Just the FACTs 2023 Volume 1
We recently celebrated the service of Drs. Ngaire Elwood and Kim Kasow, whose tenures as Vice President and Treasurer, respectively, concluded after an incredible 18 years of service combined on the FACT Executive Committee and Board of Directors. It is also my great pleasure to congratulate Dr. Joseph Schwartz for being awarded the ASFA Francis S. Morrison, MD Memorial Lectureship. As outlined in the newsletter articles regarding their service, all of these phenomenal leaders have contributed to FACT in many ways, over numerous years, and continue to do so. FACT is a better organization with their expertise and input!
I would also like to take this opportunity to welcome and encourage each of you to contribute to FACT also! This newsletter announces several ways to get involved:
- Submit your interest to serve on a FACT committee.
- Apply to become a FACT Apheresis Inspector and attend the upcoming inspector training workshop.
- Review and submit comments regarding the draft FACT Standards for Immune Effector Cells.
- Complete the FACT-JACIE Standards Feedback Survey.
- Attend an upcoming FACT education event.
Congratulations are also in order for the FACT Common Standards Committee, the FACT Technology Committee, and FACT personnel for publishing the third edition of the FACT Common Standards and launching a major upgrade of the FACT Accreditation Portal!! Stay tuned for more good things to come in 2023!
Cheers,
Catherine M. Bollard, MD
FACT President
2023 Call for Committee Volunteers
Dear Colleague:
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.
Learn more about current committee descriptions, desired expertise, and expectations: FACT Committee Opportunities.
Please submit your interest in serving as a committee member by completing the Committee Volunteer Form by April 7, 2023.
Standards Committees
• Hematopoietic Cell Therapy Committee
• Immune Effector Cell Standards Committee
• Cord Blood Standards and Common Standards*
*Volunteers for Cord Blood Standards and Common Standards Committees will be solicited at the initiation of the standards development process for the next editions of those publications.
Accreditation Committees
• Cellular Therapy Accreditation Committee
• Cord Blood Accreditation Committee
Special Committees and Task Forces
• Education Committee
• Inspector Development Committee
• Quality Management Committee
• FACT-CIBMTR Data Audit Committee
• Immune Effector Cell Task Force
• Clinical Outcomes Improvement Committee
• Regenerative Medicine Task Force
• Technology Committee
The contributions of our volunteer FACT Inspectors and committee members have been invaluable and have resulted in the tremendous success of FACT. Thank you for your dedication and support of this important effort to ensure quality patient care, improve treatment outcomes, and foster continued development in the field of cellular therapy.
Sincerely,
Catherine Bollard, MD
FACT President
Linda Miller, MPA
Chief Executive Officer
FACT is Seeking New Apheresis Collection Inspectors!
At FACT, our mission is to promote quality clinical and laboratory practice of cellular therapy and regenerative medicine. We would not be able to achieve this mission without our volunteer inspectors and are committed to providing our inspectors training and resources to ensure successful inspections.
The benefits of becoming an inspector include:
- Opportunity to observe other programs
- Networking with peers and experts
- Contribute to Standards Development
- Access to complimentary educational resources
- High quality professional development
- Opportunity to serve on FACT Committees
- Giving back to the field of cellular therapy and regenerative medicine
Consider attending FACT’s upcoming Apheresis Collection Inspector Training in conjunction with the ASFA Annual Meeting on Tuesday, April 25th from 8:00 am – 5:00 pm CT in Minneapolis, Minnesota!
To become a FACT inspector and learn about inspector qualifications visit https://www.factglobal.org/inspectors/.
Comments Requested on Draft Second Edition FACT Standards for Immune Effector Cells
The Foundation for the Accreditation of Cellular Therapy (FACT) will publish the draft second edition FACT Standards for Immune Effector Cells on March 31, 2023, for public comment during a thirty-day period. Comments will be accepted through April 30, 2023.
