Our site uses cookies to improve the contents of the site and customize it according to individual use. Please confirm that you agree to our use of cookies by clicking Yes.

If you continue without explicit consent, we will assume that you agree to our cookie policy.

厚生労働省

Specialists Introduction

Medical Innovation Support Office support consultants in cooperation with experts (specialists) in each field of R&D, pharmaceutical affairs and insurance, intellectual property management, management and financial accounting, marketing, legal affairs, and international development, as well as related organizations, including the Ministry of Health, Labour and Welfare.

What is Specialists

Experts in each field of R&D, pharmaceutical affairs and insurance, intellectual property management, management and financial accounting, marketing, legal affairs, and international development.

Depending on the specifics of your request, we offer support in cooperation with appropriate specialists and related organizations, including the Ministry of Health, Labour and Welfare.

Introduction of Support Providers

We will introduce registered support providers
(updated as necessary).

Masashi Matsunaga

Oxentia Ltd Associate Consultant

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy

Masashi Matsunaga is an experienced international business development professional working in the life sciences and chemical fields for more than 20 years. He has created invaluable personal networks in the Japanese and oversea business communities as well as government and academic societies. He also has team management skills that he developed diverse international teams both in large and small companies. Always Masashi is challengeable for new innovative businesses with creating new value to the market with understanding the key value of the technology being able to present to different level of peoples.

Shunichi Takahashi

Bayer Yakuhin, Ltd.

Main specialty areas

  • Medicines
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy

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.

Akiko Ikeda

Janssen Pharmaceutical K.K.

Main specialty areas

  • Medicines
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations

She graduated from the School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, and is a licensed pharmacist. At the pharmaceutical company, she engaged in pharmaceutical affair services (mainly in the pharmaceutical affairs of development) and she was in charge of items through the planning of medicinal product development, application, and approval. (Assigned and experienced areas: Endocrine system, infectious disease, central nervous system, cardiovascular system, anticancer drugs, etc.) Subsequently, in the policy intelligence department, she engaged in the business of the promotion of the development of medicines and the products of regenerative medicine and pharmaceutical affair policies, such as the vaccine policy, and the promotion of deregulation through working members of the industry. Through nonprofit groups, such as the DIA, she also provided support activities to promote development of the products of regenerative medicine.

Kazuhiro Kanmuri

Inter-Professional Inc.

Main specialty areas

  • Medicines
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Management
    Strategy

He engaged in pharmaceutical research and development for more than 20 years. Over the past few years, he has gained experience in Japan and in the US development organization of Daiichi Sankyo Co., Ltd., and Pfizer Inc., and has been deeply involved in strategic planning of clinical development, including overseas and overall work. His specialized fields are wide, which include company clinical trials and investigator-initiated clinical trials, organization management, strategy construction, and clinical trial operation, and he is active in the academic area of regulatory science. Currently, he engages in the consulting business as an expert in clinical development/organization and human resources development through the corporation that he established by himself. In addition to being the incumbent, he concurrently served as a visiting lecturer of an academia organization, and he belongs to DIA Japan, an industry association of the pharmaceutical industry, and served as the Vice Program Committee Chair of the DIA Japan annual convention this year.

Mayu Morishima

Beyond Next Ventures Inc.

Main specialty areas

  • Medicines
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

She graduated with a doctoral degree in biosciences from the Graduate School of Frontier Sciences, University of Tokyo. At McKinsey & Company, she engaged in the projects of pharmaceutical companies and medical device companies, which included placing novel products on the market, marketing strategies, and new market development. She participated in Beyond Next Ventures Co., Ltd., in 2016 and conducted investment and business support mainly in biotechnology, life science fields, and overseas. She concurrently served as a project promoter for the Program for Creating Startups from Advanced Research and Technology by the Japan Science and Technology Agency.

Masahiro Kanamaru

Beyond Next Ventures Inc.

Main specialty areas

  • Medical devices

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated with a master's degree in physics from the Department of Physics, Graduate School of Science, Tohoku University, and received his MBA from the Graduate School of Management, GLOBIS University. At Toshiba Corporation, he led the research and development of the next generation optical disc at the R&D center, as well as HDD planning, development, and manufacturing for cloud servers. After that, he engaged in investment in technical startups at DBJ Capital Co., Ltd. He participated in Beyond Next Ventures Co., Ltd., in 2016. He is conducting investment and business support mainly in medical devices and the technology fields. He concurrently served as a project promoter of the Program for Creating New Industry from Universities by the Japan Science and Technology Agency.

Hidehiro Ando

Representative, Andy Pharma Partners

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Management
    Strategy

He graduated from the Department of Veterinary Medical Science, Faculty of Agriculture, University of Tokyo. He joined Tanabe Pharma Corporation (present Mitsubishi Tanabe Pharma Corporation). After being assigned to the research department of pharmacokinetics, he was involved in partnership-related business of international development department, research and development planning department, etc., including establishment of a joint venture with overseas companies. Subsequently, he worked in the technology transfer department of RIKEN (Institute of Physical and Chemical Research), a regenerative medicine venture, Bayer Yakuhin, a drug discovery venture, and he established a personal office. He has engaged in business development and licensing work for about 35 years, and now, based on his experience and networks, he is supporting business development activities, such as licensing agreements and joint research of domestic and foreign pharmaceutical companies/ventures. He provides comprehensive support services ranging from looking for appropriate partners, preparing the draft of contract outline, contract negotiation, and alliance management with partners after the partnership agreement. Especially, based on experience of practicing on both sides of venture and pharmaceutical companies, he keeps in mind providing informative advice and proposals for specific action plans.

