Role of Biomarkers in Development of Personalized Drugs

The role of biomarkers in drug development is discussed in Chap. 4. In addition to personalizing the use of existing drugs, the development of new personalized drugs should start at the discovery stage. Eexamples of this are metabolomic biomarker- based drug discovery, and pharmacogenetics/pharmacogenomics-based monoclonal antibody (MAb) drug development in oncology.

Metabolomic Biomarker-based Drug Discovery

Identification of small molecule metabolites present in patient-derived samples can support discovery of novel biomarkers, which may help in the discovery of personalized medicines individualize treatments is challenging. Biomarkers for individualization of treatment can be identified using a clinical metabolomics-based approach, and concepts used in pharmacodynamic/pharmacokinetic modeling can be integrated in this process in order to increase the clinical relevance of identified biomarkers and personalized medicine (Kohler et al. 2017). A workflow chart of this process is shown in Fig. 18.2.

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