These Standards promote quality practice in immune effector cell therapies and apply to a wide range of immune effector cells used to modulate an immune response for therapeutic intent, whether genetically modified or not. This includes, but is not limited to, dendritic cells, natural killer cells, T cells, B cells, genetically engineered chimeric antigen receptor T cells (CAR-T cells), and therapeutic vaccines. The final Standards will be published in November 2023 and will become effective in February 2024.
The FACT Standards for Immune Effector Cells were reviewed and commented upon during an initial public comment period in association with the eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. The majority of comments received have been addressed through harmonizing these two publications.
Comments submitted during the first comment period clearly indicated a need to enhance standards related to cell collection. These comments have been addressed in B2.12, B2.12.1, and in a reorganized Section C that now includes general standards applicable to any cell collection followed by sections C9, C10, and C11 specific to apheresis and whole blood collection, marrow collection, and collection of other tissues such as tumor-infiltrating lymphocytes (TILs).
The purpose of this comment period will be to specifically request your comments on these new sections. Two versions of the published draft are available. One is a clean version, and the other is a redline document intended to highlight the changes made to these Standards. Minor reorganization and clarifying changes are not tracked. Some changes are new standards; however, some are intended to clarify rather than to change the intent. In addition, many changes were made to provide consistency among all sets of FACT Standards:
- Draft Second Edition FACT Immune Effector Cells Standards
- Draft IEC Redlined Document
- Visit the FACT IEC RedCap Survey for instructions and to submit your comments
If you have any questions, please contact Monique Summers, FACT Standards Development Manager at monique.summers@factglobal.org or 402-920-7010.
FACT-JACIE Standards Feedback Survey
Preparation of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, ninth edition, will commence this summer. Final publication is expected in early 2025.
FACT and JACIE invite you to complete a short survey to provide feedback and suggestions regarding the Standards. Survey results will be reviewed by the Standards Steering Committee for potential inclusion in the next edition of the Standards.
You are also encouraged to share the survey with your colleagues and promote the survey in your professional societies. Responses will be accepted through April 28, 2023.
If you have any questions or need additional information, please contact the Standards Development Manager at Monique.Summers@factglobal.org.
FACT Publishes Third Edition of the Common Standards for Cellular Therapies with a New Accompanying Accreditation Manual
The major objective of the FACT Common Standards for Cellular Therapies is to promote quality medical and laboratory practice in a broad range of cellular therapies. These Standards represent basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application throughout product development and clinical trials.
This third edition of Common Standards remains consistent with previous editions, requiring a comprehensive quality management plan and established clinical, collection, and processing procedures. Additionally, this edition reflects the maturation of cellular therapy and the inclusion of more and diverse products such as genetically modified products. Quality management requirements include specific training in good manufacturing practice appropriate to the products being collected or processed; development and review of robust written agreements with entities providing services or products; comprehensive document control; and expanded auditing, outcome analysis, and data management and reporting requirements.
“The revisions were focused on harmonization with other parallel FACT standards and on advances (real and anticipated) of novel cellular therapies that would be covered under the Common Standards,” according to Dr. Paul Eldridge, Chair of the Common Standards Committee.
In this edition, emphasis is also placed on the criticality of labeling and chain of identity / chain of custody as product manufacturing frequently involves several cooperating entities to achieve collection of the cellular starting material, manufacture of the final product, transport of the cells and products among facilities, and clinical therapy administration. Because of its value in accurate and unambiguous identification, encoding information, and labeling of medical products of human origin, full implementation of ISBT 128 coding and labeling is required where possible.
FACT is excited to announce the publication of the first Accreditation Manual to accompany the third edition Standards. Significant thanks is given to Dr. Carolyn Keever-Taylor for her work in drafting the initial document for the committee to review. The Accreditation Manual “provides a valuable tool for users to self-assess their compliance with the Standards and ensure that they are inspection ready,” Dr. Paul Eldridge.
