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Author: Finn Galloway

Meeting Recap | Modernizing Oncology Endpoints: Pathways for Evidence and Policy

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On February 5th, Friends of Cancer Research (Friends) hosted a public meeting, “Modernizing Oncology Endpoints: Pathways for Evidence and Policy” to examine how emerging early endpoints, including circulating tumor DNA (ctDNA) and artificial intelligence (AI)-enabled tumor assessments, may improve trial efficiency and inform regulatory decision-making. Realizing this potential will require convergence around evidentiary standards, scalable validation frameworks, and regulatory pathways that enable innovation to move beyond pilots and into predictable,…

Project Pulse | Evaluating AI Agreement in HER2 Assessment Using Whole-Slide Imaging: Insights from the Digital PATH Project

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Biomarkers play a key role in identifying which patients are most likely to benefit from specific therapies, and advances in digital pathology and artificial intelligence (AI) are beginning to reshape how those biomarkers are assessed. Scientists use assays, or tests to assess biomarkers. Outputs from different assays may provide different results, which could impact the…

Project Pulse | The Latest ctMoniTR Publication: Findings and Implications

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This blog post provides an overview of a recent ctMoniTR publication from Friends. A graphical abstract below summarizes the manuscript’s approach, findings, and context. Background  In oncology clinical trials, the gold standard approach for measuring efficacy of cancer therapies is by determining overall survival (OS), or the length of time a patient lives after starting…

Stakeholder Connect | Insights from September 18, 2025, CBER Office of Therapeutic Products Public Listening Meeting

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The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual public listening meeting on September 18th. During this meeting, stakeholders from regulatory agencies, patient advocacy organizations, industry, and academia convened to discuss how prior knowledge and platform approaches could be better leveraged to…

Stakeholder Connect | Insights from the July 17, 2025 Meeting of the Oncologic Drugs Advisory Committee (ODAC)

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What was the committee asked to consider?  On July 17, 2025, the U.S. Food and Drug Administration (FDA) convened the Oncologic Drugs Advisory Committee (ODAC) to vote on whether the overall benefit-risk profile of two new combination regimens (belantamab mafodotin + bortezomib + dexamethasone [BVd] and  belantamab mafodotin + pomalidomide + dexamethasone [BPd]) for treatment…

Data Driven Insights | PDUFA at a Glance – Enabling Innovation and Timely Access to New Treatments

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As FDA and stakeholders begin preparations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), Friends of Cancer Research’s new Data Driven-Insight provides a high-level overview of the program’s history, impact, and upcoming priorities. This primer provides essential context as public discussions begin around PDUFA VIII. It also highlights how user fee programs…

Data-Driven Insights | 30+ Years of Accelerated Approval: Trends, Timelines, and Impact

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Introduction and Background  The Accelerated Approval (AA) program is a drug development pathway that was established to expedite the delivery of promising treatments to patients, primarily for serious and life-threatening conditions. AA is granted based on surrogate endpoints, such as tumor size reduction in cancer patients, that are reasonably likely to predict clinical benefit. These…

Data-Driven Insights | 20 Years of FDA Leadership in Novel Cancer Drug Approvals

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In 2011, Friends published a study in Health Affairs that challenged the prevailing narrative of the time, which suggested that the U.S. Food and Drug Administration (FDA) was slower and less efficient than other regulatory authorities, such as the European Medicines Agency (EMA). This study provided evidence to the contrary, demonstrating that the FDA approved…

Meeting Recap | Advancing the Future of Diagnostics and Regulatory Innovations

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On February 4th, Friends of Cancer Research (Friends) hosted a public meeting, “Advancing the Future of Diagnostics and Regulatory Innovations,” emphasizing the dual objectives of ensuring patient safety while fostering an environment conducive to innovation—a balance that is becoming increasingly critical in an era marked by rapid technological advancements.

Project Pulse | Insights from the Digital PATH Project: HER2 Biomarker Variability Across Artificial Intelligence Models | SABCS

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Friends’ recent research on homologous recombination deficiency (HRD) involved a comparative analysis of 20 independent HRD assays, assessing both an In Silico (n=348; TCGA database) and a Clinical dataset (n=90; nucleic acids from freshly extracted archival ovarian cancer tumor samples). The assays measured a variety of outputs to define DNA damage repair dysfunction and identify patients with high-grade serous ovarian carcinoma (HGSOC) who had HRD. This is important because patients with HRD may benefit from DNA damage repair inhibitor treatments like Poly ADP-ribose Polymerase Inhibitors (PARPi).