Background of establishment
Background of establishment
High-quality human biological materials and related information (clinical bio-resources) help to improve the efficiency of clinical research and medical development in academia, increase the probability of success, and provide society with innovative medical care at an early stage. We believe that improvement of the clinical bio-resource and utilization system can help facilitate medical treatment (Precision Medicine (precision medical treatment)) for individual patients, which is expected to become more prevalent in the future.
The development of medical products, devices, analytical technologies, and services can be achieved through: ① search of drug targets ② search of seeds ③ search of compounds ④ evaluation in cells ⑤ animal studies, evaluation stages in cells and animals, leading to Phase I to Phase III clinical trials involving evaluation in humans. The "valley of death" , which lies between the evaluation stage in laboratory animals and that in humans, results in a low success rate of 1/20,000 – 1/25,000, even with promising seeds. Even if they proceed to clinical trial, only 8% will become new drugs. In addition, it takes 9-17 years for a newly developed drug to gain approval and enter the market, and the development cost is also high (100 - 150 billion yen or more; 280 billion yen according to the estimates of Tufts University). Therefore, researchers cannot access high-quality clinical bio-resources with high-precision clinical information linked to early development, and the evaluation of biological samples derived from humans in a non-clinical stage is difficult in Japan.
In order to overcome this challenge, the following conditions are required for clinical bio-resources to increase the probability of success in research and development of new drugs, diagnostics, and medical devices, which will bridge the 'valley of death':
- Access to early R&D.
- Accurate clinical and screening information must be obtained and accumulated over time.
- Quality assurance and control of collection, processing, and storage.
- Possible provision of a stable supply that meets the needs.
However, there are many unresolved issues regarding the current situation of domestic and international biobanks, which are facilities for collecting and storing clinical bio-resources. There are few resources in which the quality of samples and added information are managed under adequate systems, the supply/delivery systems are fragile, and there are many problems regarding the sustainability of operations. Japan does not have sufficient biobanks with resources meeting the conditions mentioned above.
Under these circumstances, the society needs to develop infrastructure and systems for the use of clinical bio-resources that satisfy the above conditions and can be applied to clinical research, medical products, equipment, analytical technologies, and service development.