The productivity of the pharma enterprise has fallen, as evidenced by a decline in regulatory submissions and less commercial success. Two major impediments to better productivity are an empirical decision-making process and barriers between functional areas. Better integration of the functional areas is a critical missing element. We contend that this integration requires a shift to model-based drug development (MBDD), effective integrated project teams (IPTs), and a structured, disciplined, and continual evaluation of the probability that a new drug will achieve clinical and commercial success. Clinical Pharmacology & Therapeutics (2010) 88 2, 263–268. doi: 10.1038/clpt.2010.117
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Grasela et al. (2010) studied this question.
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