|
The discovery and development of novel drugs remains a process fraught with high attrition rates and many technological, scientific and financial challenges. The cost to bring a new drug to market is estimated at $800 million and is predicted to increase 7.4 per cent above inflation on an annual basis (1). Over 75 per cent of these costs are expended on unsuccessful compounds and, in spite of billions spent on preclinical and clinical studies, post-launch withdrawal of compounds due to adverse side effects still occurs. Opportunities for the pharmaceutical industry lie in the integration of discovery and development functions to bring affordable, effective and safe drugs to patients. Many drug candidates still fail in clinical studies because we cannot accurately predict how effective or how safe these candidates will be in humans based solely on animal studies. Knowing the pharmacokinetics and pharmacodynamics of a drug candidate and the response of a patient to therapeutic intervention is crucial to successfully designing effective clinical trials. Biomarker technologies that are able to increase understanding of a drug’s mechanism of action at an early stage, precise dosing, and a regime of administration will generate valuable information on the drugs activity and accelerate the drug development process (2). |
