Date: 2016-08-26
Type of information: Nomination
Compound:
Company: Orchard Therapeutics (UK)
Therapeutic area: Rare diseases - Genetic diseases
Type agreement: nomination
Action mechanism:
Disease:
Details:
- • On August 26, 2016, Orchard Therapeutics annonced that
Anne Dupraz-Poiseau will be joining the company on September 5th, 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 FDA and the 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.
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