News Hub

by

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

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Year 2023 Was a Year Full of FACT Accomplishments

FACT is celebrating a wonderful 2023! Below is a listing of many accomplishments over the past year. These successes are only possible with the volunteer inspectors and committees and the cellular therapy and cord blood banking organizations who pursue and maintain FACT accreditation. The entire FACT community should all be proud of everything we accomplished together!

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FACT Standards Development Committees Update Several Sets of Standards 

The FACT Standards Committees have been actively updating all four sets of Standards over the past year. The following are the major accomplishments:

• December 2022: The third edition of the FACT Common Standards for Cellular Therapies was published, accompanied by the first Accreditation Manual for this set of Standards.
• March 2023: A survey was distributed to the FACT community to request feedback on the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration in advance of the ninth edition revisions.
• March 2023: A special public comment period for the draft second edition of the FACT Standards for Immune Effector Cells was offered to solicit input on updates made to accommodate differences in the collection of cells, such as from solid tumors or other tissues. 
• June 2023: The draft eighth edition of the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration was published for public comment.

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FACT Strategic Plan Focuses on Increasing Patient Access to Quality Cellular Therapy 

FACT regularly adopts three-year strategic plans to advance its organizational mission of promoting quality for patients in the evolving field of cellular therapy. On the heels of a worldwide pandemic and in anticipation of a burgeoning list of advanced therapies, FACT’s strategic plan for 2023-2025 is intended to strengthen and streamline its infrastructure to support accredited organizations and to expand beyond core accreditation activities to serve new stakeholders that are driving development in the cell therapy industry.

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Pilot FACT Audit & Assessment Services Project is Initiated 

FACT hosted an industry focus group meeting during Advanced Therapies Week in January 2023 to present preliminary plans for FACT Audit & Assessment Services (FAAS) and gather feedback from manufacturers and other stakeholders. This feedback was used to develop a menu of services, a standardized assessment and audit checklist, proposed deliverables, and a pricing structure. Beginning in Summer 2023, a pilot assessment project was launched. As part of this project, three companies selected three sites for a pilot assessment based on the companies’ needs. The pilot assessments were successful and lessons learned will be incorporated into the FAAS processes. The official launch will take place in 2024. 

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Major Upgrade to FACT Accreditation Portal Launched 

In February 2023, a major upgrade of the online FACT Accreditation Portal included new capabilities available to both applicants and inspectors. The improved portal interface has been modernized and streamlined to provide a better overall user experience and increased security. There were also enhancements to many of the pre-existing features including: 

• Document Library. 
• Application Export. 
• User Creation. 
• RFI Processes. 
• Two Factor Authentication. 
• Director Approval Processes. 

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FACT Advocates for Multistakeholder Consensus Building Efforts in the ISCT Telegraft Hub 

FACT provided an article in the ISCT Telegraft Hub that described its efforts to build consensus among multiple stakeholders and perspectives to promote quality cellular therapy in the next wave of advancements. Titled, “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 article provides a history of FACT’s consensus-building roots and then describes the organization’s current efforts: 

• The early collaborations among ASTCT, ISCT, FACT, JACIE, NetCord, and more. 
• The advent of commercially manufactured cellular therapies and the need for multistakeholder cooperation. 
• FACT participation in multistakeholder groups. 
• FACT implementation of multistakeholder solutions to reduce duplicative assessments and audits:
  - Soliciting manufacturer input in the FACT Standards development process. 
  - Supporting manufacturers’ efforts to leverage FACT accreditation. 
  - Advocating for the implementation of multistakeholder solutions. 
• Building FACT Audit & Assessment Services. 

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FACT Launches Fund Development Initiatives 

FACT welcomed its first Director of Development, Meredith Lambe, to develop and implement a fundraising plan to support FACT’s mission and vision by enriching FACT’s education and training program, prevent increased service costs, and expand access to patient therapies. To oversee fundraising efforts, a Fund Development Committee led Dr. Alan Balch, was established. FACT has initiated its fund development program to broaden and enhance its educational activities and expand training to more inspectors internationally. In addition, funding will aid in conducting additional accreditation workshops to provide essential information and resources to site personnel awaiting accreditation and ultimately accelerate delivery of quality therapies to the market safely and promptly.

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FACT Education Continues Robust Schedule Despite Pandemic Challenges 

Although adjustments were continuously made to adapt to surges in the COVID-19 rates, the FACT Education calendar remained full in 2023. In 2023, FACT hosted 12 all-day events, 5 webinars, and 5 portal sessions. These included accreditation workshops, inspector training courses, quality boot camps, Quality Management webinar series, and Immune Effector Cells for Solid Tumor webinar series.

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Global Affairs – International Tour a Success 

International efforts to assist with the development of cellular therapy programs and quality systems were in high demand in 2023. Special thanks to our dedicated and generous volunteers Daniel Couriel, Carlos Bachier, and Federico Rodriguez for organizing, educating, and serving as invaluable resources for our global partners throughout Latin America. Accreditation and quality sessions were conducted in conjunction with FACT’s partners during the GATMO Congress in Buenos Aires, Argentina; Mexican Society of Cellular Therapy and Bone Marrow Transplants & Transplantation (SMTT) in Puebla, Mexico; and the Brazilian Society of Cellular Therapy and Bone Marrow Transplantation (SBTMO) Congress in Curitiba, Brazil. FACT also held its inaugural education and training event in conjunction with the ISCT Australia & New Zealand Regional Meeting in Perth, Australia and look forward to this being an annual event.

