Kara Wacker, MBA, RAC
Foundation for the Accreditation of Cellular Therapy
United States

FACT Chief Medical Officer Phyllis I. Warkentin, MD, FASTCT, Announces Retirement After 30 Years of Leadership

FACT announced that Phyllis I. Warkentin, MD, FASTCT, founding leader and Chief Medical Officer, will retire from her position on December 31, 2026, marking the conclusion of 30 years of extraordinary service and leadership in hematopoietic cell transplantation and cellular therapy.

“Phyllis has devoted her career to advancing quality, safety, and excellence in hematopoietic cell transplantation and cellular therapy,” says FACT Board President Navneet Majhail, MD, MS, FASTCT. “When FACT was founded, the vision was both ambitious and transformative: to ensure that quality standards for transplantation and cellular therapies would be developed by the professionals who deliver them, guided by scientific evidence, collaboration, and an unwavering commitment to patient outcomes. Phyllis has been instrumental in turning that vision into a globally respected reality.”

A Founding Leader of FACT

Dr. Warkentin has been a vital leader of FACT since its founding in 1996 by the American Society for Transplantation and Cellular Therapy, and the International Society for Cell and Gene Therapy.

As a member of the founding FACT Board of Directors, Dr. Warkentin led the publication of FACT’s first peer-developed, comprehensive, patient-centric standards, developed and implemented the accreditation program, and established the organization’s headquarters through collaboration with the University of Nebraska Medical Center, hiring its first employees in 1996. She has served as the Chair of the FACT Accreditation Committee since its inception, gradually increasing her role from volunteer to full-time Chief Medical Officer. Her leadership, passion, and tireless efforts transformed the organization’s vision into a globally respected accreditation program.

Dr. Warkentin has played a major role in shaping FACT’s international reach in both Standards development and accreditation through partnerships with leading organizations in the field, including the International NetCord Foundation beginning in 2000, the European Society for Blood and Marrow Transplantation (EBMT) through the formation and collaboration with JACIE, the Joint Assurance Committee of ISCT and EBMT in 2006, and the Center for International Blood and Marrow Transplant Research (CIBMTR), among others. These collaborations have established internationally developed standards and a global framework for quality and safety in hematopoietic cell transplantation, immune effector cell therapy, and cord blood banking.

Today, FACT publishes four sets of internationally recognized standards in cellular therapy and transplantation, and accredits programs and cord blood banks worldwide. More than 200 clinical programs, and a total of over 350 cell therapy facilities are FACT-accredited, ensuring patients of quality care and laboratory services. The FACT headquarters’ team now includes 32 dedicated professionals who serve with hundreds of invaluable volunteers to support FACT’s mission.

Distinguished Career

In addition to her leadership of FACT, Dr. Warkentin is Professor of Pathology, Microbiology, and Immunology and Pediatrics at the University of Nebraska Medical Center in Omaha. At UNMC, she has served as a clinical attending transplant physician and medical director of the bone marrow collection service, Transfusion Medicine Service, and the Biologics Production Facility.

Dr. Warkentin is a graduate of Millikin University and the University of Minnesota Medical School. She is board-certified in Pediatrics, Pediatric Hematology/Oncology, and Transfusion Medicine. She has authored more than 100 peer-reviewed scientific publications in hematopoietic cell transplantation, cellular therapy, and transfusion medicine and is widely recognized for her contributions to research, education, clinical practice, and professional leadership.

Her professional honors include the American Society for Blood and Marrow Transplantation Public Service Award in 2014. In 2025, she was inducted into the American Society for Transplantation and Cellular Therapy (ASTCT) Fellows Program (FASTCT) in recognition of her exceptional achievement and service to the transplant community.

A Legacy of Integrity, Collaboration, and Service

While Dr. Warkentin’s professional accomplishments are extensive, her colleagues say her greatest contribution may be the culture she has built and nourished within FACT and throughout the cellular therapy community.

“She has cultivated a culture of integrity, collaboration, humility, and service that defines FACT today,” Dr. Majhail said. “She has mentored generations of physicians, laboratory professionals, inspectors, volunteers, and staff while always reminding us that every decision we make ultimately serves one purpose: improving the lives of patients. Her impact on FACT and on quality and patient safety across our field is unmatched, and we are profoundly grateful for her extraordinary 30 years of service.”

Dr. Elizabeth Shpall, FACT’s first President of the Board of Directors shares her admiration of Phyllis, saying “Phyllis has been the heart and soul of FACT since its inception. Her extraordinary clinical and regulatory expertise, coupled with her strategic vision and unwavering commitment, have been instrumental to FACT’s success and growth. Her leadership, insight, and dedication have left an indelible mark on the organization, and her contributions have been truly invaluable.”

Looking to the Future

Dr. Warkentin said her decision comes at a natural transition point for both her and the organization. “Promoting quality and excellence in clinical care and laboratory practice in cellular therapy through FACT has been my passion for over thirty years, as a pediatric hematology/oncology physician, specialist in blood and marrow transplantation and transfusion medicine, and as FACT Chief Medical Officer,” Dr. Warkentin said.

“It is my honor to have served in this role alongside many dedicated colleagues and volunteer leaders in the field of cell and gene therapy. I am deeply grateful for the trust and confidence placed in me, for the guidance and support of the FACT Board and volunteers, and for the lifelong friendships that have developed over thirty years.”

