Accreditation Statistics

As of January 2, 2024

Cellular Therapy Entities

  • Accredited: 260
  • Applicants: 26

Cord Blood Banks

  • Accredited: 49
  • Applicants: 10

Congratulations to the following organizations for achieving initial FACT accreditation:

  • Houston Methodist Ann Kimball & John W. Johnson Center for Cellular Therapeutics
  • Blood Assurance
  • American National Red Cross, Salt Lake City, Utah HCT/P Program

A complete list of accredited organizations can be found at www.factglobal.org.

Just the FACTs 2024 Volume 1

Posted in :: 2024 Volume 1 :: Friday, January 26th, 2024

President’s Letter 

Welcome to 2024! As you will see, our first Just the FACTs newsletter in 2024 emulates what we expect in the coming year.  Specifically, we highlight: (i) key updates regarding FACT requirements and cell therapy program processes, (ii) regulatory requirements in the evolving field, and (iii) educating a much-needed cell therapy workforce.

At the end of 2023, we published the second edition of the FACT Standards for Immune Effector Cells, and are already revising the next edition of the FACT-JACIE International Standards for Hematopoietic Cell Therapy. We also expect the publication of the next edition of the NetCord-FACT International Cord Blood Banking Standards in the coming months.

The ISCT recently hosted the Cell Therapy Liaison Meeting with the U.S. Food and Drug Administration (FDA). This meeting included presentations and discussions on hot topics in cell therapy regulation in the U.S. and the online summary provides many interesting points and suggestions.

The Tandem Meetings will be the site of the official launch of FACT’s 2024 educational programming, and we encourage everyone to take advantage of this opportunity and send your staff to learn more about the FACT accreditation process and FACT inspector training. In addition to a growing number of accredited organizations and volunteer inspectors, there has been a focus on workforce development. We therefore highlight two events in 2024, hosted by ASTCT and ISCT, that provide very hands-on, practical, and effective training environments.

In sum, there are a lot of exciting activities ahead in our field for 2024 and I wish everyone a wonderful year full of professional success and personal enjoyment!

Cheers,

Catherine Bollard
FACT President


Just the FACTs 2023 Volume 7

Posted in :: 2023 Volume 7 :: Monday, December 11th, 2023

President’s Letter 

Let’s celebrate a fantastic 2023! This newsletter highlights just a few of our accomplishments this year, all made possible by the tireless efforts of our inspectors, accredited organizations, and staff. We continue to build upon our accomplishments for the benefit of patients in need of transplantation and cellular therapy around the world. In accordance with our strategic plan, this year was dedicated to ramping up our infrastructure and staffing, and initiating new programs. I am therefore extremely happy to report that we are on schedule and looking forward to offering new services to expand patient access around the world. 

Celebration is also in order for FACT’s Past President, Dr. Helen Heslop, who was awarded the 2023 ASH Mentor Award. I was truly honored to recommend her for this award with two of Dr Heslop’s other past mentees Drs Gottschalk (St Jude’s) and Savoldo (UNC). Helen was my mentor at the Center for Cell and Gene Therapy at Baylor College of Medicine for 13 years and continues to inspire me as an innovator in cellular immunotherapy, colleague and friend. Helen absolutely epitomizes the spirit of the ASH Mentor Award and is therefore my great privilege to send her, on behalf of the FACT community, these heartfelt words of congratulations! 

Wishing you all the very best over the holiday season. 

Sincerely, 
Catherine Bollard
FACT President


Just the FACTs 2023 Volume 6

Posted in :: 2023 Volume 6 :: Thursday, October 26th, 2023

President’s Letter

As the calendar year is drawing to a close, I am writing my newsletter this month as a call to action from our FACT Community!  Specifically, FACT and the member organizations of its Professional Relations Committee is seeking collaboration on comment submissions to the Food and Drug Administration (FDA) regarding its proposed rule for phasing out enforcement discretion for laboratory-developed tests. The FDA is proposing a policy under which it intends to require laboratory-developed tests to fall under the same enforcement approach as other in vitro diagnostic products, which includes regulatory approval and oversight.

FACT and FACT-accredited programs are concerned that FDA regulation of many lab-developed tests will have a tremendous and negative impact on access to care for patients (especially children and other patients with rare diseases) and will negatively impact new test development which will impact transplant and cell therapy programs. For example, lab-developed tests such as BMT chimerism tests, genetic sequencing tests, and flow cytometric tests will all be negatively impacted.

