The mapping of the human genome and subsequent advancements in genetic technology had provided clinicians and scientists an understanding of the genetic basis of altered drug pharmacokinetics and pharmacodynamics, as well as some examples of applying genomic data in clinical practice. This has raised the public expectation that predicting patients’ responses to drug therapy is now possible in every therapeutic area, and personalized drug therapy would come sooner than later. However, debate continues among most stakeholders involved in drug development and clinical decision-making on whether pharmacogenomic biomarkers should be used in patient assessment, as well as when and in whom to use the biomarker-based diagnostic tests. Currently, most would agree that achieving the goal of personalized therapy remains years, if not decades, away. Realistic application of genomic findings and technologies in clinical practice and drug development require addressing multiple logistics and challenges that go beyond discovery of gene variants and/or completion of prospective controlled clinical trials. The goal of personalized medicine can only be achieved when all stakeholders in the field work together, with willingness to accept occasional paradigm change in their current approach. 1. Introduction Variability in clinical response to standard therapeutic dosage regimen was reported in the 1950s by many pioneers in the field. Since then, the association between monogenic polymorphisms and variations of drugs’ metabolism, transport, or target had been identified and the vision of personalized drug therapy in health care envisioned [1, 2]. Pharmacogenomic-guided drug therapy for patient is based on the premise that a large portion of interindividual variability in drug response (efficacy and/or toxicity) is genetically determined. Despite the widespread recognition of the scientific rationale and the clinical implementation of pharmacogenomic tests at several major academic medical institutions [3–7], most clinicians and researchers engaged in the discipline would agree that the early vision of achieving personalized therapy in the form of therapeutic regimens tailored to an individual’s genetic profile remains some years away. Broadly speaking, the development and implementation pathways for pharmacogenomic tests consist of several stages (Figure 1): first, discovery of pharmacogenomic biomarkers and validation in well-controlled studies with independent populations; second, replication of drug-gene(s) association and demonstration of utility in at-risk patients;
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