MIDD Strategies for Preclinical and Clinical Translation: A Collaboration Between Clinical Pharmacologists and Modeling Disciplines

Translation from preclinical to clinical development has evolved from empirical allometric scaling in the 1990s to more contemporary modeling-based approaches leveraging advancement in our understanding of pharmacokinetics, physiology and disease as well as a variety of in vitro assays and translational biomarkers. Simultaneously, emerging biotechnologies are introducing novel and complex molecules into clinical development, which may require different approaches for preclinical to clinical translation. Certara provides an integrated framework to support the translation from preclinical research to early clinical development, enabling quantitative decision-making. The framework includes a broad range of modeling approaches—such as physiologically-based pharmacokinetic (PBPK), quantitative systems pharmacology (QSP), empirical PK/PD modeling and model-based meta-analysis (MBMA)—as well as clinical pharmacology stewardship to help identify the appropriate approaches based on their deep scientific and development expertise in nonclinical-to-clinical study design, data interpretation, and dose/regimen selection.

1. Understand the evolution of translational strategies from empirical scaling to model-informed approaches in early drug development.

2. Learn how integrated modeling techniques support preclinical-to-clinical translation and enable quantitative decision-making.

Evaluate case studies that highlight the impact of cross-functional collaboration between clinical pharmacologists and modelers in optimizing first-in-human and proof-of-concept studies.