We will be providing more information in the coming weeks regarding comment submission, but the following are immediate steps that can be taken. In addition, information is provided in this newsletter which is dedicated to this issue.

  1. Submit a request to the FDA that the public comment period be extended to 120 days to allow adequate time to formulate responses that will fully inform the FDA of the impacts of this proposed rule.
  2. Review the rule and submit any initial questions you have regarding its impact to your patients to Kara Wacker at kara.wacker@factglobal.org.

Thank you in advance for your collaboration.

Sincerely,
Catherine M. Bollard, MD
FACT President


Just the FACTs 2023 Volume 5

Posted in :: 2023 Volume 5 :: Monday, September 25th, 2023

President’s Letter

Welcome to the change of seasons, whether it be Fall or Spring, depending on where in the world you reside!! With the season change, it is important for FACT to critically evaluate our momentum for change over this past year. To that end, at our recent FACT Board of Directors meeting, we discussed the tremendous progress that our organization has made regarding several key strategic initiatives. These included (i) new funding initiatives, (ii)  infrastructural growth opportunities, (iii) streamlined processes, and (iv) development and delivery of new services. The future of FACT is an exciting one, and we are eager to continue implementing our strategic plan to increase patient access to transplantation and other cell-based therapies.

We are also well on our way to resuming a regular inspection schedule following the COVID-19 pandemic and the related extensions. We express our sincerest gratitude to FACT inspectors for your commitment to our peer-review accreditation process.

The FACT team wants to also express how much we have enjoyed seeing many of you during FACT’s 2023 global Educational Tour and looks forward to announcing our next series of in-person educational events within the next couple of months. In the meantime, please join us for the Quality Management Webinar Series on embracing change when implementing a new service or product in your cellular therapy organization. Change is constant, and, as evident in our field, is critical for sustainability and growth in the ever-broadening cell therapy landscape!

Sincerely,
Catherine M. Bollard, MD
FACT President


Just the FACTs 2023 Volume 4

Posted in :: 2023 Volume 4 :: Thursday, July 27th, 2023

President’s Letter

FACT continues to ramp up efforts to globalize transplant and cellular therapy via education, inspector recruitment, and funding initiatives. We have continued our “world tour” of events these past couple of months in Minneapolis and Paris and we are looking forward to our next stops in Miami Beach, Houston, Puebla, and Perth. We have of course continued to hold events in “Virtual Land” to ensure access for all!! Bolstering the strength of our workforce is critical as demand for our services grows geographically and more cell and gene therapies/approaches are being commercialized. Therefore, please encourage and support the attendance of personnel at your programs to attend these educational opportunities and those offered by ASTCT and ISCT that are described in this newsletter.

This newsletter also lists two opportunities where we need your critical contributions and input. One such opportunity is to submit your feedback during the public comment period for the draft eighth edition of the NetCord-FACT Cord Blood Banking Standards. The other opportunity is the WBMT Global CAR-T and Cell Therapy survey to inform the World Health Organization (WHO). I thank you in advance for your engagement in the international cell therapy community.

Finally, the global nature of this newsletter is a fitting environment in which, on a sadder note, to mourn the loss of a dear friend and colleague, Ian K. McNiece, PhD. An Australian by birth, Ian was an internationally renowned leader within the cell therapy community and a strong force at FACT where he served as a Board member, an inspector, and as the Chair of the Regenerative Medicine Task Force, among his many other roles. Ian was also a beloved family member and friend as described by Dr. Richard J. Jones in a poignant article included in this newsletter. Please join me in sending Ian’s wife, Peggy, our sincerest condolences.

Sincerely,
Catherine M. Bollard, MD
FACT President


Just the FACTs 2023 Volume 3

Posted in :: 2023 Volume 3 :: Friday, May 19th, 2023

President’s Letter

I am excited to share with you FACT’s three-year strategic plan for the years 2023-2025 in this month’s newsletter. The plan, initiated in January 2023, includes three defining objectives that are critical for the effective conduct of new and ongoing mission-driven activities within the next wave of cell therapy advancements. To accomplish these objectives and prevent increased service costs, FACT hired its first Director of Development, Meredith Lambe, to develop and implement a fundraising plan to support FACT’s mission and vision over the next three years. To that end, this newsletter also describes FACT’s fundraising activities that will take place in the coming months and years.

FACT is constantly evolving, and our strategic plan will position us to continue to successfully realize our mission of improving the quality of cellular therapies for the benefit of the patients we serve. This is indeed an exciting time for our field!

