Welcome to 2024! As you will see, our first Just the FACTs newsletter in 2024 emulates what we expect in the coming year. Specifically, we highlight: (i) key updates regarding FACT requirements and cell therapy program processes, (ii) regulatory requirements in the evolving field, and (iii) educating a much-needed cell therapy workforce.
At the end of 2023, we published the second edition of the FACT Standards for Immune Effector Cells, and are already revising the next edition of the FACT-JACIE International Standards for Hematopoietic Cell Therapy. We also expect the publication of the next edition of the NetCord-FACT International Cord Blood Banking Standards in the coming months.
The ISCT recently hosted the Cell Therapy Liaison Meeting with the U.S. Food and Drug Administration (FDA). This meeting included presentations and discussions on hot topics in cell therapy regulation in the U.S. and the online summary provides many interesting points and suggestions.
The Tandem Meetings will be the site of the official launch of FACT’s 2024 educational programming, and we encourage everyone to take advantage of this opportunity and send your staff to learn more about the FACT accreditation process and FACT inspector training. In addition to a growing number of accredited organizations and volunteer inspectors, there has been a focus on workforce development. We therefore highlight two events in 2024, hosted by ASTCT and ISCT, that provide very hands-on, practical, and effective training environments.
In sum, there are a lot of exciting activities ahead in our field for 2024 and I wish everyone a wonderful year full of professional success and personal enjoyment!