The Second Industry-Academia-Government Regenerative Medicine Symposium

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Tokyo, Japan, October 17, 2017--Life Science Innovation Network Japan Inc. (LINK-J), an incorporated association founded by Mitsui Fudosan Co., Ltd. (Mitsui Fudosan) and a group of volunteers from academia, held the second Industry-Academia-Government Regenerative Medicine Symposium at Nihonbashi Mitsui Hall (Nihonbashi, Tokyo), on October 17, 2017. As at the first Industry-Academia-Government Regenerative Medicine Symposium, many relevant persons representing academic, industrial or governmental bodies attended. The symposium included lectures and panel discussions. As evident by the fact that the public seats created on that day almost filled before opening, the high level of interest in regenerative medicine and industry-academia-government cooperation is clear.

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(Left) Atmosphere of the venue; (Right) Ms. Masayo Takahashi, Board Member of the Japanese Society for Regenerative Medicine and Project Leader of, RIKEN

[Keynote Lecture]

The keynote lecture was given by Ms. Masayo Takahashi, Board Member of the Japanese Society for Regenerative Medicine and Project Leader of RIKEN, who is tackling regenerative medicine for ophthalmic conditions. She said that through her experience on two cases where regenerative treatment had been applied (retina regeneration for age-related macular degeneration), she decided that she should stop thinking about how to develop a new form of treatment within the existing regulations but start thinking about how regulations should be tailored to the desired forms of treatment, describing it as her new method. Ms. Takahashi highly evaluated the clinical studies under the "Act on the Safety of Regenerative Medicine" and the system of "Conditional and Time-limited Approval," saying that it allows doctors and companies to explore the best measures from the beginning. She asked people to understand the system, pointing out that the level of safety in clinical studies conducted in accordance with the law is ensured to be equivalent to that of investigational trials.

[Lecture 1] Industrial Perspectives

Subsequently, in Lecture 1, Mr. Eiji Kobayashi, Technical Consultant at BIOS, Inc., who has been working on regenerative medicine for kidney diseases, presented an overview of the ongoing "Kidney Regeneration Project." Mr. Kobayashi has been tackling kidney regenerative medicine using "an approach that integrates non-clinical and clinical studies," where animal experiments and clinical trials are assessed using same endpoints. Studies using pig metanephroi with bladders (developed from cloacas) have demonstrated that not only the kidneys but also the urine excretion pathway was regenerated and reconstructed. Mr. Kobayashi said that eventually a similar regenerative treatment would be available in human medicine based on the accumulating study results. In addition, as an extension of the same technique, he revealed that he had been working on kidney regenerative treatments in pets (cats) in collaboration with an agricultural department, emphasizing the importance of "academia-academia cooperation," where researchers in different fields collaborate.

Ms. Setsuko Hashimoto, President and CEO of CellSeed Inc., gave a lecture on the company's cell sheet engineering. CellSeed was established for the clinical application of cell sheets, and is currently working on the development of an epithelial cell sheet for esophageal regeneration (to prevent narrowing during the healing process for esophageal injuries) and a regenerated cartilage sheet (for the indication of knee osteoarthritis). The epithelial cell sheet for esophageal regeneration, a specialized device to attach the cell sheet to a lesion, is concurrently under development, aiming to be marketed as a combination product (a product combining different features such as drugs, devices and processed cells). During the lecture, Ms. Hashimoto displayed her enthusiasm by saying that she would like to expand unique Japanese technologies globally, introducing some examples of overseas expansion in Europe and Taiwan.

The next speaker, Ms. Naoko Iino, President and CEO of Cuorips Inc., gave a speech on the business of Cuorips, which was established in March 2017. Although it is a small company with four board members and several employees, Cuorips is one of the most attention-grabbing companies today, as it signed a contract for collaborative development with Daiichi Sankyo Inc. in October. The first challenge is the "commercialization of iPS-derived cardiomyocyte sheet," currently being developed by a team led by Mr. Yoshiki Sawa, Professor of the Department of Cardiovascular Surgery at Osaka University. As Mr. Sawa has already achieved respectable results in the development of a myoblast cell sheet, there are huge expectations from those around the company. According to Ms. Iino, the most common question since the establishment of the company is: "When will it be available?" In the lecture, Ms. Iino laid out the goal as "practical application within 5 years" and affirmed her continuous efforts.

