Outline

Overview

Japan iPS Cardiac Safety Assessment (JiCSA), a consortium organized by the National Institute of Health Sciences (NIHS), is engaged in a project focused on establishing a cardiac toxicity evaluation system by validating use of human iPS derived cardiac cells for proarrythmia prediction. This project is supported by fundings from 2014 Health and Labor Sciences Grant entitled “Development and standardization of experimental protocols using human iPS derived cells to predict adverse drug reactions in non-clinical studies”, and 2015, 2016 and 2017 Japan Agency for Medical Research and Development (AMED) Grant entitled “Research on Regulatory Science of Pharmaceuticals and Medical Devices.”

As part of this project, JiCSA is collaborating with global research initiatives in the development and standardization of drug cardiac toxicity evaluation systems including “Comprehensive in Vitro Proarrythmia Assay (CIPA),” and the data obtained from the validation studies of JiCSA will be released globally, when consensus is achieved among the members.

The goal of JiCSA’s validation studies is to establish an evaluation assay with reproducibility and predictivity. Japan Safety Pharmacology Society (JSPS) and the Consortium for Safety Assessment using Human iPS Cells (CSAHi) support the validation studies of JiCSA providing the results from their research activities.

Background

In Japan, NIHS, CSAHi and JSPS have been leading the research activities for development of drug cardiac toxicity evaluation assays using human iPS derived cardiac cells.

JiCSA is to develop protocols using in vitro multi-electrode array (MEA) systems, and conduct validation studies with the compounds determined by CIPA as TdP risk positive and negative. The validation studies are to be conducted as a national project by the JiCSA members consisted of researchers from academia, industry and government in Japan with collaboration and data-sharing with JSPS and CSAHi.

JiCSA plans to proactively contribute to the development and global standardization of drug cardiac toxicity evaluation systems using human iPS derived cells, by sharing the data obtained from the validation studies, of which consensus is achieved among the members, with Myocyte Work Stream of CIPA, or presentations at CIPA Workshops, and scientific society meetings in the US, etc.

  • 厚生労働省
  • 国立医薬品食品衛生研究所
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