Blog: Engaging Innovation

Elena Levi-D'Ancona, PhD | January 16, 2026

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

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…

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Elena Levi-D'Ancona, PhD | January 9, 2026

Data-Driven Insights | The Biomarker Qualification Program: Takeaways and Recommendations

The Prescription Drug User Fee Act (PDUFA) allows the U.S. Food and Drug Administration (FDA) to collect fees from drug sponsors that streamline reviews of new drug applications, promoting timely patient access without compromising safety. When the Act is reauthorized every five years, industry and FDA discuss goals to support and improve the drug review process. With PDUFA negotiations for the 2027 reauthorization now…

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November 21, 2025

Meeting Recap | Advocates Webinar: Annual Meeting 2025

On November 17, Friends of Cancer Research (Friends) convened or an advocates-focused webinar to discuss key themes from the 2025 Annual Meeting and examine how patient experience informs evidence generation, trial design, and regulatory decision-making. We were honored to feature advocate panelists, Kristin McJunkins, Misha Mehta, Susan Rouse, Carol Vallett, and Chris white, who drew…

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November 7, 2025

Meeting Recap | Friends of Cancer Research Annual Meeting 2025

On Tuesday, November 4th, 2025, Friends of Cancer Research (Friends) hosted its 18th Annual Meeting, bringing together experts from industry, academia, regulatory agencies, and patient advocacy. Over the past few months, Friends members Bernat Navarro-Serer, Hillary Andrews, and Mark Stewart hosted biweekly calls with expert working groups to discuss pressing topics in oncology clinical research that led to white papers released before the event. Each session at the Annual Meeting began with a brief presentation by the moderator,…

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Elena Levi-D'Ancona | October 3, 2025

Project Pulse | The Latest ctMoniTR Publication: Findings and Implications

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…

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Elena Levi-D'Ancona | October 2, 2025

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

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…

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Grace Collins | July 18, 2025

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

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…

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Grace Collins | July 12, 2025

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

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…

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May 23, 2025

Meeting Recap | Unlocking Next-Generation Therapies Meeting Recap: Sharing Next Steps and Opportunities with Advocates

On May 22, Friends of Cancer Research (Friends) hosted a public webinar exploring next steps for supporting sustainable development and manufacturing models that can expand patient access to genetically modified cell-based therapies. The webinar, "Unlocking Next-Generation Therapies Meeting Recap: Sharing Next Steps and Opportunities with Advocates," revisited policy discussions from the May 9th public meeting, and proposals from the collaborative white paper developed with the Parker Institute for Cancer Immunotherapy (PICI).

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Karina Bhavsar and Grace Collins | May 19, 2025

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

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…

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