Predicting Regulatory Expectations on Dose Optimization is Shaping ADC Clinical Development for Strategic Planning
- Analyzing recent regulatory feedback to interpret how the FDA’s Project Optimus guidance is being applied to dose selection and toxicity mitigation strategies, providing a clear roadmap for designing Phase I dose-finding studies
- Designing clinical dose-optimization strategies for antibody–drug conjugates that balance therapeutic exposure and tolerability, to proactively address regulatory expectations
- Applying lessons from Ligachem Bio’s ADC pipeline to integrate translational toxicology, pharmacokinetics, and early safety signals into adaptive Phase I study designs