Carlos Bachier, MD
Dr. Bachier has been an integral part of FACT for over two decades, first as an inspector and then as a board member from 2016 to 2024. His work on the FACT-JACIE Task Force, which he co-chairs, has been pivotal in maintaining and advancing our accreditation standards for cell therapy and stem cell transplant programs throughout Latin America. Carlos has also served on multiple committees, including the FACT-JACIE Accreditation Committee and the Global Affairs Committee, where his strategic insight and international perspective have been invaluable. As a FACT Inspector since 2002, Carlos has conducted 22 clinical inspections, always ensuring that FACT’s high standards are upheld. His leadership and commitment have been essential to the growth and success of FACT.
Just the FACTs 2025 Volume 1
President’s Letter
Dear Friends and Colleagues across the FACT Community,
Happy New Year!
Here at FACT, we look forward to a year full of exciting initiatives and collaborations, accelerated by the important groundwork we laid in 2024. Over the past 12 months, we have reaffirmed FACT’s key role to promote patient access to high quality, safe, and efficacious therapies. At the same time, we have sought feedback from new stakeholders regarding how our accreditation process can meet the needs of the entire cell therapy community. Our standards development process continued, and we updated several documents to include new scientific advances in cellular therapies and toxicity management. Our educational events continued to take us around the globe, including my home country (New Zealand), where we connected in person with numerous cellular therapy program personnel and FACT volunteers from the Southern Hemisphere and beyond!
As we embark on 2025, let us all remember that ALL patients deserve high-quality care. Those patients who are receiving cell and gene therapies have generally endured physical and emotional hardships and then face many challenges on their cellular therapy journey. The therapy they receive must be delivered in the safest way possible with the best chances for success. We are proud at FACT to guide cellular therapy programs toward providing patient care within a culture of quality.
Sincerely,
Cath
Catherine Bollard, MD
FACT President
FACT Chief Medical Officer Phyllis I. Warkentin (left) and President Catherine Bollard (right) at the ISCT ANZ 2024 Meeting in Queenstown, New Zealand.
Nominate a Peer to Apply and Join the FACT Inspectorate!
FACT inspections are conducted by volunteer experts with prerequisite education and experience. This enhances the accreditation experience by fostering peer-to-peer dialogue and idea sharing, elevating all accredited programs’ quality.
As the number of FACT-accredited organizations continues to grow, our inspectorate must also grow.
The best source of inspector candidates is the encouragement of colleagues. Do you have a peer who would be a wise and collegial reviewer of other programs? Do you know of up-and-coming experts who would enjoy the professional development that comes with inspecting? Do you wish to elevate your own program’s quality by encouraging more inspectors from your institution?
The qualifications to be an inspector are linked below. Please reach out to others who you think would be outstanding inspectors and encourage them to apply.
Our inspectors are the eyes and ears, and the heart and soul, of FACT and we are looking forward to welcoming new members to the team!
Questions? Email inspectors@factglobal.org.
Step Into Action: FACT Committee Opportunities for Inspectors and Experts
The Foundation for the Accreditation of Cellular Therapy has several committees to help FACT achieve its vision of being the premiere organization setting standards and awarding accreditation to programs in the evolving field of cellular therapy.
Considering your experience and important involvement with the FACT inspection and accreditation process, we invite you to review the charges for the committees with current vacancies and either nominate yourself or a colleague to serve as a committee member. Active inspectors receive priority consideration. All volunteers must be at a FACT-accredited organization unless otherwise specified.
Thank you for your consideration in supporting FACT’s mission. We truly value your willingness to volunteer. Given the limited number of committee positions, we may not be able to place everyone, but we encourage you to consider other ways to contribute. You could become a FACT inspector or, as a subject expert, you may be contacted to assist with other initiatives. Regardless of the committee outcome, we greatly appreciate your commitment and hope to work with you in the future!
Learn more about current committee descriptions, desired expertise, and expectations:
Please submit your interest in serving as a committee member by completing the:
Applications are due February 21, 2025.
Standards and Accreditation Committees
- Standards Committees
- Common Standards Committee
- Cord Blood Standards Committee
- Accreditation Committees
- Cellular Therapy Accreditation Committee
- Cord Blood Accreditation Committee
Special Committees and Task Forces
- Inspector Development Committee
- Education Committee
- Quality Management Committee
- FACT-CIBMTR Data Audit Committee
- Immune Effector Cell Task Force
- Clinical Outcomes Improvement Committee
- Histocompatibility Committee
Thanking Outgoing FACT Board Members: Carlos Bachier, MD, Daniel Couriel, MD, and Abba Zubair, MD, PhD
As we reflect on the tremendous contributions of our outgoing board members, we are reminded of the dedication, expertise, and passion they brought to their work. Carlos Bachier, MD, Daniel Couriel, MD, and Abba Zubair, MD, PhD, have each played an instrumental role in advancing our mission and shaping the future of our organization. Their leadership has had a profound impact on FACT, and we are grateful for the time and expertise they have shared with us.
