MVA Oncology Network

Speaker: Eva Gil Berglund, PhD, Senior Director, Regulatory Strategy, Certara

Abstract: Model-informed drug development (MIDD) plays a pivotal role in bridging preclinical findings to clinical pharmacology strategies in oncology. This session will illustrate how pharmacometrics and physiologically based pharmacokinetic (PBPK) modeling can translate preclinical data into actionable insights for designing development plans in the target patient population. The presentation will highlight how these approaches inform first-in-human starting doses, upper dose limits, and early dose-range expectations, while accounting for patient-specific oncology physiology and exposure-response relationships. High-level examples will demonstrate how mechanistic and quantitative modeling can enhance decision-making, reduce development risk, and support a more efficient and patient-centered Phase I clinical pharmacology strategy.