APPW2025

Chairperson：Yasunari Kanda（National Institute of Health Sciences）

Co-hosted by: NIKKISO CO., LTD.／FUJIFILM Wako Pure Chemical Corporation

In recent years, the FDA Modernization Act 2.0 has eliminated the requirement that drugs in development must undergo testing in animals prior to human trials. Therefore, the shift to alternative methods in drug development is steadily progressing, as evidenced by the incorporation of MPS (Microphysiological System) test results into drug application materials.
In this seminar, we will introduce human primary cell products and human iPS cell-derived products that are expected to be used as alternatives to animal testing. In the field of human primary cell products, Nikkiso Co., Ltd. has developed the human renal cell spheroid "3D-RPTEC" and will present its efforts for guideline activities and the results of the nephrotoxicity study of puberulic acid. In the field of human iPS cell-derived products, we will introduce the drug discovery research applications of the neural cell product of the "iCell" product line provided by FUJIFILM Cellular Dynamics, as well as the progress of F-hiSIEC, Fujifilm's human iPS cell-derived intestinal epithelial cells.