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

Masakazu Masujima

Partner, Mori Hamada & Matsumoto

Masa is a guru of startup legal advisory space in Japan. Based on the experiences at Palo Alto office of Wilson Sonsini Goodrich & Rosati, his advice is West Coast style; progressive, risk-base and proactive. Through more than 2 dacades of dedication to the startup space, he has advised IPOs, M&As and major cross-border fundraising for may startups, including biotech and healthcare ones, and have also worked with entrepreneurs through a variety of touch situation, such as disputes between founders, problems with investors as well as intellectual property disputes. Masa has served as a council member of numerous Government committees, such as Regulatory Reform Promotion Council, the Regulatory Sandbox Committee, the Digital Market Competition Council and the Industrial Structure Council. He is admitted to NY bar and Japan bar, and a licensed patent attorny in Japan.

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 Kono

Guest professor
Drug Discovery Science Division,Institute for Open and Transdisciplinary Research Initiatives, Osaka University

Jun Utsumi

CEO, TIR Research Consulting LLC.

JU graduated from the Graduate School of Veterinary Medicine, Hokkaido University. He holds DVM, D.Sc., MBA and has licenses of Professional Engineer (biotechnology), Radiation Protection Supervisor and Certified Scientist of Medical AI. He was engaged in research and clinical development at Toray Industries, Inc. and succeeded in commercializing the world's first opioid kappa agonist (received Awards from the Pharmaceutical Society of Japan and Okochi Memorial Foundation). After the business career, he served as a professor in Hokkaido University and Kyoto University, as well as an expert in Pharmaceuticals and Medical Devices Agency (PMDA) and a senior consultant for intellectual property at the Japan Agency for Medical Research and Development (AMED). Over 30 years of experience led him to establish a consulting company in 2018, he is also involved in medical DX support and won the Japan Open Innovation Award in 2023. He is part-time lecturers at the graduate schools of the University of Tokyo, Kyoto University, Tokyo Medical and Dental University, and the University of Tsukuba. He published “A Guide to Integrated Strategy in Drug Discovery” (Nanzando Co., 2015).

Takayuki Hirose

Patent attorney, Hirose International Patent Firm

He graduated with a master’s degree from the Graduate School, University of Tokyo. Patent attorney. After working in the intellectual property department in a major company, he was involved in lawsuit-, adviser- and application-relating services at a lawyer's office, followed by establishing his own international patent attorney's office in 2017. He offers intellectual property strategies in cooperation with companies as an adviser for multiple companies, including the Japanese Organization for Medical Device Development, Inc., (JOMDD) and Shin Nippon Biomedical Laboratories, Ltd. Furthermore, he applies for patent rights and trademarks in a wide variety of areas. He is involved in intellectual property-related services that include medical devices and pharmaceutical products. When he applies for a patent in foreign countries, he offers application strategies by placing the most importance on client’s profit, for example, to give advice to receive a subsidy or to select a foreign agent at a reasonable price depending on the company’s size.