For biotech companies developing an immuno-oncology (IO) therapy, the complexity of oncology clinical trials takes on new dimensions.
Advances in translational science, new therapeutic platforms, unique mechanisms of action, and novel trial designs are just a few of the influences shaping the dynamic IO clinical trial space.
IO-focused biotechs can still employ traditional oncology clinical trial parameters and processes, but considerations distinct to IO studies present unique scientific and operational challenges for even the most seasoned biotech executives. This white paper reviews the current IO landscape and offers guidance for biotech companies preparing for IO studies. The following topics will be addressed:
- Protocol development and regulatory approvals
- Selecting sites, educating staff, and managing data
- Enrolling the right patients
- Planning for logistics and product production
- Measuring response