Just the FACTs 2024, Volume 4
President’s Letter
FACT continues to evolve and adapt alongside the continuous changes in transplantation and cell therapies. As described in this newsletter, we have updated processes to better serve our accredited programs as well as our volunteer inspectors and committee members.
The first change that we highlight is with respect to our annual request for Conflict of Interest Disclosure. As I explained in my email to all our incredible volunteers on July 1st, we have a responsibility to mitigate the impacts of real, perceived, or potential conflicts of interest on the integrity of our work. However, we strive to make this process as quick and seamless as possible and are pleased to have rolled out the new COI disclosure management software to help you meet this obligation in the least burdensome way.
In this issue we also describe changes to the FACT accreditation goals for cell collection services. In addition to specifying the type of collection (marrow, apheresis, or other tissue), we also now specify the intent of collection (for administration or for further manufacturing). Specifying the intent of collection for which a facility is accredited brings greater transparency regarding the activities that comply with FACT Standards.
We are also happy to spread the word regarding modifications to Risk Evaluation and Mitigation Strategies (REMS) required by the United States Food and Drug Administration. Our experience and knowledge regarding cytokine release syndrome and neurological toxicities, coupled with the increasing complexities and demand for CAR T cell therapies, make this a welcome change. Stay tuned for the updated FACT-JACIE Hematopoietic and Immune Effector Cell Standards that will be released for public review soon – the updated additions include some changes that supported advocacy efforts to reduce REMS requirements.
Finally, we are celebrating Cord Blood Awareness Month alongside our colleagues at cord blood banks and at the Clinical Programs who utilize this lifesaving resource. Thank you for making cord blood units available to patients who need them. We appreciate you!
Sincerely,
Catherine Bollard, MD
FACT President
