FACT August 2023 Update: Real-World Expertise Provides Important Feedback to FACT and Other Organizations

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Kara Wacker, MBA, RAC, Strategic Planning Adminstrator
Foundation for the Accreditation of Cellular Therapy
Omaha, NE USA

The blood and marrow transplant and cellular therapy field is well known for its collaboration to fully achieve the true potential of cellular therapies. The FACT peer-based Standards development and accreditation program, founded by the American Society for Transplantation and Cellular Therapy (ASTCT) and International Society for Cell & Gene Therapy (ISCT), is a shining example. Two additional examples include the FDA Cell Therapy Liaison Meetings facilitated by ISCT and the ASTCT 80/20 Task Force. Many other multistakeholder initiatives have been in existence for decades or were formed recently as our field welcomes additional roles and perspectives. The abundant cooperation among cellular therapy stakeholders provides many opportunities to participate.

A vital perspective comes from those who directly manage cellular therapy products and care for patients. Clinical programs, cell collection and processing facilities, and cord blood banks are requested on a frequent basis to contribute to committees, public comment periods, surveys, meetings, and more. These requests are not made lightly, as organizations such as FACT are aware of the day-to-day professional and personal obligations of those whose input we seek.

Requests for participation in initiatives is a testament to the value placed on the real-world expertise and knowledge of clinicians, scientists, nurses, technologists, quality managers, data managers, and more. We encourage you to invest the time required to participate so that organizations such as FACT can better serve you and the patients in your care.

The following are recent requests for input. FACT thanks you for participating!

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Comments Requested on Draft Eighth Edition NetCord-FACT Cord Blood Banking Standards

FACT has published the draft eighth edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration for public comment through September 15, 2023.

These comprehensive Standards promote quality medical and laboratory practices throughout all phases of cord blood collection, processing, and banking to consistently achieve quality placental and umbilical cord blood units for administration and to improve patient outcomes. The final Standards will be published in December 2023.

The purpose of this public comment period is to receive your comments and suggestions on this edition of the Standards. The published draft is a redline document intended to highlight the significant changes. Some changes are new standards; however, others are intended to clarify rather than change the intent, or to provide consistency with other sets of FACT Standards. Minor reorganization and clarifications are not tracked.

Review the Draft Eighth Edition Cord Blood Standards

For instructions and to submit your comments(s), go to the Cord Blood Public Comments Survey.

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FACT Encourages Completion of CAR-T and Cellular Therapy Worldwide Survey by August 31

The Worldwide Network for Blood & Marrow Transplantation (WBMT), in conjunction with assistance from the University of Texas Health Science Center San Antonio, has initiated a CAR-T and Cellular Therapy survey. The purpose of the survey is to better understand the worldwide situation with regards to the availability of both commercially approved and investigational CAR-T therapy as well as other forms of advanced cell-based therapy (e.g., mesenchymal stromal cells). It will provide insight not only into the availability of these therapies worldwide but also of issues pertaining to accessibility, manufacturing capabilities, apheresis, accreditation, and presence of regulatory frameworks and legal oversight of these cell-based therapies.

This data gathering exercise will facilitate WBMT’s discussions with its affiliated partner, the World Health Organization (WHO), with the intention of trying to achieve equity of access to life saving cell-based treatments, especially CAR-T, worldwide. It will also help WHO in understanding the landscape of cell therapy across different regions in terms of the crucial scientific, clinical, and regulatory components needed to achieve equity of access.

This is an entirely fact-finding survey, and all results will be handled with strict confidentiality. Individual data and responses will only be accessed by the primary investigators for this survey. All results will be presented by region/country rather than by institutions. This survey is to be filled by the program director or a designee and each institution should only be represented once. Do feel free to write more in the free-flowing text area, and for those who are unable to fill every field/question, we would also like to receive your reply. It is also important to receive survey replies from those who do not have any form of cell therapy in their hospital/centre/institution.

Participation in this survey is completely voluntary. Nonetheless, we would strongly encourage participation as we expect this survey to generate important data which could lead to further important initiatives, especially with WHO.

For any further questions, inquiries, or issues with the survey, please contact:

Mickey Koh, MD, Hildegard Greinix, MD, Mahmoud Aljurf, MD, Fazal Hussain, MD
at mail@wbmt.org or mickey.koh@stgeorges.nhs.uk.

This survey should take less than 15 minutes to complete. To ensure easy access to the survey, please follow these steps:

Take this survey from a laptop, and not from a phone or other type of device.
Make sure you are connected to a secure and steady Wi-Fi network.
Copy and paste the link to the survey in an incognito/private browser. You can open the incognito mode as follows: on your keyboard, please press Ctrl, Shift, N simultaneously (for Apple users the correct combination is Command, Shift, N). Once the incognito page has opened up, you can copy and paste the link in the field and start the survey.

Link to survey: https://uthscsa.co1.qualtrics.com/jfe/form/SV_0plkcuqDW3bSpOC

Please submit your survey responses by August 31, 2023.

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Register for the 2023 AcCELLerate Forum: Join in Person or Virtually

ASTCT™, CIBMTR® and the National Marrow Donor Program®(NMDP)/Be The Match® are excited to announce that registration is now open for the 2023 AcCELLerate Forum!

Participate in person or virtually in impactful conversations regarding patient needs, therapies, and access to cell and gene therapy with advocates, industry representatives, researchers, and providers. Together we will identify needs and opportunities in the field for advocacy and sustainability.

Preliminary agenda topics include:
80/20 Updates
Access and Care Disparities in Cellular Therapy
Cost-Mitigating Approaches in Cellular Therapy
Future Directions in Cellular Therapy
Histocompatibility Impact on Safety and Efficacy
Logistics for Cell Therapy Delivery in Different Settings
Point-of-Care Manufacturing and Production
Regulatory Process for Approving New Products

View the up-to-date agenda (subject to change)
Register for the forum
Follow #accellerate23 for updates

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Upcoming FACT Educational Events

The following events are open for registration!

	FACT Clinical, Collection, Processing, & Cord Blood Banking Inspector Training Course at ISCT ANZ 2023 Regional Meeting Perth, Australia, August 15, 2023 8:00 am – 5:00 pm AWST Book you ticket now!
	FACT Accreditation and Quality Principles Workshop at ISCT ANZ 2023 Regional Meeting Perth, Australia, August 15, 2023 8:00 am – 5:00 pm AWST Book you ticket now!
	FACT Cellular Therapy Accreditation Workshop Puebla, Mexico, August 24, 2023 8:00 am – 12:00 pm CT Book you ticket now!
	FACT Processing Inspector Training Course at ISCT North America Regional Meeting Houston, TX, September 7, 2023 8:00 am – 5:00 pm CT Book your ticket now!
	FACT Cord Blood Inspector Training Course Miami, FL, September 7, 2023 8:00 am – 5:00 pm ET Book your ticket now!
	FACT Accreditation Portal 2.0 Open House – Session 1 Miami, FL, September 8, 2023 7:15 am – 8:00 am ET Book your ticket now!
	FACT Accreditation Portal 2.0 Open House – Session 2 Miami, FL, September 8, 2023 7:15 am – 8:00 am ET Book your ticket now!
	FACT QM Series 12 Webinar: Establishing Quality Indicators September 27, 2023 10:00 am – 11:00 am CT Book your ticket now!
	FACT QM Series 12 Webinar: Written Agreements November 14, 2023 10:00 am – 11:00 am CT Book your ticket now!