Anne will be joining Orchard Therapeutics Limited (“Orchard”) on September 5^th, 2016 as Chief Regulatory Officer and member of the company’s leadership team. In this position, Anne will lead Orchard’s global regulatory strategy and explore innovative pathways to expedite the development and licensing of the company’s pipeline of transformative medicines

Anne brings more than 20 years of experience of tackling R&D, clinical and regulatory challenges within medtech and biotech companies. She was previously Executive Vice President at VCLS (Voisin Consulting Life Sciences), where she was actively involved in the design, preparation and management of a high number of regulatory  applications at all stages of product development (from product regulatory classification,  clinical trial applications to registration file). Over the years, Anne has developed very effective communication links with regulatory authorities, including the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) and participated in a large number of meetings with the agencies, including Scientific Advice procedures on product development plans as well as Orphan Drug Designations and Pediatric Investigation Plans

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

"We are delighted that Anne has decided to join Orchard Therapeutics," said Andrea Spezzi, Chief Medical Officer and Nicolas Koebel, SVP Business Operations at Orchard Therapeutics. "Anne brings world-leading experience in regulatory pathways and interactions with agencies in Europe and in the United States, and she will make a significant contribution to the future growth of our company"

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 joinging Voisin Consulting Life Sciences, Anne co-founded the regulatory consulting firm Meditest International.