Just the FACTs 2025 Volume 3
President’s Letter
I think we can all agree that 2025 has seen much change and uncertainty for many in our global cell therapy community and beyond. At FACT too, throughout our nearly 30 years of standards setting and accreditation, we have experienced times of change with numerous “inflection points”. These have included periods where we have launched into new waves of cellular therapy and associated offerings, such as new Standards, new technologies, and new stakeholders. Therefore, to meet the increasing needs of the transplantation and cellular therapy community, we are embarking on new activities to meet the accelerating demands for quality cellular therapy programs with new standards and accreditation processes.
To that end, I am excited to say that last week we announced the Community CAR T Working Group, which is described in more detail within this newsletter. We have also received initial accreditation applications from 48 organizations, including transplant programs, immune effector cell programs, collection facilities, processing laboratories, and cord blood banks. This represents the tremendous growth in our field to pursue safe, effective, and accessible cellular therapies worldwide. Accommodating this growth is central to the FACT mission!
Finally, also in this newsletter, our CEO, David Schmahl, who joined FACT twelve months ago, outlines his plans for positioning FACT well into the future. In these rapidly changing times, David and the entire HQ team have been working tirelessly to move FACT forward into our next 30 years! With multiple new cellular therapy products, indications, and providers, this is indeed an exciting time for FACT!
Sincerely,
Cath
Catherine Bollard, MD
FACT President
Reflections and Visions of FACT After My First Year of Service: Commentary from FACT Chief Executive Officer, David Schmahl
Greetings from America’s upper Midwest, where I reside, and where spring is valiantly attempting to ‘break through.’ The sprouting and growth of past planting efforts is a helpful reminder that many good things (spring blooms) take forward-looking actions (fall planting) and time to materialize. I’ll come back to this metaphor.
A year has passed since my Board appointment to lead FACT’s Headquarters (HQ) Team – a privilege and honor I deeply respect. The majority of my career has been in service of individual volunteer leaders, headquarter staff members, and missions of non-profit healthcare and scientific organizations. I never take for granted the passion and importance of those I serve, and FACT has proven, as I fully expected, to be an exemplary example. I’m both humbled and energized.
I extend many thanks to all the FACT Directors, committee chairs and volunteers, and HQ Team colleagues who have made time to help me navigate the first year. All stakeholders and beneficiaries of FACT’s offerings and services, like me, have a debt of gratitude to these passionate, skilled, and knowledgeable leaders.
2026 will mark thirty years of FACT’s service to quality-driven and safe administration of cellular therapy! The vision and efforts of founding leaders – Drs. Elizabeth Shpall, Richard Champlin, Nancy Collins, Allen Eaves, Adrian Gee, Fred LeMaistre, Richard O’Reilly, Scott Rowley, Keith Sullivan, William Vaughan, and Phyllis Warkentin – continue under incredibly capable hands of current leaders, including Dr. Catherine Bollard (FACT President) and Dr. Navneet Majhail (FACT Vice President), among many others.
Today, we’re successfully and steadily executing upon FACT’s strategic plan, developed in early 2023. I’m thrilled for an in-person Board retreat this June for a thorough assessment of FACT’s progress against our goals, the field of cellular therapy (current and future), and strategic thinking that will lead to an updated plan.
Against this backdrop of strategic thinking and action-taking, I highlight here some efforts, outcomes, and data points:
- At FACT HQ, now numbering 28 dedicated and highly talented professionals, we are accelerating efforts that solidify our people and processes foundation. This remains critically important as we advance fully independent from our historical HQ partner, the University of Nebraska Medical Center. Our “FACT HQ: Engage, Develop, and Perform” framework is the feature of a HQ retreat this June.
- We are investing in our Accreditation Services line of work with additional leadership, additional coordinators, and continued development of enhancements to our Accreditation Portal launched in 2023. These investments look to the future and are proving prescient, as 2024 saw 27 organizations seeking initial accreditation (a record number, which has since climbed to 48 to date). FACT currently administers accreditation of 314 organizations, spanning 26 countries.
- FACT’s educational/learning activities continue to grow. In 2024, we hosted 12 in-person events, 12 virtual events, and offered 32 on-demand sessions. Our in-person courses are being curated in our Learning Management System and generating steadily growing demand.
- FACT Consulting Services, LLC (governed and managed independently of our Accreditation Services) managed record-level numbers of ‘Custom Solution’ client engagements in 2024. Plus, we’re building a new solution to address a large, unmet need in our industry, to be unveiled later this year. Please stay tuned.
My arrival at FACT provided an ideal opportunity for FACT to ‘re-introduce’ itself to all the various stakeholders who benefit from and engage in our offerings and services. I made the most of it, conducting a six-month “listening tour” with fellow HQ Team colleagues, volunteer leaders, and many new friends in the ecosystem of cellular therapy. To these many new friends, I offer heartfelt appreciation for the time you’ve made, the introductions you’ve fostered, and the invitations you’ve extended. I value each of you and all of these.
The processing of this listening tour leads me to frequently say: “consistent in principle; novel in practice” about things we’re now doing at FACT.