The last speaker in Lecture 1, Masanobu Kimura, President of Takara Bio Inc., gave an overview of the "Gene-modified T-cell therapy" currently under development, and the vison for regenerative medicine. According to Mr. Kimura, the development of "chimeric antigen receptor T-cell (CAR-T) therapy," which the company is developing, has also been progressing overseas with an indication for refractory leukemia, one version of which obtained marketing approval in the United States in August for the treatment of refractory leukemia in children. Mr. Kimura pointed out that although the drug price is extremely high (475,000 dollars), the pharmaceutical company suggested "performance-based billing" (payment for the drug only occurs when efficacy is confirmed), presenting his vision concerning the price of regenerative medical products, as a similar discussion will also be required in Japan.

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(Left) Chairperson for Lecture 1, Mr. Hideyuki Okano, Chairman of the Board of LINK-J and Board Member of the Japanese Society for Regenerative Medicine, and Mr. Nobuyuki Osakabe, Vice Chairman of the Forum for Innovative Regenerative Medicine; (Right) Mr. Eiji Kobayashi, Technical Consultant at BIOS, Inc.

[Lecture 2] Academic Perspectives

In Lecture 2, representatives from academia gave lectures on research issues and prospects. Mr. Akihiro Umezawa, Board Member of the Japanese Society for Regenerative Medicine and Director of the National Center for Child Health and Development, introduced his research topic, "Current situation and future prospects for clinical applications of embryonic stem cells (ES cells)." According to Mr. Umezawa, overseas research on regenerative medicine is more advanced than in Japan, and a number of areas, including ophthalmologic conditions, diabetes, and heart failure are being studied. Meanwhile, although Japan had a late start, the ban on the clinical application of human ES cells was lifted in 2014, which led to the more than 70 studies currently being planned. Mr. Umezawa himself is also designing a regenerative study on urea cycle disorders. At the end of lecture, he showed his determination to fight diseases together with patients.

The next speaker, Mr. Takashi Yamamoto, Professor of Life Science, Graduate School of Science at Hiroshima University, explained studies on genome editing and the situation in Japan. According to Mr. Yamamoto, genome editing that promotes genome modification by cutting the DNA at a specific sequence is a very important technique in studies for developing disease model cells or animals, unraveling mechanisms, inducing cancers and regenerative medicine. However, Japan has fallen far behind other nations in the amount of genome editing research in non-clinical and clinical settings. Currently, Japan is left in the dust of other countries, such as the United States, France, and China, in terms of the amount of applications by nation. In the lecture, Mr. Yamamoto presented his opinion that although basic patents in genome editing had been made by the United States, Japan should look into applications, such as diagnostics or treatments, and aim toward such technological developments.

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(Left) Chair for Lecture 2, Mr. Kohji Nishida, Board Member of the Japanese Society for Regenerative Medicine, and Tomohiro Morio, Board Member of the Japanese Society for Regenerative Medicine; (Right) Mr. Takashi Yamamoto, Professor of Life Science, Graduate School of Science at Hiroshima University

[Lecture 3] Administrative Perspectives

Lecture 3 started after the break, and some administrative personnel took to the rostrum. The first speaker was Mr. Masanori Nagai, Director of the Life Science Division, Ministry of Education, Culture, Sports, Science and Technology (MEXT). He introduced MEXT's research activities in regenerative medicine. Among the three ministries, including MEXT, the Ministry of Economy, Trade and Industry (METI), and the Ministry of Health, Labour and Welfare (MHLW), MEXT has placed the greatest emphasis on supporting basic research. Regarding this policy, Mr. Nagai explained that MEXT has been supporting "goal-oriented research managed by objectives," but it also respects the balance between basic and clinical research so that new seeds will not become depleted. He said that MEXT would like to actively support the two main pillars of "realization of regenerative medicine" and "drug development using iPS cells," as well as original basic studies through the allocation of young researchers.

The next speaker, Mr. Masahiro Uemura, Director of Bio-Industry Division, Ministry of Economy, Trade and Industry (METI), introduced METI's activities in regenerative medicine as "social needs in healthcare and policy direction." He said that unlike MEXT, which supports basic research, METI primarily supports the "industrialization of regenerative medicine," which includes the "acceleration of developments," "cost reduction in manufacturing," "promotion of collaboration among companies," and "acquisition of global standardization." In addition, METI is also focused on a project for developing research bases, such as the Life Innovation Center, dedicated to the industrialization of regenerative medicine and cell therapy in Kanagawa Prefecture. Mr. Uemura introduced METI's vision: "Make Japan into the center of innovation in the regenerative medical field" by promoting industrial developments and inviting companies. He said that he would like to continue support in a variety of ways.

