Improving productivity of modern-day drug discovery

Abstract

The pharmaceutical industry is confronted by increasing costs of clinical development and diminishing productivity. The most challenging aspect of drug development has been the failure of therapeutics in expensive Phase II or III trials, and this is most commonly due to lack of efficacy. More can be done during the drug discovery phase to optimize efficacy-testing in animal models by expending resources to explore the congruence of the animal model with the human disease. Historically, relatively little attention has been paid to validation of these models, but access to molecular mRNA and genetic profiling offers a new lens through which the similarity of these disease models to human diseases can be examined and their utility for exploring therapeutic efficacy can be optimized. Exploring congruent experimental end points in clinical and preclinical experiments will also increase confidence of success in late phase clinical development. The expense of this investment is trivial compared to the costs of a failed clinical trial, more than justifying this endeavor.