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 . 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.