Reduce uncertainty in market access
Today 90% of clinical investigations fail due to poor trial design, inability to access relevant information, difficulty in interpreting the collected data or a lack of representativity of the results. That is why a real global change of the R&D paradigm is needed to stop the decline in both the efficiency and the productivity of drug development worldwide, especially during the COVID19 pandemic.
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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.