Noriko Ogawa, Holland Innovation Network Tokyo (Innovatie Attaché Netwerk Tokio)
Origineel gepubliceerd op de site van RVO.
De Japanse samenleving vergrijst in hoog tempo. Naast uitdagingen biedt dit ook enorme kansen, o.a. voor innovatie in de lifesciences. Japan zet sterk in op valorisatie van R&D in de biomedische hoek. Onderzoek naar regeneratieve geneeskunde en cell-therapie moet versneld worden doorvertaald naar commerciële producten en diensten. Japan ziet hier een belangrijke groeimotor voor zijn farmaceutische industrie. Om innovatie en valorisatie aan te jagen heeft de Japanse regering onlangs de toelatingsregels versoepeld voor een aantal producten in de categorie regeneratieve geneeskunde. Ook bevordert de overheid actief de vorming van biomedische ‘clusters’ en publiek-private samenwerking. De bekende Japanse farmaceuten, zoals FujiFilm, Takeda, Astellas, maar ook een MedTech speler als Terumo, spelen een zeer actieve rol bij de vertaling van fundamenteel onderzoek naar concrete producten.
Building the ecosystem for accelerating industrialisation of BioMedical Engineering, Regenerative Medicine and Cell Therapy in Japan
The Japanese Ministry of Health, Labor and Welfare designated seven innovative products for the expedited review program to shorten the approval processes for industrialisation on 28 February 2017. Six of those seven products were in the regenerative medicine category. One of the designated products was a cell sheet of regenerative medicine, epithelial cells, collected from a patient’s own oral mucosa for treatment of esophagus cancer. Clinical studies have already started at hospitals and the product is expected to be launched in 2019. In order to deliver safe products to the patients speedily, in addition to the law reform such as this expedite approval system by the government, we witness a new movement of establishing ecosystems for BioMedical and regenerative medicine in Japan. These ecosystems are initiated by the triple-helix of private sector, academia and research institutes to promote early industrialisation. The expedited review program makes it possible to speed-up the launch of new products. The process is said to now be faster than in other countries for regenerative medicine and cell therapy products. This may be of interest for Dutch researchers and entrepreneurs who seek development through collaboration with Japanese partners. The programme may also help to promote Dutch cell therapy related products in Japan, including cell culture devices, equipment, material and transport. Below a few examples where Japan is turning research excellence into business opportunity.
The world’s first cellular and tissue based product for heart failure and collaborations
The world first cellular and tissue based product for the treatment of heart failure, “HeartSheet”, was launched in May 2016 by the Terumo Corporation. Terumo is the second largest medical device company in Japan. This was the first product to be designated as a ‘conditionally approved product’, with 7 clinical studies, under the expedited approval system. The “HeartSheet” is using cell sheet engineering technology developed by CellSeed Inc which first established as a start-up. Professor Teruo Okano from Tokyo Women’s Medical University developed the seed technology. They are temperature-responsive polymers which allow recovery of intact cells in a sheet form. The Center for Advanced Biomedical Sciences (TWIns) was established in the Tokyo Women’s Medical University with Waseda University. It includes the Medical Innovation Laboratory (MIL) for collaboration in medical engineering with companies such as Hitachi and Panasonic. Hitachi is developing automated cell culture equipment and transportation technology for cell sheet-based tissue engineering and advances the structure of transportation system.
-Asian review http://asia.nikkei.com/Tech-Science/Tech/2-regenerative-medicines-set-for-swift-green-light-in-Japan
-TWIns Waseda University https://www.waseda.jp/inst/twins/en/
Broad application and further opportunities for businesses in overseas markets
The Japanese company CellSeed’s pipeline for treatment research and business development applications is broad: cornea, teeth, ears, kidney, pancreas and lung. Their epithelial cell sheet will relieve inflammation after surgery and prevent from esophageal stenosis, which frequently forms after endoscopic submucosal dissection (ESD). Cell Seed is now focusing on development of regenerated cartilage sheets on which it will start clinical studies in 2017. Professor Okano and CellSeed have developed a global collaboration network. Since 2012, clinical studies were conducted and have succeeded at Karolinska University Hospital in Sweden (Hospital exemption treatment). They have announced a business alliance with Meta Tech. Inc, in Taiwan, starting in April.
-Application for Cell Sheets http://www.cellseed.com/regenerative-e/
Eco systems to stimulate creativity and early industrialization: FIRM and RINK
Currently, the applications for regenerative medicine and cell therapy technologies are: treatment, drug discovery and biobank. Major pharmaceutical and medical device companies are entering the market with startups in sequence by alliances, licensing agreements, and co-research with academia. In order to accelerate developments and grow the market, ecosystems were formed to help build the value chain from research to innovative product development to patient treatment. In Japan, the largest ecosystem of regenerative medicine is the Forum for Innovative Regenerative Medicine (FIRM) with over 250 member companies.
FIRM periodically organizes seminars to assist startups in collaboration with the Ministry of Economy, Trade and Industry. Aim is to share information and insights to grow the business. FIRM is also active in establishing guidelines. It has already created standardization for cell processing, transportation and advertisement. There are committees for regulatory issues, healthcare economics, education, compliance and others. There is a taskforce which consists of 10 companies including Astellas, Fujifilm and CellSeed, organized to accelerate application of cellular and tissue based products. They provide consultation services for industrialisation, both aimed at Japan and overseas opportunities, matchmaking and support fostering and promoting business.
-FIRM(Forum for Innovative Regenerative Medicine) https://firm.or.jp
-RMIT(Regenerative Medicine Industrial Task Force) https://firm.or.jp/rmit/en
The Regenerative Medicine and Cell therapy industrialisation network of Kanagawa prefecture (RINK) was newly established in the International Strategic zone of Life Science, “Kingsky front” in the south of Tokyo, Kawasaki city. There are over 30 members which include RIKEN Genesis, Stem Cell Evaluation Technology Research Association, Cellular Dynamics International Japan, GE Healthcare and Mizuho Bank. The aim is to build a value chain for the series of processes for cell processing, culture, evaluation, storage and transportation. The main activities are information sharing, project planning, management support and matchmaking. The infrastructure building for regenerative medicine and cell therapies are progressing and the investment for startup is increasing in Japan. Industrialization by using ecosystem with all players and collaborate globally are the path to bring the innovative products early to the market.
-RINK (Regenerative Medicine and Cell therapy Industrialisation Network of Kanagawa) http://rinkrink.jp/en/
-Members of RINK http://rinkrink.jp/en/member/
Noriko Ogawa, Innovatie Attaché Tokio, 18 April 2017
‘Het IA-Netwerk verbindt in opdracht van het ministerie van Economische Zaken kennis over internationale innovatieve ontwikkelingen en daaraan gerelateerde trends aan Nederlandse bedrijven, kennisinstituten en overheden.’
