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

Akiko Yamamoto

Nissan Chemical Corporation
Risk Management ＆Compliance Office
Risk Management Department

Graduated from the Department of Pharmacy at Kyoritsu Collage of Pharmacy (currently Keio University) and received a Ph.D. from Gifu Pharmaceutical University. Engaged in work related to each process of pharmaceutical life cycle (research and development, sales promotion, licensing/alliance, quality assurance and Good Vigilance Practice(GVP)) at Nissan Chemical Corporation. Especially, as the corporate quality assurance department leader, managed the company's pharmaceutical quality system, and maintained and improved appropriate quality assurance systems for API manufacturing sites, manufacturing contractors, and contract testing facilities. Specifically, provided support during FDA inspections and global pharma quality audits, and advised on improvements and response policies for issues raised. Also has experience in implementing regulations and change processes when adding starting material, intermediate and API manufacturing sites, and testing facilities. In addition, has reviewed documents such as license and quality assurance-related contract contents, change applications and master files to be submitted to authorities.

Tetsuo Miura

Specially Appointed Researcher, Center for Clinical Sciences, National Center for Global Health and Medicine

I worked as a product and business development manager primarily in the fields of diagnostic equipment-reagent systems and medical devices at major foreign pharmaceutical and domestic medical device companies, and also participated in global product development teams at the US and French headquarters. I have medical science knowledge in the fields of infectious diseases, immunology, cardiovascular diseases, metabolism, reproductive medicine, and laboratory medicine, as well as information on the medical field. After mandatory retirement, I served as a senior researcher at the National Center for Global Health and Medicine, responsible for developing and implementing international collaborative clinical research and clinical trials for pharmaceuticals and medical devices with clinical trial networks in Southeast Asian countries. Currently, as part of an industrial-medical collaboration project, I also provide guidance and support to companies in product development with an eye toward exit strategies such as obtaining pharmaceutical or WHO PQ approval, and being included in guidelines in cooperation with related medical sectors and societies.

Hirokazu Yamaguchi

Osamu Tabuchi

JMDC Inc. Quality Assurance Office manager

I am a dedicated professional with extensive experience in safety management and post-marketing surveillance (PMS) in the pharmaceutical industry. After joining SANWA KAGAKU KENKYUSHO CO., LTD., I focused on risk management for diabetes medications and treatments for dialysis complications. My work included PMS literature development and cardiovascular event evaluations, contributing significantly to drug development.
At CureApp, Inc, a company specializing in software as medical devices, I served as the Safety Management Officer. I successfully established the safety management system and operational processes for Japan's first therapeutic app. My involvement in risk management for various therapeutic applications, including those for hypertension, allowed me to engage deeply with the core aspects of product development.
Currently, I am the Head of Quality Assurance at JMDC, Inc, where I oversee GxP compliance and reliability assurance. I am actively involved in building a new PMS framework that combines e-source data with additional collected data, as well as managing certification acquisition and maintenance.

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.