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.

Rou Irisawa

IRISAWA Consulting LLC

Worked at Chugai Pharmaceutical Co., Ltd. for 27 years, primarily in antibody drug research and development, CMC regulatory affairs, and quality assurance, from preclinical trials stage to BLA stage. Involved in the BLA of Japan, US and EU approval for the CTD-Q of Actemra, Japan's original first antibody drug. And also involved in Japan BLA for several biologics Genentech original. Since 2017, involved in the development of many new modalities, including three SAKIGAKE designated cell products, and participated in 21 times PMDA consultations responsible for CMC regulatory and QA for cell products and gene therapy products. In 2023, became independent as a CMC regulatory consultant. Author of ""CMC Pharmaceutical Design - CMC Pharmaceutical Strategy in the Era of New Modality Pharmaceuticals"" (Yakuji Nipposha, 2022), and is the overall supervisor of the Japanese translation of A-CELL (CMC Development Guidance for CAR-T). Fellow at Tama University's Medical Care Solutions Research Institute, and a top performer in the regular course of Pharmaceutical Evaluation Science at the University of Tokyo Graduate School of Pharmaceutical Sciences in 2024. Certified in generative AI skills (November 2025).　Currently involved in various projects, including serving as CMC lecturer at seminars on how to proceed with the development of CMC for antibody drugs, cell products, gene therapy products, etc　for small company to semi-major company.

Kazuhiro Kanmuri

Inter-Professional Inc.

He engaged in pharmaceutical research and development for more than 25 years. He has gained experience in Japan and in the US development organization of Daiichi Sankyo Co., Ltd., Pfizer Inc., and CRO/consulting organizations, and has been deeply involved in strategic/regulaotry planning of clinical developmentincluding overseas organizations. His specialized fields are extensive, which include company clinical trials and investigator-initiated clinical trials, organization management, strategy development, and clinical trial operation/implementation, safety and pharmacovigillance, and he is active in the academic area of regulatory science. Currently, he engages in the consulting business as an expert in clinical development/organization and human resources development through the corporation that he established by himself and specialized CRO. In addition to being the incumbent, he concurrently served as a visiting lecturer of an academia organization, and he belongs to DIA Japan, an industry association of the pharmaceutical industry, and served as the Vice Program Committee Chair of the DIA Japan annual convention in 2018.

Hiroyuki Kajiyama

Graduated from Kyoto University Faculty of Pharmaceutical Sciences. Worked at Tanabe Mitsubishi Pharma Corporation in pharmaceutical research and development, primarily handling clinical development tasks. Since 2016, employed at the Pharmaceuticals and Medical Devices Agency (PMDA), Review Management Department, as a Technical Expert in Regulatory Science Strategy Consultation. Engaged primarily in providing consultation services on pharmaceuticals, medical devices, regenerative medicine products, focusing on academia and venture companies.

Masanori Sato

ReachMed Partners LLC President

Masanori has extensive experience in pharmaceutical R&D, alliance management, and business development. Their career evolved into leadership roles in global product launches, strategic licensing, and early-stage clinical development, particularly in antiviral therapeutics at a R&D focused pharmaceutical division of a leading Japanese conglomerate. Later, as head of the business development department, they managed global licensing agreements and partnerships with major pharmaceutical companies in the U.S. and Europe for multiple in-house pipeline assets. Since 2016, they have held leadership roles in alliance management and business development at leading U.S. biotech and European pharmaceutical companies, focusing on partnerships with Japanese firms, contract negotiations, and search & evaluation of external technologies/assets across Japan and the Asia-Pacific region. From 2021, they joined a top Japanese pharmaceutical company, where they led open innovation initiatives, incubation of internal and external seed assets, and support for venture investments. During this time, they also served as a board member for a portfolio biotech companies. In March 2025, they founded their own company, leveraging their broad expertise and network to support Japanese biotech startups and assist international startups into Japan. They hold national license for Small and Medium Enterprise Management Consultant, among others.