Team leader

Objectives of the team

To evaluate vaccine efficacy and associated adverse reactions in animal models

Description of research and development by the team

The team develops new techniques for establishing genetically modified animals and combines them with conventional techniques to develop animal infection models for vaccine-targeted pathogens and vaccine evaluation systems, which are useful for vaccine drug discovery research. The team also creates nonclinical study designs, including those for primate studies, and conducts and supports studies on nonclinical efficacy and adverse reaction evaluation in collaboration with the Central Institute for Experimental Animals, Tsukuba Primate Research Center of National Institutes of Biomedical Innovation, Health and Nutrition, and the Shiga University of Medical Science. Moreover, the team conducts GLP safety studies to facilitate a smooth transition to clinical trials.

Tasks of the team

1. 1To establish animal infection models for vaccine-targeted pathogens of infectious diseases at synergy centers according to the research needs of the respective teams for broadly supporting modalities in drug discovery research.
   • Introducing and improving the latest transgenic/genetic modification techniques, such as LNPs and viral vectors
   • Creating transgenic or knock-in small animals with human genes encoding receptors for pathogens using genome editing technology to develop genetically modified animals as model animals
   • Establishing animal infection models using genetically modified animals for use as vaccine evaluation systems
2. 2To conduct and support nonclinical efficacy and GLP safety studies
   • Evaluating the efficacy of and adverse reactions to vaccines in animal models
   • Reviewing items in safety studies and conducting such studies
   • Examining the extrapolability of human sample analysis results