The National Center Biobank Network and the member companies of the Japan Pharmaceutical Manufacturers Association (JPMA) started industry-academia-government collaboration on the construction and utilization of an integrated database of disease-specific information Toward Early Implementation of Precision Medicine, Prevention, and Preemptive Medicine

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January 25, 2021
Japan Pharmaceutical Manufacturers Association
National Center Biobank Network (NCBN)

The National Center Biobank Network (hereinafter referred to as "NCBN") and seven member companies of the Pharmaceutical Manufacturers Association of Japan (hereinafter referred to as "Pharmaceutical Manufacturers Association of Japan") have agreed to collaborate on the construction and utilization of a disease-specific information integrated database (hereinafter referred to as "disease-specific information integrated DB") in a joint industry-academia-government clinical research project sponsored by the National Institute of Medical Science of Japan (hereinafter referred to as "AMED"), The seven member companies applied for and were selected by the Japan Agency for Medical Research and Development (AMED) for the Joint Industry-Academia-Government Clinical Information Utilization and Drug Discovery Project (GAPFREE).
Through this project, a multilayered omics analysis*1 of genome, transcriptome, proteome, etc. will be conducted on samples associated with high-quality clinical information held by NCBN, and a disease-specific information integrated DB will be constructed jointly by industry, academia and government as a mechanism to match the analysis results with clinical information such as test values and image data.
By utilizing the constructed disease-specific information integrated DB, we will deepen our understanding of diseases and return it to clinical practice. We will also engage in joint industry-academia-government research to create innovative drugs through the search for disease biomarkers and drug targets, and to realize precision medicine and preventive/preemptive medicine.

Contents

In recent years, there has been a growing trend toward drug discovery based on the precise, systematic, and comprehensive analysis of disease states based on various omics data obtained from patient-derived samples linked to quality-assured clinical information. In Europe and the U.S., publicly managed databases (DBs) exist at the national level and are accessible to companies, but most DBs store only genomic data and basic clinical information. In Japan, the government-led Whole Genome Analysis and Other Action Plan is being studied, and drug discovery utilizing genome information is expected to be promoted. In addition, it is desired to construct an integrated disease-specific information DB in which multilayered omics data and clinical information are linked.
In order to construct such a DB, it is necessary, as a prerequisite, to obtain patient samples with high-quality diagnostic information and to conduct omics analysis according to the characteristics of each disease. Patient samples can be collected either by collecting samples over time from confirmed diagnosis cases or by selecting samples from a large number of typical cases. Both methods require highly accurate diagnostic performance, abundant clinical information, and highly quality-controlled samples, but only a limited number of institutions in Japan meet these requirements. The NCBN, which consists of the biobank function of the National Center for Biomedical Research and Innovation (NCCI) under the jurisdiction of the Ministry of Health, Labour and Welfare (MHLW), which is the center of clinical practice, meets these conditions, and the use of NCBN biobank samples is a major advantage in this research, which aims to construct an integrated DB of disease-specific information. On the other hand, the evolution and sophistication of omics analysis technologies has been remarkable in recent years, and we will realize the construction of an integrated DB for disease-specific information by conducting more effective analysis by combining the wisdom of participating academia and pharmaceutical companies, in addition to actively utilizing state-of-the-art technologies.
The goal of this joint industry-academia-government research is to use the disease-specific information integrated DB to bring the knowledge gained back to clinical practice to improve diagnostic accuracy and realize effective treatment in academia, and to create innovative new drugs in the pharmaceutical industry.

This project was initiated by the "realization of preventive and preemptive medicine," one of the measures to be promoted by the pharmaceutical industry in the Pharmaceutical Manufacturers Association of Japan (PMAJ) Policy Proposal 2019*2, and the seven PMAJ member companies and NCBN shared the goal to be achieved and have been working on specific studies to solve the issues.

An outline of the efforts is as follows (see figure). The ultimate goal of the joint research is to realize preventive and preemptive medicine, but to achieve this goal, it is necessary to solve many issues step by step. The "many-to-many" collaboration involving multiple academia and companies in this project is the first step (Step-1). Through the construction of an integrated disease-specific information DB and a deep understanding of diseases, academia will propose new disease classifications and early diagnosis methods, and industry will identify target molecules and biomarkers for stratified patient populations. and biomarker identification for stratified patient groups from industry.
Specifically, the project will acquire multilayered omics data from NCBN's high-quality biobank samples and prospectively obtained samples through sophisticated medical care using advanced measurement methods, and construct an integrated disease-specific information DB by linking omics data and medical information in a non-competitive manner. Each institution will then proceed to realize their respective outputs on a competitive basis by conducting their own cutting-edge analyses focusing on diseases of interest and interesting molecules.
In addition, through non-competitive data analysis in this joint research, we will also train experts in data science, biostatistics, clinical pharmacology, and regulatory science, which are indispensable knowledge for the realization of preventive and preemptive medicine.
In developing Step-1, Step-2, and Step-3, we will combine the basic and clinical research bases of academia with the applied and practical research capabilities of pharmaceutical companies, as well as the most advanced sample analysis methods, big data analysis, AI, and other methods from different fields, to continuously create innovative pharmaceutical products, as well as to develop Precision Medicine. The AMED aims to achieve the realization of future medicine, such as precision medicine and preventive/preemptive medicine, as well as the continuous creation of innovative drugs.

Figure: Positioning of the Integrated Disease Information Database in the Preventive and Preemptive Medicine Solution Concept

Outline of Research Support and Implementation System

Project name

AMED "Drug Discovery Platform Promotion Research Project" Industry-Academia-Government Joint Project for Drug Discovery Utilizing Clinical Information (GAPFREE)

Title of Research and Development

Research on drug development through industry-academia-government collaboration using an integrated database of disease-specific information based on the National Center Biobank Network".

Research and Development Representative

Yuichi Goto, Biobank Advisor, National Center for Global Health and Medicine

Participating Institutions

National Center Biobank Network (NCBN) and
National Center for Global Health and Medicine, National Center of Neurology and Psychiatry, National Institute of Longevity Sciences, National Cardiovascular Center

Pharmaceutical Cooperative Member Companies (7 companies)
Asahi Kasei Pharma Corporation, Astellas Pharma Inc., Eisai Inc., Ono Pharmaceutical Co.

Planned R&D period

December 2020 - March 2025

Explanation of Terms

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