Sincerely,
Catherine M. Bollard, MD
FACT President


Just the FACTs 2023 Volume 2

Posted in :: 2023 Volume 2 :: Thursday, April 27th, 2023

 Like many other organizations, FACT is in the midst of a busy event schedule to provide training to FACT-accredited and applicant programs and volunteer FACT inspectors. We encourage you to not only attend an event yourself, but to also encourage your colleagues and administrations to support personnel attendance as well. To that end, we are offering in-person events in conjunction with annual and regional meetings across the globe. Moreover, we are offering virtual workshops in case you cannot attend in person. This newsletter provides the details and links to all these upcoming events and I sincerely hope you will be able to attend some of these educational and training opportunities.

I also want to draw your attention to an article in this newsletter about responding to inspection citations. These findings are an opportunity for improvement. FACT accreditation is not a pass-fail event, and we encourage you to consider the process as a mechanism to improve the care you provide to your patients.

Finally, and importantly, we always seek opportunities for improvement at FACT. In particular, I urge you to submit your feedback on the draft second edition of the FACT Standards for Immune Effector Cells and the current edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. Further, if there are any other opportunities you would like to communicate, please do not hesitate to reach out. I look forward to hearing from you!

Sincerely,

Catherine M. Bollard, MD
FACT President


Just the FACTs 2023 Volume 1

Posted in :: 2023 Volume 1 :: Thursday, March 30th, 2023

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


Just the FACTs 2022 Volume 6

Posted in :: 2022 Volume 6 :: Tuesday, December 20th, 2022

Letter from the President

With the closing of 2022, I, and the FACT Board of Directors, reflected on accomplishments achieved this year and the impact those accomplishments will have in the coming year. FACT is pleased with the tremendous progress we have made to further advance our mission well into the future.

In 2022, following the transition to independent status, after a 25-year partnership with the University of Nebraska Medical Center, FACT welcomed many new faces to its international headquarters and developed a strategic plan for the next three years. We are excited to share our plans to strengthen our existing services and leverage our expertise to serve unmet needs. Both of these are necessary to meet the unprecedented demand for cellular therapies from cancer and beyond. This is going to be extremely critical as more cell therapies obtain licensure and is particularly topical this month when Atara Biotherapeutics’ Ebvallo™ (tabelecleucel) receives European Commission approval “as the first ever therapy for adults and children with EBV+ PTLD”.

In addition, I hope you will see in this newsletter an important announcement regarding the online accreditation portal. We are eager to implement a major upgrade in February to better serve our accredited programs and volunteer inspectors.

Thank you so much for another year rising to the challenge to offer care to an ever-increasing number of people in need. FACT is so proud to participate in efforts to increase the quality of and access to cellular therapy in terms of geography, resources, and indications. None of this would be possible without you.

Sending you all heartfelt thanks and wishing you a very happy time over the holidays and looking forward to exciting times ahead in 2023!

Cheers!

Cath

Catherine M. Bollard, MD
FACT President


Just the FACTs 2022 Volume 5

Posted in :: 2022 Volume 5 :: Friday, November 18th, 2022

Letter from the President

In a time of turbulence and change, it is more true than ever that knowledge is power. – John F. Kennedy

Change is all around us. It can be as natural as the falling leaves making way for falling snow, or the emergence of blossoms making way for the summer sun for those of us far enough from the equator. It can be as disruptive as a worldwide pandemic as we have all recently experienced. The changes in cellular therapy are a combination of both – the natural progression of science that builds upon past advances in medicine and the disruptive paradigm shifts that require us to do things differently. In this newsletter volume, we aim to clarify a couple of topics that are both natural and disruptive extensions of the work we do.

One is labeling. As cellular therapy products are collected for more uses and produced by a growing field of manufacturing sources, we must be able to adapt how these products are labeled. FACT requires full implementation of ISBT 128 coding and labeling, and the new “split ISBT 128 label” format developed for the “collection for further manufacturing” is also in compliance with FACT Standards. We, therefore, provide assurances that facilities may adopt the use of this label at the request of industry manufacturers and information on how to obtain assistance with the validation process.

Another topic relates to the use of CIBMTR’s Transplant Center-Specific Survival Report to evaluate clinical outcomes for U.S. allogeneic programs. This report is the most objective measure available of one-year survival rates. Its algorithm is transparent and vetted, and it is a resource for transplant Programs, and the field, to improve patient outcomes. We pulled an old article “from the archives” to explain more about this report and how it can be of use to Programs.

