Bio: Yoko Hirabayashi, MD, PhD graduated from the School of Medicine at Yokohama City University (YCU). Since April 2018, as the Director of the Center for Biological Safety and Research (CBSR), National Institute of Health Sciences (NIHS), Dr. Hirabayashi oversees safety evaluation testing and research activities. She also chairs the Steering Committee of the Japanese Center for the Validation of Alternative Methods (JaCVAM), which is a member of the International Cooperation on Alternative Test Methods, promoting international collaboration on alternative testing methods. Additionally, she serves as the Japanese National Coordinator and Vice-Chair for the OECD Test Guidelines Program.

Abstract: JaCVAM has been actively supporting the regulatory approval of novel test methods designed to reduce reliance on animal testing. While many of these efforts initially focused on local toxicity tests, they have also played a significant role in establishing test method guidelines for the IL-2 Luc assay, a key immunotoxicity test, and are now driving the development of systems capable of evaluating systemic toxicity. Among these, the microphysiological system (MPS) is recognized as one of the most promising tools for such evaluations. Although MPS has various potential applications, in vitro test methods must include exposure assessment as a crucial component of risk evaluation. To address this, CBSR, in collaboration with JaCVAM, is working on utilizing MPS with an emphasis on the first-pass effect in the small intestine and liver. Furthermore, we are proposing a project to the OECD to develop a detailed review paper on toxicokinetic analysis using MPS. This initiative aims to support the transition from the OECD Test Guideline 417 to alternative methods that do not involve animal testing for human health impact assessments. This presentation will describe the progress of these efforts, with a focus on the qualification of assessment methods for regulatory applications.