Abstract
In recent years, many biologics have been developed and the modalities of new drugs have diversified. In order to respond to this diversification, there is also a need to develop regulatory science and technology related to the safety and quality of new modalities. In response, pharmaceutical companies have converted their management policies to a system of open innovation, in which the initial stages of drug discovery and development are conducted by academia and bio-ventures. In Japan, this trend is the same, and the development of various types of basic research is necessary in all research fields to raise the level of drug discovery science and regulatory science in various ways. For researchers in academia, it is necessary for Japan, as a scientific nation, to acquire knowledge of drug discovery science and regulatory science, and to promote research with an awareness of these fields. The TRS Academia Consortium supports education and research in drug discovery science and regulatory science research by academia researchers across disciplines.