WP3 Reading Material
With $115 billion worth of branded drugs coming off patent betwee 2007 and 2012,1 continued profitability for many pharmaceutical companies relies on their ability to increase the number of new chemical entities (NCEs) coming to market—a difficult and expensive task at roughly $600 million each.2 With increasing business pressure to accelerate the pace and increase the success rate of drug development, each stage of discovery and development requires a critical review to optimize the process. Drug safety, including drug-induced hepatotoxicity, remains one of the major stumbling blocks for the industry. Under the current gold standard of human clinical trials, sustainable pharmaceutical development is restricted by study participant attrition and lengthy, iterative processes that delay or fail to discover risk factors. The unfortunate clinical and business consequences may be dramatic. Pharmaceuticals such as troglitazone and bromfenac, both of which were ultimately shown to cause extensive human liver damage, underscore the urgency to develop accurate biomarkers that can identify potentially hepatotoxic compounds during the preclinical stages of drug discovery.