Mr. Haruo Akagawa, Senior Executive Director of Pharmaceuticals and Medical Devices Agency (PMDA), explained PMDA's activities in the regenerative medical products area. PMDA conducts scientific reviews of marketing authorization applications for pharmaceuticals and medical devices and has newly established the Office of Cellular and Tissue-based Products within its reviewing office. It has started reviews, face-to-face advice and consultations to address regenerative medical products. As a result, the amount of face-to-face advice and pharmaceutical affairs consultations on R&D strategy (Regulatory Strategy Consultations) has been uneventfully increasing in recent years. Although it is the only product so far, a product utilizing the "Conditional and Time-limited Approval" system has emerged. Regarding the conditional and time-limited approval system, Mr. Akagawa said that it currently takes two to three months for the processes, and that they were trying not to make the administrative processes time-consuming, asking for understanding.

The final speaker was Mr. Yutaka Hishiyama, Executive Director of the Japan Agency for Medical Research and Development (AMED). Mr. Hishiyama summarized the Japan Regenerative Medicine Project supported by AMED and its future challenges. AMED is the research and development agency established to achieve "seamless support" with integrated management of research aids, which used to be budgeted by MEXT, METI and MHLW separately. Although it has only been two and a half years since its establishment, through five cross-sectional and four disease-area supports, AMED has steadily achieved outcomes such as "allogenic cell transplantation for age-related macular degeneration" or "drug discovery research for fibrodysplasia ossificans progressiva (FOP)." Mr. Hishiyama expressed his goal during the lecture as "I hope that the achievements yielded through AMED will be delivered to people worldwide who are suffering from diseases."

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(Left) Chairperson for Lecture 3, Mr. Tsuyoshi Takato, Vice President of the Japanese Society for Regenerative Medicine, and Mr. Akihiro Umezawa, Board Member of the Japanese Society for Regenerative Medicine; (Right) Mr. Yutaka Hishiyama, Executive Director of AMED

[Panel Discussion]

After Lecture 3, a panel discussion was held on the "concept of regenerative medicine in Japan with the background of international trends." Prior to the discussion, Mr. Yoshiki Sawa, President of the Japanese Society for Regenerative Medicine (JSRM) and Vice Chairman of the Board of Link-J, and Mr. Yoji Sato, Board Member of JSRM and Head of Division of Cell-Based Therapeutic Products, National Institute of Health Sciences, took to the rostrum. Mr. Sawa gave an overview of the new "national consortium business on regenerative medicine," the goals of which are the "promotion of clinical studies using an all-Japan approach," "cultivation of next-generation human resources by cooperating with industries" and "development of the National Regenerative Medicine Database (NRMD)." Mr. Sawa pointed out that this business will have a great impact on the JSRM's goal of "universal evolution in regenerative medicine." He said now that the new law, "Act on the Safety of Regenerative Medicine," was being enforced and clinical applications will finally begin, "how to put our hearts and souls into this new law" will become important in the coming years.

The next speaker, Mr. Sato, explained the latest global trends related to regenerative medicine. Mr. Sato pointed out that in the United States, some new systems similar to Japan's new law had been added to the "21st Century Cures Act," which is known as "a gift left by the Obama administration," such as "endpoint consultations are available even in the early phase of development," "priority review can be applied" and "accelerated approval program can be applied (if requirements are fulfilled)," and that they are also aware of its importance. In addition, he noted that discussions on the standardization of manufacturing and evaluation techniques have started worldwide, and that Japan's presence is weak in this area. Mr. Sato stated that Japan needs to express its opinion not to be left behind in this discussion, and that Japan will have problems if no action is taken.

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(Left) Panel discussion; (Right) Mr. Yoshiki Sawa, President of the Japanese Society for Regenerative Medicine and Vice Chairman of the Board of LINK-J

[Gathering for Information-Sharing]

After the symposium, a gathering was held by LINK-J for information sharing at the same venue, which was attended by the speakers as well as many of the general audience members. Attendees exchanged information in a genial atmosphere from beginning to end, with Mr. Hideyuki Okano, Chairman of the Board of LINK-J, who gave the opening toast, and Mr. Yoshiki Sawa, Vice Chairman of the Board of LINK-J, who greeted guests throughout the gathering.

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(Right) Information gathering; (Left) Mr. Hideyuki Okano, Chairman of the Board of LINK-J and Board Member of the Japanese Society for Regenerative Medicine