With bispecifics and T-cell engagers advancing rapidly, early-stage development carries significant translational, immunogenicity, and safety risk. This workshop will explore how to design integrated preclinical packages that better predict human pharmacology, safety, and immune-related liabilities, enabling more confident progression into the clinic. Participants will learn how to align mechanism-of-action, safety, and immunogenicity assessments to build confidence in human outcomes and accelerate early clinical decision-making.

This workshop will gather experts to discuss:

• Optimise biologics for safety, efficacy and immunogenicity to confidently de-risk bispecifics and TCEs before entering clinical studies
• Identify and mitigate immune-related and safety liabilities early, strengthening predictivity and reducing clinical development risk
• Leverage mechanism-of-action insights to integrate safety and immunogenicity considerations into preclinical packages to accelerate regulatory approval and clinic readiness