As Director at Voisin Consulting Life Sciences, Emmanuelle manages projects involving cellular and gene-based medicinal products; from early stages of development to late clinical development phases and up to the preparation of MAA/BLA, both in Europe & the US. She provides strategical and regulatory input. Emmanuelle has particular expertise in GMO requirements for ATMPs in Europe.
Emmanuelle has been working for 12 years in the biotech industry; first as an R&D project manager, then as head of regulatory affairs. Her Ph.D. in science added to R&D experience allows her understanding of the constraints & the challenges that developers faced daily.
She has significant experience in agency meetings and has performed 20+ scientific advice (national, supranational), as well as classification requests and PRIME applications. Emmanuelle also led orphan drug designation requests (ODD); both in the EU and US, pediatric investigation plan (PIP), and FDA (type B & C) meetings.
Before joining VCLS, she headed for 6 years the regulatory affairs department of a French biotech company. Her major achievement was granting authorization for the First-In-Human clinical trial of lentiviral vectors for therapeutic immunization (worldwide premiere). She was responsible for clinical trial applications and in charge (author/review) of core documents (Protocol, IB, IMPD, patients’ documents), and GMO specific documents. Emmanuelle started her career as a project manager in oncology for 5 years at MabLife (formerly MAT Biopharma) and worked for 2 years at St Bartholomew’s Hospital, London (UK) where she led the development of a radiolabelled monoclonal antibody intended for diagnosis and treatment of pancreatic cancer.
Emmanuelle is an active member of the ATMP group at the France Biotech Association and Alliance for Regenerative Medicines (ARM).
She holds a Ph.D. in Structural and Molecular Pharmacology from the University Paris 5.
Emmanuelle is based in our Boulogne office in France.