Welcome to 2024! As you will see, our first Just the FACTs newsletter in 2024 emulates what we expect in the coming year. Specifically, we highlight: (i) key updates regarding FACT requirements and cell therapy program processes, (ii) regulatory requirements in the evolving field, and (iii) educating a much-needed cell therapy workforce.
At the end of 2023, we published the second edition of the FACT Standards for Immune Effector Cells, and are already revising the next edition of the FACT-JACIE International Standards for Hematopoietic Cell Therapy. We also expect the publication of the next edition of the NetCord-FACT International Cord Blood Banking Standards in the coming months.
The ISCT recently hosted the Cell Therapy Liaison Meeting with the U.S. Food and Drug Administration (FDA). This meeting included presentations and discussions on hot topics in cell therapy regulation in the U.S. and the online summary provides many interesting points and suggestions.
The Tandem Meetings will be the site of the official launch of FACT’s 2024 educational programming, and we encourage everyone to take advantage of this opportunity and send your staff to learn more about the FACT accreditation process and FACT inspector training. In addition to a growing number of accredited organizations and volunteer inspectors, there has been a focus on workforce development. We therefore highlight two events in 2024, hosted by ASTCT and ISCT, that provide very hands-on, practical, and effective training environments.
In sum, there are a lot of exciting activities ahead in our field for 2024 and I wish everyone a wonderful year full of professional success and personal enjoyment!
FACT has published the second edition FACT Standards for Immune Effector Cells to be effective March 15, 2024.
These Standards promote quality medical and laboratory practice in immune effector cell therapies. These therapies include a wide range of cells that effect or modulate an immune response for therapeutic intent, whether genetically modified or not, such as T-cells, B-cells, natural killer cells, dendritic cells, genetically engineered chimeric antigen receptor T-cells (CAR-T cells), and therapeutic vaccines.
The FACT Standards for Immune Effector Cells were developed by consensus of experts in the field, reviewed during two public comment periods, and harmonized with the eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. Significant changes were introduced to reflect advances in the field and incorporate evolving cell collection types and practices. The FACT Standards for Immune Effector Cells are specifically intended for programs and persons using these therapies outside of hematopoietic cell transplantation.
FACT Staff Spotlight: Education Team Preparing to Launch FACT Offerings into Promising Future of Cellular Therapy
Education is one of the main pillars of services provided by FACT, and its importance continues to grow as more advances are made in cellular therapy and more stakeholders join the field. Maintaining a robustly effective and efficient education program is a major focus of FACT initiatives to facilitate access to therapies that improve the quality and length of life for patients. As such, we are proud to introduce the educational staff at FACT, who work closely with the FACT Education Committee and a large cadre of volunteers who share their time and expertise to implement educational offerings.
Jamie Price, MS, BA, Director of Education
Jamie Price is the new Director of Education, joining the organization in October 2023. Jamie has extensive experience managing accreditation of Continuing Medical Education (CME) programs for Endeavor Health. At FACT, she leads the Education Department and is currently focusing on implementation of a new online learning management system. The system will first include modules for inspector development and training and is one of the projects that Jamie is most excited about.
The rise of the remote working environment has enabled FACT to hire professionals from anywhere, and Jamie still feels the team camaraderie despite not being in a physical office. “I really enjoy working with everyone and everyone’s passion for what they do,” says Jamie. “It shows even when we’re not all in the same place.”
Jamie’s new role as FACT’s Director of Education perfectly fits her passion in learning and education. She is pursuing her Doctor of Education degree. She has three adult children who live across the U.S., who she and her husband love visiting when not riding their four-wheeler with their beloved Boston Terrier puppy.
Please join us in welcoming Jamie to the FACT community!
Breann Weishaar, Administrative Projects Associate
Breann Weishaar is an Administrative Projects Associate responsible for a diverse set of education-related responsibilities including graphic design, marketing, educational event coordination, customer service, online store management, and volunteer outreach. Bre began her career at FACT as a temporary staff member during her last semester of college at Iowa State as an apparel merchandising major. Her valuable contributions and interest in FACT led her to a permanent position that has given her many opportunities to grow her skills and knowledge as a young professional. “I enjoy learning more and more about the field of cellular therapy,” says Bre. “I thought my knowledge of stem cells would always be limited to high school biology.”
Bre enjoys building connections and working with FACT volunteers from around the world. She enjoys the travel and is excited about the upcoming 2024 education season and catching up with volunteers again in person at Tandem. She is also looking forward to the rollout of the learning management system.
Bre has a pet cat named Haze, and the FACT team loves to hear stories and see Haze during internal video meetings!
By Stacy Freeburg, FACT Accreditation Coordinator
Programs monitor adverse events for patient safety and report events to third party organizations (FDA, Trial Sponsors), who consider the implications of single adverse events and compile the data to identify potential trends. Management of adverse events within an organization related to the administration of cellular therapy products is required by the FACT Standards.
FACT defines an adverse event as any unintended or unfavorable sign, symptom, abnormality, or condition temporally associated with an intervention that may or may not have a causal relationship with the intervention, medical treatment, or procedure. An adverse reaction is classified as a type of adverse event. In the standards, references are made to adverse events that encompass required detection, investigation, documentation, reporting, corrective and preventive action, and the responsibility to report incidents to different entities.
If an unexpected or serious adverse reaction occurs due to cellular therapy product collection or administration for which there is a reasonable possibility that the response may have been caused by the product, the report of the adverse reaction and its outcome and investigation should be communicated to all facilities associated with collection, processing, and/or administration of the product.