“As FACT moves forward under new leadership, I am confident in its future as the premier organization setting standards and awarding accreditation in the field of cell and gene therapy for the benefit of patients.”

Dr. Warkentin is working closely with the FACT Board of Directors and CEO to support a thoughtful and seamless leadership transition. Succession plans will be shared in the coming months, ensuring stability and continuity of operations and reaffirming FACT’s commitment to continued advancement of its mission.

Tennessee Oncology First to Achieve FACT Community IEC Accreditation, Signaling Shift in Access to Cellular Therapies

FACT also announced that Tennessee Oncology has become the first community-based oncology program accredited under the FACT Standards for Immune Effector Cells in the Community Clinical Setting, 1st edition.

This milestone is a significant step toward addressing patient access to life saving cellular therapy and demonstrates that high-quality delivery of immune effector cell (IEC) therapies—such as CAR T-cell therapy—can be achieved safely and effectively in community oncology settings, bringing care closer to where patients live.

“A strategic imperative of FACT is to help expand eligible patient access to safe and quality-based CAR T therapies throughout America’s communities,” says Dr. Navneet Majhail, FACT President.  “We’re very impressed with Tennessee Oncology’s leadership and entire team, and are taking steps to accelerate other community-based programs toward the same end.”

The FACT Community IEC Standards, developed through consensus of a multi-stakeholder Working Group and published in November 2025, adapt the FACT-JACIE International Standards for Immune Effector Cells as “fit for purpose” to the services provided by community-based oncology programs while maintaining a strong foundation in quality and patient safety.

“Tennessee Oncology is incredibly proud of the high-quality care we provide to our patients every day. Becoming the first community oncology practice to earn FACT accreditation is significant and reflects our unwavering commitment to advancing clinical research and delivering the highest standard of care to patients receiving cellular therapy. We are proud to reach this historic milestone and grateful to our leadership, hospital colleagues and FACT for their collaboration and support.  We also appreciate FACT’s partnership in working collaboratively with community oncology physicians to develop the first set of fit-for-purpose standards for community-based cellular therapy programs,” says Michael Byrne, DO, FACP, Cellular Therapy Program Director, Tennessee Oncology, and Medical Director, Cellular Therapy, OneOncology.

Expanding on this, Davey Daniel, MD, Chief Medical Officer, OneOncology, says, "Tennessee Oncology's FACT accreditation is a milestone for community oncology.  It proves that high-quality CAR-T delivery is achievable outside the academic setting in a clinic-based model which is essential for the patients we serve who depend on access close to home. We're grateful to FACT for their commitment to fit-for-purpose standards in the community practice setting, and we look forward to supporting four additional OneOncology practices as they pursue accreditation."

Expanding access through community-based care models has the potential to reduce travel burdens, improve patient adherence, and address disparities tied to geography and socioeconomic status. Research shows that reducing distance to treatment centers can significantly increase the number of patients who receive CAR T-cell therapy, underscoring the importance of bringing care closer to patients.

“FACT is committed to expanding patient access and working with community oncology programs to ensure that care happens safely and with quality at the forefront,” adds David Schmahl, FACT CEO. “This first accreditation demonstrates what is possible when innovation in care delivery is paired with professionals that are passionate for patient safety and rigorous quality standards.”

FACT encourages community oncology programs and stakeholders across the healthcare ecosystem to explore the Community IEC Standards and consider accreditation as part of a broader effort to expand access to cellular therapies while maintaining the highest levels of quality and patient safety.

FACT Introduces New Intermediary Storage Checklist

FACT has developed a new Intermediary Storage Checklist in response to the increasing use of temporary storage locations outside the direct oversight of the Clinical Program, Collection Facility, or Processing Facility. The checklist supports review of temporary storage sites—such as pharmacies, blood banks, or laboratories outside the processing facility—that store cellular therapy products between key points in the product lifecycle.

This shortened, targeted checklist is issued within applicable Cellular Therapy Compliance Applications when an intermediary storage site is identified. It supports review and documentation to confirm that cellular therapy products are secure, maintained at appropriate temperatures, traceable, and managed by trained staff. It also supports evaluation of key processes, including product receipt into storage, release from storage, response to storage alarms, temperature excursions, damaged containers, and leaking product containers.

A key focus of the checklist is chain of custody. Cellular therapy products must be continuously accounted for throughout the product lifecycle, including collection, processing, storage, shipment, transportation, and other points of transfer. Documentation must clearly identify the product’s location, status, and the designated party responsible for the product at each applicable step.

Although the checklist questions are derived from the Processing Standards, they should be answered in relation to the storage services performed by the intermediary storage site. Programs should complete the checklist sequentially in the FACT Accreditation Portal, as some questions include logic that will remove non-applicable follow-up items based on prior responses. Many questions also include an option to indicate when a requirement is not applicable. Programs are encouraged to use the optional comment field to provide brief explanations for the FACT office and inspection team.

When completing the Processing Facility Grid, storage-only facilities are required to complete Table 2: Storage Facility Demographics only. The general processing facility demographics and processing activity tables do not apply unless the storage site performs processing activities.

Some requirements may appear similar to items addressed elsewhere in the Compliance Application, such as chain of custody, chain of identity, internal transfer, personnel safety, and use of personal protective equipment. However, these topics apply across multiple areas of operation and must be demonstrated within the context of the specific service being evaluated.

This checklist reflects FACT’s continued commitment to patient safety, product traceability, and documented accountability across the full continuum of cellular therapy.