Just the FACTs 2024, Volume 4
President’s Letter
FACT continues to evolve and adapt alongside the continuous changes in transplantation and cell therapies. As described in this newsletter, we have updated processes to better serve our accredited programs as well as our volunteer inspectors and committee members.
The first change that we highlight is with respect to our annual request for Conflict of Interest Disclosure. As I explained in my email to all our incredible volunteers on July 1st, we have a responsibility to mitigate the impacts of real, perceived, or potential conflicts of interest on the integrity of our work. However, we strive to make this process as quick and seamless as possible and are pleased to have rolled out the new COI disclosure management software to help you meet this obligation in the least burdensome way.
In this issue we also describe changes to the FACT accreditation goals for cell collection services. In addition to specifying the type of collection (marrow, apheresis, or other tissue), we also now specify the intent of collection (for administration or for further manufacturing). Specifying the intent of collection for which a facility is accredited brings greater transparency regarding the activities that comply with FACT Standards.
We are also happy to spread the word regarding modifications to Risk Evaluation and Mitigation Strategies (REMS) required by the United States Food and Drug Administration. Our experience and knowledge regarding cytokine release syndrome and neurological toxicities, coupled with the increasing complexities and demand for CAR T cell therapies, make this a welcome change. Stay tuned for the updated FACT-JACIE Hematopoietic and Immune Effector Cell Standards that will be released for public review soon – the updated additions include some changes that supported advocacy efforts to reduce REMS requirements.
Finally, we are celebrating Cord Blood Awareness Month alongside our colleagues at cord blood banks and at the Clinical Programs who utilize this lifesaving resource. Thank you for making cord blood units available to patients who need them. We appreciate you!
Sincerely,
Catherine Bollard, MD
FACT President
Reminder: FACT Inspectors and Committee Members Must Complete Annual Conflict of Interest Disclosure by August 1
Integrity is rooted in our mission, and we regularly monitor conflict of interest disclosures and other relevant information to identify any potential or real conflicts. FACT inspectors and committee members play an integral role in advancing the mission and goals of FACT and upholding the associated responsibilities. Respecting the importance of the conflict of interest (COI) process is also necessary when performing these roles. FACT’s accreditation and the nature of our work is critical, and we respect the seriousness of our volunteer-based accreditation and standards activities.
Closely related conflicts of interest are not inherently wrong or forbidden, but FACT must be made aware of such interests to evaluate their impact on its mission and activities to ensure the duties of an individual are carried out appropriately and not to the detriment of a fair outcome.
It is not the intent of these policies to prohibit or discourage anyone from participating in the activities of FACT or other outside interests. However, FACT is obligated to enforce adherence to our conflict of interest policies. Non-compliance may result in disqualification from participation in FACT activities.
To make it easier for our volunteers, we have implemented a new COI disclosure management software, NAVEXOne®.
- Complete FACT’s Conflict of Interest and acknowledgements using your Single Sign On (SSO) credentials: https://fact.navexone.com/home.
- Due: August 1, 2024.
- The following policies are included and can be reviewed in advance:
- Maintenance of COI: If at any other time of the year you encounter a possible conflict of interest that impacts your disclosure, please return and submit an amendment outlining the possible conflict or changes at https://fact.navexone.com/home. Good governance includes conducting this process on a regular basis; FACT will send a request to review and update your disclosures annually.
Refer to the instructions below to navigate to the online form:
- Navigate and sign on to FACT’s COI software: https://fact.navexone.com/home.
- Select My Tasks in the left navigation pane.
- Select 2024 FACT Conflict of Interest & Acknowledgements.
- Select each policy and attest to reading them by selecting Mark as Read.
- Select FACT Conflict of Interest and complete.
If you have questions, please contact Heather Conway (heather.conway@factglobal.org).
Thank you for supporting a strong culture of compliance and ethics which supports FACT’s accreditation and reputation.
FACT Accreditation Now Specifies Intent of Cell Collection Activities for Administration or for Further Manufacturing
FACT has added specificity to the scope of accreditation for cell collection. Beginning in July 2024, the online list of FACT-accredited organizations and accreditation certificates now specify two different intents of collection: collection for administration and collection for further manufacturing.
Previously, FACT accreditation encompassed all collections performed by the accredited organization, irrespective of the intended use of the collected cells. While this approach has historically served the blood and marrow transplant programs effectively, the evolving landscape of cellular therapy demands a more refined approach.
