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Balancing Innovation and Practicality in Immuno-Oncology Dose Selection

Panelists discuss how Project Optimus is reshaping dose selection, FDA expectations, trial designs, and cost. 

December 15, 2025
Balancing Innovation and Practicality in Immuno-Oncology Dose Selection
About this podcast: 

Recorded at the 2025 IO360º Summit, this podcast addresses how Project Optimus is reshaping dose selection from maximum tolerated dose to a balance of efficacy and safety. More specifically, this panel addresses FDA objectives for multi-dose selection, alternative dose-selection strategies with imaging, biomarkers and tumor burden analysis, the higher costs and longer timelines, and financial impacts for early-phase oncology companies. 

Moderated by In this discussion

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