Anne Dupraz-poiseau
Chief Regulatory Officer
orchard Therapeutics
Switzerland
Biography
Anne brings to Orchard Therapeutics more than 20 years of experience of tackling R&D, clinical and regulatory challenges for global development within medtech and biotech companies. Prior to joining Orchard Therapeutics, she was Executive Vice President at VCLS (Voisin Consulting Life Sciences), where she was actively involved in the design, preparation and management of high number of successful regulatory submissions at all stages of product development. She managed over 50 different cell, tissue and gene based therapies development programs over the last 3 years. She established strong communication links with Regulators, including the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA). Anne possesses extensive expertise in human Cell, Tissue and Gene Therapies, so called Advanced Therapy Medicinal Products (ATmPs) in Europe. Bringing together scientific and regulatory expertise in this area, she actively participated in the elaboration of the European ATmPs’ Regulation through Industry Associations and worked closely with the European Medicines Agency (EMA) on related guidelines. Anne began her career as a Research & Development Project Manager for Medtronic Sofamor-Danek after earning a joint PhD degree from the University of Dental Surgery in Nantes, France, the Free University of Berlin, Germany and the University of Medicine of Leiden, Netherlands, working on the development and evaluation of drug-device combination products aimed at bone substitution. Before joining VCLS, Anne co-founded the regulatory consulting firm Meditest International.
Research Interest
human Cell, Tissue and Gene Therapies