Annual Meeting of the Japanese Society of Toxicology
The 51st Annual Meeting of the Japanese Society of Toxicology
Session ID : S35-2
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Symposium 35: Toxicity assessment strategy using advanced in vitro model in drug discovery
A strategy for microphysiological system uses in nonclinical safety evaluation
*Yudai WATANABE
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CONFERENCE PROCEEDINGS FREE ACCESS

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Abstract

In recent years, with the establishment of the FDA Modernization Act 2.0, a large number of microphysiological systems (MPS) with more human relevancy in terms of organizational structure and function, such as three-dimensional culture, spheroids, and co-culture models with immune crosstalk has been developed. Furthermore, in pharmaceutical companies, especially in Europe and the United States, its implementation into drug discovery research and practical application are rapidly accelerating.

Although various types of MPS devices and assay systems combining cells have been developed to date, there are not many that can be used universally to meet various needs and issues. On the other hand, when considering the use of MPS in drug discovery research, especially in the field of toxicity, there are many types of research questions such as an extrapolation of side effects observed in animals to humans, identification of mechanisms of side effects, and reverse translational research based on adverse effects in clinical trial. In either situation, research questions arise suddenly, and we need to tackle quickly, especially in early phase in drug discovery.

In my presentation, I will first explain the characteristics of MPS vendor services by dividing them into 1) device supply type, 2) assay supply type that combines cells and devices, 3) contract research type, and 4) joint research and development type. Then, I will introduce the importance of clarifying the needs (context of use) that researchers should first address. Furthermore, I will introduce our challenge to establish MPS assay system quickly that combines automation of culture and other operations, and also introduce case studies using MPS in the nonclinical safety evaluation.

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