John Kwon

Bridging the gap between early in vitro safety signals and real-world clinical outcomes remains a critical challenge, particularly as more programs rely on advanced in vitro models to guide decision making. This interactive workshop brings together case-driven perspectives from small molecules and complex biologics to show how translational alignment, validation standards, and clinical feedback loops can strengthen confidence in in vitro-driven safety strategies.

• Define what “good enough” validation looks like for ADC- and radio conjugate specific in vitro models
• Distinguish between models built for mechanistic understanding versus those intended to support regulatory toxicology decisions
• Address modality-specific challenges such as payload-driven toxicity, target expression, and off-target exposure
• Share practical lessons on aligning preclinical model outputs with clinical safety expectations for high-risk, high-value programs
• Apply GI organoids for early compound screening to identify diarrhoea liability before candidate selection
• Translate organoid-derived signals into quantitative clinical risk predictions to inform dose and progression decisions
• Understand how ad hoc mechanistic profiling using organoids is evolving to explain toxicity drivers and refine compound optimization