Target Product Profile: Definition of the key features of your product to build your industrial development roadmap.
From Academic Research to Patients: Advancing methods to ensure a smooth transition from academic work to the first industrial and regulatory data.
Regulatory Landscape: Build the interaction plan and strategy of communication with EMA & FDA.
Nonclinical Development: Choose the right model for your evidence based strategy.
Clinical Plan: The backbone of your entire development plan.
CMC Accelerated Development: Help in achieving a scale up of your production method.
From EU to US: Suit your innovative therapy to the International regulatory Framework.
Access to Market: Identify the target population & price potential.
Dedicated Team
Director, Complex Biologics
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.
Associate Director, CMC & Quality
Francois’s role at VCLS is at the interface between the Complex Biologicals taskforce and the CMC division. His awareness of product specific requirements and challenges means that he is actively involved in building CMC expertize within the VCLS team, aiming towards developing pragmatic CMC strategies that are adapted to applicable product development stages. François is also involved in the authoring of scientific articles, and he is a regular speaker at international conferences.
Vice President Regulatory Strategy
Decebal Bora is a highly experienced regulatory science professional with more than 20 years in the field of health product development. As VP Regulatory Strategy at Voisin Consulting Life Sciences (VCLS), Decebal is leading all regulatory activities of the firm (regulatory science, CMC & quality, regulatory non-clinical, regulatory clinical and, publishing) on strategic and operational standpoints.
Before joining VCLS, Decebal worked for several international biopharmaceutical companies including, Biogen Inc., F.Hoffmann-La Roche Ltd, Baxter World Trade and, innovative SMEs in the field of ATMPs (eg. ActoGeniX N.V, Promethera Biosciences), NCEs (PTC Therapeutics) and biotech (Morphosys AG).
During his tenures, he has been involved in pre-registration, launch and life cycle management activities in the field of drug development with on-going interactions with the FDA, EMA, and national agencies for both GMO and gene therapies. He is instrumental in strategizing and implementing the development of innovative and complex health products.
Dr. Bora holds a Pharm.D. degree from the Catholic University of Louvain (Belgium) and a master’s degree in public health from the Jean Monnet Faculty in Sceaux (France). Decebal is active in various trade associations where he is representing VCLS.
Decebal is based in our Paris (France) office.
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