In the United States, more than 40% of new drug ingredients approved by the FDA (US Food and Drug Administration) come from universities and bio-ventures, but in Japan the percentage is as low as 20% or less.The Medical Economics Research Organization conducts a comparison between Japan and the United States of the environment surrounding research on clinical practical application (translational research) from basic research at universities.We investigated the situation through interviews with eight US institutions such as universities and research institutes, and seven Japanese institutions, and made recommendations on issues and countermeasures that Japan should solve.
As a result of the survey, the following three points are the main differences between Japan and the United States.
First of all, the idea that the role of universities in drug discovery is to create innovative seeds (ideas that will be the seeds of realization) from basic research, and that cooperation with companies is required in terms of funding is common to Japan and the United States.In addition, a technology transfer organization (TLO) that evaluates basic research from the perspective of practical application and supports intellectual property management and license agreements is required within the university, but compared to the United States, Japan has an organizational scale and the quality of human resources required. , Inferior in terms of treatment.Furthermore, in collaboration between universities and companies in both Japan and the United States, companies require universities to provide data that is difficult to obtain by the university alone, but Western companies have invested in and cooperated with universities from the early stages of research, and Japan. Companies tend to seek seeds that are directly linked to profits.
The contents of the recommendations for these are as follows.
First, in order to support research at universities where it is difficult to obtain the necessary data due to lack of funds, equipment, human resources, etc., we established a specialized research institute for the purpose of acquiring non-clinical study data, and the data obtained there is used by the university. Creating a mechanism to provide to.Secondly, regarding TLOs, rather than increasing the number of bachelor's degree holders and qualified personnel, we will acquire human resources with polite negotiation ability who can explain seeds while meeting the needs of companies and promote education.Thirdly, we are looking for a contract that is advantageous to both the university and the company, taking into consideration the cost-effectiveness of the company, which takes risks together with the university, and the financial constraints of Japanese companies.
The above three points were announced as countermeasures for creating innovation in drug discovery in Japan.
Note: The "Health Economics Research Organization" is a general incorporated foundation that aims to promote research on the domestic medical economy and medical / long-term care policies.
