chapter  1
10 Pages

Biomarkers in Clinical Drug Development: Definitions and Disciplines

Recent developments in biomedical science have enabled our health care

professionals to diagnose, characterize, and predict disease in ways no one

would have thought possible just 10 years ago. The rapid translation of

discoveries in the biology and chemistry research laboratories to patient care

has brought a dizzying array of breakthrough technologies to the bedside. The

new molecular diagnostic, imaging, flow cytometric, and many other tools now

used to characterize events such as receptor binding, gene activation, enzyme

activity, and organ function are being combined with the better-established

diagnostic tests to rapidly define the susceptibility, status, and appropriate

interventions of disease in both individual patients and populations. This

confluence of novel technologies with the conventional diagnostic armamen-

tarium has required broader nomenclature. The term “biological markers,” or

“biomarkers,” quickly served this purpose and became part of the new jargon

of experimental medicine [1,2]. This terminology and the thinking behind it

has been particularly useful in the disciplines of therapeutic research,

particularly pharmaceutical research and development, where powerful

discovery and screening technologies such as high-throughput screening,

combinatorial chemistry, tandam mass spectrometry, and DNA microarrays

have yielded an avalanche of new molecular entities requiring sophisticated

technologies, strategies, and biomarkers to demonstrate target activity, safety,

and efficacy.