Tohoku Medical Megabank Organization and Japan Pharmaceutical Manufacturers Association Launch Joint Research Toward Early Practical Application of Preventive and Preemptive Medical Solutions

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March 31, 2020
Tohoku Medical Megabank Organization, National University Tohoku Medical Megabank Organization
Japan Pharmaceutical Manufacturers Association
Japan Agency for Medical Research and Development

Key Points of the Announcement

Tohoku University Tohoku Medical Megabank Organization and Japan Pharmaceutical Manufacturers Association signed a collaboration agreement on March 17, 2020, following the signing of a collaboration agreement on January 31, 2020, and started joint research during fiscal 2019.
Through joint research such as investigating the relationship between lifestyle-related questionnaire data, MRI image data, and omics data, we will promote social implementation of next-generation medicine and further creation of innovative drugs and medical technologies through data and analysis based on drug discovery needs.

Tohoku University Tohoku Medical Megabank Organization (Director: Masayuki Yamamoto, "ToMMo") and Japan Pharmaceutical Manufacturers Association (Chairman: Joji Nakayama, "JPMA") have started joint research during fiscal year 2019 following the conclusion of a collaboration agreement on January 31, 2020.
In order to prevent and intervene in the early stages of disease, it is necessary to predict disease onset and early diagnosis before or at the early stages of disease onset. For this purpose, it is important to have a series of long-term data from the healthy state to disease onset and recovery, as well as data obtained by comparing healthy individuals and patients.
To this end, ToMMo has shared health and genomic information and biological samples of 150,000 people with the JPMA, and has been studying the details of research to achieve the "early commercialization of preventive and preemptive medical solutions "*1 recommended by the JPMA in its "Policy Recommendations 2019. We are pleased to announce that the following three joint research projects have been approved by the Ethics Committee, etc., and a joint research agreement has been signed.

Research to analyze the relationship between lifestyle, brain morphology, and cognitive and psychological functions
Preliminary research for biomarker search to stratify sleep disorders
Preliminary research on the frequency of causative pathological variants and morbidity of hereditary breast and ovarian cancer syndrome and Lynch syndrome in Japanese

ToMMo and JPMA will deepen mutual understanding and friendship, promote the development of science and technology through cooperation, and work to promote next-generation medicine (personalized prevention and personalized medicine) and further create innovative drugs and medical technologies while utilizing the results of big data, genome cohort studies *2 and other research. Through these efforts, we will extend healthy life expectancy and contribute to the realization of a society in which everyone can be healthy and active throughout their 100-year lives.

Outline of the research plan

The outline of the joint research plan is as follows. The research period is until March 2021.

Research Organization

ToMMo
JPMA and DAIICHI SANKYO K.K., Dainippon Sumitomo Pharma, TAKEDA PHARMACEUTICAL COMPANY LIMITED, TSUMURA & Co., LTD. and Janssen Pharma.

Details of Research

Analytical research on the relationship between lifestyle habits and brain morphology, cognitive function and psychological function
Among various lifestyle habits that affect individual health, we will search for risk factors, promoting factors, and protective factors against brain volume loss and cognitive decline by analyzing data focusing on sleep and activity habits and brain MRI images, cognitive and psychological functions, and physiological tests.
Preliminary studies to explore biomarkers for stratification of sleep disorders
Focusing on sleep, which has a high potential to influence an individual's health status, we will investigate the relationship between sleep quality and biochemical test values, MRI measurement information, and genomic and omics analysis*3 information, and search for biomarkers to objectively evaluate sleep status, ultimately leading to the development of risk prediction for diseases closely related to sleep status.
Preliminary study on the frequency and incidence of causative pathological variants of hereditary breast and ovarian cancer syndrome and Lynch syndrome*4 in Japanese patients.
Using genomic, lifestyle, and health information of the Tohoku Medical Megabank Project cohort study participants, we will clarify the frequency of causative genetic variants of both syndromes in Japanese, the incidence status of those with genetic variants, and the association between the incidence and lifestyle/health status, in order to develop appropriate preventive measures for those with genetic variants associated with the two syndromes, and to develop a risk assessment system for those with genetic variants associated with the two syndromes. This will enable appropriate prevention of disease onset and early detection and treatment of those with genetic changes related to the two syndromes.

