A novel in vitro approach for embryo-fetal risk assessment using human iPS cells

Abstract

In drug development, embryo-fetal risk assessment is critical to ensure safety in patients. Recently, the modality of drugs has been diversified to antibody, nucleic acids, and gene therapy; while species differences in epitopes or nucleic acid sequences limit the appropriate safety evaluations in animals. In this presentation, a convenient approach to evaluate human-specific embryo-fetal risks in vitro using human iPS cells will be introduced. Also, current in vitro systems for evaluation of embryo-fetal risk will be summarized and the usefulness of human-specific systems will be discussed.