Organizations must comply with FACT Standards and policies throughout their accreditation cycle, including submission of the Annual and Renewal Report within 30 days of receipt (refer to the FACT Maintaining Accreditation Policy). The Annual Report is sent on the 12-month anniversary of current accreditation, whereas the Renewal Report is sent 14 months prior to expiration.
These reports allow organizations to update FACT regarding their demographics, changes in key personnel, facilities, or services, and submit required documentation of corrective action, as applicable. The report also requires programs to provide an explanation of any serious or unexpected adverse event that occurs during the reporting period. As defined by the FDA, serious adverse events have a severe impact on an individuals’ health, potentially leading to life-threatening consequences, permanent damage, or extended hospital stays (refer to the FDA, “What is a Serious Adverse Event?”).
When reporting an adverse event, organizations must include an explanation and supporting documentation that demonstrates compliance with the FACT Standards and includes the following:
- A description of relevant patient details. Do not include Protected Health Information (PHI).
- A description of relevant product details, if applicable.
- A summary of how the event was identified and investigated, corrective action(s) implemented, and that appropriate follow-up of implemented corrective action(s) was performed to ensure the corrective action(s) were effective.
- 3.4.8 Management of complications related to the administration of cellular therapy products.
- B/C/D22.214.171.124 Occurrences shall be reported to other facilities performing cellular therapy product functions on the affected cellular therapy product and to the appropriate regulatory and accrediting agencies, registries, grant agencies, sponsors, IRBs, or Ethics Committees,
On December 8, 2023, ISCT hosted the landmark 20th FDA Cell Therapy Liaison Meeting (CTLM), a closed forum strategically designed to facilitate knowledge sharing and discussions between the cell and gene therapy (CGT) community and FDA, with the objective of informing the Agency of specific concerns, challenges and recent developments to advance the regulatory field.
Discussions at the 2023 CTLM covered topics including:
- Cellular and tissue material as raw “starting” material for iPSC clinical products and other cell banks
- Changing the definition of starting material
- QC testing for point of care (POC) manufacturing
- Request for guidance document clarifying which entities are required to register with FDA for the manufacture of human stem cells, HCT/Ps
- Challenges with moving cell and gene therapies into the commercial space for rare diseases
FACT encourages readers to review the entire summary of the meeting and also view the presentation slides. This information is available on the ISCT website at https://www.isctglobal.org/publications/regulatory-quality-initiatives/fda-ctlm.
Workforce development is a critical need to fill the growing demand for cellular therapy, and the following are two events aimed to train up new professionals.
ASTCT Clinical Research Training Course Applications Open
July 10-13, 2024 in Park City, UT
Apply today to take part in the ASTCT Clinical Research Training Course (CRTC). This four-day program is specifically designed for fellow and junior faculty to advance research protocols. Scholars will have the opportunity to work one-on-one with expert faculty and statisticians through formal presentations, extensive follow-up dialogue and small-group discussion.
Twelve scholars will be selected for this exclusive training course, which has led to academic and career growth for past participants. Applications close March 15, 2024.
Learn more about the curriculum and eligibility requirements on the ASTCT website.
ISCT & CMaT Hands-On Laboratory Boot Camp for Cell Therapy Biomanufacturing
April 29-May 3, 2024 at Georgia Institute of Technology
This five-day, hands-on training covers techniques central to cell and gene therapy manufacturing, including aseptic cell culture, small- to large-scale cell manufacturing, product characterization, cell banking and documentation using GLP/GMP-like best practices.
Gain practical knowledge on:
- The key steps to initiate, maintain, and expand cells in culture.
- Downstream processes such as harvesting and cryopreservation.
- How to perform sterility testing and cell product assessments.
- How to apply GLP and GMP guidelines to document cell products.
Learn more about the course and how to register on the ISCT website. Registration is due March 29, 2024. Discounted rates are available for students and academia. Inquire at Raymond@ISCTGlobal.org.
We are thrilled to announce the launch of the 2024 FACT Education season! This year offers an array of enriching experiences both virtually and in-person across the globe.
Visit FACT’s Calendar of Events to register for upcoming education opportunities.
The 2024 FACT Quality Boot Camp spotlight shines on Process Validation, where FACT instructors delve into the intricacies of developing validation plans and will cover aspects such as purpose, responsibilities, acceptance criteria, data collection, risk assessment, and summary of results. The day kicks off with an enlightening overview of validations, verifications, and qualifications. Participants will actively engage in developing validation plans for critical processes, including Bone Marrow Collection, Preparation for Administration, and Infusion, ensuring a highly interactive learning environment.
Our interactive Cell Therapy Accreditation Workshop takes a deep dive into FACT’s Standards and accreditation process, offering a dynamic format facilitated by experienced instructors. Through case studies and collaborative discussions with peers, participants will gain insight into accreditation requirements, positioning their organizations for accreditation success, maintaining readiness, and addressing common citations. The workshop covers audits, corrective action plans, and strategies for enhancing clinical outcomes and data management.
For those aspiring to become FACT inspectors, training opportunities await. Tailored exclusively for inspector trainees who have completed prerequisites, the FACT Inspector Training Course offers practical, hands-on sessions led by experienced FACT inspectors, simulating the actual inspection process. Covering technology tools, preparation essentials, common citations, inspection procedures, and post-inspection expectations, this course provides a comprehensive foundation for those looking to contribute as FACT inspectors. To explore this exciting opportunity, contact Suzanne Birnley or visit https://www.factglobal.org/inspectors/.
Get ready for a season of unparalleled learning and professional growth with FACT Education in 2024!
Thank you to our partners for their generous support: