Less than 2 months for an oncology drug and device development company
A drug and device biotech hired Catalyst Oncology to support its upcoming trial for a new therapy for patients with glioblastoma (GBM), a highly aggressive form of brain cancer. GBM is a devastating cancer indication with a five-year survival rate of only ~5%, underscoring a large unmet medical need for new treatment options. The Sponsor had motivated sites ready to go and needed Catalyst to initiate the study rapidly to help bring this therapy to patients in need.
The challenge
Recognizing that sites are largely closed during December holidays and the client’s rapid startup goal of first patient in (FPI) requested for the new year’s first quarter, work was initiated to lay the foundations for a fast start. Catalyst Oncology needed to start sites, begin clinical database build, and secure a central imaging solution. As site initiation drew closer, a patient was ready to be dosed. Catalyst Oncology needed to expedite contracting for regulatory and legal coverage to be in place for this initial patient’s treatment in early January.
The solution
Using a passionate and dedicated team, Catalyst Oncology designed a responsive plan that helped to get the first patient dosed as quickly as possible. As there was an absolute deadline beyond which this patient would become ineligible, Catalyst Oncology:
The Catalyst Oncology team members involved are highly experienced in oncology research and were empowered and enabled to make decisions.
The outcome
Catalyst Oncology successfully delivered on the Sponsor’s FPI milestone in less than two months, and most importantly, the initial GBM patient received access to a novel, potentially beneficial treatment. Catalyst Oncology continues to support the company’s drug and device development program and has added additional patients to the active trial.
