Accreditation Statistics

As of June 3, 2024

Cellular Therapy Entities

  • Accredited: 262
  • Applicants: 30

Cord Blood Banks

  • Accredited: 48
  • Applicants: 10

 

Initial Accreditations

  • Cord Blood Bank University Hospital Basel Cord Blood Collection (Fixed and Non-Fixed sites), Banking, and Release for Administration of Unrelated and Related Donations
  • Cord Blood Bank Geneva Cord Blood Collection (Fixed, Non-Fixed sites), Banking, and Release for Administration of Unrelated and Related Donations

     

A complete list of accredited organizations can be found at https://accredited.factglobal.org/.

Just the FACTs 2024, Volume 3

Posted in :: 2024 Volume 3 :: Monday, June 24th, 2024

President’s Letter

We are excited to publish this June newsletter because the articles underscore the importance of the FACT accreditation process to enhance patient access to quality cellular therapy.

After years of meetings, presentations, and brainstorming, a solution to the unsustainable audit burden on health care sites and cell product manufacturers is here! FACT Audit & Assessment Services (FAAS), provided by FACT Consulting, is now available. In late 2023, a pilot project validated our processes, and we received positive feedback from three cell therapy companies and three apheresis facilities. If you are a site that is approached to undergo a company audit, suggest that the company contact us for our services. If you are a cell therapy company, we suggest initiating an assessment program with us so that we can customize our processes to your needs. I refer you to the informative article in this newsletter for more details.

In addition, I am delighted to highlight that we continue to accredit programs around the world, and in this newsletter we congratulate the Abu Dhabi Stem Cells Center on its initial accreditation for cellular therapy product processing with minimal manipulation – the first FACT accredited program in the United Arab Emirates!

Finally, to expand our services and global footprint, we are also keenly in tune to the need for more quality cellular therapy programs. To increase awareness, Blood Advances recently published an article submitted by our Immune Effector Cell (IEC) Task Force emphasizing the importance of quality systems and FACT accreditation for immune effector cellular therapy programs. Please feel free to share this open access article with your colleagues interested in providing these therapies and encourage them to seek FACT accreditation!

Cheers,

Catherine Bollard, MD

FACT President


Pilot Assessments Validate the Effectiveness and Efficiency of FACT Audit & Assessment Services

Posted in :: 2024 Volume 3 :: Monday, June 24th, 2024

By Liz Ferraro, FACT Audit & Assessment Services Manager

FACT Audit and Assessment Services (FAAS) is the latest addition to the suite of services offered by FACT Consulting.  Our primary objective is to address the complex issue of multiple manufacturers auditing the same treatment site.  Each assessment we perform combines the options for a standardized checklist of applicable geographic regulations supplemented by custom requirements of a particular client. The final assessment report is provided to the client, and then identifying and proprietary information of the client is removed so that the report can be made available to additional stakeholders such as manufacturers, sponsors, license holders, or registries seeking assessment of the same site.  This process not only alleviates audit burden on the sites but also optimizes resource allocation for the client(s) pursuing site assessment.

To validate the efficacy of our approach, FAAS conducted pilot assessments with three different manufacturers, each seeking qualification of a different cellular therapy collection site.  These assessments were conducted in the presence of the manufacturers, allowing for direct observation of our process and solicitation of feedback regarding its effectiveness and appropriateness.

The overall feedback from both manufacturers and sites was positive.  They expressed satisfaction with various facets of the process, including the thoroughness of preparation, expertise of the FAAS team, value to both the site and the manufacturer, and tangible outcomes derived from each assessment.

Testimonials from site personnel underscored their potential for improvement facilitated by our approach, with comments such as:

  • “We feel this will help us improve.”
  • “This was a very robust audit.”
  • “The audit approach was polite and effective.”

Manufacturers were satisfied with the comprehensive nature of our assessments, commenting:

  • “This is a more robust assessment than what we typically do.”
  • “If you assess the entire operation at a site we are interested in, we will request the report without going on-site.”
  • “We like that you can assess for our specific elements in addition to the standard FDA regulations.”

This feedback underscores the value FAAS brings to the site assessment process. In short, FAAS assessments are effective and efficient, and a more valuable use of sites’ and clients’ resources than the audits currently performed.

