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Kara Wacker, Strategic Planning Administrator 
Foundation for the Accreditation of Cellular Therapy
Omaha, NE USA

FACT announced in April 2025 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 engages 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 also includes 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. 

The alphabetical list of members includes: 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. Ke Ning (Florida Cancer Specialists), Dr. Ameet Patel (Florida Cancer Specialists), 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). 

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. Other observers include David Schmahl, FACT CEO, and JACIE leaders (Dr. Charles Crawley, Dr. Lynn Manson, and Tuula Rintala). Kara Wacker (FACT) will administer and guide the group’s effort. 

“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. “The working group includes diverse expertise, perspectives, and experiences, while respecting practical considerations of organizational efficiency and administration.” 

This effort 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. 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.

This effort 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. 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 is confident in community-based IEC programs’ abilities to achieve FACT accreditation and expects the output will be more accessible to this segment of providers by including requirements specific to the scope of services they provide. This approach complements modular accreditation that is already administered by FACT, and the working group’s output will allow community-based clinics to readily identify relevant requirements.

FACT will mark its 30th 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 appointed to the role in 2024 by FACT’s Board of Directors to ensure such future-focused work is prioritized.