With the increasing utilization of cells collected by apheresis for further manufacturing purposes, it has become important to distinguish between collections intended for administration to patients and those earmarked for subsequent manufacturing processes. Although our inspection and accreditation scope already encompass collection for further manufacturing, we recognize the need to explicitly acknowledge this distinction in our accreditation listing.
No new standards are needed to address the purpose of the collection; however, the implementation of certain standards, particularly for labeling, storage, and transportation, may be expanded in the Collection Facility as cell collections are used for different intent. In addition, accredited facilities frequently collect cells at several different collection sites that are detailed on the FACT Facility Grid in the Compliance Application. Some sites may be more appropriate for the different types of donors and collections.
FACT believes that the addition of this enhanced designation to our accreditation listing will underscore to manufacturers that the Collection Facility adheres to FACT Standards for the collection of cellular starting materials for advance therapies or research purposes. Currently, the most common purpose for this type of collection is for immune effector cell therapies.
Collection Facilities eligible for the designation “for further manufacturing” are those that collect cells that are further manipulated into a final cellular product intended for administration to a patient and list those collections and collection sites on their FACT Compliance Application Grid.
FACT Submits Letter to the Editor of New York Times Regarding Cord Blood Bank Article
The New York Times published an article on July 15, 2024 titled Promised Cures, Tainted Cells: How Cord Blood Banks Mislead Parents that described families’ negative experiences with cord blood banking. FACT empathizes with the families featured in the article and wrote a letter to The New York Times editor to state that cord blood has proven benefits and to emphasize the importance of the quality of cord blood units.
The full letter is below, and is also posted on the FACT website.
July 19, 2024
RE: Promised Cures, Tainted Cells: How Cord Blood Banks Mislead Patients
To the Editor of the NY Times:
The Foundation for the Accreditation of Cellular Therapy (FACT) empathizes with families with disappointing cord blood banking experiences described in the July 15 article. Cord blood therapies have proven benefits. We emphasize that the quality of the cord blood units is critical for positive outcomes.
FACT sets quality standards and awards voluntary accreditation in cord blood banking. Standards are developed by experts; open for public comment prior to publication; and cover cord blood collection, processing, storage, and release. Use of an accredited bank provides the best assurance of viable and safe cord blood units suitable for treatment.
FACT Standards address several concerns raised in the article. Standards require that:
- Advertising claims are supported by scientific literature.
- Collections are performed by trained professionals according to standard operating procedures.
- Supplies are qualified and inspected prior to use.
- Transport of cells is appropriate.
- Testing is performed prior to storage.
- Families are notified if privately banked units do not meet quality specifications.
FACT encourages parents considering cord blood banking to ask questions, understand the potential limitations, and consider working with a FACT-accredited cord blood bank.
Sincerely,
Phyllis I. Warkentin, MD Catherine M. Bollard, MBChB, MD
FACT Chief Medical Officer FACT President
FDA Modifies REMS Requirements for CAR T Cell Therapies; ASTCT Thanks 80/20 Task Force for Advocacy
On June 26, 2024, the United States Food and Drug Administration (FDA) announced modifications to Risk Evaluation and Mitigation Strategies (REMS) for Chimeric Antigen Receptor (CAR) T cell therapies to reduce the burden on the healthcare system without compromising patient safety. Several commercially approved CAR T cell therapies are under REMS programs due to the risks of cytokine release syndrome (CRS) and neurological toxicities.
The 80/20 Task Force of the American Society for Transplantation and Cellular Therapy (ASTCT) has advocated for reduced REMS requirements due to the cumulative expertise and enhanced quality processes, including requirements in the FACT Standards. ASTCT conveyed its thanks to the task force, including co-chairs Fred Locke and Sarah Nikiforow, for their efforts.
Under the modified REMS programs, risks can be conveyed through current product labeling, including a boxed warning and Medication Guides, and previously required educational and training materials were thereby found to be redundant. Reporting of adverse events suggestive of CRS or neurological toxicities are also removed due to their redundancies with routine safety monitoring.
A REMS requirement that remains, however, is that hospitals and clinics dispensing CAR T cell therapies must have immediate access to a minimum of two doses of tocilizumab for each patient prior to infusion.