Background of joint research

Since fiscal 2011, ToMMo has been conducting a health survey of 150,000 local residents, mainly in the areas affected by the Great East Japan Earthquake, with the understanding and cooperation of local residents, in conjunction with the rehabilitation of medical care and the reconstruction of medical institutions in the affected areas. We are also conducting the world's first three-generation cohort survey from birth. At the same time, a biobank of biological samples and health information has been established, and by analyzing genome, health, and medical information together, we aim to build a next-generation medical system for drug discovery research and personalized medicine.
Meanwhile, in January 2019, the JPMA formulated the "JPMA Policy Proposal 2019" and announced that it will work on cutting-edge research and development incorporating innovative technologies such as health and medical big data, AI, and genome medicine, in an ecosystem built by a wide range of stakeholders from industry, academia, and government. The meeting was attended by over 100 participants from the industry, academia, and government. The objective is to create a favorable environment where innovation in the life science field can be realized to extend the healthy life expectancy of the people and to enable economic growth, which in turn will create the next innovation and further develop science.
Following the above process, the two parties planned to start full-scale preparations for a large-scale joint research project in FY2019, starting with a pilot study during FY2019, followed by a full-scale joint research project in FY2020 and beyond. On January 31, 2020, the two parties signed a collaboration agreement for the promotion of next-generation medicine, and decided to proceed with industry-academia collaborative projects promoted by ToMMo and JPMA regarding next-generation medicine (personalized prevention and personalized medicine).
Now that the pilot research plan has been initiated through various procedures including ethical review, the two parties will work more closely together to acquire and analyze additional data based on drug discovery needs through joint research such as investigating the relationship between lifestyle-related questionnaire data, MRI image data, and omics data, etc. The TMM project will promote the social implementation of next-generation medicine and the further creation of innovative drugs and medical technologies.

Reference

About the Tohoku Medical Megabank (TMM) Project

The TMM project aims at reconstruction from the Great East Japan Earthquake and realization of personalized prevention and medical care. Tohoku University Tohoku Medical Megabank Organization and Iwate Medical University Iwate Tohoku Medical Megabank Organization are the implementing institutions of the TMM project. The TMM Project has been conducted by the Japan Agency for Medical Research and Development (AMED), which has been serving as the research support organization for this project since fiscal year 2015.

Explanation of Terms

1

Policy Proposals 2019, Preventive and Preemptive Medical Solutions: JPMA's Policy Proposals 2019 is a policy proposal released by JPMA on January 24, 2019, with the subtitle "Toward the Pursuit of Innovation and the Resolution of Social Issues," and is aimed at realizing the "JPMA's Industrial Vision 2025," what the pharmaceutical industry The proposal outlines what is required of the pharmaceutical industry and what it should communicate to society in order to realize the "Pharmaceutical Manufacturers Association Industry Vision 2025". Preventive and preemptive medicine solutions are services and systems that solve, improve, and provide solutions to social issues for the realization of preventive and preemptive medicine, as proposed in the vision.
2

Genomic cohort study: A cohort study (a study in which a specific group of people are followed over a certain period of time to elucidate the relationship between environmental and genetic factors, such as lifestyle, and disease), especially one in which genomic information is obtained from the participants.
3

Omics analysis: A generic term for genome analysis (comprehensive analysis of genetic information), metabolome analysis (comprehensive analysis of metabolites), proteome analysis (comprehensive analysis of proteins), and transcriptome analysis (comprehensive analysis of mRNA).
4

Hereditary Breast and Ovarian Cancer Syndrome and Lynch Syndrome: Hereditary Breast and Ovarian Cancer Syndrome (HBOC) is a disease that causes breast and ovarian cancer due to pathological variants in the germline of BRCA1 and BRCA2 genes *5. Lynch syndrome is a disease such as colorectal cancer caused by pathological variants in the germline of multiple genes, including the MLH1 gene. In both cases, it has been shown that there is a strong association between genetic changes and the development of the disease.
5

Pathological variants: changes in genes that cause disease (variants: differences in genetic information due to base substitutions, deletions, or insertions).

For further information, please contact

Tohoku University Tohoku Medical Megabank Organization

Contact person: Fuji Nagami
Phone: 022-717-7908
E-mail: pr@megabank.tohoku.ac.jp
FAX: 022-717-7923

Public Relations Division, Japan Pharmaceutical Manufacturers Association

Phone: 03-3241-0374

For inquiries about AMED projects, please contact

Biobank Division, Department of Basic Research Projects, Japan Agency for Medical Research and Development

Phone: 03-6870-2228
E-mail: tohoku-mm@amed.go.jp

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