FACT June 2023 Update: Strategic Plan Focuses on Increasing Patient Access to Cellular Therapy

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Kara Wacker, MBA, RAC, Strategic Planning Administrator
Foundation for the Accreditation of Cellular Therapy
Omaha, NE USA

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.

Download 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 and meet excellent standards, accreditation, and education services within the next wave of advancements in cellular therapy. The defining objectives are as follows:

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 Launches Fund Development Initiatives

As part of the strategic plan, 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 was established and is led by Committee Chair Alan Balch, PhD. The committee is comprised of members of the FACT’s Board of Directors including Wanxing Cui, MD, PhD, Carlos Ramos, MD, Abba Zubair MD, PhD, Patrick Hanley PhD, Carlos Bachier, MD and Navneet Majhail, MD along with FACT Chief Executive Officer Linda Miller, FACT Chief Medical Officer Phyllis Warkentin, MD, and Meredith Lambe.

FACT will soon execute 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.

The fund development program encompasses three initiatives.

The first initiative is a Sponsorship Program that will enable companies to support FACT training and education workshops, quality boot camps, and webinars.

The second initiative is an Affiliate Program. Companies, including pharmaceutical, biotherapy, suppliers, and technology companies, will have the opportunity to join FACT as an Affiliate to receive timely information and discounts regarding education programs, receive recognition on the FACT website and newsletter, and participate in exclusive affiliate forums to share vital information related to accreditation. Sites interested in becoming accredited may also join as an Affiliate to take advantage of FACT resources at a discounted rate and have access to information about the FACT Standards and accreditation requirements.

Lastly, FACT will be applying for grant funding with corporations, private and public foundations, and government agencies to broaden the Education

Program, provide resources to low-to-middle income countries lacking the necessary resources to receive accreditation, and offer scholarships to site

personnel and professionals interested in attending FACT workshops. FACT will also accept individual donations to support FACT’s services.

If you are interested in sponsoring an upcoming FACT educational event, please contact Meredith Lambe at meredith.lambe@factglobal.org.

Thank you for your consideration in supporting FACT!

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Upcoming FACT Educational Events

The following events are now open for registration!

	FACT Virtual Quality Boot Camp: Apheresis Collection, Processing, and Cord Blood Banking Virtual, June 23, 2023 9:00 am – 6:00 pm CT Book your ticket now!
	FACT Clinical, Collection, Processing, & Cord Blood Banking Inspector Training Course at ISCT ANZ 2023 Regional Meeting Perth, Australia, August 15, 2023 8:00 am – 5:00 pm AWST Book your ticket now!
	FACT Accreditation and Quality Principles Workshop at ISCT ANZ 2023 Regional Meeting Perth, Australia, August 15, 2023 8:00 am – 5:00 pm AWST Book your ticket now!
	FACT Processing Inspector Training Course at ISCT North America Regional Meeting Houston, TX, September 7, 2023 8:00 am – 5:00 pm CT Book your ticket now!