banter and General Discussion, page-10522

When the stirring's done may I lick the spoon







Branch Chief - Cell Therapy Branch 2; Office of Therapeutic Products; US Food & Drug Administration

Experienced reviewer for cell and gene therapy products throughout all stages of the product development lifecycle (pre-IND, IND, and marketing applications/BLAs) with more than a decade of experience in medical-related research focused on immunology and development of cellular therapies for treatment of cancer and immune-mediated disorders.

1. Will BLA or IND applications that were under review in OTAT prior to the reorganization be affected? Will the processing of these applications take longer because of these changes?
   • OTP’s goal is to maintain review teams for existing applications throughout the reorganization. However, the responsible offices and divisions, as well as the signatory authority responsible for existing applications, may change – this will be determined by several factors, including how far along the review of the application is at the time of the reorganization.
   • OTP is committed to meeting all statutory commitments.

I am trying to find out what the Cell Therapy Branches do?

Klinker heads up Branch 2- what does Branch 2 do?

Does it process BLA's ?????????

I will keep looking- but have errands to run- go ahead, make my day.....................happy sleuthing


Reg