Join this workshop to navigate the shifting regulatory landscape for non-clinical safety, where the focus moves from traditional animal-heavy packages to a weight of evidence framework.

• Discussing policy inconsistencies across health authorities regarding animal usage, focussing on non-human primate studies
• Exploring ‘weight of evidence’ approaches for well-established or characterized targets to potentially waive or refine studies
• Debating scientific examples such as the necessity of repeated NHP studies for new generations of B-cell depleting CD3 T-cell engagers
• Uncovering the possibility of referencing marketed products for weight of evidence studies
• Advancing the idea of a ‘bridging study’ via in vitro comparative data rather than a full GLP NHP study when a new molecule only has slightly modified Fc regions