Regulatory & Safety
- The therapeutic-index problem as the central constraint on ADC progress, and how the field is responding
- How regulatory frameworks are adapting (or failing to adapt) to increasingly complex conjugate formats
- Designing for safety from day one versus managing toxicity in the clinic
- Understanding and getting ahead of recurring class toxicities such as ILD, ocular, and peripheral neurotoxicity
- Class effects versus molecule-specific risks
- What generalizes across payloads and what does not
- Regulation as a standalone theme versus embedded across design, CMC, and clinical decisions
- Building a joined-up regulatory and safety strategy from first-in-human through commercial lifecycle
- Global divergence and convergence: navigating IND, comparability, and multi-region submissions
- Can better preclinical and biomarker tools move safety understanding upstream of the clinic?