Agenda details are forthcoming but we are pleased to announce the following sessions:

• Non-canonical biologics formats: challenges in bioanalytics, PKPD and biotransformation for complex biologics formats

• Challenges in FIH dose projections

• Developmental and reproductive toxicology (DART) assessment with biotherapeutics: what did we learn and where to go?

• Non-animal testing strategies

• Seeing is believing: New frontiers in imaging

• Predicting immunogenicity during early drug development: hope or despair?