Online Program

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Thursday, September 13
Thu, Sep 13, 2:45 PM - 4:00 PM
Thurgood Marshall West
Study Design and Statistical Considerations in Precision Medicine Product Development

Study Design and Statistical Considerations in Precision Medicine Product Development (300738)

*Mary Lin, FDA 

Keywords: Gene Therapy, Cell Therapy, randomization

In this presentation, we will talk about statistical issues in the Biological Licensure Application review of KYMRIAH, which is the first FDA approved CAR-T therapy. In addition, we will talk about statistical issues related to the timing of randomization in gene and cell therapy trials, based on INDs we have reviewed.