JAPAN HEALTH SCIENCES FOUNDATION

Activities

The Japan Health Sciences Foundation controls the following seven projects.

Research Fund Project on Publicly Essential Drugs and Medical Devices

The three projects,the "Health Sciences Basic Project and the Integrated Study Project in Drug Innovation Science" conducted by JHSF,the "Orphan Drug Development Research Project conducted by the Ministry of Health, Labour and Welfare (MHLW) and the Project to Promote the Development of Anti-AIDS Pharmaceutical Products" conducted by JHSF, were all integrated in FY1999 into “Research on Health Sciences focusing on Drug Innovation”. In FY2006, the Research Fund Project on Publicly Essential Drugs and Medical Devices was started.

This project entered its third phase in fiscal year 2004, in which innovative research topics have been introduced.

List of Projects ; [ fiscal year 2004 ]

Research on Publicly Essential Drugs and Medical Devices

(1)

Key Research
R&D of advanced and basic technology in the field of the health sciences including drug innovation is conducted under a program of joint research involving both the public and private sectors. This is based on subsidies provided by the Ministry of Health, Labour and Welfare, and the trust budgets provided by private companies to the national research institutions. The four research areas listed below have been set.

·	Development of orphan drugs
·	Regulatory science for drug development
·	Development of prevention, diagnosis and treatment for publicly important diseases
·	Use of human tissues for drug development

(2)

Research for Encouragement of Young Researchers
The target of subsidization for this research includes advanced or basic research into the above four research areas, conducted individually by researchers aged 37 or less from the domains of industry, academia and government.

Research on the Development of Anti-AIDS Drugs

(1)

Key Research
Based on the subsidies from the Ministry of Health, Labour and Welfare and trust budgets from the private companies to national research institutions, joint research involving both the public and private sectors is conducted in order to develop pharmaceutical products that are effective in the treatment of AIDS. The three research areas listed below have been set.

·	Development of anti-HIV drugs and treatments for HIV/AIDS complications
·	Development for post-exposure prophylaxis of AIDS
·	Basic technologies for the development of anti-AIDS drugs

(2)

Research for Encouragement of Young Researchers
The target of subsidization for this research includes advanced or basic research into the above three research areas, conducted individually by researchers aged 37 or less from the domains of industry, academia and government.

In order to facilitate the smooth progress of its research operations, JHSF is promoting nine projects using MHLW subsidies.
These include;
　　“Overseas Researcher Invitation Program,”
　　“Overseas Assignment Program for Japanese Researchers,”
　　 “Flexible Research Staff Utilization Program,”
　　 “New Technology Transfer Promotion Program,”
　　 “International Joint Research Program,”
　　 “Survey and Prediction Program,”
　　 “International Research Grant Program,”
　　 “Overseas Research Entrustment Program”
and “Research Results Dissemination Program.”

Health and Labour Science Research Promotion Project

JHSF provides the following support programs using Ministry of Health, Labour and Welfare (MHLW) subsidies in order to facilitate the smooth development of the four research areas covered under the MHLW Health and Labour Science Research Program(HLSPR). These include Research on Human Genome Tailor-made, Research on Regenerative Medicine for Clinical Application, Research on Emerging and Re-emerging Infectious Diseases and Research on Intractable Diseases.

1.	Overseas Researcher Invitation Program Research collaboration with overseas countries will be promoted by inviting overseas researchers who are conducting important research in the four designated areas of HLSRP.
2.	Overseas Assignment Program for Japanese Researchers JHSF will promote a training program for researchers by dispatching young Japanese researchers who are conducting research in the four designated areas of HLSRP to attend overseas universities and research institutions in order to support and encourage the development of their research.
3.	Overseas Research Entrustment Program Regarding research in the four designated areas of HLSRP that would be carried out more efficiently if conducted by overseas research institutions, JHSF will entrust development to the overseas institutions themselves. Similarly, JHSF will entrust the supply of research material that cannot be easily obtained in Japan to appropriate overseas institutions.
4.	Younger Researcher Fostering and Utilization Program JHSF will invite young Japanese researchers for research in the four designated areas of HLSRP in order to train our human resources as core researchers and also with the aim of improving both research performance and researcher capabilities.
5.	Research Support Staff Utilization Program Research on Human Genome Tailor-made and on Regenerative Medicine for Clinical Application (limited to fields related to human genome analysis) are promoted by allowing the participation of research supporters.
6.	Research Results Dissemination Program Regarding the results of the four designated research areas of HLSRP, JHSF will hold conferences for the publication of research results and publish easy-to-understand booklets in order to explain the contents of the research to the general public as well as to researchers.
7.	Promotion Program for the Preparation of Intellectual Infrastructures to Support Drug Innovation (Research on Human Genome Tailor-made) For the preparation of infrastructures to promote basic fundamental and developmental research leading to drug innovation, JHSF is preparing research resources of broad application and high quality, such as cells, genes, animal embryos and human tissues. It is also conducting surveys and research in these fields.