The Common Standards Committee consists of 13 expert members. Members reviewed clinical, collection, processing, and quality requirements. Following months of reviews and revisions, comments were submitted during an open public comment period. The committee considered all feedback, which totaled almost 100 comments, submitted by professionals from industry, clinical, non-profit, and regulatory settings. Final revisions were drafted by the committee and approved by the FACT Board of Directors. The FACT leadership expresses its gratitude to the committee members for their dedication and work to revise this third edition.
The third edition Common Standards became effective on March 30, 2023. All organizations accredited under these Standards are now expected to be in compliance with the requirements. Compliance Applications and inspections under the Common Standards will now only be accepted for the third edition.
Third Edition Common Standards [free download]
Third Edition Common Standards Accreditation Manual [free download]
Purchase printed copies of Standards
Purchase printed copies of the Accreditation Manual
It’s Here! FACT Accreditation Portal Version Launched on February 1, 2023.
We are pleased to announce the launch of major upgrades to the FACT Accreditation Portal! Part of this upgrade includes a new address. For quick access to the portal, bookmark the following link: https://portal.factglobal.org
FACT has prepared user How-To Guides to assist in navigating the portal’s new features. These can be accessed on our website in the Portal Resource Center. Your username and password have not changed.
We are Happy to Announce a New Feature: Tasks
The new Task feature replaces the Request for Information (RFI) for Follow-up when an organization needs to submit information in follow-up to a request or citation. Tasks allow coordinators to create stand-alone requests in response to a citation at the time of the FACT Annual Report or at another time in response to a request from a committee, such as the FACT-CIBMTR Data Audit Committee or the FACT Clinical Outcomes Improvement Committee.
This feature expedites time required to locate and respond to these requests. Please refer to the How-To: Respond to a Task guide.
Your Accreditation Coordinator is a valuable resource for any questions.
Special thanks to our technology partner Forbina Consulting for leading the development of the new version of the Portal.
FACT Service Awards Presented to Ngaire Elwood, PhD and Kim Kasow, DO
With heartfelt gratitude and admiration, FACT presented Service Awards to two outgoing Board members: Drs. Ngaire Elwood and Kim Kasow. These long-term and esteemed leaders of FACT lent a tremendous amount of energy and guidance to FACT during a time of significant organizational growth and global challenges during their tenures on the Board of Directors, and we look forward to continuing our friendship and working relationship with them into the future. Thank you, Ngaire and Kim, for all that you do for FACT and your colleagues!
Ngaire Elwood, PhD
(9 years in Leadership, 14 years as Inspector)
Board Member: 2014-2022
Vice President: 2017-2022
Member, Education Committee: 2011-Present
Member, Cord Blood Accreditation Committee 2010 – Present
Member, Cord Blood Bank Standards Steering Committee 2009-Present
Regenerative Medicine Task Force: 2020-Present
Member, Grievance Committee: 2017-2022
Member, New Business Development Committee: 2023-Present
FACT Inspector since 2008 and performed 14 cord blood inspections
Kim Kasow, DO
(9 years in Leadership, 16 years as Inspector)
Board Member: 2014-2022
Treasurer: 2018-2022
Chair: Finance Committee: 2018-2022
Chair: Quality Committee: 2015-Present
Member, Technology Committee: 2020 – Present
Member, Cell Therapy Standards Committee: 2019 – Present
Member, Cell Therapy Accreditation Committee 2015 – Present
Member, Grievance Committee: 2015-2022
Member, Public Relations & Marketing: 2013-2015
Member, New Business Development Task Force: 2023-Present
FACT Inspector since 2006 and performed 21 clinical inspections
Joseph Schwartz, MD, MPH to Receive the ASFA Francis S. Morrison, MD Memorial Lectureship
The ASFA Past President Council has awarded the Francis S. Morrison, MD Memorial Lectureship to Joseph Schwartz, MD, MPH. This esteemed award recognizes individuals whose contributions have, or will likely have, a major impact on the field of apheresis medicine. Dr. Schwartz will deliver a lecture during the 2023 ASFA Annual Meeting in Minneapolis.
