Abstract
In a move indicative of the enthusiastic support of precision medicine, the U.S. President Barack Obama announced the Precision Medicine Initiative in January 2015. The global precision medicine ecosystem is, thus, receiving generous support from the United States ($215 million), and numerous other governments have followed suit. In the context of precision medicine, drug treatment and prediction of its outcomes have been important for nearly six decades in the field of pharmacogenomics. The field offers an elegant solution for minimizing the effects and occurrence of adverse drug reactions (ADRs). The Clinical Pharmacogenetics Implementation Consortium (CPIC) plays an important role in this context, and it aims at specifically guiding the translation of clinically relevant and evidence-based pharmacogenomics research. In this forward-looking analysis, we make particular reference to several of the CPIC guidelines and their role in guiding the treatment of highly relevant diseases, namely cardiovascular disease, major depressive disorder, cancer, and human immunodeficiency virus, with a view to predicting and managing ADRs. In addition, we provide a list of the top 10 crosscutting opportunities and challenges facing the fields of precision medicine and pharmacogenomics, which have broad applicability independent of the drug class involved. Many of these opportunities and challenges pertain to infrastructure, study design, policy, and science culture in the early 21st century. Ultimately, rational pharmacogenomics study design and the acquisition of comprehensive phenotypic data that proportionately match the genomics data should be an imperative as we move forward toward global precision medicine.
Highlights
Precision medicine requires a multicomponent strategy targeting both the human host and her/his environment
The Precision Medicine Initiative (PMI) has a strong mandate to address biological variation and will boost the global precision medicine innovation ecosystem, as the United States has a large share in biomarker and omics research, which are central to the PMI
extensive metabolizers (EMs) and intermediate metabolizers (IMs) should continue with treatment as recommended, and poor metabolizers (PMs) should reduce dosage with titration by 50% given that they are at risk of experiencing adverse drug reactions (ADRs)
Summary
Precision medicine requires a multicomponent strategy targeting both the human host and her/his environment. In a context of global precision medicine, drug treatment and prediction of its outcomes has been important for nearly six decades since the inception of the field of pharmacogenomics in the mid-20th century (Kalow, 1961). It is said that up to 95% of responses to medication are accounted for by one’s genetic make-up (Kalow et al, 1998) With this in mind, there has been a great deal of interest vested in establishing concrete pharmacogenomic associations and the development of pharmacogenomics-based predictive tools. We will make particular reference to several of the CPIC guidelines in the context of cardiovascular disease (CVD), major depressive disorders, cancer, and human immunodeficiency virus (HIV) treatment, and their role in alleviating ADRs. The scope will, be limited to selected and well-described pharmacogenomic associations (Table 1), and it is not intended to be fully comprehensive. We provide an outlook highlighting opportunities and some of the important challenges to be overcome in the field
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