Consensus-Built ‘Fit-for-Purpose' Quality and Safety Standards for Community Oncology Programs

OMAHA, NEBRASKA / ACCESS Newswire / November 10, 2025 / The Foundation for the Accreditation of Cellular Therapy (FACT) today published the Standards for Immune Effector Cells in the Community Clinical Setting, 1st edition, to help community oncology programs deliver transformative cell therapies closer to where eligible patients live and work.

"These Standards, and FACT's accompanying voluntary accreditation, will help assure community-based caregivers, patients, and all stakeholders that the patient journey will be grounded in quality and safety," says Dr. Catherine Bollard, President of the FACT Board of Directors.

While familiarity with and use of cell therapies continues to grow among physicians, demand still exists for clear and consistent information. In a 2024 survey from IQVIA, ~70% of referring physicians said they would benefit from more, or a lot more, information about cell therapy. These Standards respond to that need.

"FACT spent several months inviting feedback from a wide range of stakeholders in cell and gene therapy, and took action with the appropriate urgency," says FACT CEO David Schmahl. "We'll continue to listen and respond to the needs of providers, patients, and other stakeholders."

Development began last spring when FACT convened the Community CAR T Working Group, comprised of community-based physicians, leaders from academic medical centers, and representatives of medical societies. The Community IEC Standards adapt the FACT-JACIE International Standards for Immune Effector Cells, 3rd edition, to meet the "fit-for-purpose" needs of community-based oncology programs.

"Currently, many patients eligible for cellular therapy must be referred for treatment to hospitals far away from where they live, often resulting in the treatment not being received. We must expand access for treatment much closer to where these patients live. These Standards help community oncology programs do this, with relevant guidance addressing quality and safety through the patient journey," says Working Group member Michael Byrne, DO (Tennessee Oncology).

"FACT is committed to expanding patient access and working with community oncology programs to see that care happens safely and with quality at the forefront," added Schmahl.

FACT urges all parties interested to access these Standards and be part of the solution to bring these transformative therapies to more patients.

Since 2017, FACT has accredited 181 programs for IEC administration in five countries. Overall, 319 organizations in 26 countries are accredited by FACT. For more information, visit www.factglobal.org.

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.

Contact Information

Media Contact
fact@factglobal.org
(402) 920-7001

SOURCE: Foundation for the Accreditation of Cellular Therapy