Track 05 of 9
Toxicology & Safety Pharmacology
Organ-on-chip, predictive toxicology, immune-related toxicities.
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.
Focus areas
- 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