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Designing Confident IO Therapies: A Collection of QSP Projects eBook

Immuno-oncology drug development promises durable responses — but response heterogeneity, complex mechanisms of action, immune-mediated toxicity, and the difficulty of designing combinations make development decisions hard to get right with data alone.

QSP models for immuno-oncology drug development connect mechanism, dose, schedule, biomarker behavior, and clinical outcome in a single framework — making them well suited to questions that are otherwise hard to answer empirically. This eBook walks through 14 real-world quantitative systems pharmacology case studies spanning monoclonal antibodies, bispecific antibodies, T cell engagers, engineered cytokines, oncolytic viruses, CAR-T therapies, and mRNA-based vaccines. Each case shows how immuno-oncology modeling supported a specific development decision — from first-in-human dose selection to combination strategy to biomarker interpretation.

Download this eBook to learn how QSP modeling for immuno-oncology supported:

  • A ~10x higher first-in-human starting dose for a T cell engager compared to traditional MABEL approaches
  • A 50-100x higher starting dose for a tri-specific T cell engager — later validated in the clinic and licensed by AbbVie
  • Immuno-oncology dose optimization for a PD-L1x4-1BB bispecific balancing two competing mechanisms
  • RP2D selection under cytokine release syndrome (CRS) constraints, with positive regulatory feedback

Get the eBook to see how these quantitative systems pharmacology case studies turn immuno-oncology’s biological complexity into clearer clinical strategy.

About the author

Senior Director, QSP

Diana Marcantonio has 20+ years of experience, including 15+ years in pharmaceutical and biotech industries, with a background in biological engineering. In her current role, she is responsible for guiding strategy and providing biological and disease area expertise on modeling projects to help clients make informed decisions during drug R&D. Prior to joining Certara, she worked in drug discovery research, where she led cross-disciplinary project teams from target identification through lead selection.

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