Mitigating study start-up risks in a biotech's early phase immuno-oncology study

Confronting an unexpected challenge A biotech sponsor was developing a treatment targeting people with advanced solid tumors who are beyond the standard of care. They selected Fortrea to run their Phase I/Ib open-label study of its genetically modified organism (GMO). The sponsor had selected a manufacturing vendor for its investigational medicinal product (IMP), but its regulatory submission was rejected due to insufficient testing, setting the study timeline back by five and a half months.