One example (of several) with large impact for physicians, patients, and other stakeholders is the convening of the ‘Community CAR T Working Group,’ announced just last week. For more, please visit https://factglobal.org/education-and-resources/general/press-releases/car-t-working-group/.
FACT is engaging in the right conversations with the right stakeholders.
FACT is listening and taking leadership actions.
FACT is investing in HQ Team staff and solutions.
FACT is investing to remain on pace or ahead of the pace of change of cellular therapy.
I have full confidence in, and unwavering commitment and energy to, seeing these ‘plantings’ lead to future ‘sprouts’ and ‘blooms.’ As always, I invite and value ALL opportunities to listen and learn. Don’t hesitate to contact me at david.schmahl@factglobal.org.
Respectfully and gratefully,
David
FACT Convenes ‘Community CAR T Working Group’ to Review and Propose Clinical Accreditation Standards
FACT has announced 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.
FACT Accreditation: Meeting Growing Demand and Expanding Access
By Sarah Litel-Smith, BSMT (ASCP)
As the field of cellular therapy and cord blood banking continues to advance, the demand for accreditation by FACT has never been greater. Clinical programs, collection and processing facilities, and cord blood banks worldwide recognize the value of FACT accreditation in ensuring high-quality patient care, adhering to rigorous consensus standards, and promoting continuous improvement. The increasing demand reflects a commitment to quality and an understanding that FACT accreditation is not only beneficial but also accessible and attainable for organizations of all sizes and structures.
The volume of initial FACT applicants continues to grow, demonstrating an ongoing trend of institutions seeking accreditation for the first time. The most recent data reflects 48 initial accreditation applicants: 5 Cord Blood Banks, 25 clinical hematopoietic cell transplantation programs (many who also provide immune effector cell therapy), 3 clinical immune effector cell programs, and 15 service providers (collection and/or processing facilities accredited independently of a clinical program).
FACT accreditation is not exclusive to large, academic institutions. Many smaller, outpatient-based programs are successfully achieving accreditation, demonstrating that facilities of all sizes can meet these internationally recognized quality standards. FACT provides extensive resources, educational materials, and expert guidance to help organizations navigate the accreditation process efficiently. Each applicant is assigned an Accreditation Coordinator for ongoing assistance throughout the accreditation process.
Organizations, regardless of structure, benefit from FACT accreditation through enhanced patient care; standardized quality practices; and increased credibility among patients, donors, and stakeholders. Accreditation also streamlines audits and inspections, reinforces a commitment to quality, and fosters collaboration with other accredited institutions. A full list of accredited programs is available at www.factglobal.org/accredited-programs.
As accredited programs continue to expand, FACT remains committed to supporting organizations in ensuring that high-quality cellular therapy and cord blood banking services are accessible to patients worldwide. Whether your program is a large academic center or a small community-based facility, FACT accreditation is within reach, providing measurable benefits for both providers and patients alike.
Available Online: Meeting Summary of the 21st Cell Therapy/FDA Liaison Meeting
Each year, FACT and several organizations regularly collaborate with the United States Food and Drug Administration (FDA) to identify and then discuss important topics in cellular therapies during the Cell Therapy/FDA Liaison Meetings (CTLM). These meetings provide important opportunities to express challenges and desired outcomes to the FDA.
The 21st CTLM, hosted by the International Society for Cell & Gene Therapy (ISCT), occurred on November 19, 2024. Topics included:
- Labeling of Cellular Therapy Starting Materials for Further Processing
- GxP Compliance for Phase 1 and Phase 2 Clinical Trial Manufacturing
- Manufacturing Cellular Products Using Viral Vectors
- FDA’s Current Views and Strategies on The Ban of Plasticizers (DEHP) Used in Manufacturing and Banking of Cord Blood and Blood Products
- Cord Blood as Starting Material for Adoptive Immunotherapies
- Cell Therapy Products: Framework for Relating Mechanism of Action, Potency & Efficacy
- Use of Research-grade Material for Manufacturing due to Source Material Constraints
The presentation slides and a meeting summary are available on the ISCT website after logging in or providing minimal demographic information. All are encouraged to read the information presented to the FDA. While on this webpage, see also summaries from past CTLMs!
Register for Upcoming FACT Education Events!
May
May 6 – FACT Laboratory Processing Inspector Training Course* prior to the 2025 ISCT Annual Meeting | New Orleans, LA
- *FACT Inspector Training Courses are for approved trainees only. An approved trainee is someone who meets the initial qualifications and has completed the required prerequisites. FACT will directly notify applicants when they are approved and are eligible to register for training. If you are unsure of your trainee status, please contact inspectors@factglobal.org before registering.
May 19 – FACT-WMDA Cellular Therapy Accreditation & Quality Principles Workshop at the CTTC/IDRC Joint Annual Conference | Québec City, Quebec, Canada
June
June 24 – FACT Apheresis Collection Virtual Accreditation Workshop | Zoom
September
Sept. 25 – FACT Apheresis Collection Virtual Quality Boot Camp | Zoom
