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World Bispecific Summit

World Bispecific Summit

Dose optimization strategies for bispecific T-cell engagers in oncology

John Burke, PhD

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VP, QSP Consultancy

  • The FDA’s Project Optimus initiative aims to reform dose optimization and selection for oncology therapies to maximize the efficacy of a drug as well as the safety and tolerability.
  • Mechanistic modeling approaches, such as Quantitative Systems Pharmacology (QSP), support this effort by enabling the selection of a more targeted clinical starting and efficacious dose in oncology.
  • We will present case studies where we developed QSP models in collaboration with our partners to predict efficacious dose and determine First-in-Human starting dose.
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