Gene Therapy Immunogenicity 2022
We are excited to be presenting at this conference!
Biosimulation Model-informed Gene Therapy Development: Predicting Human Dose and Immunogenicity
Piet van der Graaf, PharmD, PhD|
Senior Vice President, Quantitative Systems Pharmacology
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