Transforming the Drug Development Process
Abstract
In today's drug development environment R&D spending is out-pacing productivity. The pharmaceutical industry is under pressure to stem attrition rates and alter business strategies to account for the fact that fewer blockbuster drugs are going to market. As a result companies will need to run more trials than ever before in order to achieve more drug launches. But the traditional phased approach to drug development does nothing to address time and cost inefficiencies that might offset this. The FDA's Critical Path Initiative was an acknowledgement of the need to commercialize drugs more quickly and economically. But how to do this without slowing down drug development or worse, rush unsafe drugs to market?
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