Muriel O’Byrne, Head of International Regulatory Affairs at Regeneron, warns that Europe’s clinical trial landscape faces a critical challenge: science is outpacing the regulatory system. In an interview for World Clinical Trials Day 2026, she highlighted that inconsistent application of EU rules, particularly around the Clinical Trials Regulation and data sharing under the European Health Data Space, risks driving trials away from the region.
O’Byrne, who holds a PhD in neuroscience from Trinity College Dublin, is optimistic about advances in genetics, AI, and precision medicine. She cited the Regeneron Genetics Centre’s work pairing large-scale genetic data with disease information, enabling faster identification of promising drug targets. Gene therapies like CRISPR also hold transformative potential by addressing disease at its root cause, she noted.
On leadership, O’Byrne emphasized authenticity and adaptability. The Regeneron European business office in Dublin operates on a democratic, inclusive model, while newer teams across Europe benefit from more structured guidance. Her core advice: there is no single right way to lead; success depends on reading what people need.