Linda Miller, MPA
Foundation for the Accreditation of Cellular Therapy (FACT)
United States
This year marks a significant milestone for the Foundation for the Accreditation of Cellular Therapy (FACT): 30 years of advancing quality and patient safety in cellular therapy and transplantation. What began as a bold vision to standardize excellence in hematopoietic cell transplantation has grown into a global movement that continues to shape the future of cellular therapies.
Over the past three decades, FACT has worked in close partnership with the clinical, laboratory, and collection communities to establish consensus, evidence-based standards that promote high-quality care and protect patients undergoing some of the most complex and life-saving therapies in medicine. Through accreditation, education, and collaboration, FACT has helped embed quality as a cornerstone of cellular therapy practice worldwide.
Reflecting on FACT’s founding, Elizabeth Shpall, MD, FACT’s Founding President, emphasized the organization’s original purpose:
“FACT was created to ensure that patients receiving cellular therapy could trust that their care met the highest standards of quality and safety. That commitment has remained unwavering for 30 years, even as the field has evolved in extraordinary ways.”
Phyllis Warkentin, MD, FACT’s Founding Chief Medical Officer, highlighted the enduring importance of standards and collaboration:
“From the very beginning, FACT brought together diverse experts with a shared goal—to improve outcomes for patients through continuous quality improvement. The strength of FACT has always been its ability to listen to the field and respond thoughtfully as science advances.”
As cellular therapy enters a new era defined by rapid innovation, FACT’s mission is more relevant than ever. Looking ahead, the organization’s strategic imperative focuses on increasing patient access to cellular therapies, while remaining agile and responsive to emerging and evolving treatments, including novel immune effector and genetically modified cells. FACT is committed to ensuring that quality frameworks evolve alongside scientific discovery, supporting both innovation and patient safety.
Navneet Majhail, MD, FACT’s President, underscored this forward-looking vision:
“As we celebrate 30 years of impact, we are equally focused on the future. FACT is committed to expanding access to life-saving cellular therapies for patients everywhere, while continuing to adapt our standards and accreditation programs to meet the needs of a rapidly changing field.”
No celebration of FACT’s legacy would be complete without recognizing the extraordinary contributions of its volunteer inspectors. These dedicated professionals generously give their time, expertise, and passion to support accreditation visits around the world. They are among the most giving professionals in cellular therapy, and FACT is deeply grateful for their unwavering commitment to excellence and patient safety.
FACT also proudly recognizes the vital contributions of its committee members—experienced professionals from across the field who work diligently to guide the development and implementation of FACT’s strategic initiatives. Their insight, leadership, and commitment ensure that FACT remains responsive to the evolving needs of patients, programs, and the broader cellular therapy community.
Throughout this year-long anniversary celebration, FACT will reflect on its history, honor the individuals who have shaped its journey, and highlight the work still ahead. Together with its volunteers, partners, and accredited programs, FACT looks forward to continuing its mission—improving quality, advancing safety, and expanding access to cellular therapies for patients worldwide—for decades to come.
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