Balancing Efficacy & Safety Through Biomarker-Guided Dosing

• How can predictive, pharmacodynamic, and longitudinal biomarkers be integrated to define the therapeutic window across dose-escalation and expansion phases?
• What are the major challenges in translating preclinical biomarker signatures into patient-ready dosing strategies, and how can teams improve assay readiness, sampling timing, and clinical decision-making?

Designing & Deploying Combination Biomarkers to Guide DDR Combination Therapies

• How can combination biomarkers be structured to improve predictive accuracy, while maintaining patient eligibility and minimizing operational complexity in trials?
• What practical and regulatory-aligned strategies support the development, validation, and clinical feasibility of multi-analyte or pathway-level biomarker panels in DDR combination studies?