Role of the Genomics Revolution in Pharmaceutics

Abstract

The genomics revolution, which has seemingly pervaded all of the biological and biomedical sciences, has brought about its most impressive advances in the pharmaceutical sciences. The technological advances in high-throughput DNA sequencing, in assessing gene expression for thousands of transcripts, and in RNA construFcts to silence specific genes have not only been the driving force behind genomic studies, but have also contributed to an emerging paradigm shift that is occurring in pharmacology, drug development, and pharmacotherapeutics. The molecular tools now readily available to laboratories have hastened the shift from drug development based largely on chemistry to one based on our growing biological knowledge of the physiological and molecular effects of compounds.1 It is now becoming possible with these tools to assess at the cellular level the nature of drug action, toxicity, and tolerance. Similarly, our understanding of human disease is being refined, which will lead to more precise therapeutic interventions based on more precise understandings of disease states. Ironically, the area of genomic-driven advances in pharmacy that enjoys the most public press is also the area where the advances are the least certain. Much has been written about the age of personalized medicine where each patient’s genetic makeup will determine an individual-specific course of drug treatment designed to be the most efficacious and safe. Pharmacogenetics, which has been an active area of research for over 50 years,2 seeks to provide patients efficacious therapeutics with minimal adverse drug reactions based on their genetic makeup (genotype) at one or more genes determining drug metabolism and/or drug transport (drug metabolism or transport pharmacogenetics) or in genes that are the direct targets of drug action (drug target pharmacogenetics). The literature is extensive, including several new journals detailing studies showing gene-drug relationships and the importance of including a patient’s genetic makeup in guiding …