Blog: Engaging Innovation

Natalie Snider-Hoy, PhD & Grace Collins | September 25, 2026

Stakeholder Connect | Insights from the September 23rd Molecular and Clinical Genetics Panel (MCGP) Meeting

What was the committee asked to consider?  On September 23, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) convened the Molecular and Clinical Genetics Panel (MCGP) of the Medical Devices Advisory Committee to consider data supporting a premarket approval application (PMA) for GRAIL’s Galleri test. Galleri is a qualitative,…

Read More

Donna Short | September 15, 2026

Advocate Insights | Artificial Intelligence in Oncology—An Advocate’s Perspective

The debate over AI in oncology is not only about what this technology can do, but whether it can be developed collaboratively and used responsibly to serve and improve outcomes for all patients.  While researching this topic and organizing my thoughts, I recognized the transition of articles on artificial intelligence (AI) as the years went by. AI began to emerge from dreams to reality. We went from focusing on generalizations for AI use and proper guidance…

Read More

Natalie Snider-Hoy, PhD | September 3, 2026

Stakeholder Connect | From Guidance to Action: What Operation TrialBlazer Means for the Future of Oncology Drug Development

In June 2026, the U.S. Department of Health and Human Services (HHS) launched a new initiative called Operation TrialBlazer to “strengthen U.S. leadership in clinical research, accelerate the development of lifesaving treatments, and ensure that patients have access to the most innovative therapies in the world.” This initiative is a department-wide effort across the U.S. Food and Drug Administration (FDA),…

Read More

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…

Read More

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…

Read More

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…

Read More

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.…

Read More

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…

Read More

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…

Read More

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…

Read More