We also incorporated feedback to improve our processes, such as facilitating clear and frequent communication among the site, the client, and FAAS. FAAS remains committed to continual improvement, and will continue to seek feedback and refine our processes to ensure we are exceeding expectations of both clients and sites.

For those interested in learning more about how FAAS can address their specific challenges, whether that be manufacturers needing assistance to manage assessment workload or sites seeking to reduce their audit burden, we invite inquiries through the following channels:

  • Contact Liz Ferraro at liz.ferraro@factglobal.org to ask questions or discuss your particular needs.
  • Manufacturers, sponsors, license holders, and registries may also submit a no-cost, no-commitment Needs Assessment Form, available on the FACT Consulting website, to expedite input and proposals from FAAS.

Let’s work together to enhance patient access to essential cell and gene therapies through collaborative partnership and innovative solutions.


Abu Dhabi Stem Cells Center is First Cellular Therapy Processing Facility in United Arab Emirates to Earn FACT Accreditation

Posted in :: 2024 Volume 3 :: Monday, June 24th, 2024

Abu Dhabi Stem Cells Center (ADSCC) has achieved internationally recognized accreditation from FACT, making it the first and only cellular therapy processing facility in the United Arab Emirates to earn this distinction. Led by Prof. Yendry Ventura, MD, ADSCC received accreditation on April 2, 2024, specifically for Cellular Therapy Processing with minimal manipulation.

Prof. Yendry Venturay, CEO of ADSC and Adjunct Professor at UAE University, expressed his gratitude, commenting, “Under the guidance of UAE’s wise leadership and in line with the UAE’s national agenda in healthcare, ADSCC has a clear vision and mandate of pioneering cellular therapy on a global scale and bringing medical breakthroughs close to bedside, which plays a crucial role in positioning Abu Dhabi and the UAE at the vanguard of healthcare innovation. With this landmark FACT accreditation, we are breaking new ground in addressing complex diseases through cutting-edge treatments such as stem cell transplants and other cellular therapies. The journey towards accreditation has been both extensive and stimulating, and we take immense pride in being the first institution in UAE to receive it. This achievement reaffirms our commitment to continue investing in providing the highest standards of patient care and offering top-tier cellular therapy services that is on par with the best globally.”

Dr. Phyllis Warkentin, FACT Chief Medical Officer, commended ADSCC, stating “FACT accreditation represents a commitment to quality throughout an organization and requires dedication and perseverance. I congratulate Prof. Ventura and the team of the Abu Dhabi Stem Cells Center on achieving FACT accreditation, the first cellular therapy product processing laboratory in the United Arab Emirates to reach this milestone.”


Blood Advances Publishes Commentary on The Importance of a Quality Infrastructure for Immune Effector Cellular Therapy

Posted in :: 2024 Volume 3 :: Monday, June 24th, 2024

Blood Advances, the peer-review journal of the American Society of Hematology (ASH), published commentary from the FACT Immune Effector Cell Task Force regarding the importance of a quality infrastructure and how FACT accreditation can help.

A robust quality infrastructure is key to safe and effective delivery of immune effector cells: how FACT-finding can help (Curran, K., et. al, 2024), explains to a broad audience of hematology/oncology providers the importance of developing a quality system to deliver immune effector cell (IEC) therapy within its extremely complex patient and product journeys. In the context of FACT accreditation, the article outlines challenges that a verified quality system that meets peer-established requirements can alleviate.

We encourage our colleagues in the FACT community to share this article widely with departments, specialists, and practices that may be interested in providing IEC therapy to patients. Access to these groundbreaking therapies is only beneficial to patients if they are safe and effective. According to the article’s abstract:

“Immune effector cells (IECs) include a broad range of immune cells capable of modulating several disease states, including malignant and nonmalignant conditions. The growth in the use of IECs as both investigational and commercially available products requires medical institutions to develop workflows/processes to safely implement and deliver transformative therapy. Adding to the complexity of this therapy are the variety of targets, diseases, sources, and unique toxicities that a patient experiences following IEC therapy. For over 25 years, the Foundation for the Accreditation of Cellular Therapy (FACT) has established a standard for the use of cellular therapy, initially with hematopoietic cell transplantation (HCT), and more recently, with the development of standards to encompass IEC products such as chimeric antigen receptor (CAR)-T cells. To date, IEC therapy has challenged the bandwidth and infrastructure of the institutions offering this therapy. To address these challenges, FACT has established a programmatic framework to improve the delivery of IEC therapy. In this study, we outline the current state of IEC program development, accreditation, and solutions to the challenges that programs face as they expand their application to novel IEC therapy.”

