EU-Japan Centre for Industrial Cooperation Opportunities for Cooperation between EU and Japan on Biotechnology in Healthcare: Japan Bioventures Landscape Tokyo, April 2018 Esther RODERGAS 1 Disclaimer The information contained in this publication reflects the views of the author and not necessarily the views of the EU-Japan Centre for Industrial Cooperation, the European Commission or Japan authorities. The author believes that this paper is reliable and reasonably clear. While utmost care was taken to check and translate all information used in this study, the author and the EU-Japan Centre may not be held responsible for any errors that might appear. This report does not constitute legal advice in terms of business development cases. The author can be contacted at [email protected] 2 Executive Summary Japan is one of the major countries that European biotech companies target in their expansion when it comes to internationalisation. This report intends to be a useful source of information for European SMEs and clusters considering potential cooperation with Japan. In the healthcare sector, and more specifically in the therapeutics development field, partnerships between European and Japanese pharmaceutical companies well established in their respective local markets has typically involved License agreements on co-development and commercialisation rights. The Japanese inlicensor would typically get the rights on a product of European origin to pursue its clinical development in Japan, obtain the local regulatory approval, and commercialise it in the domestic Japanese market. The reverse situation was possible as well, when products developed in Japanese companies pipelines were licensed-out to European based companies. In an era of open innovation, partnership models are evolving, and can go well beyond pharma licensing deals on co-development and product commercialisation rights. Moreover, European biotech SMEs often present alternatives to the traditional therapeutic product development, and business models are frequently based on discovery platforms and services to facilitate research and drug development. This report is therefore focussing on public research institutions and academic bioventures in Japan, which may hold great potential for collaboration with European SMEs. Biotechnology policies in Japan are presented in the first section of the report, exploring the Regulatory mechanisms for approval of regenerative medicines which Japan pioneered (sections 2&·3). A brief presentation of Japan science and technology indicators, and major cooperation programs in health with the European Union is given in sections 4&5. The chronology of the evaluation of Academia-Industry relations in Japan, leading to the current situation of academic bioventures is presented in sections 6 & 7. Section 8 includes an overview of the Japanese biotech academic landscape. A comprehensive description of all the laboratories doing biotech research in Japan was beyond the scope of this report. Major universities and flagship research centres are presented, explaining how relations with industry are organised for each centre. A selection of innovative academic bioventures is provided, linked to the research laboratory which was at the origin of the technology offered by these companies. 3 The global health innovative technology fund is presented in section 9, as an interesting model of tripartite collaboration with Japan, potentially interesting to EU biotech companies. Section 10 describes the most active Japanese clusters and innovation hubs with interest on international collaboration biotechnology and healthcare. The report concludes with some practical recommendations for EU biotech companies considering entering the Japanese market. 4 List of abbreviations AMED Agency for Medical Research and Development ALS Amyotrophic Lateral Sclerosis CiRA Center for induced pluripotent stem cell Research and Application CDMO Contract development and manufacturing organization CRO Contract Research Organization EMA European Medicines Agency EU European Union ES Embryonic stem cell FDA Food and Drug Administration (US) GDP Gross Domestic Product GHIT Global Health Innovative Technology Fund GMP Good manufacturing Practices HFSP Human Frontier Science Programme HGF Hepatocyte Growth Factor iPSC Induced Pluripotent Stem Cell IFReC The Immunology Frontier Research Center IMSUT Institute of Medical Science University of Tokyo ICGC International Cancer Genome Consortium IHEC International Human Epigenome Consortium IHMC International Human Microbiome Consortium IMPC International Mouse Phenotyping Consortium IoT Internet of Things JABEX Japan Association of Bioindustry Executives JBA Japan biotechnology Association JPY Japanese Yen LiC Lifescience Industry Center in Kanagawa LINK-J Life science Innovation Network Japan MHLW Ministry of Health Labour and Welfare MAB Monoclonal Antibody METI Ministry of Energy Trade and Industry MEXT Ministry of Education, Culture, Sports, Science and Technology MOTHERS Market of High Growth and Emerging Stocks (Tokyo Stock Exchange) MoU Memorandum of Understanding 5 M&A Mergers and Acquisitions NEDO New Energy and Industrial Technology Development Organization NGS Next Generation Sequencing NISTEP National Institute of Science and Technology Policy OECD Organisation for Economic Co-operation and Development PMDA Pharmaceuticals and Medical Devices Agency PMI Preventive Medicine and Diagnosis Innovation Program QbIC Riken Quantitative Biology Center RCAST Research Center for Advanced Science and Technology RMP Regenerative Medicine Product RPE Retinal Pigment Epithelium SMEs Small and Medium Size Enterprises 6 Table of contents Disclaimer ............................................................................................................................................. 2 Executive Summary .............................................................................................................................. 3 List of abbreviations ............................................................................................................................. 5 Table of contents ................................................................................................................................... 7 List of Bioventures/companies mentioned in the report: ...................................................................... 9 List of Figures ..................................................................................................................................... 11 List of Tables ....................................................................................................................................... 12 1. Introduction ............................................................................................................................... 13 2. Japan Biotechnology Policies ................................................................................................... 15 3. Regulatory policies for the promotion of Regenerative Medicine ........................................ 17 4. Japan Science and Technology Indicators .............................................................................. 21 5. European Union-Japan Cooperation on Health ..................................................................... 24 6. Industry- Academia Collaborations in Japan. ........................................................................ 26 7. Entrepreneurship and policies supporting Bioventures in Japan ........................................ 30 8. Japan Academic Landscape- An Overview............................................................................. 34 Internationalization of Japan Universities: Japan Top Global Universities Project ................................................. 34 World Premier International Research Center Initiative (WPI) ............................................................................... 35 Industry-Academia track record of collaborations................................................................................................... 37 University start-up creation: Accumulated number of academic ventures ............................................................... 37 The University of Tokyo .......................................................................................................................................... 38 The Institute of Medical Sciences of the University of Tokyo (IMSUT) ................................................................. 38 The Translational Research Initiative by the University of Tokyo........................................................................... 39 The Research Centre for Advanced Science and Technology (RCAST) ................................................................. 41 The University of Tokyo- Organisation of the Collaborations with Industry .......................................................... 42 Support to venture companies at the University of Tokyo ....................................................................................... 42 7 Kyoto University ..................................................................................................................................................... 48 Center for iPS Cell Research and Application (CiRA) ............................................................................................ 48 Institute for Integrated Cell Material Sciences (ICeMS) ........................................................................................