chapter  9
22 Pages

Pharmacogenomic Biomarkers

Recently, two independent groups released the first draft of the human genome

[1,2]. This astounding achievement has resulted in a slate of editorial comments

about how this knowledge will revolutionize medicine and drug development.

Identification of genes that cause or modify risk for disease and those that affect

response to therapy or predict the development of a side effect have been

espoused as a means to improve therapeutic outcome [3]. The term “the right

drug into the right patient” has often been used to describe the effects the genetic

revolution will have on drug development. While studying the human genetic

code undoubtedly will reveal many secrets that ultimately will impact drug

discovery and development, maturation of genetic associations into successful

genetic biomarkers requires multiple, time-consuming steps. We are at the

beginning of a long pursuit whose ultimate goal is improved patient care.

However, for most disease states, genetic biomarkers to identify patients at risk

for that disease, stratify patients by clinical outcome, indicate treatment response,

or predict adverse event occurrences are in reality, several years away.