(Global Technology Comparison on specific topics)
Technology Development, Strategic Plan and Regulation for Standardization of iPS Cells/CRDS-FY2009-GR-03
Executive Summary

Since 2006, the Life Science Unit at JST-CRDS (Unit Leader, Makoto Asashima Principal Fellow) has held workshop “Overview of Life Science” biennially. In the discussion at the workshops our unit placed stem cell research as one of the most important areas in life science research, and provided several strategic proposals contributing to the progress of stem cell research and development in Japan (for detailed information in Japanese, Especially since the successful establishment of human induced pulripotent stem (iPS) cell in November 2007, the Life Science Unit has kept monitoring the stem cell research strategies in other countries. In 2009, the G-TeC (Global Technology Comparison) Unit carried out a large-scale international survey related to translational research and industrialization of iPS cell technology. This report was made in our joint project across the Life Science Unit, the G-TeC Unit and the deliberation team for regenerative/artificial multi-cellular system research and development at JST-CRDS, to develop a strategic plan for standardization and quality control of iPS cells by an international survey, data analysis and interviews of the technology, strategy, and rules around this area.

1. So far, no established standardization in rules and technologies for iPS cell has been made in the world wide for both research and clinical purpose. However, researchers and stem cell bank community have started to collaborate for making international consensus around iPS cell standardization. In most cases, such collaborations are similar to those of human embryonic stem (human ES) cells.
2. In United States and United Kingdom, stem cell banks have their technology development division for quality control (e.g. WiCell International Stem Cell Bank and Wicell Research Institute, UK Stem Cell Bank and National Institute for Biological Standard and Control). Such organizations have played leading roles for the standardization of human ES cells, and may also work well for the standardization of iPS cell.
3. UK Stem Cell Bank currently delivers their stem cell lines for free (excluding shipping cost), while the price list of the stem cell lines has been published. This may reflect their strategy that more research data using the stem cell lines distributed by UK Stem Cell Bank make the bank more powerful in terms of their presence in international discussion.
4. Since the European Union (EU) is a united association across the European countries with various ethical values and cultures, the European Medical Agency (EMA) strategically focuses not on ethical aspect, but on the technical aspect in regulating stem cell research. This makes no difference between human ES cells and other stem cells in their regulation. This may work well in making the standardization of stem cell technology more efficient 5. In Japan, we are still on the way to iPS cell standardization. Element technologies and regulations around them are developed, and then we need to develop the future management plan for stem cell banks Japan has, and to enhance the research community working for quality control technology.

Based on the above, JST-CRDS would provide following strategies for the standardization of iPS cells.
1. Standardization of the technologies (and regulations) related to iPS cells is an international issue, and Japan should actively lead the international discussion with the past experience and achievement in iPS cell research to build a consensus.
2. The current competitive advantage of Japan in iPS cell research will not last without strategic and continuous research and development. It is essential to monitor international trend in both policy and technologies in iPS cell research, especially in the standardization to steer and revise Japanese strategic plan.
3. Knowledge sharing in research through academic paper(s) or technical report(s) is important for the research community to facilitate the standardization of iPS cells. Japan should promote such activities. “Technology and Research Associations (in Japanese, Gijutsu Kenkyu Kumiai)” system may be useful expedient.
4. Japan should develop a strategy for banking and quality control of iPS cells, on the basis of current situations in the cell banks, the research activities, and the related budget. Wisconsin International Stem Cell Bank and UK stem cell bank, where banking, quality control, and technology development are in the same facility, may be a model for reference.