FOR IMMEDIATE RELEASE

April 10, 2025

FACT CONVENES ‘COMMUNITY CAR T WORKING GROUP’ TO REVIEW AND PROPOSE CLINICAL ACCREDITATION STANDARDS

OMAHA, Neb. -  The Foundation for the Accreditation of Cellular Therapy (FACT) is announcing the formation of a ‘Community CAR T Working Group’ (working group) to discuss and propose clinical accreditation standards for community-based providers of CAR T cell therapies. 

The working group builds on months of outreach by FACT to a wide variety of stakeholders and engagement in various forums to discuss the multiple, complex challenges surrounding eligible patient access to these innovative therapies.

Comprised primarily of community-based physicians currently administering—or preparing to administer—CAR T therapies, the group will also include leaders from academic medical centers and physician and clinical quality experts from FACT and other professional societies whose members include oncologists practicing in both community and metro settings.

Recognizing the financial and clinical complexity delivering cell therapies, FACT has also invited representatives from both commercial and public health insurers to participate as observers.

“FACT is committed to promoting access for all eligible patients to life-saving cellular therapies in safe and quality-focused clinical settings. Toward that end, we’re committed to doing our part by partnering with this critically important cohort of physician providers,” says Dr. Catherine Bollard, President of FACT’s Board of Directors.

This effort will operate in association with the development of the upcoming third edition of the FACT Standards for Immune Effector Cells, scheduled for release later this year. FACT originally addressed the emergence of Immune Effector Cell (IEC) therapies, including CAR T cells, nearly ten years ago by publishing the first edition of these Standards.

FACT will mark its 30^th anniversary in 2026 and is widely regarded as a critically essential contributor to helping physicians practice medicine within quality- and safety-focused infrastructure and systems.

“Innovative cancer treatment pathways must move closer to where eligible patients live and work. The working group reflects a recognition of the importance of expanded input into standard development and accreditation. We’ll lead the effort with appropriate urgency and expertise,” says FACT’s CEO, David Schmahl, who was recently appointed to the role by FACT’s Board of Directors to ensure such future-focused work is prioritized.

About FACT

Founded in 1996, FACT is a non-profit corporation co-founded by the International Society for Cell and Gene Therapy (ISCT) and the American Society for Transplantation and Cellular Therapy (ASTCT) to develop patient-centric standards based on current science, focusing on quality and safety. In addition, FACT offers corresponding voluntary accreditations, aligned with the services offered by the applying program. FACT engages and interacts with hundreds of peer experts in its administration of these efforts.

Since 2017, FACT has accredited 167 programs for IEC administration in 5 countries. Overall, 313 organizations in over 20 countries are accredited by FACT.

For more information, visit www.factglobal.org.

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