FOR IMMEDIATE RELEASE

June 13, 2025

FACT Represented at Distinguished Cell and Gene Therapy Roundtable Attended By HHS Secretary, FDA Commissioner, CMS Administrator

OMAHA, Neb. — The Foundation for the Accreditation of Cellular Therapy (FACT) was represented last week at a roundtable of distinguished leaders of America’s cell and gene therapy industry. Food and Drug Administration (FDA) Commissioner Dr. Marty Makary convened 23 leading voices from America’s top research universities, patient advocacy organizations, and industry. Representing FACT was its Board Chairperson, Dr. Catherine Bollard.

The session, co-led by Dr. Vinayak Prasad, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), provided a rare forum for direct dialogue between federal healthcare leadership and the field’s most experienced experts. The goal from the perspective of the FDA, as described by Commissioner Makary, was “listening and learning and evolving” as well as to “challenge deeply held assumptions on how we do things” to improve the safe and effective delivery of cell and gene therapy cures to Americans.

In Dr. Bollard’s introduction, she highlighted her connection to FACT and reiterated its deep-rooted mission by stating, “Thirty years ago, physicians in our field recognized the curative potential of cell and gene therapies and the need to do everything possible [to deliver] quality-focused patient safety treatments that will keep our patients safe. So shortly after, FACT developed a voluntary accreditation process for all the facilities that provide these novel cell and gene therapies…” She continued by reminding the panel that, “Our field already has this built-in safety mechanism in place, and these initial efforts [by FACT] have really thrived and expanded over the past 30 years.” 

Dr. Bollard concluded her remarks by focusing on FACT’s most recent priority, which includes enabling greater access to innovative therapies for patients worldwide. She stated that, “FACT is currently helping to bring CAR-T therapies closer to where qualified patients live. We are looking ahead to ensure our Standards will also be accessible to cell therapies that are being developed for non-cancer diseases with patient populations that are literally in the hundreds of thousands…this is really close to my heart, to be in a leadership role with all the cell and gene therapy experts who make FACT what it is.”

These comments echo FACT’s mission of improving the quality of cellular therapy through peer-developed standards, education, and accreditation. FACT’s Care Standards are developed through expert consensus and based on published medical evidence using committees consisting of knowledgeable clinicians, scientists, technologists, and quality experts who span the entire continuum of cell manufacturing. Since 2017, FACT has accredited 175 clinical programs for IEC administration in five countries. Overall, 314 programs in 26 countries are accredited by FACT.

Notably, the roundtable discussion included participation from US Department of Health and Human Services Secretary, Robert F. Kennedy, Jr., and Centers for Medicare & Medicare Services Administrator, Dr. Mehmet Oz, ensuring the input, insights, and recommendations of the participants would reach the highest levels of decision-makers within President Trump’s administration.