Abstract
The cost to discover and develop a drug is increasing dramatically; however, the number approved
new drug products on the decline. Drug manufacturers, desperate for ways to expedite the drug
discovery process while decreasing the expense, are turning to biomarkers as one possible solution.
Biomarkers in Clinical Development: Implications for Personalized Medicine and Streamlining R&D
examines the current state of biomarker development and application, with a close look at the
technologies and how they are being deployed from research to the clinic.
Biomarkers can be influential in every phase of drug development, from drug discovery and
preclinical evaluations through each phase of clinical trials and into post-marketing studies.
Biomarkers can predict a patients response to a compound, act as a surrogate endpoint, and aid in
making efficacious and cost-saving decisions or terminating drug entities more quickly during the
research process. Patient enrichment strategies are using biomarkers to identify certain patient
populations that are m ore likely to respond to the drug therapy or to avoid specific adverse
events. This shift toward "pe rsonalized medicine," in which the patient receives a
treatment based on their genetic as well as medical profile, is helping the drug industry to achieve
the goal of cost-effective and faster research.
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