I started my career at Servier in 1998 by creating and leading an R&D team of biostatisticians, SAS programmers, physicians, and medical writers (30+ people), with focus on safety (IAS and meta-analyses in the context of RCTs and MA dossiers and supporting PV responsibilities with PSUR-DSUR and RMP).

Then, from 2008, as a pharmacoepidemiologist by training, I created and led the department of pharmacoepidemiology (including pharmacoepidemiologists, biostatisticians and data scientists working on RWD sources (e.g., CPRD, ...).  In 2016, my team took on more responsibility with the emergence of RWE and became the global department of pharmacoepidemiology and RWE at Servier. My team (15+ people) was in charge of regulatory post-authorization safety/Efficacy studies (PASS/PAES) and was a core member of the evidence generation plans (EGP) across the company's portfolio. The EGP included epidemiology projects fueling the early clinical development strategy, innovative clinical trials designs (e.g. RWD-external comparator arms) and RWE studies for R&D, Medical Affairs, HEOR and Market Access global/local stakeholders. The team also used analytics (SAS, R, AEP) and numerous EU and US RWD sources. On top of my executive leadership role, for 11 years (2009-2020), I was the Servier internal pharmacoepidemiologist and methodologist expert in charge of the "Mediator trial".​

 

From November 2020 to February 2024, I was Vice President Real World Strategy at Aetion, a Health Technology company in RWE. Along with a strategic leadership role in Europe and implementing partnerships (with EMA, Health Agencies, HTA bodies, Academics, Data sources and Registries), I oversaw the RWE projects sponsored by the EMA by providing scientific and functional leadership to the team, as well as a PI role on some projects.

 

I’m well-tested in using the widest range of RWD sources, RWE methodologies and partnerships (including numerous Databases and Registries, ENCePP centers and CROs across the EU, North America, Japan and China).

I’m also well versed in communications and oral explanations with the EMA (PRAC, CHMP, PDCO, ETF and CAT), National Health Authorities and HTA Bodies.

Finally, I was involved in some IMI projects (e.g. EMIF & EHDEN) and I've been a member of the ISPE for 13 years, the ISPOR for 5 years, the Get Real Institute for 2 years, and the ENCePP WG 2 "Transparency & Independence" for 2 years.

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Therapeutic areas with specific capabilities: cardiovascular, neuropsychiatry, diabetes, neuromuscular (SMA), rheumatology, oncology, vaccines and in paediatrics.

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