French National Institute of Health and Medical Research
Biostatistical Modelling and Pharmacometrics
|WP 5 – lead||Prof. France Mentrefirstname.lastname@example.org||Webpage|
Founded in 1964, the French National Institute of Health and Medical Research (INSERM) is a public scientific and technological institute which operates under the joint authority of the French Ministry of Health and French Ministry of Research.
As the only French public research institute to focus entirely on human health, in 2008 Inserm took on the responsibility for the strategic, scientific and operational coordination of biomedical research. This key role as coordinator comes naturally to Inserm thanks to the scientific quality of its teams and its ability to conduct translational research, from the laboratory to the patient’s bed. From the outset, Institute has forged close partnerships with the other public and private research establishments as well as hospitals to fulfil its missions. 80% of Inserm’s 318 research units are currently set up in university hospitals or cancer research centers.
Our research group is located within the School of Medicine of University Paris Diderot and is funded by INSERM and University Paris Diderot. The title of our team is “Biostatistical Modelling and Pharmacometrics” (www.biostat.fr) and Professor France Mentré is head of the team.
We develop statistical methods for non-linear mixed effects models which are used in pharmacometrics and model-based drug development. We apply them mainly for evaluation of anti-infective drugs in collaboration with colleagues.
In this area of NLMEM, we are involved mainly on methods for design evaluation/ optimisation, methods for model evaluation, methods for testing of genetic covariates, methods for estimation without linearisation. We developed the packages PFIM, npde and saemix in R used in academia and pharmaceutical industry.
Main Project Tasks and Experiences related to the project: Main methodological research areas of INSERM UMR 738: models and methods for therapeutic evaluation in chronic diseases are biostatistical modelling and pharmacometrics, exact estimation methods in non-linear mixed effects models, design optimisation in non-linear mixed effects models, model evaluation and model selection, covariate tests and pharmacogenetics. INSERM UMR 738 is fully responsible for the work package “Optimal design in mixed models to analyse studies in small population groups”.
Professor France Mentré is part of the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115156, with financial contributions from the European Union’s Seventh Framework Programmemee (FP7/2007-2013). In this project called “Drug Disease Modelling Resources”, she is member of the Work package responsible for developing new tools, especially in tasks for adaptive designs and model evaluation.
Professor France Mentré is associate editor of the recently launched (2012) online journal of the Nature Publishing Group called “Pharmacometrics and System Pharmacology”