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The decreased number of new drug approvals (NDAs) has been a topic of considerable debate over the past decade. While the research and development budgets in the pharmaceutical and biotechnology industries have increased approximately threefold in this time, the number of NDAs has remained constant with increasing attrition rates. In 2008, only 8% of the new chemical entities (NCEs) entering clinical trials were ultimately introduced to the market as compared to 14% in 1985. This has led to various initiatives, the most notable being the NIH Roadmap Initiative and the FDA’s Critical Path and Phase 0 clinical trial initiatives, to enhance the biomedical science activities driving drug discovery.
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