We understand that these topics focused on labeling formats and survival scoring for a complex therapy bring about change which may sometimes seem daunting. We hope these clarifications will equip readers with new knowledge that embraces advancements intended to ultimately improve the safety and quality of cellular therapy.

Sincerely,
Catherine M. Bollard, MD
FACT President


Just the FACTs 2022 Volume 4

Posted in :: 2022 Volume 4 :: Wednesday, October 26th, 2022

Letter from the President

After decades of discovering new therapies, improving quality, and increasing patient access, the FACT community of accredited organizations and expert inspectors has much wisdom to share. Fortunately, several opportunities exist for us to provide advice and direct the future of cellular therapy. It is our responsibility to take advantage of those opportunities.

Over the past several years, FACT has submitted numerous comments to regulatory agencies, participated in multistakeholder groups, and has built relationships with industry. We can therefore assure you that your input is incredibly valued. We also know that our field is one in which we all are open to new ideas for the sake of advancing cellular therapies for the patients. Our unwavering commitment, though, is to safety and quality. To that end, I encourage you to please continue to provide feedback (especially when requested!) and advocate for the importance of accreditation. In this newsletter, we have included several announcements that include requests for comments from the United States Food and Drug Administration (FDA) and the Standards Coordinating Body, as well as updates from the FACT Professional Relations Committee.

Finally, to highlight FACT’s goal to recognize the value of communicating and sharing the knowledge from our accredited organizations and inspectorate within our own network, we are inviting guest authors to contribute to our “Just the FACTs” newsletter. I therefore encourage you to read the piece written by Eunice Kim and Heather Steinmetz on “Qualification and Validation” that is adapted from a well-received presentation from a previous FACT event. If you would like to submit an article or article topic for consideration for inclusion in the newsletter please do not hesitate to reach out to: fact@factglobal.org. Once again, I want to thank you for all you do to enhance the cell therapy field to ultimately improve outcomes for the patients we serve!

Cheers,

Catherine Bollard, MD
FACT President


Just the FACTs 2022 Volume 3

Posted in :: 2022 Volume 3 :: Wednesday, August 17th, 2022

Letter from the President

In this month’s newsletter, there are updates regarding Standards from a variety of organizations, including ICCBBA, the United States Food and Drug Administration (FDA), and, of course, FACT. We work diligently to remain aware of and participate in public comment periods to advocate for the benefit of our accredited organizations and partners. I encourage all of you to also submit requested feedback whether as an individual, as part of your healthcare institution, or within your professional activities. The very nature of the FACT community is peer review and input, and it is important to apply this same principle to external organizations whose activities have an impact on our daily work caring for patients.

I also extend my congratulations to King Abdulaziz Medical City – Riyadh, Saudi Arabia for earning FACT accreditation! This is the first cellular therapy accreditation awarded by FACT in Saudi Arabia, and we commend the program for its dedication to achieving this confirmation of quality. FACT continues to offer its support globally to encourage accreditation and quality cellular therapy programs for patients everywhere.

Sincerely,

Catherine Bollard, MD
FACT President


Just the FACTs 2022 Volume 2

Posted in :: 2022 Volume 2 :: Friday, June 17th, 2022

Letter from the President

“It was great to see you!” After two long years of only virtual connection, we finally were able to say this again. FACT had a wonderful time over the past few weeks seeing colleagues in person at the annual meetings of various professional societies including ISCT and the Tandem Meetings with ASTCT and CIBMTR. In some ways, it was like no time has passed, and in other ways, it was like reuniting with long-lost friends. Our popular and interactive workshops returned to their hands-on format, the quality boot camp resumed their group-based learning, and we are thrilled to have had the opportunity to train many new inspectors. I personally would like to give you a heartfelt, “Welcome to the team!”

A major theme of this newsletter is highlighting the participation of FACT members in the public review and comment periods of multiple draft publications. Calling on the expertise within several FACT committees, we have submitted comments to numerous requests from related organizations and governmental agencies as highlighted in this newsletter. As a Standards setting organization, FACT understands the importance of soliciting and providing critical feedback for the development of appropriate, relevant, and useful guidelines; therefore, we encourage your participation in this important process. Thank you as always for your engagement and support!

Cheers,

Catherine Bollard, MD
FACT President


Just the FACTs 2022 Volume 1

Posted in :: 2022 Volume 1 :: Monday, March 7th, 2022

Letter from the President

FACT ushered in 2022 with the promise of a fresh start to a new year – and a time of transformation for our organization. Importantly, we completed our transition to independent status which will ultimately facilitate FACT’s ability to grow our organization and expand our portfolio to keep up with the rapid pace of growth in the cell therapy field. To that end, we welcomed new staff along with two new Board members, hosted a multi-stakeholder event focusing on advancing new cellular therapies, and scheduled in-person educational events for the first time in two years!

