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.