Just the FACTs – January 2026
FACT Appoints Navneet Majhail, MD, MS, FASTCT as President and Welcomes Three Additional Leaders to Board of Directors
FACT 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.
Highlights of FACT’s Activities and Outcomes in 2025
David Schmahl, CEO of FACT
On behalf of FACT’s Board of Directors, volunteer leaders, and headquarters staff, I’m privileged to share with you highlights of our efforts and outcomes of the past year. The information is a celebration of the value FACT brings to the quality, safety, and access of cellular therapies to patients who need them.
This is also a celebration of the commitment and expertise of FACT’s “army of volunteers” behind our peer-based and consensus-driven efforts. These activities and outcomes reflect the dedication, expertise, and hard work of hundreds of peers who volunteer to advance FACT’s mission. I hope our volunteers take earned pride in your volunteer contributions to FACT. We sincerely appreciate and thank you.
Equally important to FACT’s daily operational work is the planning and delivery of offerings to assure eligible patients are experiencing quality and safety as cellular therapies expand and evolve. In 2025, FACT re-committed itself to being part of the many solutions needed to bring CAR T therapies closer to where ALL patients live and work. FACT supports the CAR T Vision (see www.cartvision.com) and published critically important “fit for purpose” IEC-in-Community Standards in November.
The information that follows is organized by main areas of FACT’s work and associated service lines, reflecting both the dedication of our Headquarters staff as well as all FACT volunteers – the life-blood of our organization. “FACT Forward” is a phrase we’re using more and more, and you are an essential part of it.
Respectfully and gratefully, David
Celebrating 30 Years of FACT: Advancing Quality, Safety, and Access in Cellular Therapy
Linda Miller, FACT Chief Operating Officer
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.
To honor these remarkable volunteers, FACT warmly invites attendees of the upcoming Tandem BMT Meetings in Salt Lake City, Utah, to join us for a 30th Anniversary FACT Volunteer Recognition Breakfast on Thursday, February 5, 2026, from 7:00–9:00 am, at the Hilton Salt Lake City Center. This special event will be an opportunity to celebrate our volunteers, reflect on FACT’s 30-year journey, and connect with colleagues who share a commitment to quality and patient-centered care.
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.
FACT Appreciates the Volunteer Experts who Joined the FACT Inspectorate in 2025
Janice Donoghue, Inspector Development Specialist
Congratulations to the FACT Inspector Trainees that completed all requisites to become active inspectors in 2025. A total of 34 individuals became new active inspectors last year, and 2 additional inspectors added a new qualified inspection category. These esteemed volunteers devoted time and commitment to successfully:
- Pass the FACT Inspector Standards Test
- Complete the FACT Inspector Training program (including pre- and post-training requisites)
- Attend a FACT Training Inspection with a FACT Mentor
Please join us in welcoming the following individuals to the FACT inspectorate:
| Ambuga Badari, MD |
| Banner MD Anderson Cancer Center |
| Clinical CT/IEC |
| Jessika Barrera, BS, MLS (ASCP) |
| Sarah Cannon Transplant and Cellular Therapy Program Cell Processing Laboratory @ Methodist Hospital |
| Minimal Processing |
| Catherine Delanoix, MS, RN |
| The University of Texas MD Anderson Cancer Center Stem Cell Transplantation and Cellular Therapy |
| Clinical CT |
| Radowan Elnair, MBBS |
| Roger Williams Medical Center Blood and Marrow Transplant Program |
| Clinical CT/IEC |
| Magdi Elsallab, MD, PhD |
| The Massachusetts General Hospital Hematopoietic Cell Transplantation and Cellular Therapy Program |
| Minimal Processing |
| Manuel Espinoza-Gutarra, MD |
| The University of Alabama Adult and Pediatric Bone Marrow Transplantation and Cell Therapy Program |
| Clinical CT/IEC |
| Taylor Fitch, MD, MPH |
| Arthur M. Blank Hospital Blood and Marrow Transplantation Program |
| Clinical CT/IEC |
| Zhubin Gahvari, MD, MS |
