David Uguen | SVP, Head of Regulatory Affairs
Orchard Therapeutics

David Uguen serves as senior vice president and head of regulatory affairs of Orchard Therapeutics where he is responsible for steering the global regulatory strategy across all stages of the company’s pipeline of approved and investigational hematopoietic stem cell (HSC) gene therapies—spanning preclinical research to clinical development regulatory submissions and post-marketing commitments. This includes overseeing regulatory interactions with agencies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and UK’s Medicines and Healthcare products Regulatory Agency (MHRA), ensuring compliance and facilitating submissions for orphan drug designations, INDs, CTAs, and marketing approval pathways. Throughout his career, David has operated at the nexus of regulatory policy, strategy, and operational execution. He joined Orchard Therapeutics in 2018 from Onxeo (now Valerio Therapeutics), where he was director, regulatory science. Previously he held positions of increasing responsibility at several consulting firms and pharmaceutical companies, including Baxter and Eli Lilly and company. David earned a Pharm. D. from the Université de Rennes in Paris and a Master’s of International Drug Development and Registration from Paris-Sud University. He led the team recognized as a Futures Award winner in the 2024 TOPRA Awards for Regulatory Excellence.