Friends of Cancer Research (Friends) is honored to announce the election of Dr. Richard Pazdur to the organization’s Board of Directors. During his 26 years at the U.S. Food and Drug Administration, including as founding director of the Oncology Center of Excellence, Dr. Pazdur built and led the regulatory framework that defines how cancer therapies are…
Friends of Cancer Research is deeply saddened by the passing of longtime board member David Mitchell, a tireless patient advocate whose lived experience with multiple myeloma shaped a decade of courageous leadership on behalf of patients nationwide. David devoted his life to ensuring patient voices were central to policy, innovation, and access to care. Below, Ellen Sigal,…
Artificial intelligence (AI) holds promise to enable new approaches to diagnostic testing and digital pathology; however, realizing this potential requires coordinated approaches to evaluate performance and support consistency across platforms. A new manuscript from Friends of Cancer Research (Friends) Digital PATH Project, published in Modern Pathology, establishes a foundation for advancing conversations around evaluating performance and…
Genetically modified cell-based therapies, such as chimeric antigen receptor T-cell (CAR T) therapies, hold extraordinary promise for patients with rare cancers, but progress can be hampered by regulatory, manufacturing, and financial systems that are not designed to serve very small patient populations. Friends of Cancer Research (Friends) and the Parker Institute for Cancer Immunotherapy (PICI) outlined strategies in…
“Rick Pazdur has been a tireless public servant and one of the most trusted leaders in biomedical innovation. His decades of dedication to patients, science, and collaboration across sectors have strengthened FDA’s role as a global standard-bearer for cancer care and therapeutic development. At a time when the agency faces both extraordinary opportunity and complexity,…
The FDA’s Biomarker Qualification Program (BQP) has had limited impact in qualifying new biomarkers over its eight years of operation, according to a new analysis from Friends of Cancer Research (Friends) published in Therapeutic Innovation & Regulatory Science. While the BQP created a framework for biomarker development, we believe targeted resources, stronger collaboration, and more…
Friends is leading a research partnership, the External Control Arm (ECA) Pilot Project, to inform the use of ECAs in clinical development and regulatory decision-making. The project will evaluate the use of external data from 8 different sources—including both historical clinical trial data and real-world data (RWD)—to construct a series of ECAs to inform practical…
New research led by Friends of Cancer Research (Friends) shows that decreases in circulating tumor DNA (ctDNA) on treatment are associated with improved overall survival (OS) in patients with advanced non-small cell lung cancer (aNSCLC) treated with immunotherapy or chemotherapy. Read the Publication “ctDNA continues to hold promise as an early endpoint for regulatory decision-making.…
Friends of Cancer Research (Friends) launched the next phase of an initiative to improve how to interpret interim overall survival (OS) data in oncology clinical trials. Building on discussions during Friends 2024 Annual Meeting, this new effort focuses on developing practical frameworks and simulation tools to support decision-making around immature OS data in an effort…
A new framework developed in partnership with Friends of Cancer Research (Friends) and the Parker Institute for Cancer Immunotherapy was published in The Journal for ImmunoTherapy of Cancer, Intentional heterogeneity in autologous cell-based gene therapies: strategic considerations for first-in-human trials. This pertinent collaborative manuscript emphasizes the need for flexible approaches to efficiently characterize and advance…