Daniel Couriel, MD
Dr. Couriel has been a dedicated member of the FACT community since 2018, with a leadership tenure that has left a lasting impact. As the Chair of the New Business Development Committee in 2022, he helped drive key initiatives that expanded FACT’s reach and influence. Daniel also served on the FACT-JACIE Accreditation Committee, further strengthening our global presence and standards. His role as a FACT Inspector since 2018, conducting 8 clinical inspections, speaks to his unwavering commitment to quality and excellence. We thank Dr. Couriel for his time, expertise, and leadership over the past six years.
Abba Zubair, MD, PhD
Dr. Zubair’s tenure on the FACT board from 2017 to 2024 has been marked by tireless dedication to both the leadership and inspection sides of our organization. As Chair of the Inspector Development Committee, Abba has been instrumental in shaping the next generation of FACT Inspectors. His service on the Cell Therapy Accreditation Committee and the Grievance Committee has helped to ensure that our processes remain robust and fair. Having completed 33 inspections including 11 apheresis collection, 5 processing laboratory, and 17 cord blood inspections—Abba’s expertise has been essential to the quality assurance at FACT. His contributions have left an enduring legacy, and we are incredibly grateful for his work.
FACT Seal of Accreditation and Press Kit Can Now be Accessed Via the Accreditation Portal
Achieving renewal or initial FACT accreditation is a tremendous achievement that open doors and establishes trust among patients, families, clinical trial groups, payers, registries and more. FACT has long provided a Seal of Accreditation and Media Press Kit to accredited programs to help them prominently announce their accreditation and indicate this accomplishment on various digital and print materials.
We are very excited to announce a new process for accessing the FACT Seal of Accreditation and Media Press Kit. Organizations no longer have to email FACT and request access to this information. It is now automated in the portal once an organization achieves accreditation.
Instructions for organizations:
- To access the Seal of Accreditation and Media Press Kit, an Organization Director or Co-Director must first complete and sign the FACT Seal of Accreditation License Agreement available through the left navigation pane in the Portal.
- The materials will then be available to the Organization Director, Organization Co-Director, Facility Directors, Quality Managers, and the primary contact.
- A view of the screen that appears after the Organization Director or Co-Director selects FACT Seal of Accreditation in the left navigation pane of the accreditation portal is provided below.
Frequently Asked Questions:
- If an organization signed a Seal License Agreement prior to this new process, do they have to perform the new process in the Accreditation Portal?
Yes, if they want to access the seals through the accreditation portal. - If an organization changes directors and are mid-cycle, does the new director have to agree to the license agreement?
No, the agreement is connected to the organization’s accreditation and, unless they withdraw or are suspended, access to the seal is continuous. - If an organization loses their accreditation or withdraws from the process, can they access the seal?
No, access will be removed if an organization is no longer accredited. - If an individual is associated with more than one organization, do they have to agree to the FACT Seal of Accreditation License Agreement for each organization?
Yes, each organization will be listed and, depending on the individual’s role, will have to agree to the conditions. - Does an organization have to sign the agreement after each cycle (during a renewal accreditation)?
No, if the organization has not lost its accreditation, access to the seal is continuous for the individuals with the roles listed above.
FACT Advances Collaboration with Cell and Gene Therapy Stakeholders
As FACT continues directives from its 2023-2025 Strategic Plan to streamline its accreditation process and promote patient access to cellular therapies, we continually seek feedback about the value of FACT accreditation and the inspection and accreditation process.
In the second half of 2024, we conducted a virtual “road show” during which we established new and strengthened existing relationships with a wide variety of cell and gene therapy stakeholders, including accredited organizations, pharma and biotech companies, community cancer centers, professional associations, payers, patient advocacy groups, and supply chain companies.
These interactions were extremely productive, and FACT will be launching a communication campaign in 2025 to describe our role in cell and gene therapies to entities not yet familiar with our organization; outline pathways to accreditation for new cellular therapy programs including community-based clinics; and clarify misperceptions about the scope of FACT Standards, inspections, and accreditation goals. Several collaborative initiatives will also be launched, which will be announced in the coming months.
We are looking forward to working with many stakeholders in the cell and gene therapy field to make qualified, safe, and efficacious cellular therapies available to all patients who would benefit from them.
This effort also highlighted the value of existing collaborations, and we are grateful to all the stakeholders who have worked together over the past few decades to advance cell and gene therapies well into the future.
Multistakeholder Group Develops Risk-Based Assessment Process for Qualifying Facilities Collecting Cellular Starting Material
The multistakeholder Deloitte NextGen Industry Working Group’s site certification workstream developed a risk-based assessment process for qualifying facilities collecting cellular starting material (CSM). This effort was a shining example of experts in the field developing a process that meets the needs and obligations of the many types of entities involved in the cellular therapy product supply chain.
An article published in December 2024 in Transplantation and Cellular Therapy proposes that manufacturers adopt this process, and the authors provide the associated tools and instructions for how to use them.
