Cell therapy (part of regenerative medicine) continues to attract attention as biopharmaceutical sponsors invest heavily in cell-therapy-driven pipelines, invest in manufacturing capacity and war for talent. Just in the first half of 2019, cell-based ventures raised $4.8 billion. The number of clinical trials involving novel-cell based experimental treatments saw a considerable uptick. As more providers offer gene therapy-based treatments and clinical investigators take-on gene therapy-based experimental medicines, the topic of safety, quality and excellence becomes paramount—and accreditation potentially becomes a differentiator. Enter FACT aka the Foundation for the Accreditation of Cellular Therapy, at the University of Nebraska Medical Center (FACT).

Accreditation and the Prominence of University of Nebraska Medical Centers’ ‘FACT’

An organization few outside of regenerative medicine may have heard of, the Foundation for the Accreditation of Cellular Therapy, at the University of Nebraska Medical Center (FACT), promotes quality patient care and laboratory practices in cellular therapies. As it turns out, over 90% of all eligible U.S. facilities and programs (involved with cell-based therapy) are FACT accredited.

What is FACT?

Founded in 1996, FACT establishes standards for high quality medical and laboratory practice in cellular therapies. A non-profit corporation, it was co-founded by the International Society of Cellular Therapy (ISCT) and the American Society of Blood and Marrow Transplantation (ASBMT) for the purposes of voluntary inspection and accreditation in the field of cellular therapy.

What are the Standards?

FACT Standards are evidence-based requirements set by world-renowned experts vested in the improvement and progress of cellular therapy. Standards for Hematopoietic Progenitor Cells (HPC) and other nucleated cells obtained from bone marrow, peripheral blood, and umbilical and placental cord blood are developed by consensus within committees consisting of knowledgeable clinicians, scientists, technologists, and quality experts who represent the entire continuum of cell manufacturing and administration. The organization positions its “unparalleled depth and breadth” to inform Standards tracing the entire life of a cell product from donor selection to collection, processing, storage, release and ultimately administration to patient.

Harvard/Dana-Farber/Mass General Recent Research Reference

In 2017, researchers from Massachusetts General Hospital, Harvard Medical School, and Dana-Farber Cancer Institute produced a report highlighting the increasingly usefulness of the FACT standards for novel cellular therapies outside of traditional hematopoietic stem cell transplantation or hematopoietic progenitor cell (HPC) therapies currently under clinical research evaluation across America and the world. More specifically, FACT built upon the experiences and Standards of established for HPC programs and established new standards for the use of Immune Effector Cells (IEC), including gene-modified T cells and natural (NK) cells. These standards specify the clinical and quality infrastructure to help facilitate safe administration of immune effector cells while formalizing subsequent monitoring and reporting of patient outcomes to support the incredibly important continuous improvement paradigm in this important emerging field.

Voluntary FACT Program Overview

A voluntary accreditation program, it was founded by a network of peers helping each other to improve cellular therapy practices. Rigorous and comprehensive inspections are balanced with a collegial approach that is designed to encourage buy-in, participation, and the achievement of minimal standards—all to benefit patients.

Volunteer inspectors bring international expertise, implement multiple level of review, and oversight to ensure accreditation is rewarded consistently, thoroughly, and objectively based on international standards. The organizations that have achieved FACT accreditation have developed and implemented a foundation of high-quality practices that result in cell products and patient care that are sought after by physicians and patients.

Who is FACT’s Chief Medical Officer

Phyllis I Warkentin, MD 

FACT Accreditation

As it turns out, FACT Accreditation can elevate the position of the provider representing quality and excellence for the benefit of patients, payers and governments. FACT claims on its website that whether the provider is a patient care facility, laboratory, or cord bank:

·         FACT is the only accrediting agency that addresses all quality aspects of cellular therapy and cord blood banking including collection, processing and administration

·         Transplant physicians and patients are more confident when products from a FACT accredited transplant center or cord blood bank

·         International clients seeking quality cellular products rely on adherence to known standards and accreditation

·         Clients seeking cellular therapy products require that minimum standards be met for the exchange or use of cellular products—FACT-accredited programs meet or exceed all of these standards according to their website.

Accreditation Process

TrialSite News offers a link to their Accreditation website for process overview, which includes a multi-step process, including 1) Preparation 2) Application and 3) Submission followed by 4) Coordination then 5) On-site Inspection and  6) Outcome and finally 7) Response.

Accreditation Preparation: FACT Consulting Services

The FACT organizations offers consulting services to help organizations ready themselves for the process. Based out of the University of Nebraska Medical Center, the consulting team distributed nationwide is listed hereLinda Miller, MPA, is the CEO of the consulting organization based out of UNMC.

Call to Action: Interested in learning more about FACT Accreditation Services? Contacts include Linda Miller, CEO, Andra Moehring, Standards Development and Supervisor of Accreditation Services, and Sarah Litel-Smith, MSMT (ASCP).

Source: Foundation for the Accreditation of Cellular Therapy

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