OHE is pleased to announce that Dr Francois Maignen has joined the team as Head of Operational Research and Data Analysis. Francois’s principal areas of expertise are in the clinical development (methodology of clinical trials) and regulation of medicines for human use.
Francois worked at the European Medicines Agency for 15 years. Here he gathered extensive experience in clinical safety and regulation of medicines in the EU (mainly oncology and cardiovascular and similar biological medicinal products in collaboration with the Committee for Medicines for Human Use), as well as extensive knowledge of pharmacovigilance (detection of new safety signals for centrally authorised medicinal products in collaboration with the Pharmacovigilance Risk Assessment Committee). He was directly involved in the implementation of the EU database of individual case safety reports (EudraVigilance).
As a statistician, Francois has contributed to the implementation of statistical methods of signal detection and analysis in EudraVigilance. He has conducted and supervised pharmacoepidemiology and data mining studies on the statistical aspects of pharmacovigilance statistical signal detection via the PROTECT IMI public private partnership research project.
He has mainly worked on the use of the time to onset of adverse drug reactions as a potential approach to signal detection and on the masking effect of measures of disproportionality analysis1,2,3. Francois has also actively contributed to international harmonisation activities with the Council for International Organizations of Medical Sciences (CIOMS VII (development safety update report) and VIII (signal management)). His work on the exchange of information signals between Regulatory Authorities has been the stepping stone of the principles of signal management in the new EU pharmacovigilance legislation.
Following his experience at the EMA, and before joining the OHE, Francois worked in the scientific advice team at the National Institute for Health and Care Excellence (NICE). He advised companies on the clinical development of new technologies in various therapeutic areas (mainly oncology, cardiovascular, neurology ad orphan diseases) both in the framework of NICE, SEED (Shaping European Early Dialogue) and EMA-HTA parallel procedures (in collaboration with the CHMP Scientific Advice Working Party).
Francois has developed an interest in the practical, regulatory and methodological constraints of drug development of medicines pre- and also post-approval (including the conduct of post-authorisation efficacy studies) and the evidence generation for health technology appraisal purposes. For example, Francois has advised companies on the issues associated with the conduct of (non-comparative) single arm trials and the minimisation of biases associated with the use of external (non-concomitant) controls and on the issues associated with the conduct of cost-utility analyses using extrapolations based on non-inferiority studies.
He has also advised companies selected for the adaptive licensing pilot (and the issues associated with the use of observational or real world evidence after conditional approval), and was involved in the IMI ADAPT-SMART project. Francois has developed and maintained the NICE scientific advice database and he has performed an analysis of the scientific requests in which NICE was involved since 2009 (publication submitted to Nature Reviews: Drug Discovery, presented at the ISPOR meeting in Amsterdam, 2014)4.
Francois holds a doctorate in pharmacy, a post-graduation diploma in hospital pharmacy and public health and a MSc in molecular pharmacochemistry, experimental pharmacology and metabolism (Université René Descartes, Paris V, France). Francois also holds a MSc in applied statistics (Birkeck College, University of London, England).
1. Maignen, F., Hauben, M., Tsintis, P., 2010. Modelling the time to onset of adverse reactions with parametric survival distributions: a potential approach to signal detection and evaluation. Drug Saf, May 1;33(5):417-34.
2. Maignen, F., Hauben, M., Hung, E., Van Holle, L., Dogne, J.M., 2014. A conceptual approach to the masking effect of measures of disproportionality. Pharmacoepidemiol Drug Saf, Feb;23(2):208-17.
3. Maignen, F., Hauben, M., Hung, E., Van Holle, L., Dogne, J.M., 2014. Assessing the extent and impact of the masking effect of disproportionality analyses on two spontaneous reporting systems databases. Pharmacoepidemiol Drug Saf, Feb;23(2):195-207.
4. Maignen, F., Osipenko, L., Gajraj, E., Chivers, R., 2014. Trends in early engagement between industry and HTA: Analysis of scientific advice service provided by NICE since 2009. Value in Health, Nov;17(7):A441.
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