General Project

JHSF conducts the following activities through six subcommittees which are operated by supporting member companies to promote its research and development in the health sciences.

Operations related to Development Promotion

·	Survey, investigation and promotion on preparation of conditions contributing to the progress in R&D of pharmaceuticals and food products apply advanced technologies such as biotechnology.
·	Cooperation for the Research on Health Sciences focusing on Drug Innovation (Survey and Prediction Program).

Operations related to Regulations and Standards

·	Cooperation with the administrative authorities in the setting up of regulations and standards for pharmaceuticals and food products concerning the application of advanced technologies such as biotechnology, by examining the contents and applications of the regulations and standards, gathering opinions from the industrial sectors and making proposals concerning them.
·	Collecting of information on regulations and standards for pharmaceuticals and food products in connection with the application of advanced technologies such as biotechnology from inside as well as outside Japan, the provision of such information to the supporting member companies, and conducting investigations and research into regulations and standards that will be required in the future by exchanging opinions with the administrative authorities and inviting leading specialists from the academic circle to give hearings and lectures.
·	Collaboration with overseas counterpart organizations, the collection of information on regulations approving pharmaceutical products in overseas countries and the provision of such information to supporting member companies.

Operations related to Research Resources

·	Surveys and investigations into research resources for use in R&D in the field of health science, such as human-derived samples, test animals, tissues, cells, genes, animal embryos and chemical substances.
·	Cooperation for the activities of the Health Science Research Resources Bank (HSRRB).

Operations related to Technology Transfer and Training

·	Cooperation for the Research on Health Sciences focusing on Drug Innovation (New Technology Transfer Promotion Program).
·	Organizing and opening of public symposia for the Research on Health Sciences focusing on Drug Innovation (Research Results Dissemination Program) and the promotion of the transfer of new technologies to industry through the symposia.
·	Organizing and opening of public symposia on both basic and advanced science and technologies related to medical and pharmaceutical sciences.
·	Education of supporting members through training meetings related to the medical and pharmaceutical sciences.
·	Planning and holding of conference "Bio-Interface" etc., aimed at providing a liaison (intermediate) function in joint research between industry, academia and government.

Operations related to Information

·	Compilation and publication of JHSF's bulletin "Human Science".
·	Construction of databases on R&D and technical information, and the provision of access to such information.
·	Cooperation for the Research on Health Sciences focusing on Drug Innovation (Survey and Prediction Program).
·	Administration of the JHSF's web site, and liaison with the Web Site Administration Committee.

Operations related to Planning

·	Planning, investigation and proposals on long and mid-term issues and on trans-organizational issues.

TLO Project Approved by the Ministry of Health, Labour and Welfare

In May 2003, JHSF established the Health Science Technology Transfer Center (HSTTC) as a TLO approved by the Ministry of Health, Labour and Welfare (MHLW),based upon support from MHLW.
HSTTC oversees the following operations aimed at the effective utilization and return to society of the research results from the national research institutions under MHLW.

(1)	Regarding inventions by researchers at national research institutions under MHLW that are to be inherited by the national government, JHSF takes over from the national government the right of application of patents and enforce establishment of various rights and the maintenance and administration of the patents and other rights.
(2)	Marketing and licensing for private sectors including the registered members of HSTTC, based on applicable patent rights, etc.
(3)	JHSF collects the fees produced by licensing and permission of patents and other rights and returns a part of these to the national government.
(4)	JHSF holds education and training on patents for researchers in national research institutions.
(5)	JHSF performs other related operations required by the HSTTC, holds lectures and provides information on technology transfer.

