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

Tomohiko Goto

TAIYO Pharma Co.,Ltd CMC Solutions Dept. Manager

Having extensive experience and achievements in formulation development, new drug application processes, investigational drug formulation development, support for overseas clinical trials, plant construction and GMP acquisition through long years at a pharmaceutical company, and more recently, engaging in CMC activities for investigational drug development and clinical trial advancement at a medical bio-venture company within Shonan i-Park(Kanagawa,Japan), I hope to contribute as a part-time CMC supporter for MEDISO. I am passionate about supporting the swift delivery of unmet need pharmaceuticals developed by domestic and international medical pharmaceutical venture companies to patients. Among many support areas, if I can contribute my specialized and niche knowledge in the CMC field (particularly in formulation development) to address challenges in cutting-edge bio-venture research worldwide through the MEDISO project, and support quicker entry into clinical trials, it would be most gratifying.

Hiroki Yamada

Medii, Inc. CEO, M.D.,Ph.D.

Miyuki Nagao

Globizz Japan Corporation　Tokyo Office Director

After graduating from a U.S. university, she began her career at Globizz Corp., the U.S. headquarters of Globizz Japan, where she was engaged in FDA registrations and regulatory research across the medical device, pharmaceutical, and food sectors. Through her involvement in a wide range of projects for international clients, she cultivated substantial, practice based expertise in FDA regulatory compliance. She subsequently joined Globizz Japan and currently serves as a Project Coordinator at the Tokyo office. In this capacity, she develops and proposes tailored support plans for companies seeking entry into the U.S. market, while overseeing comprehensive project coordination between U.S.-based consultants and clients. By working closely with a team of subject matter experts—including FDA consultants at the U.S. headquarters—she delivers highly precise and effective regulatory support. Drawing on her direct experience participating in FDA inspections, she also provides on site inspection assistance and collaborates with specialists to offer practical services, including interpretation support, Quality Management System (QMSR) development, Form 483 response preparation, and CAPA planning.

Yasuhisa Matsukawa

Nobutaka Tani

Chair Person, Nonprofit Organization Japan Organoid Repository
Independent Consultant (New Business in Life Sciences)

He graduated with a master’s degree from the Department of Synthetic Chemistry, Graduate School of Engineering, University of Tokyo. He led the research and development and the launching new project for medical devices, including blood purification system and brain and heart catheters, at Kaneka Corporation. After that, he was involved in RD of the whole life science, including biopharmaceuticals, as the head of the Life Science RD Center, while investing in medical venture companies such as DDS and establishing joint ventures. He then moved to JSR Corporation and established JSR Life Sciences. He led the launch of the life science project for M&A as the first president since JSR Life Sciences was established. As a part of open innovation, he established a CVC and invested in or acquired venture companies in Japan and overseas, while successively holding the positions of president of the invested companies.