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Tue. Mar 10, 2026

Wed. Mar 11, 2026

Thu. Mar 12, 2026

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Drug Safety Evaluation Using Physiologically Relevant Human Hepatocyte Organoids

On April 9, 2025, the U.S. Food and Drug Administration (FDA) announced a roadmap to phase out animal testing in the evaluation of antibody-based drugs and other products. Subsequently, on April 24, 2025, the U.S. National Institutes of Health (NIH) declared its policy to promote New Approach Methodologies (NAMs)—which incorporate cutting-edge technologies such as human organoids and organ-on-a-chip systems—for human drug evaluation, with the aim of reducing reliance on animal testing.In response to these international trends, it is becoming increasingly important in basic research to advance the use of human tissue models and to integrate complex human biological systems, disease mechanisms, and real-world data. Here we would like to feature a series of comprehensive presentations covering drug discovery, safety assessment, organoid research, and international trends to deepen understanding among participants. In addition, we will discuss the challenges and limitations of non-animal testing approaches and provide a forum to share future perspectives in this rapidly evolving field.

Advancing Human Relevant Physiological Models for Drug Development: Challenges and Future Perspectives

The 103rd Annual Meeting of The Physiological Society of Japan

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[1S06a-03]Drug Safety Evaluation Using Physiologically Relevant Human Hepatocyte Organoids

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