Imaging biomarkers for drug development


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Ambros Beer
Technische Universität München, Munich, Germany

Abstract

Modern pharmacological research increasingly uses the identification of molecular key players of a given pathological process for the development of specific targeted drugs. Noninvasive imaging tools are of potential use in this process of target identification and drug development, as they enable the visualization and quantitative assessment of the expression of molecular targets and their interaction with potential ligands at a functional and molecular level. Imaging technologies are highly attractive for the drug development process in this respect, as they allow gathering such information from the intact organism repeatedly and unlike biopsy samples allow to evaluate tissue heterogeneity more easily. Multiple studies have used structural and functional imaging to document therapy efficacy, mainly during preclinical drug development and early phase clinical trials. Moreover, imaging biomarkers might serve as early surrogate parameters for therapy response with the potential of being used in clinical drug evaluation. Promising results in this respect have e.g. been achieved with [18F]FDG-PET. As another example, dynamic contrast enhanced MRI or CT is increasingly used to assess efficacy mostly of antiangiogenic drugs. Although the impact of imaging on drug discovery has been modest in the past, noninvasive imaging methods are rapidly evolving and will hopefully become increasingly important in the process of drug development. As a perspective, advances in targeted probe development as well as imaging technologies like combined MR-PET, will allow us to use multimodality multiparametric imaging for use in drug development and assessment of drug efficacy in clinical trials. The use of hybrid molecular imaging methodologies combined with targeted probes might potentially help us to noninvasively phenotype tumour biology in its full complexity in a “one-stop-shop” approach, thus allowing for efficient high throughput studies within the cascade of preclinical and clinical drug development.