A biotech company was experiencing issues with its Phase I/II Project Optimus-optimized design and needed to transition from its CRO partner. The study was in solid tumors and planned to enroll 192 patients (30 in the escalation cohort) at 30 sites (six in the escalation cohort) across the U.S. and Europe. The project faced significant time pressure as milestones around the first site initiated (FSI) were linked to the sponsor’s funding, and mid-project challenges arose when U.S. FDA feedback on the IND application required a protocol amendment. Despite these obstacles, Worldwide demonstrated rapid execution by beating the sponsor’s FSI goal nine weeks after regulatory pack submission and just 12 weeks after the kick-off meeting.
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