Adopting risk-based assessments such as this approach will be critical for cellular therapy programs to be able to offer the many cellular therapy products that are increasing in number and diversity to patients. Many facilities are reaching a critical point in which they will not be able to onboard additional products because of the duplicative and unfunded burdens associated with each individual manufacturer. By utilizing measures of quality already in existence, and evaluating the risks associated with a given product and a given facility, site qualification can be more streamlined for both industry and programs and make more products available to patients.
Risk-Based Qualification of Cellular Starting Material Collection Sites: Tools to Determine Scope of Manufacturer Audits and Reduce Duplicative Efforts. Holman, Peter et al. Transplantation and Cellular Therapy, Official Publication of the American Society for Transplantation and Cellular Therapy, Volume 30, Issue 12, 1171 – 1177. Available at https://www.astctjournal.org/action/showCitFormats?doi=10.1016%2Fj.jtct.2024.09.006&pii=S2666-6367%2824%2900657-2.
FDA Publishes Several Guidance Documents Related to Donor Eligibility Determination
This article was updated after publication to include the FDA’s revision of the final guidance documents.
The U.S. Food and Drug Administration (FDA) published six guidance documents on January 6, 2025 related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The documents, listed below, relate to donor eligibility determination and include two final and four draft documents.
Shortly after publication, on January 20, the Trump Administration published an Executive Order (EO) for a Regulatory Freeze Pending Review. Paragraph (3) of the EO advises executive departments and agencies to consider postponing any published rules that have not yet taken effect for 60 days from this date for the purpose of reviewing any questions of fact, law, and policy that the rules may raise. This includes guidance documents issued by the FDA.
In response to the EO, the FDA announced on February 3 that it revised the final documents to recommend implementation of the final guidances over a longer timeframe, by May 4. Per the FDA, “The revised implementation date will permit FDA to consider the comments received thus far prior to the implementation date. Permitting the Agency additional time to further review and consider the guidances, including comments received, as well as seek additional comments is consistent with the President’s January 20, 2025, memorandum entitled, ‘Regulatory Freeze Pending Review.'”
FACT is evaluating how to move forward appropriately in accordance with the guidance documents while also monitoring any changes made by the FDA. This includes reviewing FDA’s recommendations for donor screening and evaluation for mycobacterium tuberculosis (Mtb) and sepsis. We encourage transplant and cellular therapy programs to continue doing the same while more about the mandated implementation timeline becomes known.
FDA Guidance Documents
Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Draft Guidance
Your Feedback is Requested – What are the Benefits and Challenges of Implementing the ISBT 128 CoI Identifier?
The Standards Coordinating Body (SCB) is interested in advancing the implementation of the ISBT 128 Standard, ST-028 ISBT 128 Chain of Identity (CoI) Identifier. This standard will promote a globally unique identifier that will track an advanced therapy throughout collection, production, and administration. The SCB’s multistakeholder CoI working group proposes use of the ISBT 128 CoI Identifier because an increasing number of entities have custody of an advanced therapy product(s), in an increasing number of manufacturing steps, as it transitions from collection of the starting cellular material(s) to manufacturing to clinical use.
The SCB working group includes experts from healthcare providers, software developers, therapy manufacturers, ICCBBA, accrediting organizations including FACT, and others. The group is writing an article on the benefits and challenges the field has encountered or foresees while implementing the ISBT 128 CoI Identifier. The working group is seeking different perspectives across the entire process of implementing the CoI Identifier. It is also looking for perspective on the implementation of solutions to these challenges.
Please complete this survey by February 14, 2025 so that the SCB can account for your unique perspective in the article.
Register for Upcoming FACT Education Events!
February
Feb 10. – FACT Quality Boot Camp prior to Tandem 2025 Meetings | Honolulu, HI (Last Day to Register is January 31, 2025)
Feb 11. – FACT Cellular Therapy Accreditation Workshop prior to Tandem 2025 Meetings | Honolulu, HI (Last Day to Register is January 31, 2025)
Feb 11. – FACT Clinical Inspector Training Course* prior to Tandem 2025 Meetings | Honolulu, HI
- *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.
April
Apr. 8 – FACT Apheresis Collection Inspector Training Course* at ASFA 2025 | Montréal, Québec, Canada
- *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
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.
June
June 26 – FACT Apheresis Collection Virtual Accreditation Workshop | Zoom (Early Bird Registration Ends July 31, 2025 – Save $55!)
September
Sept. 4 – FACT Cord Blood Bank Accreditation Workshop at Cord Blood Connect 2025 | Miami Beach, FL (Early Bird Registration Ends July 31, 2025 – Save $55!)
Sept. 4 – FACT Cord Blood Bank Inspector Training Course* at Cord Blood Connect 2025 | Miami Beach, FL
- *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.
Sept. 25 – FACT Apheresis Collection Virtual Quality Boot Camp | Zoom (Early Bird Registration Ends July 31, 2025 – Save $55!)
