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

Kunishige Masui

Managing Partner

Graduated from Kyoto University Faculty of Law, University of Tokyo Law School, and University of California, Irvine LLM. 2014 - 2021 at Nagashima Ohno & Tsunematsu; 2020 - 2021 at Smith, Gambrell & Russell, LLP （US law firm）. Established Masui & Partners in December 2021. Mr. Kunishige Masui assisted numerous startups, from angel rounds to companies nearing IPO, and has also assisted in the launch of many new businesses, including cross-border localization. He is well versed in the legal and financing issues that arise for startups and new business development, and provides support as a mentor for JETRO, Healthcare Innovation Hub, Kawasaki-NEDO Innovation Center （K-NIC）, Venture Café Tokyo, and IDEC. In addition to providing easy-to-understand explanations of foreign legal systems in comparison to those in Japan, he also specializes in removing obstacles to business growth by not only providing answers to "points that clients have actually consulted with" but also by digging into "points that need attention that clients are not yet aware of.”

Chia-Feng Lu

Shareholder(Senior Partner), Greenberg Traurig, LLP

Chia-Feng Lu represents life sciences companies and industry associations in strategic regulatory and legislative worldwide to guide and develop new legislation and policy, to frame effective approaches to working with the various agencies on compliance and investigation issues. He has intensive experience in provision of the guidance to companies introducing novel technology products, such as AI, block chain, 3D-printing, cancer immunotherapy, digital health, cell / gene therapy, precision medicine-related products and services, RNAi drug, as well as SMART device. In his past experience, he has already assisted companies in translating the scientific ideas from Nobel Laureates into the successful commercial launch of at least two products. In addition, he advises investment banks, private equity firms, and venture capital groups on their evaluations of the technologies, deal structures, and the resulting business impacts, as well as regulatory uncertainty with respect to novel technology and compliance. He specializes in various issues in connection with biotech investors or life sciences companies’ research & development strategy, portfolio management, corporate strategy planning, partnerships, licensing, project finance, auction, investment, and M&A. He has also served as an adjunct faculty member of a number of leading academic institutions in the U.S. and Japan, and an advisor to numerous government agencies.

Hirokazu Yamaguchi

Kazufumi Nakamura

Mitsui & Co. Global Investment, Inc.　Investment Director

Kazufumi Nakamura is an Investment Director focused on the investment in biotech in US and China. By leveraging his experiences and networks in Pharma, Biotech and Academia, he connects companies to those experts to expand business and gain scientific insight to help the companies succeed with their important missions.
Kazufumi has over 20 years of healthcare and life sciences experience, spanning business development, investment, entrepreneurship and R&D. Prior to joining MGI, he co-founded a biotech to accelerate innovations through academic institutions in Japan. Previously, he engaged in business development and conducted scientific evaluation, and license-in and license-out of pharmaceutical products at Santen Pharmaceuticals. In addition, he was responsible for creating relationships with the leading academic institutions and innovators, gaining Santen early access to innovation. Prior to Santen, he held a number of clinical development roles at Janssen Pharmaceuticals, including the development of Alzheimer’s disease and Rheumatoid arthritis programs.

Motohiro Kobayashi

University of Yamanashi Hospital, Clinical Trial Management Office, Associate Professor

With over 30 years of practical experience in pharmaceutical companies, ranging from basic research to clinical development, licensing activities, and regulatory audits. Subsequently, I served as a technical expert in the Innovation Commercialization Support & Strategic Consultation Division of the Pharmaceuticals and Medical Devices Agency (PMDA), dealing with regulatory consultation services for academia and venture companies (especially for regenerative medicine products and pharmaceuticals). Currently, I am working in the clinical research support department of a university, supporting physician-led clinical trials and clinical research. I have experienced numerous pre-meetings and face-to-face advice with PMDA. I also have experience in application support for public research and development projects (such as Seeds C, etc.) by the Japan Agency for Medical Research and Development (AMED). In particular, I can provide detailed support for the development of regenerative medicine products (including quality and non-clinical).