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Fri. Mar 27, 2026

Sat. Mar 28, 2026

Sun. Mar 29, 2026

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Current status and future of immunotoxicity and immunogenicity assessment for biopharmaceuticals

Co-sponsored by:<br>The Pharmaceutical Society of Japan,<br>The Japanese Society of Immunotoxicology

This joint symposium with the Japanese Society for Immunotoxicology (JSIT) was planned primarily to share knowledge and researches on immunotoxicology, and to contribute to the advancement of immunotoxicology, a field of pharmaceutical science. The content included an overview of immunological safety in drug development and clinical settings, followed by researches concerning current situation and prediction of idiosyncratic adverse reactions in clinical setting. It then covered the current states and evaluation methods for immunotoxicity assessment in drug development for new modalities, biopharmaceuticals and oligonucleotide therapeutics. Finally, a symposiast introduced the current discussion in the JSIT regarding the revision of the ICH S8 Guidelines "Immunotoxicity studies for human pharmaceuticals". The current S8 guidelines were issued 20 years ago, and we believe additional descriptions regarding new modality drugs and hypersensitivity reactions are necessary. Anticancer and antiallergic drugs that modulate the immune system have been developed and marketed based on the achievements of Nobel Prize laureates Dr. Honjo and Dr. Sakaguchi. However, how to evaluate their safety remains challenges in the drug development. Through this symposium, we hope pharmaceutical researchers, pharmacists, and students to have interests in immunotoxicology.

Immunotoxicity for Drug Development and Clinical Applications

The 146th Annual Meeting of the Pharmaceutical Society of Japan (Osaka)

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[JS03-4]Current status and future of immunotoxicity and immunogenicity assessment for biopharmaceuticals

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