16th JBF Symposium
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Session Details

Symposium

[D3-A2]Bioanalysis in Cellular and Gene Therapies: Standardization and Implementation

Wed. Mar 5, 2025 1:25 PM - 2:55 PM JST
Wed. Mar 5, 2025 4:25 AM - 5:55 AM UTC
Medium Hall(2nd Floor)
Chairman:Makoto Niwa(Nippon Shinyaku Co., Ltd.), Takeshi Hanada(Daiichi Sankyo Co., Ltd.)
1:25 PM - 1:55 PM JST(4:25 AM - 4:55 AM UTC)

[D3-A2-01]Overview of the ICH S12 Guideline "Nonclinical Biodistribution Considerations for Gene Therapy Products"

*Daisuke Temmizu1,2 (1. Japan Pharmaceutical Manufacturers Association, 2. Bristol-Myers Squibb K.K.)
1:55 PM - 2:25 PM JST(4:55 AM - 5:25 AM UTC)

[D3-A2-02]Key Considerations in Biodistribution Assessment of Cell Therapy Products: Towards Standardization

*Syunsuke Yamamoto1 (1. Takeda Pharmaceutical Company Limited)
2:25 PM - 2:55 PM JST(5:25 AM - 5:55 AM UTC)

[D3-A2-03]Implementation and Utilization of Bioanalytical Technologies in Cell and Gene Cell Therapy Programs

*Satoshi Kitamura1 (1. Astellas Pharma Inc.)
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