Catherine has over 30 years’ experience in clinical research and regulatory affairs in the pharmaceutical and biotech industries and has developed robust expertise for gene therapy development from Phase 1 to Phase 3 under US and EU regulations. She conducted many regulatory filings, IND and Scientific Advice meetings with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other European national competent authorities.
Catherine spent 20 years at Transgene as Senior Director, Head of Regulatory Affairs setting up and leading the regulatory affairs department and supervising global regulatory activities for the development of Transgene’s gene therapy products. Since Transgene, she has held senior leadership and regulatory roles at Voisin Consulting Life Sciences, TxCell (a subsidiary of Sangamo Therapeutics), Elsalys Biotech and most recently Enterome.
Catherine holds a PharmD and a Master’s degree in applied and basic toxicology from Paris University. She began her career in clinical research roles at Ipsen and Sanofi Pasteur.