As Vice President at VCLS, Valerie is responsible for leading the CMC Group in the design and optimization of CMC strategies adapted to the stage of product development and aligned with the relevant regulatory requirements and innovative pathways. This service covers conventional small molecules, biologics and gene and cell therapy products and includes the provision of advice on all regulatory and technical aspects of biotechnology product development.
In addition to this role, Valerie has experience of managing technical transfer projects across multiple manufacturing sites and countries. This encompasses process changes, scale up and the development of comparability strategies to bridge the different stages of clinical development. She also has specific expertise in analytical method development and validation for the set–up of release and stability testing and in the design of relevant potency assays taking into consideration the product mode of action and regulatory expectations. She is also responsible for the preparation of the pharmaceutical sections of Regulatory Applications (IND, IMPD MAA and BLA/NDA), together with briefing documents for Agency meetings.
Valerie brings to the role over 20 years of international bio-industry experience, during which time she has acquired an in-depth knowledge and understanding of EU and US regulations, which is of significant value to clients. She has also been involved in the selection of CMOs and analytical laboratories, the coordination of manufacturing and method transfer, validation, comparability, and the coordination of GMP audits.
Prior to joining VCLS, Valerie spent 12 years at Genzyme Corp. where she gained significant experience in protein chemistry, assay development and validation, as well as product and bioprocess characterization. She then joined Repligen and gained further expertise in monoclonal antibodies, peptides, and biopolymers.
Valerie is a member of the Parenteral Drug Association and co-leader of the Gene and Cell based therapies task force, mandated to address quality and production challenges specific to ATMPs. She also shared responsibility for the preparation of the PDA Technical Report on Cell Based Therapy Control Strategy (2019), focusing on the development of a risk-based approach to design a relevant and targeted control strategy, adapted to cell-based therapy.
Valerie obtained a Ph. D. in Molecular and Cellular Biophysics at the University of Orleans in the field of lectins and glycoproteins followed by a two–year post-doctoral fellowship at Eli Lilly and Co. in Indianapolis, where she was responsible for the development of analytical tools for the assessment of recombinant glycoproteins.