Citation:

Kevin J. Curran, Sarah Nikiforow, Carlos Bachier, Yen-Michael Hsu, David Maloney, Marcela V. Maus, Philip McCarthy, David Porter, Patricia Shi, Elizabeth J. Shpall, Basem William, Kara Wacker, Phyllis Warkentin, Helen E. Heslop; A robust quality infrastructure is key to safe and effective delivery of immune effector cells: how FACT-finding can help. Blood Adv 2024; 8 (4): 1053–1061. doi: https://doi.org/10.1182/bloodadvances.2023010401


ISCT and CMaT Report Success of Hands-On Laboratory Bootcamp for Cell Therapy Biomanufacturing; Fills Gap in Workforce Development

Posted in :: 2024 Volume 3 :: Monday, June 24th, 2024

Workforce development is a buzz phrase spoken frequently during multistakeholder meetings and conferences, and rightfully so. As ISCT stated in a recent email, “The U.S. Food and Drug Administration (FDA) has approved 34 CGT products as of March 2024 and is expected to approve up to 20 CGT products annually by 2025.” With this explosive growth, laboratories will have substantial needs for a qualified workforce. An innovative solution provided via a collaboration between the International Society for Cell & Gene Therapy (ISCT) and the NSF Engineering Research Center for Cell Manufacturing Technologies (CMaT) at Georgia Tech is the Hands-On Laboratory Bootcamp for Cell Therapy Biomanufacturing.

ISCT recently published an article that outlined the resounding success of the first bootcamp, which took place this year from March 29 through April 3. The author, Raymond Lam, provided daily synopses over the course of the five-day bootcamp. This article provides detailed insight into how laboratories and their personnel can benefit from participating in a future bootcamp.

The second ISCT-CMaT Hands-on Laboratory Bootcamp for Cell Therapy Biomanufacturing Course will be from August 5–9, 2024. Register now to secure your spot!

Read about the first course

Register for the next course


ASTCT Provides List of Open Access Articles to Facilitate Provider Learning and Continuing Education

Posted in :: 2024 Volume 3 :: Monday, June 24th, 2024

The American Society for Transplantation and Cellular Therapy (ASTCT) recently provided a list of sample open access articles to email subscribers, which are valuable resources for continuing education. (Remember – journal article reviews can be used for FACT continuing education requirements!) See the list the society provided below.

Not only are these articles available for free, but they provide a glimpse into the benefits of becoming an ASTCT member. Join the society to access all journal articles, network with colleagues, and impact advocacy efforts.

 

 

Chimeric Antigen Receptor T Cell Therapy for Myeloma: Where Are We Now and What Is Needed to Move Chimeric Antigen Receptor T Cells Forward to Earlier Lines of Therapy? Expert Panel Opinion from the American Society for Transplantation and Cellular Therapy

Read Article

INSPIRED Symposium Part 4A: Access to CAR T Cell Therapy in Unique Populations with B Cell Acute Lymphoblastic Leukemia

Read Article

A Day 14 Endpoint for Acute GVHD Clinical Trials

Read Article

Digital PCR Improves Sensitivity and Quantification in Monitoring CAR-T Cells in B Cell Lymphoma Patients

Read Article

Thiotepa-Based Regimens Are Valid Alternatives to Total Body Irradiation-Based Reduced-Intensity Conditioning Regimens in Patients with Acute Lymphoblastic Leukemia: A Retrospective Study on Behalf of the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation

Read Article

Clinical Impact of Cytokine Release Syndrome on Prolonged Hematotoxicity after Chimeric Antigen Receptor T Cell Therapy: KyoTox A-Score, a Novel Prediction Model

Read Article

Subjective Oral Dryness following Hematopoietic Cell Transplantation: A Report from the Orastem Study

Read Article

If They RECUR, You Should Refer: A Community Oncologist Patient ID Roundtable Summary

Read Article


Register for Upcoming FACT Education Events!

Posted in :: 2024 Volume 3 :: Monday, June 24th, 2024

AUGUST

SEPTEMBER

 

View the Full Educational Library and Upcoming Events at https://learn.factglobal.org/