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New Publication Outlines a Framework to Support More Efficient Clinical Development Programs

New Publication Outlines a Framework to Support More Efficient Clinical Development Programs

A new publication by Friends of Cancer Research (Friends) was published in Cytotherapy, “Accelerated Development of Genetically Engineered Cellular Therapies: A Framework for Extrapolating Data Across Related Products.” This exciting manuscript examines the current opportunities and challenges with development approaches of genetically engineered cellular therapies to propose solutions to optimize development.

The publication outlines a risk-based approach and assessment aid designed to evaluate opportunities for leveraging data across different product versions of cellular therapy products.

“Genetically engineered cell therapies are emerging as a promising new approach for treating patients with cancer.” said Dr. Jeff Allen, President & CEO of Friends of Cancer Research. “This risk-based approach to evaluate the extent to which data from one cellular therapy product can be applied to another has the potential to expedite development.” 

Another critical outcome of the proposed framework outlined in the manuscript is its ability to enable a patient-centric approach for informing trial designs and data collection to support more efficient clinical development programs.

“We aim to accelerate the development of these cellular therapy products, ultimately benefiting patients with cancer and the immunotherapy field,” said Dr. Allen. 

This project was possible through bringing together key experts to examine lessons learned and was informed by a public meeting hosted by Friends on May 22nd, 2023 “The Next Generation of Cellular Therapies: A Blueprint to Accelerate Development.”

Join us for an upcoming cell and gene therapy public meeting hosted by Friends and PICI on May 6, 2024 in Washington, DC. Learn more and register here.

Manuscript Authors
Mark Stewart, Michael Kalos, Vicki Coutinho, Marc Better, Jonathan Jazayeri, Jennifer Yohrling, Julie Jadlowsky, Miriam Fuch, Shalini Gidwani, Carsten Goessl, Patrick J. Hanley, Jane Healy, Wen Liu, Brittany McKelvey, Laura Pearce, Shari Pilon-Thomas, Hillary Andrews, Monica Veldman, Judy Vong, Susan P. Weinbach, Jeff Allen.

Manuscript Partners
Friends of Cancer Research, Next Pillar Consulting, Geni Consulting, Pharmefex, Kite, A Gilead Company, Johnson and Johnson Innovative Medicine, Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Novartis,  Allogene Therapeutics, GSK, Center for Cancer and Immunology Research, Children’s National Hospital, The George Washington University, Merck & Co., Inc., Lyell Immunopharma, Canadian Cancer Trials Group, Department of Immunology, Moffitt Cancer Center, Genentech Inc., A2Bio, Bristol Myers Squibb.

About Friends of Cancer Research
Friends of Cancer Research (Friends) is working to accelerate policy change, support groundbreaking science, and deliver new therapies to patients quickly and safely.  We unite scientists, industry researchers, patient advocates, and policy makers to build unique collaborations able to instigate progress faster than any one organization working alone. This collaboration among partners from every healthcare sector ultimately drives advances in science, policy, and regulation that speed life-saving treatments to patients.

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