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

Daisuke Sugiyama

Hiroshima University, Translational Research Center, Professor

He obtained his PhD thesis at University of Tokyo. After working at several hospitals as a clinician, he has engaged in medical reserach at University Paris 6 (French Government Scholar), Dartmouth College (JSPS research fellow), Kyushu University and Hiroshima University. Based on the experiences working at ARO research core hospital and starting up bio-venture company, he supports and conducts both translational and clinical researches.

Yoshinori Kubodera

A certain pharmaceutical co., ltd.
CMC regulatory Affairs dept.

Master degree (Biology) at Waseda university graduate school. I joined a pharmaceutical company in 1989, where I was involved in analytical development for biopharmaceuticals, manufacturing process development for bio drug substance and work for the CMC regulatory affairs department currently. I have been involved in domestic NDA and approval for five antibody drugs and one regenerative medicine product. I have also worked on global MAA for two antibody drugs. In addition, I have experiences with consultations with domestic and oversee health authorities, as well as submissions for domestic/global CTAs. As part of industry activities, I had participated in domestic working groups for ICH Q6B (Specifications), M4Q (CTD-Q), and Q11 (Development and manufacturing for drug substance), and I took part in the global Expert Working Group for ICH Q13 (Continuous Manufacturing).

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.

Mineki Takechi

Cardio Intelligence Inc. Chief Development Officer
Director

After working at Fujitsu Ltd. on the development of products and services such as image processing system and cloud information service for home healthcare, as well as research and development in information retrieval and AI, and new business development, I engaged in the construction of a pulmonary hypertension patient registry at the International University of Health and Welfare Mita Hospital. Since 2020, I have been serving as CDO at Cardio Intelligence Inc., responsible for the development of software medical devices for arrhythmia analysis and regulatory affairs. Since 2021, I have also been serving as COO, overseeing overall business planning and execution.

Masato Kishida

My global achivements are categorized in two main types as follows: 1. Succesfully cordinating and facilitating several business globalization projects of some orphan products for CNS disorders and inherited metabolic disorders as a project leader, and 2. Outstanding success in the legal entities' establishment of three key area, e.g., a global clinical development head office in EU, two clinical and RA offices in the US & Brazil and an ASEAN region business head office in Singapore. Global business expansion is composed of two main phase. First one is to elaborate specific business plan from global business policy to clinical development strategy to draw the master of global business big picture. Next one is to implement the fixed road map and steamlined action plans on the timeline basis under the frequent risk assessment and business environment analysis.