To continue protecting patient safety following CAR T cell therapy, compliance with FACT Standards for provider qualifications, education, and training; quality systems; and therapy administration are critical. We applaud all Immune Effector Cell Therapy programs for voluntarily complying with these rigorous standards to provide safe and effective therapies.
Cytotherapy Article Illustrates Increasing Variations in MNC Collection Requirements for Commercial and Investigational Products
Cytotherapy published Handling the different requirements for commercial and investigational MNC collections by apheresis (Bobr, Roberts, et al, 2024), an article that illustrates in a compelling way that MNC collection requirements are increasing in variety.
The authors analyze MNC starting material collection requirements from all FDA-approved and some investigational CAR T cell products for which collection is performed at the University of Nebraska Medical Center. They identify discrepancies and suggest mitigation strategies.
The article includes the following illustration of the requirements for eight different products. This illustration clearly conveys the overwhelming differences that Collection Facilities must manage and presents the risks to compliance in a visibly astounding way.
The article provides example efforts of several stakeholders in the field to reduce and minimize variations, including working groups to harmonize manufacturer requirements and the development of quick-reference work aids for collection staff. Many people from FACT-accredited programs, including FACT inspectors and committee members, volunteer on multistakeholder groups in support of these efforts and we appreciate the valuable time and thought you contribute to this important issue.
Handling the different requirements for commercial and investigational MNC collections by apheresis. Bobr, A., Roberts, T., Koepsell, S., Williams, S.M., Schwartz, J. April 6 2024. Cytotherapy, Volume 26, Issue 8, 948 – 953. doi: 10.1016/j.jcyt.2024.04.001
Cord Blood Association Celebrates Cord Blood Awareness Month with New Newsletter, Cord Blood Connect
July is Cord Blood Awareness month, and the Cord Blood Association (CBA) has celebrated the month with many activities:
- Promoting cord blood banking and its benefits to patients.
- Publishing its first newsletter – sign up today!
- Encouraging registration for the 2024 Cord Blood Connect.
- Announcing the inclusion of best practices for transporting blood stem cell products in commercial aircraft cabins in the FAA Reauthorization Act of 2024 in the United States. Read more
FACT is proud to work with cord blood banking experts around the world and appreciates the work you do to preserve lifesaving material for patients in need.
FDA Publishes Letter to Health Care Providers Regarding Blood Culture Media Bottle Shortage
BD Life Sciences notified customers in June to expect a shortage of its BD BACTECTM blood culture bottles and intends to provide ongoing updates. The United States Food and Drug Association (FDA) is working closely with this supplier and published a letter to health care providers on July 10, 2024. In this letter, the FDA recommends that health care providers develop strategies to prioritize the use of blood culture media bottles based on clinical need.
To prepare for and adapt to shortages, consult the following webpages for recommendations and resources:
- BD BACTECTM Blood Culture Vial Supply
- Disruptions in Availability of BD BACTEC Blood Culture Media Bottles – FDA Letter to Health Care Providers
- American Society for Clinical Pathology (ASCP) Webinar and Resources for Imminent BD Blood Culture Media Bottle Shortage
Register for Upcoming FACT Education Events!
View the Full Educational Library at https://learn.factglobal.org/
View the Calendar of Upcoming Events* at https://learn.factglobal.org/calendar
*Hover your mouse over an event to view the full name and description.
AUGUST
- August 1, 2024: QM Series 12 Webinar #5 – How to Implement a New Process
- August 6, 2024: FACT Cellular Therapy Accreditation Workshop at ISCT ANZ Regional Meeting 2024
- August 22, 2024: QM Series 12 Webinar #6 – Evaluation of the Implementation of a New Process
SEPTEMBER
- September 12, 2024: VIRTUAL FACT Quality Boot Camp – Process Validations (EARLY BIRD REGISTRATION ENDS JULY 31ST!)
- September 18, 2024: QM Series 12 Webinar #7 – Preparing for Interruption of Operations
OCTOBER
- October 1, 2024: DAY 1 – VIRTUAL FACT Cord Blood Bank Accreditation Workshop
- Please note that registration is for the entire event and cannot be done separately for each day.
- October 10, 2025: DAY 2 – VIRTUAL FACT Cord Blood Bank Accreditation Workshop
NOVEMBER
- November 6, 2024: QM Series 12 Webinar #8 – The Program’s Perspective: Three Views
STAY TUNED….2025 Event Registrations COMING SOON! Download the 2025 FACT Education Calendar.
