Clinical Research and Commercial Products are Both within Scope of FACT Standards
Although clinical research has been a major part of the blood and marrow transplant (BMT) field since its inception, recent developments have prompted questions regarding the scope of FACT Standards. The number of programs participating in research of new cellular therapy products beyond minimally manipulated hematopoietic progenitor cells (HPCs) is increasing. Furthermore, two immune effector cell (IEC) products are now commercial and treated as “standard of care.”
FACT Standards apply to both clinical research and standard of care cellular therapy products. If an accredited program provides both types of products, then it must comply with FACT Standards for both. There is not an option to be accredited for only one or the other.
Both cellular therapy products administered within the context of clinical research, and products administered within regulatory licensure (such as Kymriah® and Yescarta®), must comply with FACT Standards as they are applicable to the requirements. Products must be collected and processed using controlled and documented procedures; personnel must be trained and competent; recipient and donor health must be evaluated and managed; facilities, equipment, supplies, and reagents must meet specifications; and records must be created and maintained.
Both clinical research and licensed cellular therapy products must be incorporated into the program’s quality management (QM) program. As more products are administered, this is challenging due to the involvement of additional providers and companies, increasing data collection and reporting requirements, varying protocols, and more. These challenges, though, are the very reasons why a QM program can help the program! Evaluating, creating, and documenting procedures and protocols, training staff on those procedures, and maintaining a centralized mechanism to access documents and records will assist the program with maintaining control of its services.
The FACT Immune Effector Cell Task Force acknowledges these challenges and seeks to provide resources and education to assist programs experiencing the growing types of products administered. For example, see the article from a past Just the FACTs newsletter regarding reporting adverse events for commercial products and the IEC resources webpage. The task force is also hosting a webinar on January 30, 2019 to describe programs’ approaches to using nonconforming commercial products. These resources are based on real-world program experiences, and we appreciate the questions and feedback programs have provided FACT as we all learn more about these exciting new developments in cellular therapy.
David Porter, MD, Director of Cell Therapy and Transplantation at Penn Medicine (second from left), Member of FACT’s IEC Task Force, presents “CAR-T Cells: On the road to a cure” at the University of Nebraska Medical Center Hematologic Malignancies Research Meeting. With him are Julie Vose, MD, MBA, James Armitage, MD, and Phyllis Warkentin, MD.
