Biosimulation Model-informed Gene Therapy Development: Predicting Human Dose and Immunogenicity

Time: 12:00 pm
day: Day 1 Tracks 2 AM


  • Regulatory-ready IG simulator developed in consortium with eight pharmaceutical companies, now licensed by FDA
  • Applied to gene therapy for predicting human dose from pre-clinical data, to translational phases, and through clinical development
  • Case studies highlighting application to various modalities: AAV, mRNA and gene editing