With Gratitude, We Welcome New FACT Inspectors!

We are so pleased to announce several additions to the FACT inspectorate in 2023. Our inspectors are not only the eyes and ears of FACT but are integral to providing quality cellular therapy amidst the growth in number of healthcare institutions and the wave in therapeutic advancements. The peer-based FACT inspection and accreditation processes evaluates organizations through the perspective of experts with relevant education and experience, and protects patient access, sound research, and workforce availability.

There are many benefits to volunteering as a FACT inspector, including:

• 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

The following individuals performed their first active inspection in either cellular therapy or cord blood in 2023. Thank you for advancing the FACT mission for quality cellular therapy for the benefit of patients!

Apply to be a FACT Inspector

Julie Annis, MLS(ASCP)

Cellular Therapy Processing – Minimal Manipulation of HPC

Cara Benjamin, PhD

Cellular Therapy Processing – Minimal Manipulation of HPC

Ed Brindle, MSc, MLT

Cellular Therapy Processing – Minimal Manipulation of HPC

Kathryn Bushnell, MSHS, MLS(ASCP), CABP(AABB)

Cellular Therapy Processing – Minimal Manipulation of HPC

Hannah Choe, MD

Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy

Brianna Cunigan, MSN, RN

Apheresis Collection

Alexandra De Los Rios, DVM

Cord Blood Collection

Patrick DeMartino, MD, MPH

Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy

Bhagirathbhai Dholaria, MBBS

Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy

Laura Finn, MD

Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy

Amy Hawkins, BSN, RN

Apheresis Collection

Yen-Michael Hsu, MD, PhD

Cord Blood Processing

Themis Karaoli, BS

Cellular Therapy Processing – Minimal Manipulation of HPC

Indreshpal Kaur, PhD, MS

Cellular Therapy Processing – Minimal Manipulation of HPC, More-than-Minimal Manipulation of Any Type of Cell

Gesine Kögler, PhD

Cord Blood Banking, Collection, and Processing

Christopher Leonforte, MSc

Cord Blood Processing

Juan Merayo-Rodriguez, MD

Cord Blood Banking, Collection, and Processing

Carolyn Mulroney, MD

Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy

Yuk Kuen (Jess) Oh, MT(ASCP), MLS(ASCP)CM

Cellular Therapy Processing – Minimal Manipulation of HPC

Nicole Prokopishyn, PhD

Cord Blood Processing

Muthalagu Ramanathan, MD

Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy

Albert Ribickas, MT(ASCP)

Cellular Therapy Processing – Minimal Manipulation of HPC, More-than-Minimal Manipulation of Any Type of Cell

Margo Rollins, MD

Apheresis Collection

Baheyeldin Salem, MD

Clinical Hematopoietic Cellular Therapy

R. Alejandro Sica, MD
Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy

Olive Sturtevant, MHP, MT(ASCP), SBB/SLS
Cellular Therapy Processing – Minimal Manipulation of HPC, More-than-Minimal Manipulation of Any Type of Cell

Sarina Torres, MSN, RN, BMTCN, QIA(ASCP)
Apheresis Collection

Korrynn Vincent, BS
Cord Blood Processing

Joan Woeltz, MS, MLS(ASCP)
Cellular Therapy Processing – Minimal Manipulation of HPC

More-than-Minimal Manipulation of Any Type of Cell

Zheng Zhou, MD
Clinical Hematopoietic Cellular Therapy

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FACT Vendor Survey for Supplier Directory

FACT is surveying sites and vendors, suppliers, and pharmaceutical companies involved in cell therapy to determine your interest in a FACT Supplier Directory that would be available as a resource for FACT-accredited programs. 

Interested manufacturers, suppliers, and vendors that provide resources or services or engage with FACT-accredited sites would have the option to secure a listing in the online Supplier Directory with an annual tax-deductible donation. The organization name, location, website, contact information, organization representative, and a brief description of the organization’s product(s) or service(s) would be included in the listing. The Supplier Directory will be updated periodically. All FACT-accredited sites will have access to the Supplier Directory.

If you/your organization would be interested in being included in the Supplier Directory, please complete the survey below. Based on significant interest, we are now accepting responses until December 31, 2023.

Complete the accredited organization survey

Complete the manufacturer, supplier, and vendor survey

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FACT Professional Relations Committee Collaborates on Input to Regulatory Agencies in the United States

Member organizations of the FACT Professional Relations Committee have robust advocacy programs that initiate and respond to legislative and regulatory affairs around the world. They report on their activities on a quarterly basis during committee meetings. Occasionally, there are proposals for which the committee feels concerted efforts are necessary, and the member organizations collaborate to submit comments or express support. The committee worked on two such proposals in the second half of 2023.

