Abstract

Research and Development of Microphysiological Systems in Japan Supported by the AMED-MPS Project

Seiichi Ishida, Professor, Sojo University

Microphysiological Systems (MPS) is expected to be novel humanized in vitro test methods that addresses the unmet needs for new drug development. In Japan, the AMED-MPS project is being promoted under the leadership of AMED (the Japan Agency for Medical Research and Development) and Ministry of Economy, Trade and Industry(1). In this project, along with the development of Japan-original MPS for commercialization, there have been discussions on the technical requirements that need to be solved for MPS to be implemented in industry. Stakeholders from academia developers, suppliers of MPS, users of pharmaceutical industry, and the regulatory section are participating in these discussions actively. In this presentation, firstly the development status of Japan-original MPS will be introduced. And, secondly, we would like to present and discuss the concept of "technical requirements for industrial implementation of MPS" from the viewpoint of regulatory science based on the discussions in AMED-MPS project by showing how to establish “Context of Use” from unmet needs that MPS is required to solve and how to promote standardization of MPS. (1) Seiichi Ishida: Research and Development of Microphysiological Systems in Japan Supported by the AMED-MPS Project. Front. Toxicol. doi: 10.3389/ftox.2021.657765