Brigid Bondoc will be speaking on a panel led by Lumanity at the World Orphan Drug Congress titled “Rare Disease Regulatory Pathways in Flux: Navigating FDA and EMA Changes in 2026” at 12:10 p.m. on June 10, 2026. The panel will discuss and analyze the rapid regulatory changes that rare disease drug development faces in 2026. Panelists will analyze FDA and EMA guidance, outline mid-year changes to accelerated approval standards, provide guidance for preparing for updated manufacturing and CMC requirements for gene and cell therapies in rare indications, and identify strategies to maintain development timelines.
To learn more about the conference, visit the event website.
