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

Authors: Grasela TH, Slusser R
Publication: Clin Pharmacol Ther
Division: Cognigen


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.

By, Thaddeus H Grasela, Slusser R