Vision of Japan Health Science Foundation
 
IV. Principal Objectives and Tactics
 
1. Reinforcement and Expansion of HSRRB
The HSRRB, the new facility of which was opened in October 2000 in Sennan-shi, Osaka, is a public research resources bank. It was founded with the perspective the establishment of an organization that provides genes and cells of higher animals including human, human tissue and animal embryo should be the most urgent and important issue for the nation. Since then genes and cells has been supplied to researchers widely. For the future, the bank is requested to enrich and enforce its function for human tissues and animal embryos, which is expected to contribute greatly for Japan's life science and drug innovation studies. The supporting members regard the human tissue bank as the most important function of the HSRRB, expecting the Bank to enrich it and the Foundation to meet the needs. The Foundation is going to establish the service system to supply human tissues, placing a priority on the concern for the ethical aspect. It also aims to establish a local infrastructure that could supply any research resources assumed necessary in the future researches so as to totally contribute evolutions in the fields of drug innovation and health cares.
In order to enforce the function of research resources bank, it is vital to foster the researchers who are honored internationally. Forming the opportunities for communication such as collaborative research with banks of high leveled, advanced foreign countries is also needed. And the construction of database for information on the compounds will be discussed, because the information is one of the research resources. Based on the above views, plans for respective bank operation are set as follows:

1) Human Tissue Bank
Effort will be made to increase the number of medical organizations that could provide specimen to expand HSRRB. Reviews will be made about the roles and tasks of the Foundation regarding challenging issues of the research use of tissues driven from autopsy corpuses and of organs/tissues incongruent for implantation. Another effort will be made to establish a system for supplying and accepting the specimen smoothly. Further, a possibility of the bank as a cell and tissue bank for regenerative medicine will also be discussed.
2) Animal Embryo Bank
The collection and maintenance of useful living resources including disease model animals such as transgenic, knock-out and -in, or spontaneous animals is promoted. At the same time, the preservation and supply system of embryos are reinforced in order to facilitate the use of them in research and development. The handling of rat embryos largely requested by researchers will also be discussed.
3) Cell Bank and Gene Bank
The collection, storage, quality control and stable supply system for the standardized research resources will be enforced to meet with the advanced research development and medical needs such ad genomic drug discovery, genomic medicine, regenerative medicine, etc. The enforcement of supply system will be achieved based on the interaction with researchers of industry/academia/government, consortium, and respective academic societies, the exchange of resources and the networking with representative banks of advanced foreign countries, and the international information exchange through mutual studying abroad.
4) Database Services
By providing information on HSRRB and other domestic and overseas research resources, trends of number of patients and other reference data, the Bank aims to contribute to basic medical and pharmaceutical researches and innovative drug innovation. The Bank will prepare an infrastructure for providing the latest information and will offer a platform for well balanced information exchange.
2. Future Development of Public/Private Collaborative Research Operations
In view of the changes in circumstances surrounding the Foundation, it would be necessary for the public and private joint operations to incorporate not only with advanced basic researches but with advanced application researches. The followings indicate the ways that the new joint operations among industry, academia and government initiated by the Foundation should be.

1) Research Fields
Currently, there are seven research fields. These covers varied fields that enable any firm from any industrial area composing the Foundation to apply the collaborative researches. In the future, it will be essentially necessary to set up novel research areas to meet requests from supporting members.
The Foundation has been promoting such joint operations claiming its vital role in the advanced basic research field. This policy had met with the needs of supporting members at the era of birth of new technologies such as biotechnology and genome. However, at the present day of practical use of these technologies, the members' concerns are shifted to the practical application studies such as SNPs analysis and translational researches. The Foundation's future joint operation, therefore, should expand its target to the advanced application researches concerning drug innovation and medicine by applying the biotechnology and genomic technologies where the Foundation has played a leading role. By expanding the field of application studies, the Foundation is expected to restore its activities to the public community in a clearer and more concrete form.
The regulatory science is a new, basic and leading research field that evaluate pharmaceuticals appropriately at each stage of its development and manufacturing. The research of this field has to be proceeded by many firms and government with a common perception on this issue and thus, the role that the Foundation should play is deemed important. In this field, an ethics issue without experiment will be studied as one of subjects.
One of the key targets of the research development promotion policies by the Ministry of Health, Labor and Welfare is the field of drug discovery and clinical study aiming at the new drug innovation. It is extremely important to vitalize the clinical research of pharmaceuticals and to promote local clinical trials for the Japanese to enjoy the progress of modern medicine. The examples of such researches are the SNPs analysis of the Japanese in regards to pharmacokinetics, efficacy and safety, the translational research of advanced medicine such as regeneration medicine, the pathologic index for the life-style related diseases and the preparation of evaluation standards for drug efficacy.
Based on the above, the following new fields in addition to the current researches is proposed to adopt for future joint research operations.
 
