Division of Cell Therapy 1, under Office of Cellular Therapy and Human Tissue CMC, and one of the OTP’s 6 offices, has 2 branches. Dr. Klinker heads up Branch 2.
(Division of Cell Therapy 2 has got 2 branches as well but they are for Tissuee Engineering).
See org chart - second left most box in the second tier - here:
https://www.fda.gov/media/170491/download
For Klinker’s branch 2, their responsibilites are:
here - see especially bullet points A, D & E on pp.2 and 3:
https://www.fda.gov/media/170498/download
Their job it is to evaluate BLAs, direct review committee activities and make recommendations, so yes they are key to the final approval decision.
Division of Cell Therapy 1, under Office of Cellular Therapy and...
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