National research institutions under MHLW that are the targets of this project

■ National Institute of Health Sciences (NIHS)

■ National Institute of Public Health (NIPH)

■ National Institute of Infectious Diseases (NIID)

■ National Rehabilitation Center for Persons with Disabilities

■ National Cancer Center (NCC)

■ National Cardiovascular Center (NCVC)

■ National Center of Neurology and Psychiatry (NCNP)

■ International Medical Center of Japan (IMCＪ)

■ National Center for Child Health and Development (NCCHD)

■ National Center for Geriatrics and Gerontology (NCGG)

■ National Institute of Health and Nutrition (NIHN)

■ National Hospital Organization(NHO)

■ National Institute of Occpational Safety and Health , Japan(JNIOSH)

■ National Institute of Biomedical Innovation (NIBIO)

Research Resources Supply Project

JHSF established the Health Science Research Resources Bank (HSRRB), under the full support of the Ministry of Health, Labour and Welfare (MHLW) in October 1995.
The function of the bank was to supply researchers in industry, academia and government with cells and genes collected, standardized and controlled by the JCRB (Japanese Collection of Research Bioresources) banks of the National Institute of Health Sciences (NIHS) and the National Institute of Infectious Diseases (NIID).
In order to further enhance the bank operations, with the support of the MHLW, JHSF opened a new facility at Rinku Minamihama, Sennan-shi, Osaka in October 2000, and transferred its operations there from Osaka City. In FY2001, the new facility launched its human tissue and animal embryo bank operations.
When the National Institute of Biomedical Innovation (NIBIO) opened in Saito, Ibaraki-shi, Osaka in April 2005, its cell bank, gene bank and animal embryo bank were linked closely to the JCRB banks of NIBIO.
At present, the facility runs the following five bank operations in order to supply research resources to researchers in industry, academia and government and particularly in the fields of the health sciences including medicine, pharmacology and basic biology.

1.	Cell Bank Storage, multiplication and quality control of normal and disease-related cells derived from human and other mammalian sources to supply researchers.
2.	Gene Bank Storage, multiplication and quality control of normal and disease-related genes derived from human and other mammalian sources to supply researchers.
3.	Tissue Bank Storage and quality control of human tissues or samples derived from them, provided through due process, to supply researchers.
4.	Animal Embryo Bank The storage of embryos derived from disease model mice and gene-recombined mice to supply researchers. Embryo deposit services are also provided.
5.	Database Service Implementation of a database of research resources, patient trends and other literature that would be useful in basic research in medical and pharmaceutical sciences and drug innovations for information provision to researchers.

Center for Accreditation of Laboratory Animal Care and Use

Hitherto, animal testing institutions in Japan have managed themselves independently according to management guidelines issued under amendments to the Japanese law for the prevention of cruelty to animals. Recently, however, there has been a call for the establishment of an external system to evaluate the independent management system.
Accordingly, the Center for the Accreditation of Laboratory Animal Care and Use was established as an external organization with the purpose of assessing and verifying compliance to the “Basic Guidelines for Proper Conduct of Animal Testing and Related Activities in the Research Institutions under the Jurisdiction of the MHLW,” (hereinafter referred to as the “Basic Guidelines”).
The objective of the center is to promote the optimum enforcement of scientific animal testing.

Assessments are conducted by the center in “document surveys,” based on documents in a form specified by the center and submitted by applicants, and in “field surveys,” based on visits to the organization that is conducting the animal testing.
The results of the surveys are examined by the Evaluation Subcommittee for compliance to the Basic Guidelines. When the results of the assessments are approved, a certificate is issued by the Administration Committee, which is the top decision-making body of the center.

Publishing Project

JHSF conducts the periodical collection and survey of the latest scientific information, compiles this into survey reports and distributes it to its members in accordance with their exacting requirements.
In order to further promote understanding of the information in the survey reports among the general public in the future, JHSF is planning to enhance its publishing operations by compiling publications that can be distributed through the available sales channels of the publication industry.