As Associate Director at Voisin Consulting Life Sciences, Emmanuelle manages projects involving cell, gene & tissue-based medicinal products (“ATMPs”); from non-clinical to clinical phases, both in Europe & the US. Emmanuelle has a particular expertise in GMO requirements for experimental drugs in Europe.
Emmanuelle brings 12 years of experience in the biotech industry. Her Ph.D. in science added to R&D experience allows her understanding the constraints & challenges that developers faced daily.
Emmanuelle started her career as a project manager in oncology for 5 years for a biotech company. Where she led the development of a radiolabelled monoclonal antibody intended for diagnosis and treatment of pancreatic cancer.She then headed for 6 years the regulatory affairs in another French biotech company Her major achievement in this position was granting an authorization for First-In-Human of lentiviral vectors for therapeutic immunization (a worldwide premiere). She gained significant experience in agency meetings and has performed several scientific advices, as well as ITF meetings and classification request (at the EMA). Emmanuelle also led orphan designation requests (EMA, FDA) and pre-IND meeting (FDA). She was responsible for clinical trial applications and in charge (writing/review and approval) of core documents (Protocol, IB, IMPD, patients’ documents) and GMO specific documents.
Emmanuelle is an active member of the ATMP group at the France Biotech association and has participated in the writing and release of a Q&A document on ATMPs (and in a round panel on ATMP in clinics. She has also recently joined several international associations.
She holds a PhD in Structural and Molecular Pharmacology from the University Paris 5. Emmanuelle is based in our Boulogne office in France.