Developing the relevant set of potency assays for cell-based medicinal products comes with numerous challenges due to the complex nature of the products. This paper highlights several approaches to consider when designing the potency assay strategy in the framework of current EU regulatory expectations.
Valerie Pimpaneau, François Gianelli, Anne Dupraz Poiseau & Jean-Hugues Trouvin, (Professor at Paris Descartes University).
May 2015 - Regulatory Rapporteur
Valérie Pimpaneau, Vice President 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. 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.
François Gianelli, Senior Regulatory Scientist
He is involved in different projects for biologicals regulatory and CMC support. François is involved in authoring and reviewing CMC content (IMPD/IND and MAA/NDA/BLA), and performs gap-analysis of CMC development. He is also involved in Product Positioning and Regulatory Strategy, preparation of Training Supports, Life Cycle Management, and Clinical Trial Applications follow-up.
Anne Dupraz Poiseau, Executive Vice President
Anne manages multidisciplinary teams dedicated to complex and innovative healthcare product development programs, including for regenerative and personalized medicine.Anne has 20 year experience working with Medtech and Biotech companies, on R&D, clinical and regulatory challenges, specifically in the areas of Oncology, Spinal surgery, Orthopedics, Rheumatology, Ophtalmology, Dermatology and Wound care.