| University of Wisconsin Madison Stem Cell Transplant and Cellular Therapy Program |
| Clinical CT/IEC |
| Qingdong Guan, PhD, F(ACHI) |
| Manitoba Blood & Marrow Transplant Program |
| M/MTM Processing |
| Gaurav K. Gupta, MD, PhD |
| Memorial Sloan-Kettering Cancer Center – Blood and Marrow Transplant Program |
| Apheresis |
| Thoraya Henein, MT(ASCP) |
| The Blood and Marrow Transplant Program at Northside Hospital |
| Apheresis |
| Samantha Hodgins, HBSc, MSc, CCRP |
| The Ottawa Hospital Research Institute’s Biotherapeutics Manufacturing Center – Cell Manufacturing Facility |
| M/MTM Processing |
| Yogesh Jethava, MD, FACP, MRCP(UK), FRCPath(UK) |
| Advocate Bone Marrow Transplant and Cellular Therapy Program at Advocate Lutheran General Hospital |
| Clinical CT/IEC |
| Phillip Johnson, MMedSC(Path) |
| Queensland Cord Blood Bank At The Mater |
| Minimal Processing (additional inspection category) |
| Stephan Kadauke, MD, PhD |
| Children’s Hospital of Philadelphia Division of Oncology; Cellular Therapy and Transplant Section |
| M/MTM Processing |
| Grace Kim, MLS |
| Hackensack Meridian John Theurer Cancer Center Stem Cell Transplantation and Cellular Therapy Program |
| Minimal Processing |
| Scott Koepsell, MD, PhD |
| University of Nebraska Medical Center/Nebraska Medicine Hematopoietic Cell Transplantation Program |
| M/MTM Processing (Additional inspection category) |
| Stephanie Larson, MSN, RN, BMTCN |
| Sarah Cannon Transplant and Cellular Therapy Program @ TriStar Centennial |
| Clinical CT/IEC |
| Isabelle Louis, PhD |
| Cellular Therapy Program – CHU Sainte-Justine |
| Minimal Processing |
| Michael Maffie, MBA, C(ASCP) |
| Mathews Center for Cellular Therapy |
| Minimal Processing |
| Cheryl Martinez, MS, RN |
| Prisma Health Cancer Institute Transplant and Cellular Therapy Program |
| Clinical CT |
| Candace Mayle, DNP, APRN |
| Arkansas Children’s Hospital |
| Clinical CT |
| Jeremy Pantin, MD (MB.BS.), FACP |
| Sarah Cannon Transplant and Cellular Therapy Program @ TriStar Centennial |
| Clinical CT/IEC |
| Marcia Emelia Pereira, MSN, APRN, AGPCNP-BC, AGACNP-BC |
| Blood and Marrow Transplant Program at Miami Cancer Institute |
| Apheresis |
| Laleh Ramezani, BS, MLT |
| USC Blood and Marrow Transplant Program |
| Minimal Processing |
| Rikin Shah, MD |
| Orlando Health Cancer Institute Bone Marrow Transplant and Cellular Therapy |
| Clinical CT/IEC |
| Nancy Shreve, FNP, MS, RN |
| The Children’s Mercy Hospital Blood and Marrow Transplant Program |
| Clinical CT |
| Sheryl de Silva, BS (BIOS) |
| BMDI Cord Blood Bank |
| Cord Blood Bank |
| Yuliya Smirnov, MS, RN, OCN |
| Northwest Marrow Transplant Program at Oregon Health & Science University, Legacy Good Samaritan Hospital and Medical Center and Doernbecher Children’s Hospital |
| Clinical CT |
| Sandeep Srivastava, PhD |
| Hoxworth Blood Center University of Cincinnati Academic Health Center |
| M/MTM Processing |
| Swati Srivastava, MD |
| Cleveland Clinic Blood and Marrow Transplant Program |
| Apheresis |
| Nabil Tabish, MD, MS |
| St. Jude Children’s Research Hospital Department of Bone Marrow Transplantation and Cellular Therapy |
| Apheresis |
| Jay Tanna, MS, RAC |
| Children’s National Health System Blood and Marrow Transplant Program |
| M/MTM Processing |
| Kimberly Weirick, DNP, RN, NEA-BC |
| The Ohio State University Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
| Apheresis |
| Junann Whish-Wilson, BS |
| BMDI Cord Blood Bank |
| Cord Blood Processing |
| Timothy Wiltshire, PhD |
| Mayo Clinic Rochester Blood and Marrow Transplant Program |
| M/MTM Processing |
Clarifying Labeling for Third-Party Manufacturer Products
Sarah Litel-Smith, Manager, FACT Accreditation Services
Phyllis I. Warkentin, MD, FASTCT, FACT Chief Medical Officer
The recently published FACT-JACIE Standards for Hematopoietic Cellular Therapy, Ninth Edition (version 9.1) and FACT-JACIE International Standards for Immune Effector Cells, Third Edition (version 3.1) both include Standard D7.4.10, which requires cellular therapy products from third-party manufacturers to have labels that meet FACT-JACIE requirements and Applicable Law. This article provides clarification on the explanation provided in the accompanying FACT-JACIE Accreditation Manuals.