(1) Advanced application research field
(2) Regulatory science research field
(3) Field of drug discovery and clinical study
 
2) Research Organization
The structure of the public and private joint research organization consists of the governmental research institutes and private firms (mainly supporting member companies), suggesting the origin of this system. Currently, however, the academics (universities) is taking part in it at the request of private sectors that inquired to carry out much more advanced and basic researches through participation of them. Further, there are requests for the joint research between private and academic sectors. When viewing such requirement and considering the future ways the joint research operations led by the Foundation, it would be necessary to establish a platform that enables joint researches based on an equal footing of three parties. Within this framework, the Foundation intends to promote the collaboration and cooperation of industry, academia and government, and to play a major role in order to obtain really useful results for the health of people.
3) Research Funds
There is no particular problem on the amount of current funds. However, a review for the amount would become necessary, if the frame of joint research be altered to such form as the consortium type.
Meanwhile, the major problem is that the research funds are usually remitted at the latter half of December. The funds are finally delivered to researchers when the two-thirds of a year has passed which then should be used up until the end of March, next year. Researchers are strongly dissatisfied with the current remittance timing. It is expected that the Ministry of Health, Labor and Welfare improves the timing and method of remittance to enable researchers to use the funds more efficiently.
Another issue is that the funds are remitted in the name of respective researcher. This is convenient in tracing the flow of the funds, however, several problems are caused such as that the Tax Office regards the funds as a personal income. The Foundation intends to request the Ministry of Health, Labor and Welfare to remit the funds directly to corporation or research institute.
3. Challenge to the New Operations
The new and the Foundation' original operations are proposed to not only strengthen the constitution of the Foundation but to make it more attractive.

1) Expansion of Liaison Function
(1) Bio-Interface
To execute the liaison activity, especially that of public and private sectors, is the most suitable activities for the Foundation and the area of expectation from supporting members. However, the liaison between industry and government alone cannot be said as sufficient. In the Autumn of 200, the "Foundation Functions Strengthen Project WG" was set up in the General Operations Committee in order to discuss the liaison activity of JHSF. According to a survey against supporting members conducted by the WG, many required a liaison function between ventures and/or TLOs of universities. Following such needs, the " Bio-Interface " (the intellectual interaction for the drug discovery) aiming at professional communications among supporting members, bio ventures and university TLOs are held periodically. The Foundation will strive for developing this Bio-Interface while enforcing its liaison function.
(2) TLO Function of National Institutes governed by MHLW
Recently many TLOs were founded centering around universities but their functions do not work effectively yet. The problem for them would be that, two key abilities that TLO should essentially possess in pursue its mission are not reached to the business level:. The ability to excavate patentable excellent inventions and to take out patents, and the one to carry out the marketing for the licensing to the private sector are less mature.
As for National Institutes, the infrastructure of their TLOs is not so well reinforced that their intellectual assets can be utilized effectively. It would be the most appropriate activity for the Foundation as a nonprofit foundation, if it could support them in the excavation of the excellent inventions out of their research results, the filing of the patents in patentable or useful form, and the promotion of the licensing and transferring of to supporting member companies. For realizing this, there would be many issues to be reviewed carefully and be solved such as securing staff, mid and long term profitability, support from the government and understandings of supporting member companies.
2) Introduction of Consortium-type Research Operations initiated by JHSF
Organizing the research consortium initiated by the Foundation and operated by the government and enterprises would be one of the future activities of the Foundation as well as proceeding with the existing public and private joint researches.
In the midst of growing stage of novel drug discovery technology represented by post-genome, supporting members concern most in how to approach such new technologies and thus, the needs for research consortium on novel technologies would increase. The Foundation, therefore, will demonstrating its leading role as a tractive force in developing the Foundation's original plan incorporating supportive members' needs and in organizing the consortium.
3) Establishment of Entrusted Ethics and Examination Committee
In using the human tissue bank of HSRRB, it is defined to be indispensable for the research development plan requesting the transfer to be judged from scientific and ethical points and the Ethics and Examination Committee of the Foundation is executing this severely. The Committee consisting of the specialists of respective fields and maintaining a high level of scientific and ethical examination could be the standard of this kind in Japan. By disclosing the contents of discussion of this Committee, many other facilities could refer to the Committee's examination as a guideline for their own examinations which then would contribute greatly for maintaining the quality of ethical examination in Japan.
Meanwhile, as the history of ethical examination is relatively short in Japan with a limited numbers of specialist, there are many requirements for entrusting the ethical examination to the third party. In view of this situation an establishment of the Entrusted Ethics and Examination Committee within the Foundation that takes charge of ethical examinations is recommended.
4) Measures for Computerization of Application/Notification Procedures
Through "e-Japan Priority Plan" (decided in March 29, 2001at the meeting of IT Strategic Headquarter Conference of the Third Advanced Information and Telecommunications Society Promotion Headquarter established in the Cabinet), the Japanese government instructed to all ministries would engage in the development of a common system infrastructure to electrically handle application/notifications within 2002, where the applications of multiple procedures and the delivery of information or results will be administered electrically.
In response to such government's decision, the Foundation will prepare an electric filing system (e.g., application and notification of results, distribution of application forms, guidance for how to write the application, etc.) for the applications of Health Science General Research Operations such as drug innovation submitted by participating researchers to the Foundation. This system will make the application procedures flow more smoothly and the operating effectiveness of participating researchers improve much. Further, the introduction of on-line electronic settlement that enables management of the HSRRB and the public and private joint operations will be discussed for the benefit of supportive members.
The computerization of these procedures is the top priority issue for the government, the Foundation's effort in promoting it would meet not only with its policy as a non-profitable body but in supporting the administration.
5) Publishing Operation as a Profit Making Business
The publishing operation will be reviewed from the point of profitability. The Foundation has been gathering the latest scientific information inquired strongly from supportive members, conducting domestic and overseas surveys, preparing reports on these activities and distributing it to supportive members at no or a small cost. The quality of the reports could be favorably compared with other research firms' reports sold at a large sum. The Foundation is, therefore, planning to carry the publishing operating as a profit making business by preparing publications that could be sold commercially such as above mentioned survey reports.