Arthur Van Leerberghe is a senior clinical operations leader with over 20 years of experience in the life sciences industry. He has supported drug development programs across all clinical phases, through regulatory approval and label extensions, with a strong focus on rare and ultra-rare diseases. Arthur brings deep expertise in clinical program management, operational transformation, and change management. He currently serves as Executive Director of Development Business Operations at Mirum Pharmaceuticals, following senior leadership roles across the U.S., Europe, and Switzerland.
In rare disease development, evolving development plans can leave sponsors managing multiple active trials with overlapping sites, investigators, and fragmented governance. In this case study, Mirum describes how it consolidated four ongoing studies across two indications into a single, unified trial. Developed in close collaboration with regulators, the approach was grounded in maintaining continuity of care through a site- and patient-centric model, while enabling a more streamlined and adaptable development pathway.
The discussion will highlight the governance and operational principles that supported consolidation—improving oversight and reporting efficiency—while delivering measurable resource and budget benefits and preserving access to treatment for patients, up until commercial launch.
Key takeaways
-Decision criteria and sequencing for consolidating active trials into a single-study approach
-Governance practices that simplify oversight and improve execution
-How protocol design can reduce friction for sites and strengthen patient centricity
-Operational lessons learned and practical considerations for teams navigating trial consolidation