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

Yoshiki Kawabata

President, MedX Inc.

Advantage from over 35 years of multiple company & responsibility experience in medical device industry, helping foreign companies to enter into Japanese market. Key highlights in the past achievements are : with Johnson & Johnson Mdecial Company, worked with US R&D team to develop new product which reflecting Japanese patient and physicians needs - three years resided in Cincinnati, Ohio: HeartFlow Inc., which developed the first "program device" - FFRCT, enabling non-invasive detection of FFR, applied and received regulatory approval and reimbursement as a first product and company. : in Palette Lifesciences Japan, establishment of new subsidiary for start-up company which transferred the business from exclusive distributor. Started with minimum number of direct resources and having multiple partnerships with logistics, finance and regulatory affairs, revitalized the business and achieved a 149% growth over the last year of distributor.

Shunichi Takahashi

Bayer Yakuhin, Ltd.

After joining Mitsui Pharmaceuticals Co., Ltd., he worked at　Nihon Schering K.K., Berlex Biosciences (a US subsidiary of Schering AG). In 2007, he joined Bayer due to management integration. Over the past 15 years, he was in charge of exploring new projects and verifying concepts in drug discovery research, especially in the areas of cardiovascular systems, immunity, stem cell research, etc. Subsequently, he was in charge of the project management cardiovascular system area manager of development headquarters, the primary care manager of the medical affairs headquarters, and he has been in his current role since 2014 (Open Innovation Center director). He leads strategic partnerships and joint research with Japanese academies and venture companies. He is also verifying new pharmaceutical business models that take advantage of big data, AI, IoT, and others. In 2018, he launched the first venture incubation facility (CoLaboraotor Kobe) as a foreign-affiliated pharmaceutical company and is focusing on fostering ecosystems.

Tomohisa Hayasaki

GVA LPC Attorney-at-Law / Partner
The Leader of The Team ""Medical / Healthcare / Cosmetic Industry""

After registering as a lawyer, I have been handling disputes such as corporate and labor disputes, as well as providing legal support for the designing lawful business models of new businesses and for funding. In addition, I have been providing legal support for businesses in the field of medical and beauty based on my knowledge of laws relating to medicals including the Japanese Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and the Japanese Medical Care Act. In particular, I have been providing extensive support for numerous businesses operating in new field such as Software as Medical Device (SaMD) and Non-Software as a Medical Device (Non-SaMD), telemedicine/home call medical services, and also for companies utilizing medical information by employing new technologies such as AI. I am also addressing legal issues faced by companies using advance technologies. Furthermore, I have expertise in the latest marketing trend and offer advice on marketing strategies based on the Japanese Act against Unjustifiable Premiums and Misleading Representations, advertising regulations in Japan such as medical advertising regulations, and medical and pharmaceutical devices regulations.

Akihiko Okuno

SK Intellectual Property Law Firm (SKIP) Managing Partner
SCM BioMedica Co., Ltd. Co-Founder

Master's degree in Cell Structure Research, Department of Applied Bioengineering, Graduate School of Agriculture and Life Sciences, University of Tokyo, Japanese Patent Attorney, Information Security Administrator, and JPAA Intellectual Property Management Consultant certification. As a FoundX supporter of the University of Tokyo,　He supports the intellectual property strategies of many IT and bio-related startups. He specializes in supporting the planning of intellectual property strategies in a variety of fields including biotechnology, pharmaceuticals, and medical devices. In addition, together with Dr. Yoshimasa Tanaka of Nagasaki University (a genius researcher who developed Opdivo with annual sales of over 1 trillion yen together with Dr. Tasuku Honjo, winner of the Nobel Prize in Medicine and Physiology), he established SCM Biomedica Co., Ltd. He co-founded the company and is currently trying to manage his own drug discovery startup.

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.