For products manufactured under an FDA Biologics License Application (BLA) or used under an Investigational New Drug (IND) application, required label content is dictated by applicable regulations. Therefore, a product bearing an FDA-approved label as part of a BLA or IND is compliant with the Standards because it meets Applicable Law. FACT does not require relabeling of licensed (BLA) or regulatory-authorized (IND) products by the receiving facility.
Although some third-party manufactured products may not bear ISBT 128-compliant labels, these may be acceptable if they have regulatory approval and provide sufficient traceability and chain of identity. Relabeling such products may introduce risks of error, confusion, delay in administration of the therapy, or conflict with regulatory information.
FACT encourages the use of ISBT 128 coding and labeling to the extent possible to improve safety and traceability. Supplemental labels are permissible when the institutional practices would increase safety and traceability. In addition, accredited facilities should:
- Encourage in-house and third-party manufacturers to use ISBT 128 coding and labeling when feasible.
- Encourage alignment with labeling expectations in Appendix I of the Standards.
- Encourage use of enhanced features of ISBT 128 coding and labeling as defined by ICCBBA in its Standards for cell collections intended for further manufacturing, including:
- Use of the Hybrid Label (ICCBBA ST-018), that incorporates both ISBT 128 traceability elements and manufacturer-specific information.
- Use of the Chain of Identity Identifier (ICCBBA ST-028).
The ICCBBA Standards referenced above were developed by collaborating stakeholders representing cellular therapy programs, industry, professional societies, and accreditation organizations. These approaches support traceability and consistency without creating conflicts with regulatory labeling.
FACT Consulting: A Trusted Partner
Federico Rodriguez BSMT, SBB (ASCP), FACT Consulting Client Services Manager
FACT Consulting is your trusted partner in advancing excellence in patient care and laboratory practice. As a subsidiary of the Foundation for the Accreditation of Cellular Therapy (FACT), FACT Consulting offers customized, fee-for-service consulting solutions designed to meet the unique needs of cellular therapy programs.
Our consultants are recognized experts in cellular therapy with deep knowledge of the rapidly evolving regulatory and clinical landscape. They deliver practical, actionable strategies to help organizations strengthen quality systems, achieve and maintain compliance with accreditation standards, and confidently prepare for FACT inspections.
One of its most recent efforts to support expansion of Immune Effector Cells in the Community Clinical Setting is the development of strategies to prepare those centers to achieve FACT provisional accreditation. For eligible centers, FACT now provides a pathway wherein a Clinical Program demonstrates compliance with all FACT Standards except those related to patient numbers and length of attending physician experience. Provisional accreditation confirms a program’s readiness to safely and effectively administer cell therapies.
What sets FACT Consulting apart is unparalleled access to leading practitioners in the field. With an average of more than 20 years of hands-on experience working with FACT, our consultants bring proven expertise, a strong commitment to quality excellence, and a collaborative approach to driving meaningful and sustainable improvement.
Partner with FACT Consulting to enhance operational performance, elevate quality outcomes, and achieve inspection readiness with confidence.
To learn more, visit FACT Consulting or contact Federico Rodriguez, FACT Consulting Client Services Manager at 402.920.7027.
2026 FACT Education: Empowering the Next Generation of Quality and Safety
Breann Weishaar, FACT Communications and Design, Senior Associate
FACT Education is heading into 2026 with momentum—and a milestone. After an incredible 2025 that saw more than 800 professionals trained through in-person and virtual programs, FACT now celebrates 30 years of service to the cellular therapy community. As we reflect on where we’ve been, we remain focused on what comes next: empowering the next generation of quality and safety leaders across the field.
