(Global Technology Comparison on specific topics)
Benchmarking Report on Bioartificial organ-related research & development/CRDS-FY2010-GR-03
Executive Summary

The Prime Minister of Japan and his cabinet published “The New Growth Strategy” in June 2010. Following the strategy, the Council for Science and Technology Policy reported “The Science and Technology Basic plan” in December. Both of the documents described “life-innovation” as one of the most important issues, and set the goal of the realization of safety and efficacy of medical care as well as the improvement of quality of life (QOL) of the elderly, disabilities, and patients. To achieve the goal, the research and development of regenerative medicine and other alternatives is emphasized.
Along with the above, the Center for Research and Development Strategy (CRDS) at the Japan Science and Technology Agency (JST), JST-CRDS, issued the strategic initiative entitled “Research and Development of Human Cellular and Tissue Engineering for Clinical Development” in September 2010. CRDS also conducted international comparative survey by comparing the current Japanese strategy with that of other areas/countries having similar policy plans. In this survey, JST-CRDS focused on 1) current status of stem cell- and regenerative medicine-related research across basic, translational, and clinical stages and their future perspective, 2) support system of translational research, and 3) strategic plan to progress bio-artificial organs using biomaterials, and took following results.

<United States of America and Canada>
In the United States, the National Institutes of Health (NIH) supports the research and development of element technology in stem cell- and regenerative medicine-related research field while the Armed Forces Institute of Regenerative Medicine (AFIRM) supports more practical development of regenerative medicine and bioartificial prosthetics, and each state government invests his own competitive fields. With these supports, the US researchers are leading the research and development of regenerative medicine in the world. Executive branches of science policy like NIH and AFIRM encourage the regulatory agency, such as the FDA, to share the information with the researchers in the very early step of the clinical development, which has brought positive results for promoting clinical trials of human stem cell therapies. Other than these initiatives, we will follow a new institute establishing to progress the translational research in the NIH.
Canadian researchers are ranked as the top-10 countries in the related element fields, with supports from the federal and state governmental similar to those of the US. They are expected to progress the translational research with expansion of early phases of clinical trials inside of the country.

Although individual countries have their own visions of the ethical and regulatory issues, their direction to promote the stem cell research and regenerative medicines are quite accordant in total. The United Kingdom, France, Germany, Spain, and Italy developed the element research fields and progressed the clinical translations, but they are still behind in the number of the applications for international patents compared with the US and Japan. Recent trends of the funding by the 7th Framework Programme( FP7) demonstrated that Hungary, Netherlands, and Belgium are gaining powers.

<Asia-Pacific, South America>
Our current survey revealed that many emerging countries including China, South Korea, Singapore, India, Thailand, Australia, and Brazil, invest their governmental fund to stem cell research and regenerative medicine markets. Especially, China is becoming more powerful in these couple of years as demonstrated by our quantitative survey regarding the numbers of peer-reviewed journal papers, clinical trials, and international patents applications. The numbers are ranked the second place next to the US. South Korea is also ranked as top-10 countries. The eastern Asian countries including these two nations are expected to become more powerful in terms of the number of international patents in the future.

Our quantitative analyses of the academic journals in the latest five years showed that Japan has been ranked within top-5 in the world, and the number of the application of international patents regarding somatic stem cells and biomaterials are ranked the second place next to US. This result means that Japanese research and development in the related fields have showed high-level international competitiveness. However, relatively lower increase rate of the number of peer-reviewed journal papers is shown compared to that of other countries. Further more, the pathway from basic research to clinical translation in Japan can be much more competitive.

Taken together with these results, JST-CRDS would provide following strategies for the implementation of the research and development to progress the human cellular and tissue engineering for clinical development including stem cell and biomaterial research.
 Establish an efficient translation system from element, basic research to clinical achievement in regenerative medicine using cellular and tissue engineering, which includes concrete evaluation axis, scheduled review management, and information sharing with regulatory agency.
 Introduction of objective and comparable evaluation measures for the research and development. AFIRM developed its measurement system, AFIRM-modified Technology Readiness Level in the Technology Readiness Assessment, originally established by NASA, and used as a tool for measuring achievement of a given project.
 To integrate potential element technology and basic research results toward clinical development, it would be needed to support interdisciplinary communication in the related research field including basic, translational, and clinical stages. Research coordinator staffing and liaison conference funding would be important to achieve this strategy.

This bench-marking report may bring more effective and implementable pathway to realize the strategic plan demonstrated in the previous proposal of “Research and Development of Human Cellular and Tissue Engineering for Clinical Development” by the JST-CRDS.