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Content of the case study


Uncertainty at the time of market access 

From bench top to patients, the life of a new medical product is a continuous accrual of data aimed at answering the question: “Can the activity observed on a Petri dish result in improved health benefits for patients (and the population)?”.This data accumulation process is punctuated by decision-making taken in uncertain settings. One of the most challenging decisions because of this uncertainty is market access.


The fundamentals of the NOVA Modeling & Simulation solution

The three components of NOVA’s solution are: (i) the disease model, which is a mathematical representation of the disease; (ii) the drug model, which is a mathematical representation of the behavior of the compound in the body, from administration to its target(s) in the disease model; (iii) the virtual population (VP), which is a collection of virtual individuals defined by a set of values of model parameters.


A few illustrative examples for market access applications

M&S can help by eliminating most of the uncertainty that makes market access difficult.Illustration examples of Modeling & Simulation applied to market access: (i) treatment of reperfusion injury; (ii) prevention of lung graft rejection; (iii) interaction between a anti HBV NMP and established treatments; (iv) non persistent efficacy in chronic treatment.