While first-in-human trials remain the ultimate test, this workshop focuses on how to de-risk programs earlier. It tackles the critical industry challenge of poor translation by moving beyond standard animal models to validate new in vitro systems and design smarter, more predictive non-clinical packages. Attend this workshop to improve the probability of clinical success by:

• Evaluating the predictive value of organoids, microphysiological systems, and computational models against historical clinical data for known toxicities like ILD and ocular toxicity.
• Developing a framework for reverse translation, using clinical safety signals to refine and calibrate preclinical models for better future predictions.
• Navigating the FDA’s NAMs initiative. Discussing practical strategies for implementing New Approach Methodologies and preparing robust data packages to support regulatory submissions with reduced reliance on animal studies.