Improving productivity with model-based drug development: An enterprise perspective

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.