I am a founder of Medicines Development and Training (MDT) services (www.mdt-services.eu). I am specialist in dermatology, in regulatory science and in health technology assessment for reimbursement purposes with more than 25 years of experience as an expert in clinical and regulatory field. For 12 years I was serving as a Head of Scientific Advice at the French Medicines Agency (ANSM) and was member of several working parties at the EMA (Scientific Advice Working Party (SAWP), Efficacy working Party (EWP), Biosimilar Medicinal Products Working Party (BMWP)). As SAWP Vice-Chair, I was involved in the review of more than 1000 scientific advices in 10 years. In 2010 I joined the Haute Autorité de Santé (HAS), France, as Deputy Director for Health Technology Assessment, and was in charge of European activities related to relative effectiveness assessment, in particular those coordinated by the EUnetHTA, such as early dialogues with developers and methodology of assessment for reimbursement purposes. I also coordinated the SEED (Shaping European Early Dialogues) project financed by European Commission to support early dialogues between developers and HTA bodies as a permanent activity in Europe. Since September 2015 I consult on clinical drug development strategies and act as member of the NDA Advisory Board. My main research areas cover endpoints for marketing authorization/relative effectiveness assessment and bridging of efficacy – effectiveness gap in product development.

As Board Member of European Access Academy, I am actively involved in EU HTA Regulation review and implementation process.