Skip to main content
Home / Resources / Conferences / World Bispecific Summit

World Bispecific Summit

World Bispecific Summit

Dose optimization strategies for bispecific T-cell engagers in oncology  

John Burke, PhD

|

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.