with chemotherapy alone, these associations were more pronounced when assessing the 7–13-week timepoint. The majority of patients had the same category of molecular response at both timepoints. These findings support a growing body of evidence from Friends’ ctMoniTR Project. With additional studies planned, these findings bring us closer to a reliable early indicator of treatment efficacy, potentially transforming how we evaluate cancer therapies and accelerate drug development timelines. Thank you to the authors: Hillary Andrews, PhD, Nevine Zariffa, Katherine Nishimura, Yu (Yulia) Deng, Megan Eisele, Joe Ensor, Carin E., David Fabrizio, Emily Goren, Vincent Haddad, Minetta Liu, Dimple Modi, Achim Moesta, Katie Quinn, Adam Rosenthal, Diana Merino Vega, wei zou, Antje Hoering, Mark Stewart, Jeff Allen   #ctDNAFriends #ctDNA 

Thank you to everyone who joined our 29th Annual Cancer Leadership Awards Celebration! It was truly such a fun evening hosting a visionary group of people dedicated to advancing oncology for all patients. This year’s Ellen V. Sigal Advocacy Award went to Dr. Peter Marks for his steadfast commitment to advancing public health through scientific integrity and regulatory excellence. Dr. Peter Marks is a hematologist and oncologist who served as the Director of the FDA's Center for Biologics Evaluation and Research (CBER) from 2016 to 2025. Dr. Marks has played a critical role in the development and approval of cell and gene therapies that improve the outcomes of people with cancer. The Marlene A. Malek Public Service Award went to Dr. Mark McClellan for his exceptional leadership and enduring contributions to public health. Dr. McClellan is the Director of the Duke-Margolis Institute for Health Policy and the Robert J. Margolis Professor of Business, Medicine, and Health Policy at Duke University. His work has focused on improving healthcare quality, payment reform, and the development of real-world evidence. Watch Dr. Marks (https://lnkd.in/e-cmGEfp) and Dr. McClellan's (https://lnkd.in/e6Z4kXjA) award videos on our YouTube. A special thank you to our sponsors who made the evening possible!

How can prior knowledge be better leveraged to accelerate the development of cell and gene therapies, while still maintaining safety and quality?   Friends of Cancer Research submitted public comments to tomorrow’s FDA CBER OTP Public Listening Meeting, Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies.   In our comments, we recommend: • Frameworks for extrapolating data across related genetically engineered cellular therapies to reduce redundancy while ensuring safety, • Approaches to scalable and decentralized manufacturing that can expand access to therapies, particularly in rare disease contexts, and • Opportunities for collaboration among regulators, developers, and stakeholders to support efficient, safe innovation.   These recommendations build on our recent publications and provide actionable strategies to help the FDA and developers streamline the development of cell and gene therapies, reduce redundancy, and advance safe and efficient pathways that ultimately improve patient access.   We appreciate the FDA’s efforts to foster collaboration and dialogue on these issues and look forward to continuing our work together to advance the safe and efficient development of cell and gene therapies.   Read the full comment: https://lnkd.in/ebVeRVcQ. #cellandgenetherapy #cancerresearch

Research funded by the NIH is the cornerstone of new advances against the toughest diseases we face, and it fuels jobs and economic growth across the United States. Every dollar invested in NIH generates $2.56 in economic activity, contributing nearly $95 billion to the U.S. economy in FY2024 and supporting over 407,000 jobs across nearly every congressional district. Cutting back now would weaken America’s economy, weaken our national security, and cede leadership in medical innovation. On Thursday, September 18, 2025, a nationwide coalition of nearly 400 medical research advocacy organizations representing millions of Americans will gather on Capitol Hill to thank lawmakers for their longstanding support of NIH and to urge Congress to provide a robust funding increase in Fiscal Year 2026 to safeguard the future of lifesaving medical research. Take action today: https://lnkd.in/gJiqMwc!  #RallyMedRes #FundNIH

Check out the Q3 2025 edition of the Friends of Cancer Research Advocacy Newsletter!   In this issue, we spotlight: • ai.RECIST Project – Learn about our new project in tumor response assessments through AI integration. • Engaging Innovation Blog – Insights from the July 17 ODAC hearing and the latest on PDUFA Reauthorization. • 2025 Leadership Awards – Celebrate the achievements of our 2025 awardees’ contributions to research and patient advocacy.   Read the latest issue and subscribe to stay ahead of developments shaping cancer research and patient advocacy: https://lnkd.in/eAmsi2Ja.   #patientadvocacy #cancerresearch