Blog: Engaging Innovation

Grace Collins | August 3, 2026

Stakeholder Connect | Insights from the July 30 Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) Meeting

What was the committee asked to consider? On July 30, the U.S. Food and Drug Administration (FDA) convened the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) to consider data intended to support accelerated approval of a regimen combining intratumoral vusolimogene oderparepvec (RP1), a novel oncolytic immunotherapy from Replimune, and systemic nivolumab for adult patients…

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Grace Collins | July 30, 2026

Data-Driven Insights | Fast to Start, Slow to Scale: U.S. Oncology Trial Start-Up in a Global Context

Oncology clinical trials are increasingly conducted globally, with recent trends indicating a growing share of trial activity outside of the U.S. In 2025, 80% of patients in pivotal trials supporting novel cancer drug approvals by the FDA were enrolled outside of the U.S.1 Such global trials are critical for generating data across distinct regional and…

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Sonia Seth | June 29, 2026

From Innovation to Implementation: What Baby KJ Reveals About the Future of Personalized Therapies

In 2025, an infant known as Baby KJ became one of the first patients to receive a personalized CRISPR-based gene-editing therapy, specifically designed to correct the mutation causing his life-threatening Carbamoyl phosphate synthetase (CPS1) deficiency. This rare metabolic disorder prevents the body from properly clearing ammonia which could lead to rapid toxicity and death without…

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Misha Mehta, PhD - in honor of Neev | June 11, 2026

Advocate Insights | In My Game, Everybody Wins: A Mother’s Case for Federal Investment in Pediatric Brain Tumor Research

My son Neev was four years old when he slid his winning Bingo card across the table to another child. “In my game,” he said, “everybody wins.” He meant it. He lived it. He was the kind of child who made sure every new kid at preschool had someone to sit with at lunch, no teacher had to ask.…

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May 12, 2026

Meeting Recap | Unlocking Next-Generation Therapies

On May 6, Friends of Cancer Research (Friends) and the Parker Institute for Cancer Immunotherapy co-hosted a public meeting, “Unlocking Next-Generation Therapies” to explore opportunities to advance next-generation therapies, including innovative approaches in cell therapy development. The oncology landscape has shifted dramatically over the last 30 years, transitioning from chemotherapy-based treatment toward molecularly and immunologically…

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Grace Collins | May 1, 2026

Stakeholder Connect | Insights from the April 30 Oncologic Drugs Advisory Committee (ODAC) Meeting

What was the committee asked to consider? On April 30, 2026, the U.S. Food and Drug Administration (FDA) convened the Oncologic Drugs Advisory Committee (ODAC) to consider the benefits and risks of two regimens for treatment of cancer.    The morning session focused on the results of the SERENA-6 trial, which was intended to support a new…

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April 14, 2026

Meeting Recap | Application of External Control Arms in Oncology Drug Development

On April 7, Friends of Cancer Research (Friends) hosted a public meeting, “Application of External Control Arms in Oncology Drug Development” to explore opportunities to advance the use of external control arms (ECAs) in oncology drug development. ECAs are constructed from external data sources, such as prior clinical trials or real-world data (RWD), and can provide valuable comparative evidence for evaluating new therapies, particularly when traditional randomized controlled…

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February 17, 2026

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

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,…

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Elena Levi-D'Ancona, PhD | January 28, 2026

Project Pulse | Modernizing Tumor Assessment: Integrating AI into Oncology Clinical Trials

Friends of Cancer Research (Friends) convened a multidisciplinary working group to examine how to incorporate artificial intelligence (AI) into tumor assessment workflows in oncology clinical trials. The group developed a white paper exploring the potential of emerging AI-enabled tools to enhance tumor assessment, as well as key considerations for the adoption and regulatory approval of AI-enabled imaging endpoints that…

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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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