As part of this transition year, FACT would also like to share an important update regarding accredited continuing education credits. In 2025, FACT partnered with the Endeavor Health as part of a joint providership, to offer AMA PRA Category 1 Credits™ for eligible education events. This collaboration allowed FACT to provide over 60 CME credits to eligible U.S. physicians, helping streamline professional and licensure requirements. Due to Endeavor’s own reaccreditation requirements, this initiative will be paused for 2026. FACT remains committed to resuming CME offerings as soon as possible and expanding the types of credits available in the future.
FACT’s in-person education journey begins, as it does every year, at the Tandem Meetings—this time in Salt Lake City, Utah. On Monday, February 2, FACT will host a Quality Boot Camp, followed on Tuesday, February 3, by an Accreditation Workshop and Clinical Inspector Training. Later that week, FACT will recognize its volunteers with a Volunteer Recognition Breakfast on Thursday, February 5. Attendees are also encouraged to stop by Booth 128 in the Exhibit Hall to connect with the FACT team and pick up some special 30th-anniversary swag.
From there, FACT heads to Madrid, Spain for the 2026 WMDA & EBMT Annual Meetings. On March 21–22, FACT will offer a Cord Blood Banking Inspector Training and a Cord Blood Banking Accreditation Workshop. Members of the FACT Cord Blood Standards Committee will also be onsite as they begin planning the 9th Edition NetCord-FACT Standards, making this an especially exciting moment for the cord blood community.
The spring continues back in the United States at the 2026 ASFA & WAA Joint Meeting in Denver, Colorado, where FACT will host an Apheresis Collection Inspector Training Course on April 21 and participate in the exhibit hall. Those interested in becoming inspectors are encouraged to explore eligibility requirements at https://factglobal.org/inspectors/ or reach out with questions at inspectors@factglobal.org.
April remains busy as FACT once again partners with the 2026 CTTC Annual Meeting to bring education opportunities to our Canadian colleagues. This year, FACT will host an Accreditation Workshop and also plans to participate in the exhibit hall, with more details to be shared as the meeting approaches.
Later in the year, FACT travels to Melbourne, Australia for the ISCT ANZ Regional Meeting, where an Accreditation Workshop and a Clinical Inspector Training Course are planned. FACT’s final scheduled stop for 2026 will be at the ASH Annual Meeting in Orlando, Florida, where the organization will host an exhibit booth.
As always, FACT continues to look for new opportunities to reach and support the global cellular therapy community. If there is a conference you would like FACT to attend in the future, requests may be submitted through the Ask FACT form at https://www.factglobal.org/ask-fact/. Please note that all educational offerings are subject to change.
In addition to in-person events, FACT remains committed to expanding access through virtual education. Building on lessons learned since the COVID-19 pandemic, FACT’s 2026 virtual offerings include webinars, workshops, and boot camps designed to meet learners where they are. The year begins with a webinar introducing the new Community Immune Effector Cell (IEC) Standards, recorded on January 27, 2026. Those who missed the live session may register for the on-demand version free of charge.
FACT will also host a Virtual Workshop on Apheresis Collection & Laboratory Processing Accreditation on June 25, 2026, followed by a Virtual Boot Camp on Apheresis Collection & Laboratory Processing Quality Management on September 10, 2026. The boot camp will feature interactive lectures and small-group breakout sessions. While examples may focus on collection and processing, both events are applicable to professionals across cell and gene therapy programs.
Rounding out the year is one of FACT’s most anticipated offerings: Quality Management Webinar Series 14. The four-part series will run from July through November 2026, with options to register for individual sessions or bundled LIVE or On-Demand access. LIVE participants will receive real-time access and recordings, while On-Demand registrants will receive recordings and access to evaluations required for certificates of completion.
FACT looks forward to learning with you throughout 2026 as we continue to empower the next generation of quality and safety. To stay informed about upcoming and on-demand education opportunities, as well as receive industry and newsletter updates, subscribe to FACT’s Mailing List. For questions about FACT’s educational offerings, please contact FACT Events at factevents@factglobal.org.
2026 Education Calendar: https://learn.factglobal.org/EducationEvents
Upcoming Events: https://learn.factglobal.org/upcoming-events
On-Demand Education: https://learn.factglobal.org/on-demand
