Host: The Japanese Society of Toxicology
Name : The 51st Annual Meeting of the Japanese Society of Toxicology
Date : July 03, 2024 - July 05, 2024
In vitro evaluation systems are increasingly common in safety studies of pharmaceuticals. This is due to modality diversification leading to the development of highly species-specific drugs, making it difficult to evaluate efficacy and safety in animals. Furthermore, the US enacted the FDA Modernization Act 2.0 in 2022, allowing in vitro data to be accepted in drug applications and encouraging alternatives to animal testing. In particular, interest is growing in Microphysiological systems (MPS), in which cells are cultured in a microenvironment mimicking in vivo reactions. The use of human-/iPS-derived cells is expected to enable MPS to detect human-specific reactions, and perfusion culture and composite culture may mimic in vivo reactions.
Outside Japan, systems for integrating MPS development, use, sales, support, and CRO services already exist, and MPS have been used in IND applications. In Japan, however, barriers such as the lack of collaboration between developers and users are hindering the introduction of MPS. To counter this, in 2017, the Japan Agency for Medical Research (AMED) initiated the Development of Drug Discovery Support Basic Technology Applying Regenerative Medicine Technology (AMED-MPS) project to promote the development of devices and cells for MPS. AMED-MPS2, the second phase of the project, started in 2022 and focuses on practical application. SNBL participates in the AMED-MPS2 project, acting as a bridge between developers and users. In this presentation, I talk about how we, as a CRO, are integrating MPS and contributing to practical application.
