Press Releases

Universally respected, renowned cellular therapy and transplant expert tapped to help drive FACT’s strategic imperatives for the future

OMAHA, Neb. - The Foundation for the Accreditation of Cellular Therapy (FACT) today announced the appointment of Dr. Navneet Majhail as President of FACT’s Board of Directors.

Dr. Majhail is a board-certified hematologist and the Physician-in-Chief, blood cancers, HCA Healthcare Sarah Cannon Cancer Network. He oversees the Sarah Cannon Transplant and Cellular Therapy Network that consists of 11 programs in the US and UK, providing care to more than 1,600 hematopoietic cell transplant and cell and gene therapy recipients each year. He has previously served as the President of the American Society for Transplantation and Cellular Therapy.

FACT also welcomes the following three widely respected leaders to its Board of Directors, effective immediately: Nicole Aqui, MD (Perelman School of Medicine at the University of Pennsylvania), Rachel Cook, MD, MS (OHSU Knight Cancer Institute), and Joseph (“Joel”) McGuirk, DO, FACP (The University of Kansas Medical Center).

As President, Dr. Majhail will chair the FACT Board of Directors, extending his volunteer Board service that began in 2021. He will lead the Board’s overall promotion of FACT’s mission, strategic thinking and goal setting, and direction of policies and efforts to advance quality and safety in the field of cellular therapy.

“I am deeply honored and delighted to serve our field through this FACT leadership role,” says Dr. Majhail. “FACT is celebrating 30 years of developing Standards, Accreditations, and Education offerings that are invaluable for the assurance of safe and quality care throughout patients’ entire treatment journey. Our foundation uniquely positions us for tomorrow.”

FACT is taking many key steps to maximize impact and value to all present and future stakeholders engaged in cell and gene therapy. “We are actively engaging, listening and taking action on multiple fronts,” says Majhail. “Doing our part to see the curative potential of CAR T therapies brought with quality and safety closer to where patients live is our current #1 future-focused priority, and our IEC-in-Community Standards and novel accreditation pathways demonstrate this,” he adds. “We are stepping up with the urgency that our field and patients need.”

In this role, Dr. Majhail succeeds Dr. Catherine Bollard, whom he acknowledges with gratitude and respect. “Dr. Bollard’s tireless, effective leadership has put FACT in a great position for the future, and I’m honored to follow her footsteps,” adds Dr. Majhail.

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.

For more information, visit www.factglobal.org.

Media Contact
fact@factglobal.org
+1 (402) 920-7001

Consensus-driven pathway helps assure quality and safety in programs new to cell therapy

OMAHA, Neb. - The Foundation for the Accreditation of Cellular Therapy (FACT) today announced the availability of a novel voluntary accreditation pathway intended to increase the availability of transformative cell therapies and bring these therapies closer to where patients live and work.

FACT provisional clinical accreditation requires the same documentation and inspection processes as full accreditation, but can be awarded prior to the provider fulfilling the standard associated with prior treatment of a minimum number of patients.

Over the past year, FACT has actively engaged with a wide range of stakeholders in the cell therapy field to learn what must be done to help more eligible patients receive these potentially curative therapies with assurances of quality and safety. FACT’s leadership re-committed the organization to help expand patient access to cell therapy through collaborative discussion, peer- and consensus-driven action taking, and appropriate urgency.

A recent example of FACT action-taking was publication of its Standards for Immune Effector Cells in the Community Clinical Setting, 1st edition, developed in part through consensus-driven guidance from the FACT Community CAR T Working Group, who first convened in June of this year.

“Too many eligible patients are not receiving the curative benefits of CAR T. FACT firmly believes that these therapies can and should be available closer to where they live, in safe and quality-focused clinics,” says Dr. Catherine Bollard, President of FACT Board of Directors.

The Community CAR T Working Group, which included representatives from national payer organizations, also identified a significant, real-world challenge facing community providers working to administer CAR T therapies; reimbursement practices. Specifically, providers face substantial financial risk when investing in what’s needed to deliver CAR T therapies safely and effectively, without the assurance of reimbursement.

“FACT’s Standards require that a minimum number of patients be treated prior to the program becoming eligible for FACT accreditation. However, treating patients without the assurance of reimbursement presents significant risk and might prevent eligible patients from receiving these life-changing therapies. Our provisional clinical accreditation addresses the conundrum with the same rigor and requirements everyone expects and can trust from FACT,” says FACT CEO David Schmahl.

“Achieving FACT provisional clinical accreditation signals to all stakeholders the program’s readiness to treat patients with safety and quality at the forefront and should be respected and viewed accordingly,” he adds.

FACT urges all parties interested in learning more about the FACT provisional clinical accreditation to visit here, or to email questions to fact@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.

For more information, visit www.factglobal.org.

Media Contact
fact@factglobal.org
+1 (402) 920-7001

Consensus-built “fit-for-purpose” quality and safety standards for community oncology programs

OMAHA, Neb. -  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 in 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 fact@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.

For more information, visit www.factglobal.org.

Media Contact
fact@factglobal.org
+1 (402) 920-7001

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.

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.

For more information, visit www.factglobal.org.

Media Contact
fact@factglobal.org
+1 (402) 920-7001

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 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 recently appointed to the role by FACT’s Board of Directors to ensure such future-focused work is prioritized.

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.

For more information, visit www.factglobal.org.

Media Contact
fact@factglobal.org
+1 (402) 920-7001

OMAHA, Neb. - Shandong Qilu Stem Cell Engineering Co., Ltd. (Shandong CBB) in Jinan City, Shandong, China, achieved internationally recognized accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT), on February 18, 2025. Shandong CBB is the first and only cord blood bank in mainland China to receive this recognition. Under the leadership of Baijun Shen, MD, the bank has demonstrated its commitment to quality by meeting FACT’s Standards for cord blood collection, banking, and release for administration of both unrelated and related donations.

A spokesperson for Shandong CBB notes, “FACT accreditation represents a rigorous validation of our commitment to global standards of excellence in cellular therapy and cord blood banking. This achievement not only elevates the quality of healthcare services in China but also strengthens international trust in our capabilities. The accreditation process was a transformative journey for our team, reinforcing the importance of collaboration, precision, and continuous improvement. We hope this milestone inspires further advancements in the field across the region.”

With FACT-NetCord accreditation, Shandong CBB demonstrates its commitment to meeting the highest international standards in the field of cord blood banking.

Dr. Phyllis Warkentin, MD, FASTCT, FACT Chief Medical Officer, states, “Achievement of accreditation by FACT is a significant accomplishment for the Shandong Qilu Stem Cell Engineering Co., Ltd., of Jinan City, the first Cord Blood Bank in mainland China to reach this milestone. Through this accreditation, Dr. Zhonghua Chu, Cord Blood Bank Director, Dr. Baijun Shen, and the staff at the Cord Blood Bank and Processing Facility, in conjunction with numerous collaborating hospitals that provide cell collections have demonstrated their dedication, resilience, and commitment to providing high quality products for the patients they serve. FACT recognizes this important accomplishment and the leadership of the Shandong Qilu Stem Cell Engineering Co., Ltd., in the field and the region.”

The Foundation for the Accreditation of Cellular Therapy (FACT) establishes and promotes high-quality standards for cellular therapy and cord blood banking worldwide.

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.

For more information, visit www.factglobal.org.

Media Contact
fact@factglobal.org
+1 (402) 920-7001