European Journal of Molecular & Clinical Medicine

Abstract

Translational medicine science and the volume of information generated in this field have grown exponentially in the last decade and continue to grow faster every day. This has generated a huge amount of data. The application of Modeling and Simulation (M&S) in drug development has also grown in the last two decades, but mostly has been limited to analysis of single studies or to analysis of pooled data from several studies. Such application traditionally has been used either to support a new drug application or to make Go/No Go decisions about a given development program. However, rarely M&S has been integrated as a tool in portfolio management based on a quantitative evaluation of all the data in hand (e.g., translational Medicine data). In other words, many organizations utilize M&S still as a tool aiding study data analysis or at best a tool to guide a given development program, but not use M&S in portfolio management systematically (the large dashed box shown in the Fig. 1).