FOR IMMEDIATE RELEASE

April 25, 2025

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

The working group is operating in association with the development of the upcoming third edition of the FACT-JACIE Standards for Immune Effector Cells, scheduled for release later this year. The expected output will guide physicians toward the development and maintenance of  quality- and safety-focused infrastructure and systems closer to the homes and workplaces of eligible patients.

Comprised primarily of community-based physicians currently administering—or preparing to administer—CAR-T cell therapies, the working group  also includes leaders from academic medical centers, representatives of professional societies whose members include oncologists practicing in both community and larger metropolitan settings, and members of FACT headquarters.

The alphabetical list of participants includes: Judith Alberto, MHA, RPh, BCOP (Community Oncology Alliance), Dr. Courtney Bellomo (New York Oncology Hematology), Dr. Michael Byrne (Tennessee Oncology), Dr. Jason Chandler (West Cancer Center), Dr. Mitul Gandhi (Virginia Cancer Specialists), Dr. Stephen Grubbs (American Society of Clinical Oncology), Dr. Houston Holmes (Texas Oncology), Molly Kisiel, MSN, FNP-BC (Association of Cancer Care Centers), Michael Lehmicke, MSc (Alliance for Regenerative Medicine), Dr. Carolyn Mulroney (Sarah Cannon Transplant and Cellular Therapy Program at MountainView Hospital), Dr. David Porter (Penn Medicine and American Society for Transplantation and Cellular Therapy), Dr. Joseph Schwartz (FACT), Dr. Leo Wang (City of Hope), Dr. Phyllis Warkentin (FACT).

“The working group includes diverse expertise, perspectives, and experiences, while respecting practical considerations of organizational efficiency and administration,” says Dr. Catherine Bollard, President of FACT’s Board of Directors.

Recognizing the financial and clinical complexity of delivering cell therapies, FACT has also invited representatives from both commercial and public health insurers to participate as observers. Also observing will be FACT CEO, David Schmahl. Ms. Kara Wacker (FACT) will administer and guide the group’s effort.

About FACT

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

Since 2017, FACT has accredited 175 clinical programs for IEC administration in five countries. Overall, 314 programs in 26 countries are accredited by FACT.

For more information, visit www.factglobal.org.

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