Driving the Biomarker Rational: A Fully Integrated Translational Pharmacology Concept for Focused Drug Development

摘要

An enormous amount of data is generated during a drug development process, from pre-clinical experiments to study data from clinical trials, all serving the purpose of finding the mode-of-action, the accompanying biomarker for the targeted drug. The data along the way are multidimensional, from different sources, and spanning various disciplines, thus making it difficult to gather and analyze them in an efficient fashion. 4SC has integrated a translational pharmacology unit, where patient characteristics and internally as well as externally generated data comprising pharmacokinetics, pharmacodynamics and OMICS-based data, are brought together. All these data are stored in a fit-for-purpose designed database, allowing the combination and analysis of complex interaction models, thus supporting the systems biology rational and serving the purpose of streamlining a mode-of-action and biomarker development. The general outline of the database will be shown, along with the systems biology and statistical channels, where the data are turned into scientific context. In order to illustrate this kind of approach, exemplary data from 4SC's HDAC inhibitor Resminostat will be shown, which has been tested in four clinical trials in different cancer indications.