FACT is pleased that Dr. Schwartz has received this award, and recognizes his many efforts to advance and recognize the field of apheresis medicine via his involvement in FACT. Dr. Schwartz has been a FACT inspector since 2005 and serves on numerous FACT committees, including terms as Technology Committee Chair, Past Standards Committee Chair and Accreditation Committee Vice-Chair, and is a previous FACT Board member.
Congratulations, Yossi, and thank you for your contributions to the fields of apheresis medicine and cellular therapy!
From the ISCT Telegraft Hub – Continuing FACT’s Tradition of Consensus Building into the Next Wave of Cellular Therapies: Incorporating Multistakeholder Perspectives into FACT Accreditation and Assessment & Audit Services
The following article was published in the March 2023 ISCT Telegraft Hub. Read on for a trip down memory lane and a journey to the future regarding FACT’s collaborative efforts to advance new cellular therapies. FACT thanks ISCT, a principal member, for its support of FACT initiatives. To become an ISCT member, visit https://www.isctglobal.org/membership/join.
“Great things in business are never done by one person; they’re done by a team of people.” —Steve Jobs
FACT’s mission is to improve quality cellular therapy for the benefit of patients. Adapting to rapid advances in science and paradigm-shifting methods of delivering health care is what we do, and we have been successful thanks to the input of a variety of perspectives.
FACT has collaborated with multistakeholder groups since it was founded in 1995. Our very genesis was the result of collaboration between the American Society for Transplantation and Cellular Therapy (ASTCT) and the International Society for Cell & Gene Therapy (ISCT) to develop the first comprehensive set of Standards for hematopoietic progenitor cell transplantation.[i] Since then, FACT has worked with many organizations. In 1999, we co-published the Hematopoietic Cell Standards with JACIE to expand quality beyond U.S. borders. In 2000, we partnered with NetCord, now part of WMDA, to create standards and accreditation for cord blood banking.[ii] Since 2013, we have served as a recognized accreditation for the United States National Cord Blood Inventory (NCBI)[iii] and have conducted supplementary inspections against NCBI-specific criteria. We also partner with organizations on quality initiatives, such as the joint Data Audit Committee with the Center for International Blood & Marrow Transplant Research (CIBMTR).[iv] Other stakeholders we work with include ICCBBA, the American Society for Apheresis (ASFA), the Cord Blood Association (CBA), Be the Match, and more.
The Advent of Commercially Manufactured Cellular Therapies and the Need for Multistakeholder Cooperation
Following successful clinical trials of chimeric antigen receptor (CAR) T cell therapies, FACT published its Standards for Immune Effector Cells[v] in 2017 and implemented an associated accreditation program at the request of accredited programs, FACT inspectors, and payers. The commercialization of the first licensed CAR T cell products[vi] that year led FACT to expand our circle of collaborators to commercial and clinical trial product manufacturers.
The transition from clinical trials to commercial manufacturing led to unexpected challenges for health care institutions and manufacturers alike. One of these is duplicative audits by multiple manufacturers at FACT-accredited sites that already undergo rigorous inspections on a regular basis. For their part, manufacturers were trying to implement processes in compliance with their regulatory submissions within disparate health care sites using collections from inherently variable human donors for cellular starting material.
There was a strong desire from stakeholders to leverage FACT accreditation to identify sites that could collect cellular starting material and administer final cellular therapy products within the context of Good Tissue Practices (GTPs) and quality systems. FACT-accredited sites wished to minimize the redundancy of manufacturer audits, and the conflicting observations that result.
FACT’s first interactions with our manufacturer colleagues consisted of telephone calls, emails, and in-person introductions. Through comparison of FACT Standards to manufacturers’ audit checklists, review of manufacturers’ audit observations, and communication on challenging issues between industry and health care sites, we identified ways to clarify or add to our Standards to maintain the relevance of FACT requirements amid the exciting evolution of cellular therapies. We also demonstrated that our robust accreditation program can accommodate the transition from clinical research to commercialized therapies at sites while fulfilling regulatory obligations of manufacturers.
