In the decade since their market entry, immuno-oncology (IO) therapies have transformed the care of patients with cancer globally. Biotech innovation has advanced translational science, therapeutic platforms, and new trial designs to fuel the IO pipeline. However, biotech sponsors embarking on IO clinical studies must be prepared to face unique scientific and operational challenges.

This white paper reviews IO innovation in cell and gene therapies, as well as five primary operational challenges, including diversity in patient enrollment, and how to plan for success.