Kara Wacker, MBA, RAC,
Strategic Planning Administrator
Foundation for the Accreditation of Cellular Therapy
Omaha, NE USA
Liz Ferraro,
FACT Manager of Audit & Assessment Services
Foundation for the Accreditation of Cellular Therapy
Omaha, NE USA
FACT continues to fulfill its strategic plan and results from its most recent activities show that our initiatives are supporting our mission to improve the quality of cellular therapy for the benefit of patients.
Pilot Assessments Validate the Effectiveness and Efficiency of FACT Audit & Assessment Services
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:
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 (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
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
Register for Upcoming Events via FACT’s New Online Calendar
To enhance the organization and accessibility of FACT’s robust educational offerings, we recently updated our online calendar of events and listing of on-demand material. Visit https://learn.factglobal.org/upcoming-events to browse our offerings and register today!
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