Designing advanced therapies that survive scale: from early decisions to commercial readiness

Advanced therapy developers face intense pressure to accelerate timelines, but speed without early discipline across CMC, delivery, analytics, and manufacturing can introduce risks that surface later and derail progress. This panel will examine why promising programs often stall between initial clinical signal and late-stage advancement, and how early strategic decisions set a foundation for scalability, comparability, cost control, regulatory confidence, and patient access.

Drawing on experience across nucleic acid therapeutics, nanomedicine, viral vectors, and cell therapy, the discussion will explore which elements teams should lock in early versus where flexibility is essential. Panelists will also highlight the technical assumptions most likely to break under scale-up, regulatory scrutiny, or commercialization pressure—and how to proactively de-risk.