Clinical Pharmacology – Biomolecular
2019 PharmSci 360
This is a symposia on model-informed dose selection and optimization of novel biotherapeutics. This session will include discussion of first in human and Phase 2/3 dose selection and optimization strategies for novel biotherapeutics. General clinical pharmacology perspectives from both industry and regulatory perspectives will be provided. Case study discussions of novel biotherapeutics to be discussed will include CAR-T and bispecifics.