Pharmacogenetic issues in biopharmaceutical drug development

Abstract

Several converging factors, including the sequencing of the human genome, fine manufacturing and chemical synthesis processes, and the advent of targeted biotherapeutic molecules, make this an exciting era in personalized medicine. Pharmacogenetics, the term used to describe idiosyncratic responses to drug therapy having a genetic basis, has become much more than a few SNPs in some drug-metabolizing enzymes. With the advent of biopharmaceutical drugs such as monoclonal antibodies, cytokines, and peptidomimetics, the term pharmacogenetics must be interpreted in a much broader sense. Indeed, biopharmaceutical agents are often subject to traditional pharmacogenetic polymorphisms. But much more than that, pharmacogenetics encompasses the use of any and all genetic information available or obtainable from an individual and/or pathogenic organisms that can be put into use in clinical practice. By their very nature, many of the diseases in question are multigenic and do not lend themselves to simple pharmacogenetic analysis. Some key examples of these and other issues surrounding the use of genetic information to combat human diseases are presented. © 2008 Humana Press, a part of Springer Sciencc+Business Media, LLC. All rights reserved.