Just the FACTs 2022 Volume 5

Posted in :: 2022 Volume 5 :: Friday, November 18th, 2022

Letter from the President

In a time of turbulence and change, it is more true than ever that knowledge is power. – John F. Kennedy

Change is all around us. It can be as natural as the falling leaves making way for falling snow, or the emergence of blossoms making way for the summer sun for those of us far enough from the equator. It can be as disruptive as a worldwide pandemic as we have all recently experienced. The changes in cellular therapy are a combination of both – the natural progression of science that builds upon past advances in medicine and the disruptive paradigm shifts that require us to do things differently. In this newsletter volume, we aim to clarify a couple of topics that are both natural and disruptive extensions of the work we do.

One is labeling. As cellular therapy products are collected for more uses and produced by a growing field of manufacturing sources, we must be able to adapt how these products are labeled. FACT requires full implementation of ISBT 128 coding and labeling, and the new “split ISBT 128 label” format developed for the “collection for further manufacturing” is also in compliance with FACT Standards. We, therefore, provide assurances that facilities may adopt the use of this label at the request of industry manufacturers and information on how to obtain assistance with the validation process.

Another topic relates to the use of CIBMTR’s Transplant Center-Specific Survival Report to evaluate clinical outcomes for U.S. allogeneic programs. This report is the most objective measure available of one-year survival rates. Its algorithm is transparent and vetted, and it is a resource for transplant Programs, and the field, to improve patient outcomes. We pulled an old article “from the archives” to explain more about this report and how it can be of use to Programs.

We understand that these topics focused on labeling formats and survival scoring for a complex therapy bring about change which may sometimes seem daunting. We hope these clarifications will equip readers with new knowledge that embraces advancements intended to ultimately improve the safety and quality of cellular therapy.

Catherine M. Bollard, MD
FACT President