A comprehensive portal site for Medical Innovation Support Office (MEDISO).Medical Innovation Support Office

Takato Noumi

Representative Director, FORESIGHT&LINX Cp., Ltd.

At his consulting company, he is currently providing practical support for constructing research strategies, business development, and licensing regarding to drug discovery to pharmaceutical companies and biotech venture companies in Japan and overseas. After completing his postgraduate course, he worked in basic research in molecular biology for 10 years followed by joining the Research Division of the headquarters of Novartis. Subsequently he served as the head of theTsukuba Research Laboratories of GlaxoSmithKline K.K. He had engaged in drug discovery research from a global point of view for 15 years. After that, he has been involved in searching for and evaluating drug discovery seeds and technologies and developing international businesses and licensing at Sanofi S.A. in France and his own consulting company for 10 years. He has a broad network of connections with pharmaceutical companies, biotech venture companies, academia, and venture capital firms in Japan and overseas.

Saaya Hirai

Globizz Corp.　Senior Manager

After graduating from a university in Taiwan, she began her career at Globizz Japan as a Business Planning Specialist. In this role, she developed proposals for Japanese companies seeking entry into the U.S. market and provided support for FDA compliance, including assistance with Quality Management System (QMS) development for medical device manufacturing facilities and FDA inspection readiness. She later transitioned to Globizz Corp., the U.S. headquarters of Globizz Japan, where she currently coordinates FDA submission projects and conducts regulatory research and registration activities. In addition, she supports Japanese companies in expanding their presence in the U.S. medical device market by accompanying them to major industry exhibitions, assisting with trade show participation, and joining business meetings to facilitate market development. Leveraging her proficiency in English, Japanese, and Chinese, she plays a key role as a bridge in international projects. Her support experience includes FDA submission strategy development, 510(k) submissions, Breakthrough Device designation requests, U.S. KOL interviews, reimbursement strategy support, and assistance with establishing U.S. corporate entities.

Yutaka Tomioka

Project Researcher, Department for the Promotion of Medical Device Innovation, National Cancer Center Hospital East.
Chief Regulatory Scientist, ayumo Inc.
Chief Development Officer / Director, Atransen Technologies, Inc.

Ph.D. (Engineering). I began my career at the Pharmaceuticals and Medical Devices Agency (PMDA), where I worked in medical device review and reliability inspection (reliability standards compliance inspections and on-site GCP inspections for medical devices). My responsibilities included the approval review, consultation services, and reliability inspections for a wide range of medical devices, including novel medical devices. Drawing on my 10 years of experience at the regulatory authority, I moved to National Cancer Center Hospital East in July 2019 to support the development of medical devices originating in Japan. At National Cancer Center Hospital East, I supported medical device development led by both academic institutions and companies. I left my full-time position at National Cancer Center Hospital East at the end of 2025, and joined ayumo Inc. in January 2026 (current position), where I lead the regulatory affairs team.I also joined Atransen Technologies, Inc. in May 2026 (current position). I currently hold part-time positions at National Cancer Center Hospital East, Yokohama City University, and the National Defense Medical College, while also supporting a number of startups, pharmaceutical companies, medical device manufacturers, academic institutions, and small manufacturing workshops (machi-koba) in Ota Ward, Tokyo.

Yoshiki Kawabata

President, MedX Inc.

Advantage from over 35 years of multiple company & responsibility experience in medical device industry, helping foreign companies to enter into Japanese market. Key highlights in the past achievements are : with Johnson & Johnson Mdecial Company, worked with US R&D team to develop new product which reflecting Japanese patient and physicians needs - three years resided in Cincinnati, Ohio: HeartFlow Inc., which developed the first "program device" - FFRCT, enabling non-invasive detection of FFR, applied and received regulatory approval and reimbursement as a first product and company. : in Palette Lifesciences Japan, establishment of new subsidiary for start-up company which transferred the business from exclusive distributor. Started with minimum number of direct resources and having multiple partnerships with logistics, finance and regulatory affairs, revitalized the business and achieved a 149% growth over the last year of distributor.

Masato Kishida

My global achivements are categorized in two main types as follows: 1. Succesfully cordinating and facilitating several business globalization projects of some orphan products for CNS disorders and inherited metabolic disorders as a project leader, and 2. Outstanding success in the legal entities' establishment of three key area, e.g., a global clinical development head office in EU, two clinical and RA offices in the US & Brazil and an ASEAN region business head office in Singapore. Global business expansion is composed of two main phase. First one is to elaborate specific business plan from global business policy to clinical development strategy to draw the master of global business big picture. Next one is to implement the fixed road map and steamlined action plans on the timeline basis under the frequent risk assessment and business environment analysis.