As Senior Medical Director with VCLS, Florence is Head of the Non Clinical and Clinical Development group. She provides advice on medical and clinical aspects of projects involving the design of clinical development plans, clinical trial protocols, Scientific Advice Procedures, regulatory document writing, Risk Management Plans and Paediatric Investigation Plans.
Prior to joining VCLS, Florence spent more than 11 years at the French Regulatory Agency (AFSSAPS then ANSM), where she gained a solid background in evaluation of European submissions (Centralized, Decentralized/Mutual Recognition and national procedures). These projects concerned mainly New Chemical Entities, Combination Products, Biologics and Well Established Products. Her work included clinical evaluation of Applicants’ submissions (initial Marketing Authorisation Applications and variations), requests for early access programs and clinical trial applications (CTAs) as well as dialogue with Applicants prior to, during, and beyond Marketing Authorizations. She made several presentations at the CHMP, in meetings of the Scientific Advisory Group (SAG), the Committee for Advanced Therapies (CAT) and collaborated with European Regulatory Agencies on a regular basis. She was also involved in the elaboration of national and European guidelines and recommendations. Florence provided expertise in various fields such as oncology, cardiovascular/thrombosis and neurology.
Florence also worked for 15 years in clinical development in the pharmaceutical industry where she participated in a variety projects for JANSSEN and UPSA-BMS group where she was Medical Director. She also served as Senior International Project Manager at Laboratoires SERVIER. She planned and managed clinical trials and development plans and provided technical support to R&D teams in Europe, the USA -including meetings with the FDA and other non-EU countries (Israel, South Africa, Asia, Japan).
Florence’s international background, allows her to work successfully in multi-cultural and multi-lingual environments. She has extensive experience of working with key opinion leaders (KOLs), in the context of managing expert panels, collecting medical advice on the development plans and elaboration of guidelines and recommendations.
Florence earned a Medical Doctor Degree from the University René Descartes-PARIS V, a post-graduate Degree in Methodology of Clinical Trials from the University PARIS VII, and a post-graduate Master’s Degree in Pharmaco-Economics applied to the Pharmaceutical Industry from the University Lyon I, in France. In addition to her medical training in France, she gained additional medical experience in hospitals affiliated with UCLA, UCI and UCSD (Southern California, USA) and in Bonn (Germany).