Just the FACTs, Volume 11
To those of you in the Northern Hemisphere, the days are getting shorter meaning you obviously should be sleeping better—oh, I forgot, we’re transplanters so that’s not allowed. Well, drive carefully in the dark, while all our colleagues down south, enjoy the longer days for more golf—oh, I forgot, we’re transplanters so we probably don’t play golf.
Down to the real stuff, the CIBMTR committee on Infection and Immune reconstitution is doing important work to help us all learn more about post-transplant infections, one of the big opportunities for improvement of patient outcomes. The FDA Cell Therapy Liaison Meeting (CTLM) in March addressed a number of topics, one of which is the collection of MNCs that are then sent to outside companies for manufacturing. The variation of collections (which are really a part of the manufacturing flow, but that is another bone to pick) was raised, both technical issues and the patient issues affecting the cell quantities and therefore product effects was accepted as an important question by the FDA.
Lastly, I invite you to one or more of the FACT activities at the upcoming TCT meetings: The Inspection and Accreditation Workshop and Leadership courses are on Tuesday, February 18th, prior to the opening of the TCT conference, and the Quality Boot Camp is on the 19th, the TCT pre-conference day. On the 20th there will be a gathering for International Delegates hosted by the FACT Global Affairs Committee. We look forward to seeing you at one or more of these in 2020!
Enough for now, I have to go change the battery in my headlamp . . .
Sincerely,
Dennis Gastineau, MD
FACT President