Toxicology & Safety Pharmacology

Featured Session · 05 of 35

The FDA Modernization Act 2.0 has formally opened the door to non-animal alternatives, accelerating adoption of organ-on-chip, microphysiological systems, and AI-based in silico tox prediction in IND-enabling packages. WCPD 2027 will cover validated liver, cardiac, and kidney chip platforms (Emulate, CN Bio, TissUse), the FDA's ongoing qualification programs, and predictive DILI and proarrhythmia models. Immune-mediated toxicities will receive dedicated sessions: cytokine release syndrome and ICANS in CAR-T and bispecifics, immune checkpoint inhibitor irAEs, and the ocular and ILD risks emerging across the antibody-drug conjugate class.

Topics covered in this session

FDA Modernization Act 2.0 and microphysiological systems
Organ-on-chip: liver, cardiac, kidney, gut, BBB platforms
CAR-T and bispecific toxicity: CRS, ICANS, on-target off-tumor
ADC class toxicities: ocular, ILD, neutropenia management
In silico DILI and hERG/proarrhythmia prediction
Genotoxicity and nitrosamine impurity risk assessment
Immune-related adverse events from checkpoint inhibitors

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