This module will begin with an introduction to biomarkers and their importance. The different types of biomarkers will be discussed in detail with relevant...

Pharmacogenomics, Adverse Drug Reactions and Biomarkers (PHAY0019)

This module will begin with an introduction to biomarkers and their importance. The different types of biomarkers will be discussed in detail with relevant examples. This will include the use of surrogate endpoints in clinical trials, the use of prognostic, pharmacodynamics and pharmacogenomics biomarkers in drug development. The module will then explore the concept of biomarker research and identification of new biomarkers. Some of the technologies used for biomarker identification will be covered such as the use of proteomics and metabolomics along with some current imaging techniques. The qualification and validation by the regulatory authorities of novel biomarkers for use in preclinical and clinical studies will be examined. Examples will be provided of current biomarkers for disease and toxicity. The translation of biomarkers from laboratory to the bedside will be explored.

 The second part of this module addresses the individual responses of patients to drugs as a result of genomic variations called polymorphisms in the form of SNPs, microsatellite repeats and copy number variations (CNVs) in genes coding for drug metabolizing enzymes, drug transporters and drug targets. This is the basis of pharmacogenomics and explains not only variability in patient response but also many of the adverse drug reactions that occur.

 Examples of Adverse Drug Reactions are used to illustrate their relationship with these genome polymorphisms and the interactions between drugs and drugs and environmental factors. The increasing importance of genetic screening and the development of personalized medicines are key outcomes of pharmacogenomics and these rely on the development of companion diagnostics. The importance of diagnostics and biomarkers to personalised medicines will be considered.