CMC & Quality
Valerie Pimpaneau is responsible for the management of projects involving the development of CMC, bio-analytical and quality strategies for Drugs, Biologics, Gene and Cell Therapy.
She heads up the activities of the regulatory CMC group built to provide assistance to product development with a staff combining strong technical background with good regulatory expertise. Her experience in the Biopharmaceutical industry allows Valerie to interface efficiently with the technical and regulatory teams and help coordinate CMC activities in line with the product development phases.
She actively contributes in the preparation of pharmaceutical sections of IND and IMPD for Clinical Trial Applications, Module 3 and 2.3 of MAA or BLA/NDA submissions, briefing package for Scientific Advice. She also participates in agency meetings to discuss CMC questions and strategy at different stages of development. As process often evolves in the course of product development she also participates in the design of comparability strategies to allow bridging clinical development. She is involved in the preparation of gap analysis, due diligence and risk assessments in support product development.
On the technical side, Valerie advises on process and method development and validation and has been involved in the management of complete technical transfer projects in the context of manufacturing site changes. This includes identification of CMOs and analytical laboratories, coordination of manufacturing and method transfer, validation, coordination of GMP audits.
Valerie brings 17 years of international experience in the bio-industry field including 12 years at Genzyme Corp. where she managed analytical development and quality control activities. In this role she gained significant experience in protein chemistry, assay development and validation as well as product and bioprocess characterization. She managed several technology transfer exercises across multiple sites and countries and worked actively in defining comparability strategies to support regulatory submissions in the framework of scale-up, manufacturing process changes and manufacturing site transfer.
Valerie obtained a Ph. D. of Molecular and Cellular Biophysics at the University of Orleans in the field of lectins and glycoproteins. She then completed a two year post-doctoral program with Eli Lilly and Co. in Indianapolis, where she was involved in the development of analytical tools allowing the quality assessment of recombinant glycoproteins. Valerie continued to gain international experience by joining Repligen and then Genzyme in Cambridge, Massachusetts and extended her area of expertise to monoclonal antibodies, peptides, and biopolymers. In 2005 she transferred to Genzyme Flanders in Belgium to implement and ensure the analytical support needed for the startup of a new bio-manufacturing plant. She is based in Rennes, France.