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Support for the Life Saving Leave Act (H.R. 3024)

Be the Match led an effort to express support for the Life Saving Leave Act (H.R. 3024), which ensures bone marrow and blood stem cell donors nationwide have up to 40 non-consecutive, unpaid hours of leave without a risk to their jobs. Most patients in need of blood and marrow transplantation have only one match on the nation’s bone marrow registry, but job-related barriers to donation can prevent patients from receiving the transplant. One of the top-cited obstacles to saying “yes” to being a donor are job-related barriers. 

Many member organizations of the Professional Relations Committee signed on to a statement of support for the Act. Via the statement, the widespread support of this bill was shared through the American Society for Transplantation and Cellular Therapy (ASTCT)’s Day on the Hill on Sept. 14.

Read more from Be the Match

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Comments in Response to the FDA Proposed Rule on Laboratory Developed Tests

As reported in a previous article, the Professional Relations Committee has followed efforts to change Food and Drug Administration (FDA) oversight of laboratory-developed tests (LDTs). The FDA currently practices enforcement discretion for these tests but seeks to phase out the discretion approach and begin requiring approval under medical device regulations.

The committee thanks everyone who participated in the request for extending the public comment period. The FDA declined this suggestion, and comments were due on December 4.

Several member organizations shared their general impressions regarding the proposed rule, and then submitted individual organizational comments to the FDA. 

FACT’s comments expressed appreciation to the FDA for its commitment to public health, stated that the proposed rule broadly combines a diverse number of LDTs into a single approach, and suggested that the current proposal should be revised to apply to large-volume, mass-produced, and direct-to-consumer tests that are IVDs offered as LDTs. This is where the greatest potential risks, and the greatest potential gains, to public health are present. FACT also specifically suggested that general enforcement discretion be continued for LDTs utilized by clinical laboratories at accredited hospitals and health care systems to support the provision of hematopoietic cell transplantation and cell and gene therapy, including post-therapy monitoring tests and off-label use of FDA-approved test kits and devices. These tests are often used in urgent, life-saving situations and utilize innovative techniques to facilitate the delivery of new therapies with new side effects. Narrowing the scope of the proposed rule would mitigate risks to patient access to therapies and continue prompt intervention of side effects. This approach would substantially benefit public health while avoiding a tumultuous phase-out approach for a wide variety of tests in scale and purpose.

Read the proposed rule

FACT-accredited programs can rest assured that their interests are well represented; however, the specific input of individual experts cannot be understated. FACT announces situations in which it feels that diverse submissions are necessary to fully explain the impact of proposed legislation and regulations, and we encourage you to take advantage of those opportunities to influence future requirements.

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Congratulations to Helen Heslop – Recipient of the 2023 ASH Mentor Award

Congratulations to Dr. Helen Heslop, Past FACT President, for receiving the 2023 ASH Mentor Award. The American Society for Hematology (ASH) rewards outstanding mentors in the hematology community to recognize the value it places on mentorship. It defines mentoring as the process of guiding, supporting, and promoting the training and career development of others. The key roles of a mentor include, but are not limited to, providing

• Intellectual growth and development
• Career development
• Professional guidance
• Advocacy
• Positive role modeling

Per the ASH press release, “Dr. Heslop is a highly respected mentor who is known for her inclusivity and commitment to helping her mentees advance in their careers. She is an exceptional physician-scientist who has made significant and lasting contributions to the field of hematology. One of her remarkable achievements is her ability to nurture a diverse group of mentees, including female physician-scientists and individuals from backgrounds historically underrepresented in hematology. Many of her mentees have gone on to become successful independent investigators. Among those she mentors, Dr. Heslop is recognized as an ideal leader who is patient, kind, and one who consistently prioritizes the success of her trainees.

Dr. Heslop’s primary research focuses on the development of adoptive immunotherapies. By genetically modifying cells, she has worked to improve hematopoietic stem cell transplantation and cancer therapies. She strives to ensure that her findings are translated from the lab to clinical trials to improve the lives of individuals living with cancer and blood disorders.”

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FACT was Proud to be an Inspiring Partner of World Cord Blood Day 2023 

FACT proudly participated in World Cord Blood Day on November 15, 2023 as an inspiring partner. In addition to the free World Cord Blood Day virtual conference, FACT celebrated by making several resources prominently available to celebrate. These cord blood resources are still available!

FACT World Cord Blood Day 2023 Playlist Check out FACT's World Cord Blood Day playlist on YouTube for resources and information on cord blood banking presented by experienced FACT Inspectors around the world! View Playlist

World Cord Blood Day 2023 - FREE Virtual Conference - November 15 Join the FREE virtual conference happening now, presented by Save The Cord Foundation! Can't make it today? No worries! Sessions will be available on demand until December 15, 2023. Reserve a Spot

Visit the FACT Cord Blood Bank Library for the most recent FACT Standards, guides, and forms.	Get shopping! Visit the Educational Recordings page in the FACT Store for a catalog of on-demand cord blood banking virtual offerings.	Apply to become a FACT Cord Blood Bank Inspector! FACT Inspectors have access to nearly $2,000 of educational content annually.
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