ABSTRACT

Bringing new drugs to market is an increasingly difficult task. The costs associated with research are rising, and the list of criteria necessary for acceptance continues to grow. According to statistics compiled by the Pharmaceutical Research and Manufacturers of America (PhRMA), 90% of the compounds that enter the development cycle fail to reach market (1,2). Many of the failures have been attributed to poor pharmacokinetic performance that was not discovered until late in development, after substantial research investment had already been made (3). At the same time, accelerating improvements in high throughput screening (HTS) and advances in molecular biology and genomics have led to a proliferation of new potential targets that compete for resources. These targets offer the opportunity for new and innovative products, as well as for leadership in the marketplace by firms able to exploit such products effectively and expeditiously. Thus, pharmaceutical companies are under the combined pressures to rapidly find leads for the many new targets available and to focus on better quality leads with improved chances of survival.