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

Posted in :: 2023 Volume 3 :: Friday, May 19th, 2023

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.

View the FACT 2023-2025 Strategic Plan

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 Announces 2017-2020 Strategic Plan

Posted in :: 2017 Volume 2 :: Thursday, October 26th, 2017

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.

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.

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.

Organizational health is one of FACT’s greatest strengths.