So yes, the future looks very promising indeed! This success could never have been achieved without our volunteers, colleagues, and friends building a peer-to-peer organization that encourages a culture of quality and has now provided service for patients for over 25 years! It is an incredible honor to build upon the transformational vision of our founding Board members. At the end of 2021, we reflected on our major accomplishments from our 25th anniversary year and are therefore extremely pleased to share these with you, too.

Happy New Year!

Catherine Bollard, MD
FACT President


Just the FACTs 2021 Volume 5

Posted in :: 2021 Volume 5 :: Tuesday, October 26th, 2021

The past few years have brought many dramatic changes in cellular therapy, but some things never change. FACT’s deep appreciation for collegial, peer-to-peer collaboration remains, and has been a bedrock to our organization as we navigate challenges and opportunities. To that end, FACT is continuing to evolve as evidenced by the recent review and revision of our Bylaws by FACT’s Board of Directors to keep pace with the ever-expanding cell therapy field!

In this newsletter, articles do not necessarily announce “new” concepts, but reaffirm our commitment to principles we have long supported. Quality management principles, regulatory compliance, and interorganizational initiatives are here to stay at FACT. We review donor eligibility requirements for donor lymphocyte infusions, describe the Circular of Information for the Use of Cellular Therapy Products, explain outcome analysis requirements for new cellular therapy products, and renew our commitment to ISBT 128 coding and labeling. FACT continues to be a criterion for U.S. News & World Report’s Best Hospitals List, an inspiring partner for World Cord Blood Day, and supportive of related organizations’ efforts. We also want to acknowledge the election of one of our past Presidents, Dr. Helen Heslop, to the National Academy of Medicine!

We heard on many occasions how FACT accreditation has helped cellular therapy programs and cord blood banks navigate the COVID-19 pandemic and grow along with advances in the field. As we look to the future, we can feel confident in our ability to handle new developments because of our rich history of achieving FACT accreditation together.

Cheers,

Catherine Bollard, MD
FACT President


Just the FACTs 2021 Volume 4

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021

A hallmark of a strong quality culture is the concept of continuous quality improvement. At FACT, we embrace that spirit and are always open to opportunities to improve our Standards, our inspection and accreditation processes, and the cellular therapy field as a whole. There are many examples of these types of activities within this newsletter.

We extend our sincerest appreciation to our volunteer Standards Committee members, volunteer inspectors, and accredited organizations for their tireless efforts this year. Two months ago, we published the eighth edition FACT-JACIE Hematopoietic Cellular Therapy Standards. It is always a labor of love. This edition was obviously no exception given the chaos of the past year; however, the committee did not deter from its work to revise and update our Standards. Both inspectors and accredited organizations alike explored the unknowns of virtual inspections. Not only have these inspections gone well, but we have implemented process improvements that have been discovered via the virtual inspection process.

Finally, please identify ways in which you can participate in the many efforts to harmonize industry requirements. You have the direct experience and expertise to leverage decades of lessons learned and accomplishments so that newer cellular therapies can experience the same growth and success as transplant. One such example, applying to be part of the standards working group on industry requirements for apheresis collection, is due by the end of this week.

Sincerely,

Catherine Bollard, MD
FACT President


Just the FACTs Volume 3

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

In my first letter to the FACT community earlier this year, I explained that one of my goals is to continue FACT’s position as the lead promoter for maintaining and improving the quality of cellular therapy for the benefit of patients. The unique collaborative model established by FACT is special, and we are excited to continue advancing this model into new cell therapeutics in clinical trials and in the marketplace.

One of the first steps we are taking is to pursue independent status from FACT’s long-time home, the University of Nebraska Medical Center. This change will allow us to continue to rapidly accommodate progress in the field as we have done in years past. FACT will support the extraordinary growth in cellular therapies, indications, and stakeholders, and becoming independent is one example of our commitment to you.

It is fitting that this change will come to fruition at the time of a milestone anniversary. This newsletter highlights exciting ways we are honoring our 25-year history, including our virtual events that always receive high marks of praise and preparing to publish the eighth edition of the FACT-JACIE Standards. There are examples of accomplishments our volunteers have achieved and collegial advice our programs are always willing to share with each other.

Please join us in celebrating our 25th anniversary and the exciting opportunities ahead for FACT.

Cheers, Cath