Affiliations: Eli Lilly and Company, Lilly Corporate Center,
Indianapolis, IN 46285, USA
Note: [] Address for correspondence: Sandra C. Kirkwood, Eli Lilly and
Company, Lilly Corporate Center DC 0444, Indianapolis, IN 46285, USA. Tel.: +1
317 433 9492; Fax: +1 317 277 2934; E-mail: [email protected]
Abstract: Pharmacogenomic biomarkers hold great promise for the future of
medicine and have been touted as a means to personalize prescriptions. Genetic
biomarkers for disease susceptibility including both Mendelian and complex
disease promise to result in improved understanding of the pathophysiology of
disease, identification of new potential therapeutic targets, and improved
molecular classification of disease. However essential to fulfilling the
promise of individualized therapeutic intervention is the identification of
drug activity biomarkers that stratify individuals based on likely response to
a particular therapeutic, both positive response, efficacy, and negative
response, development of side effect or toxicity. Prior to the widespread
clinical application of a genetic biomarker multiple scientific studies must be
completed to identify the genetic variants and delineate their functional
significance in the pathophysiology of a carefully defined phenotype. The
applicability of the genetic biomarker in the human population must then be
verified through both retrospective studies utilizing stored or clinical trial
samples, and through clinical trials prospectively stratifying patients based
on the biomarker. The risk conferred by the polymorphism and the applicability
in the general population must be clearly understood. Thus, the development and
widespread application of a pharmacogenomic biomarker is an involved process
and for most disease states we are just at the beginning of the journey towards
individualized therapy and improved clinical outcome.
