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

Shin-ichi Kamachi

CRO-K Co.,Ltd

Completed doctoral course at Kyushu University Graduate School of Pharmaceutical Sciences. After joining Chugai Pharmaceutical Co., Ltd. Research Institute in 1977, he worked consistently on pharmaceutical research and development. He has experience in approving one small molecule drug and four biopharmaceuticals. He also has the experience of being the first Japanese company to recommend approval for a central review of EMA. He took early retirement in 2004 and mainly assists with biopharmaceutical CMC and non-clinical testing. After establishing the Japanese branch of an American biopharmaceutical consulting company (Biologic Consulting Group, BCG), he currently serves as a senior consultant for CLOCK Co., Ltd., providing support and advice on the development of biopharmaceuticals.

Hirohumi Shido

I am a UI/UX design expert and specialize in driving product development. As a product manager at a medical startup, he was in charge of renewal and new planning for multiple SaMD products. My experience ranges from planning to obtaining regulatory approval, and I have won a Good Design Award for a healthcare product. These experiences have made me realize the importance of experience design and usability in SaMD products with a diverse mix of stakeholders.

Masakatsu Noguchi

SMILE CURVE, Inc.

Ph.D. in life sciences. Worked at consulting firm Dream Incubator, consulting in industry-academia collaboration, business support for tech startups (bio, semiconductor, environmental energy), new business development for large corporations, and overseeing government mega-projects. Previously employed at Abbott Japan and Singapore, managing product marketing for diagnostic tests, pharmaceuticals (women's health), and Asia-Pacific marketing for medical IT. As Business Development Director at Sanamedi, facilitated the commercialization of new medical devices, handled regulatory applications and market launches, and supported investments in and assistance to startups. Additionally served as an evaluator for AMED, and as a mentor for NEDO and university accelerator programs. Currently working independently, he serves as a specially appointed associate professor in the Hiroshima University and as an strategic advisor of MEJ.

Tadashi Sameshima

I have been engaged in product development and business operations of medical devices and regenerative medicine products for 37 years at Terumo Corporation. I have experienced the development of medical devices such as extracorporeal circulatory and blood transfusion devices, as well as the development to commercialization of cellular products. In addition, I am able to provide specific advice on various stages of development based on my participation in joint research with universities, collaboration among companies, discussions with government agencies, and activities of industry associations.

Yoshimi Naruo

Orizuru Therapeuics, Inc. Associate Director, IP&Legal Ph.D., Patent attorney

Education: Ph.D. in Bioinformatics/Systems Biology, Tokyo Medical and Dental University. Conducted research in systems biology at RIKEN for 3 years (student internship). Experience: 5 years of experience in drug regulatory affairs at an originator pharmaceutical company, followed by 2 years as an in-house IP specialist handling invalidation and infringement matters at a generic pharmaceutical company. Patent prosecution primarily in the fields of pharmaceuticals, biotechnology, and food at an IP law firm. Fulfilling a long-held aspiration to join a startup, she took on the role of Vice President of Legal IP & Strategy at Splink, Inc., where she contributed to winning the Grand Prix at the 3rd IP BASE AWARD hosted by the Japan Patent Office and the 2022 WIPO Global Awards hosted by the World Intellectual Property Organization (WIPO). Currently, she is responsible for intellectual property and legal affairs at Orizuru Therapeutics, Inc., a company aiming to commercialize regenerative medicine derived from iPS cells. She leads the formulation of IP strategies and the development of an IP portfolio. Her strength lies in creating IP strategies with a focus on pharmaceutical regulatory affairs, and she strives to provide practical advice in the face of limited resources and uncertainties surrounding technology and commercialization.