Marie
Deneux, Ph.D.
Senior Director,
Drugs and Biologics
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As Senior Director, Regulatory Science, Drugs and Biologics, Marie assists international clients in the design and implementation of global product development plans and associated regulatory strategy, in particular in the area of rare diseases. She is involved in the development of biotech products, new chemical entities, cell and gene therapy medicinal products and repurposed drugs. Marie has extensive experience in interactions with the European Medicines Agency (EMA), national European Health Authorities and the Food and Drug Administration (FDA), in particular in coordinating SME meetings, Scientific Advice Request/Protocol Assistance/Parallel Scientific Advice with FDA and FDA Type B meetings and associated background documentation, while taking into consideration global development constraints. Marie is also in charge of preparing and coordinating centralised Marketing Authorisation Applications (MAAs), as well as New Drug Applications (NDAs) and Biologics License Applications (BLA), including writing CTD Modules and managing the team of experts involved, as well as coordinating the preparation of written and oral answers as part of the assessment procedures.

Marie has significant expertise in writing and assembling of orphan drug designation (ODD) applications in Europe and in the United States. She makes recommendations on the feasibility of these applications and leads discussions on the optimal path to obtain designation from the European Commission and the FDA. Marie also leads the activities specifically related to orphan medicinal products, in particular the strategic discussions around orphan similarity, market exclusivity and justification of significant benefit.

Within VCLS, Marie is also actively involved in the European activities generated by the implementation of Regulation (EC) No 1901/2006 on medicinal products for paediatric use. This includes recommendations on the design of Paediatric Investigation Plan (PIP) strategies - i.e. on the possible combinations of pediatric studies, extrapolation of data obtained in adults or in other pediatric subsets, partial or total waiver and/or deferral - preparation and submission of PIPs and interactions with the Paediatric Committee (PDCO).

Marie received an engineering degree from INA-PG (Institut National Agronomique Paris-Grignon). The INA-PG curriculum covers in-depth courses ranging from biology and food science to chemistry and mathematics. She developed international experience while working abroad at the National University of Bogot√°, Colombia, on the ethno-pharmacology project investigating the use of Croton Leptostachis for the treatment of malaria.

After returning from Colombia, she earned her Ph.D. in cellular and molecular pharmacology in the French National Center for Scientific Research (CNRS).

Marie is based in Florida, and frequently commutes to VCLS offices in Cambridge, MA and Paris, France.