Join this workshop to explore how mechanistic modelling, in vitro systems, and translational data can be used to address non-clinical gaps and support a shift from animal-heavy approaches toward predictive, weight-of-evidence frameworks.

• Identifying scientific inconsistencies across current non-clinical approaches, with a focus on the role and limitations of non-human primate data
• Applying PK/PD and systems-level modelling to support weight-of-evidence frameworks, clarify risk, and inform non-clinical decision-making
• Leveraging existing clinical and marketed product data, supported by comparative modelling, to strengthen confidence in new molecules
• Aligning modelling and translational strategies with differing global regulatory expectations to enable more consistent and efficient development pathways across regions
• Exploring how sponsors can proactively engage regulators with modelling-supported non-clinical packages to align on expectations early and avoid late-stage study requests