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!
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 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.
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.
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. Official launch will take place in 2024.
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.
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.
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.
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.
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 Curitba, 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.
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 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.
The defining objectives are interdependent and critical to effectively conduct ongoing mission-driven activities. Accomplishing each of these is necessary to perform excellent standards, accreditation, and education services within the next wave of advancements in cellular therapy. The defining objectives are:
Defining Objective #1: INFRASTRUCTURE
Establish an organizational structure sufficient to meet the growing demand for FACT services.
There are new stakeholders with different needs and expectations, including additional medical specialties and the pharmaceutical and biotechnology industry. FACT will adjust its operating model in order to better serve these markets, while prioritizing the ability of health care institutions, including FACT-accredited organizations, to provide cellular therapy in the context of growing regulatory and operational requirements.
Defining Objective #2: ACCREDITATION PROCESS
Streamline the FACT accreditation process to increase efficiencies for accredited organizations, volunteer inspectors, and FACT staff.
Accredited organizations and inspectors are satisfied overall with the FACT accreditation process. Via surveys, they identified opportunities for more efficient completion of initial and renewal accreditation, improved retention of inspectors and staff, and enhanced ability to meet the growing demand in number and variety of cellular therapy programs.
Defining Objective #3: GROWTH
Implement growth opportunities to advance the FACT mission in the evolving field of cellular therapy.
There are two major areas of rapid evolution in cellular therapy: 1) new indications for cellular therapies that involve an increasing number of medical specialties and a wider variety of health care facilities and 2) a rise in regulatory approved investigational or commercially licensed cellular therapy products manufactured by biotechnology or pharmaceutical companies, or by investigators at sites distant from the intended recipient’s treatment. These additional complexities create greater risks to patient safety and product efficacy, making FACT accreditation even more important for establishing and maintaining quality programs. FACT has also been recognized as a potential contributor to solving significant challenges affecting patient access. Prioritized growth opportunities include auditing services, new program-start up, and modular accreditation.
FACT’s strategic plan anticipates and addresses opportunities and challenges for the next several years. The strategic plan also identifies several “Defining Objectives.” Although all the goals in a strategic plan are important and meant to be accomplished, several are designated as highest priority. Accomplishing these priority goals defines FACT’s success over the next period of time.
The three defining objectives and additional goals for the 2017-2020 period are:
Defining Objective #1: INSPECTIONS
The highest possible level of excellence and consistency in inspections of programs and facilities.
Defining Objective #2: IMMUNE EFFECTOR CELL THERAPY
Rapid mobilization of an accreditation service for immune effector cellular therapy programs.
Defining Objective #3: FINANCES
Sufficient financial resources to sustain operations and build reserves for the development of mission-directed products and services and for surviving an economic downturn.
Strategic Objective #4: REGENERATIVE MEDICINE
Continued promotion of the FACT Common Standards for Cellular Therapies, and readiness to introduce disease- or medical specialty-specific standards when appropriate.
Strategic Objective #5: CLINICAL OUTCOMES IMPROVEMENT
Cellular therapy programs that know how to prevent, investigate and correct deficiencies in clinical outcomes.
Strategic Objective #6: STANDARDS
Clear and user-friendly FACT standards and effective transition between editions of standards.
Strategic Objective #7: ACCREDITATION
Consistency in the awarding of FACT accreditation.
Strategic Objective #8: CORD BLOOD BANKING
Recognition of FACT as the premier accreditation for both public and private cord blood banks.
Strategic Objective #9: EDUCATION
Recognition that education is as important as standards and accreditation within FACT’s mission to promote quality in cellular therapy.
Strategic Objective #10: ORGANIZATIONAL EFFECTIVENESS
Organizational health is one of FACT’s greatest strengths.