Specialists Introduction

Yutaka Kono

Guest professor
Drug Discovery Science Division,Institute for Open and Transdisciplinary Research Initiatives, Osaka University

Masaho Ishino

After engaging in medical research for 25 years, I became a patent attorney (JAPAN). Over the next 20 years, I have supported medical researchers in creating intellectual property and planning research strategies, as well as engaged in contract practice and technology transfer of university IP. Intellectual property strategies for regenerative medicine and other new modalities require not only a high level of expertise in both cutting-edge medical research and intellectual property rights, but also comprehensive knowledge covering clinical development and regulations. Utilizing my experience of contributing to the development research and practical application of university-originated seeds as a representative of an institution responsible for the AMED's Project of Translational and Clinical Research Core Centers and an organizer of nationwide academia intellectual property networks, I aim to contribute to raising the potential of intellectual property of academia/venture.

Katsuhiro Fukunishi

Takeshi komatani

Takeshi S Komatani is currently principal litigation certified patent attorney in the field of chemical/pharma and bio/life sciences at a patent law firm, and has a number of counsels, including in academia, start-ups and big pharma internationally. Takeshi received his PhD from the University of Tokyo, Japan, received his LLB and LLM (global legal practice) from Keio University, and is currently a visiting professor at Kobe University, teaching IP strategy in entrepreneurship and Doshisha University (Kyoto). He has completed CEIPI Summer School on IP (University of Strasbourg), France. He is also qualified as a pharmacist with a certificate of Kampo and natural medicines specialist qualification. He was a researcher at F Hoffmann-La Roche in Basle, Switzerland. He has completed the EU-recognised PharmaTrain course at Osaka University, and is qualified as a board-certified member of the Japanese Association of Pharmaceutical Medicine. He is a member of the AIPPI and vice chair of TRIPS SC and a member of IP-GRTK SC and Pharma SC, and a member of the editorial board of the Pharmaceutical Patent Analyst (UK). He is also a member of JPAA, APAA, IPAJ, PSA, JPA, CSAIP and AAAS. He has lectured in academia, including at Japanese and German universities and WIPO Academy, and contributed to a number of articles.

Kazushi Kamitani

JPRO CONSULTING OFFICE, FOUNDER

Advisor & Coordinator at MEDISO. He understands domestic and oversea culture and practices, having experience of working for Japaense and international firms. For his own business, he provides business supports to startups; business development, fund raising, and oversea business, working with governmental organizations. Recently, he focuses on bridging Japan and Australia, working with Australian state government.

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.

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 MESIDO. 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.

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.

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.

Akiko Yamamoto

Nissan Chemical Corporation
Environment, Safety and Quality Assurance Department
Quality Assurance Group
Senior Advisor (contract employee)

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.

keiji Asada

Amenichi Consulting, LLC, CEO

Graduated from Auburn University with a degree in Chemical Engineering. Currently, serving as the CEO of Amenichi Consulting, LLC, a consulting firm specializing in regulatory compliance (FDA) and marketing support for companies entering the U.S. market, particularly in the fields of pharmaceuticals, medical devices, and regenerative medicine products. With extensive industry experience and expertise, he assists clients in developing business plans, securing funding, and establishing operational structures. Additionally, he provides comprehensive support, from the formulation to the execution of business strategies, to help clients enhance their competitiveness. Furthermore, he leverages his network to match clients with the most suitable business partners. With a global perspective, he offers customized services tailored to the needs of each client, aiming for sustained growth and success. Amenichi was established in 2018 and has supported over 50 companies since its inception.

Hiroki Yamada

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

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.

Tsutomu Hoshiba

Kievit Scientific LLC President

For over 30 years, I've established and managed Japanese life science companies in the US and Europe. In 2021, I founded Kievit Scientific in Philadelphia, utilizing my Western-acquired experience, up-to-date information, and network. I assist Japanese companies in the pharmaceutical, medical device, and chemical sectors in their international expansion, from strategic planning to product development and market entry. Harnessing my understanding of different cultures and wide-ranging scientific knowledge, I provide solutions to challenges faced by Japanese academia and startups in their global ventures, with the aim of supporting as many Japanese companies as possible to succeed overseas. Furthermore, through these endeavors, I promote the widespread adoption of innovative medical technologies, striving to realize a society where the benefits are extended to many.

Satoshi Morimoto

Morimoto Phrma Partrnering, Representative

Representative of Morimoto Pharma Partnering. Master of Science in Applied Biochemistry, Graduate School of Waseda University. I stared my carrier at the former The Green Cross Corporation (now Mitsubishi Tanabe Pharma Corporation), experienced in pharmaceutical R&D, product strategy planning, and business development. During that time, I was dispatched as the liaison to Germany for four years. My last position was Director of Business Development. Then, I joined to CMIC Holdings, where I led the business development of rare disease drugs as Director of Business Development and Head of IPD Company. From 2016, I spent six years at the Mitsubishi Chemical Group's Life Science Institute(LSII) as head of the Regenerative Medicine Division, where I was involved in the early stages of cell product development, initiating clinical trials, and leading the construction and operation of cell processing facilities.　After retiring from LSII in 2021, I started own business as a consultant. I would like to provide practical advice based on my experience in the development and commercialization of rare disease drugs and regenerative medicine products. In addition, I would like to provide practical advice on business development from the perspective of having been introduced to various projects from venture companies over 30 years.