Translational insights from early trials across diverse patient populations

Heterogeneity in early patient cohorts can reveal critical differences in safety, PK and PD, and biomarker performance. This session outlines how to interpret these signals, refine translational assumptions, and design studies that account for variability without compromising analytical rigor.
Key takeaways

• Characterize sources of variability that influence early safety and PK and PD readouts
• Assess how population diversity affects biomarker strategy and translational fidelity
• Interpret early signals to adjust dose selection, escalation, or monitoring plans
• Apply frameworks that incorporate demographic and clinical heterogeneity into study design
• Strengthen predictive validity by integrating real-world variability into early decision-making