Modeling in the pharmaceutical industry
Modeling & simulation (M&S) methodologies are established quantitative tools, which have proven to be useful in supporting the research and development (R&D), regulatory approval, and marketing of novel therapeutics. Applications of M&S help to design efficient studies and interpret their results in context of all available data and knowledge to enable effective decision-making during the R&D process.
There are two main sets of modeling approaches: the population-based models which are well-established within the pharmaceutical industry today and fall under the discipline of clinical pharmacometrics (PMX), and the systems dynamics models which encompass a range of models of (patho-)physiology amenable to pharmacological intervention, signalling pathways in biology, and substance distribution in the body (today known as physiologically-based pharmacokinetic models) – which today may be collectively referred to as the quantitative systems pharmacology models (QSP).
M&S Decisions historically works on the convergence – or rather selected integration – of PMX and QSP approaches into ‘middle-out’ drug-disease modelling platforms, which retain selected mechanistic characteristics while remaining parsimonious, fit-for-purpose, and able to address variability, uncertainty aspects, as well as the testing of covariates.
- To develop Drug-Disease modeling platforms to be used as quantitative companion tools in support of decision-making across the R&D continuum;
- To apply such platforms of quantitative knowledge integration towards projects to address recurring questions on compound selection, dose & dose scheduling, therapeutic window, biomarker selection, patient populations, and selection, combination therapies, study design optimization.