`Statistical review of gene and cell therapies and related research topics'

Xue (Mary) Lin, CBER/OBE/DB, Food and Drug Administration

Abstract:

In this presentation, first we will talk about the statistical issues in the biological licensure application review of KYMRIAH^®, which was the first CAR-T therapy approved by the FDA. In addition, we will discuss statistical issues related to the timing of randomization in the study design of gene and cell therapy trials, all based on INDs we have reviewed. At the end, we will touch upon some research topics we are working on.   

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