These activities were insightful, but done in silos one manufacturer at a time. Complex challenges require a wide variety of perspectives representing the entire value stream of cellular therapy, including starting material collection, laboratory processing and storage, chains of identity and custody, distribution, administration, and patient follow-up. Eventually, many organizations created multistakeholder groups to address these challenges.
FACT Participation in Multistakeholder Groups
Multistakeholder groups have generated ideas and practical solutions that have the potential to reduce bottlenecks in cellular therapies and thereby increase patient access. Though listing all multistakeholder groups is beyond the scope of this article, the following are examples of groups in which FACT participates to address redundancies:
- ASTCT 80/20 Task Force: This task force considers challenges and potential solutions to issues related to duplicative documentation requirements for each approved cellular therapy product and proposes that 80 percent of manufacturers’ requirements for onboarding and ongoing operations of commercially available products could be standardized and streamlined.[vii]
- Deloitte NextGen Industry Working Group: This working group provides a platform for cell and gene therapy leaders to exchange perspectives, share best practices, and develop solutions, including streamlined and more rapid site certification.[viii]
- Standards Coordinating Body: The Standards Coordinating Body (SCB) complements current Standards Development Organizations and their processes for standards development by engaging regenerative medicine stakeholders.[ix]
FACT Implementation of Multistakeholder Solutions to Reduce Duplicative Assessments and Audits
Via our work with multistakeholder groups, we confirmed that a majority of manufacturers’ needs for assessing collection and treatment sites are already covered by compliance with FACT Standards. Manufacturers need documented assessment of sites that specifically verifies compliance with the applicable regulations as they apply to their cellular therapy products. The following are ways in which FACT is addressing manufacturers’ needs to reduce burden on health care institutions:
- Soliciting manufacturer input in the FACT Standards development process: FACT Standards are developed by consensus of experts, based upon published medical evidence and best practices. By understanding manufacturers’ needs and regulatory framework, standardized requirements can be developed to advance the field. By proposing and vetting those requirements via the FACT Standards Development process, incorporating them into draft consensus standards, and reviewing public feedback, the result is increased standardization. This can reduce auditing obligations, simplify quality agreements, and direct more resources to product manufacturing and patient care.
- Supporting manufacturers’ efforts to leverage FACT accreditation: FACT provides manufacturers documentation of how its Standards, inspections, and annual reports relate to regulations. We also provide policies, procedures, regulatory crosswalks, and other documents to support manufacturers’ due diligence processes. Finally, though not required, we acknowledge to accredited programs the benefits of providing their final accreditation report to manufacturers when requested. These activities support progress toward a single assessment that is already recognized by several stakeholders.
- Advocating for the implementation of multistakeholder solutions: Examples of multistakeholder solutions implemented by organizations include ISBT 128 standards for labeling of cells collected for further manufacturer and a Chain of Identity (CoI) Identifier published by ICCBBA, the Cellular Immunotherapy Data Resource (CIDR) data registry managed by CIBMTR, and the Risk Assessment and Scope Determination Forms developed by the Deloitte NextGen IWG Site Certification Workstream. These solutions offer streamlined processes that are in compliance or harmonized with FACT Standards and accreditation.
- Expanding FACT services to manufacturer-requested site assessments: To support adoption of rapid developments in cellular therapies and high patient demand, FACT will conduct cellular therapy product-specific assessments beyond the current FACT accreditation program. This includes product-specific surveillance audits in conjunction with FACT inspection visits, provision of qualitative data regarding accredited sites to manufacturers as part of their site qualification processes, and evaluation of non-FACT-accredited sites, providing assistance in meeting GTP regulations.
Building FACT Assessment & Audit Services
The two main goals of FACT’s assessment and audit services will be to reduce redundant assessments at FACT-accredited sites already qualified to participate in cell therapy and more quickly and effectively qualify additional sites.
We believe that FACT is a natural fit for assessment and audit services because we can:
- Review a larger sampling of records representing more than an individual manufacturer, leading to better identification of trends and potential systemic noncompliance.
- Standardize assessments while reviewing product- or protocol-specific items as needed.
- Guide sites on how to correct deficiencies, potentially shortening the time to closure of the assessment.
- Coordinate and streamline assessments with its accreditation process, further reducing duplication and potentially reducing the need for in-depth surveillance audits.
FACT hosted an industry focus group meeting during Advanced Therapies Week in January to present our preliminary plans and gather feedback from manufacturers and other stakeholders. We are using this feedback to develop a menu of services, a core assessment and audit checklist, proposed deliverables, and a pricing structure. These items will be provided to an industry advisory group for further refinement. This year, we plan to conduct pilot assessments and audits with participating companies to verify and further develop our processes.
If you are interested in participating in the development of FACT assessment and audit services, or utilizing our services, please contact Liz Ferraro, Manager of Assessment and Audit Services, at liz.ferraro@factglobal.org. We plan to incorporate as many perspectives as possible. Our intention is to develop these services to be a WIN-WIN-WIN for health care institutions, manufacturers, and, most of all, patients.
[i] Foundation for the Accreditation of Cellular Therapy and Joint Accreditation Committee – ISCT and EBMT. FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration (Eighth Edition); 2021.
[ii] Foundation for the Accreditation of Cellular Therapy and International NetCord Foundation. NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration (Seventh Edition); 2019.
[iii] Health Resource Services Administration. National Cord Blood Inventory Contract Summary (NCBI); 2022. Available: https://bloodstemcell.hrsa.gov/about/contracts/national-cord-blood-inventory-contract-summary-ncbi.
[iv] Foundation for the Accreditation of Cellular Therapy. FACT and CIBMTR Announce Joint Data Audit Program; 2016. Available: https://news.factglobal.org/fact-and-cibmtr-announce-joint-data-audit-program/.
[v] Foundation for the Accreditation of Cellular Therapy. FACT Standards for Immune Effector Cells (First Edition, Version 1.1); 2018.
[vi] Food and Drug Administration. 2017 Biological License Application Approvals; 2018. Available: https://public4.pagefreezer.com/browse/FDA/29-01-2023T09:49/https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2017-biological-license-application-approvals.
[vii] Nikiforow, S. et al. (January 2023). Paving the Road for CAR-Ts: ASTCT 80/20 Task Force consensus on challenges and solutions to improving efficiency of clinical center certification and maintenance of operations for commercially approved immune effector cell therapies. Transplantation and Cellular Therapy. doi: 10.1016/j.jtct.2023.01.021.
[viii] Davis, S. (April 2021). Industry Working Group finalizes cell-collection labeling standards for cell and gene therapies to improve patient safety. Deloitte Health Forward Blog. Available: https://www2.deloitte.com/us/en/blog/health-care-blog/2021/industry-working-group-finalizes-cell-collection.html.
[ix] Standards Coordinating Body. Overview; accessed 2023. Available: https://www.standardscoordinatingbody.org/overview-mission.
Future Stops in FACT’s 2023 Education Tour
FACT Virtual Apheresis Collection and Processing Accreditation Workshop
Virtual, Wednesday, April 19, 2023
8:00 am – 5:00 pm CT
FACT Apheresis Collection Inspector Training Course
Minneapolis, MN, April 25, 2023
8:00 am – 5:00 pm CT
FACT Quality Boot Camp focused on quality principles for Apheresis Collection, Processing, and Cord Blood Banking
Virtual, June 23, 2023
9:00 am – 6:00 pm CT
FACT Accreditation and Quality Principles Workshop
Perth, Australia, August 15, 2023
8:00 am – 5:00 pm AWST
Registration Open Soon!
FACT Processing Inspector Training Course
Houston, TX, September 7, 2023
8:00 am – 5:00 pm CT