Satoru Suzuki

Head of pharmaceutical affairs division OrphanPacific Inc

Main specialty areas

  • Medicines

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

He contributed to the study of biological/diagnostic agents, research planning (intellectual property, license), clinical development, post-marketing studies, quality assurance, and management planning (venture investment, new healthcare, and regenerative medicine, etc.) in pharmaceutical companies and the biosimilar business in bio-venture companies. Currently, he is involved in manufacturing/distribution businesses of orphan drugs at CMIC, as well as medical information utilization and business creation. He mainly provides advice on pharmaceutical/regulatory strategies based on his experience as a general manufacturing/marketing manager and supports preparing business plans and constructing organization of startups. He graduated with a master's degree from the Graduate School of the Tokyo University of Science and is a licensed pharmacist. He graduated with a doctoral degree from the Graduate School, Tokyo Medical and Dental University. He received his MBA from the Anglia Ruskin University. A researcher of Social Cooperation Program of IT Healthcare at the Graduate School of Pharmaceutical Sciences, University of Tokyo. A member of the Japan Association for Chief Financial Officers and Institute for Health Economics and Policy.

Katsuyuki Nakajima

Representative Director, Nakajima Associates Ltd.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Management
    Strategy

He graduated with a master’s degree from the Graduate School of Science, Osaka University, and received a doctor of medicine in Nutrition Science from the School of Medicine, Osaka University. After contributing to Gunma Prefectural Institute of Public Health and Environmental Sciences, he was involved in the establishment of JIMRO Co., Ltd. After that, at the parent company, Otsuka Pharmaceutical Company, he was consistently involved in the diagnostic business and promoted research and development of new technology, science, and sales. Since 2005 when he started a consulting company, Nakajima Associates, he has worked to acquire FDA approval for new diagnostic technology developed mainly by Japanese diagnostic agent manufacturers, as well as instructing sales activities in Europe and the United States. He has served as many visiting professors in medical schools in Japan and the United States and used the network of personal connections built there to back up business that brings out new diagnostic agents and research reagents to the world.

Yoshinori Shinoki

PAREXEL consulting general manager, PAREXEL International Corp.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Management
    Strategy

He graduated from the Department of Biopharmaceutical Sciences, Kyoto Pharmaceutical University, and is a licensed pharmacist. At Sawai Pharmaceutical Co., Ltd., and Eli Lilly Japan K.K., after taking charge of clinical development, SOP/training, sales planning, management planning office, etc., he acquired experience in planning and implementing various clinical development plans as a project leader for newly developed items in the project management department. In addition, he was involved in formulating a drug price negotiation strategy, post-marketing clinical studies and post-marketing surveillance, and market planning. After that, he launched the clinical development department at Global CRO. Since 2015 when he took his current position, he has supported the planning of the clinical development of development items for small and biological products, as well as negotiating with regulatory authorities. Recently, in addition to medicines, he also supports clinical development strategies of medical devices and the products of regenerative medicine (gene therapy products and cell/tissue processed products) and planning.

Masanobu Naruto

Representative, Phronesystems (consulting)
Senior Research Fellow, Toray Corporate Business Research, Inc.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy

He has experienced and learned from many failures and successes through his career of research, planning, business development and business operation, which include co-development with domestic and global companies. In his experiences with startup companies, including opposite extremes of excellent bio-ventures and unsuccessful bio-ventures gave him practical wisdom of startup management. He was involved in the evaluation and review of about 90 startup companies at venture capital institutions. He graduated with a master's and doctoral degree in chemistry from Osaka University. He studied abroad at the Department of Molecular Biology, University of California, Berkeley, for two years. At Toray Industries, Inc., he contributed to R&D, business development and business operation of pharmaceuticals, serving as general manager(s) of several divisions including Regulatory Compliance Division, Pharmaceutical Research Laboratories, and Pharmaceuticals Division. After retiring from Toray, he has been working in the consulting business, and serving as Senior Research Fellow at Toray Corporate Business Research, Inc. and committee member at several public institutions for R&D. He has published 38 academic papers in English (total citation, 2090) and 37 opinion articles on research and development in Japanese journals.

Kenichi Yamahara

Associate Professor at the Pharmaceutical Research and Development Department of Institute for Advanced Medical Sciences, Hyogo College of Medicine
Associate Professor at the Hematology Department of Blood Transfusion & Cell Therapy Center, Hyogo College of Medicine (additional post)
Director of Japan Biomedical Co., Ltd.
Director of CTEX Co., Ltd.

Main specialty areas

  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Management
    Strategy
  • Intellectual
    property
    management

From the time of a former position at the National Cerebral and Cardiovascular Center, he planned and implemented the formulation of the amnion-derived mesenchymal stem cells and investigator-initiated clinical trials for acute grafts versus host disease/Crohn's disease in cooperation with Hokkaido University Hospital under the support by Health and Labour Sciences Research Grants/AMED. He often had PMDA consultations on the products of regenerative medicine and acquired knowledge of laws and regulations. Taking advantage of the experience, he founded a venture, Japan Biomedical Co., Ltd., which manufactures the domestic bovine serum NeoSERA® for the products of regenerative medicine by satisfying the standards for biological materials in January 2017. Furthermore, in order to aggressively develop investigator-initiated clinical trials of cell therapy making use of university hospital infrastructures, he founded a venture, CTEX Co., Ltd., from Hyogo College of Medicine in February 2018. Recently, he participated as a medical expert in company clinical trials of the products of regenerative medicine. Currently, he is working on the practice of cell therapy development initiated at the university hospital while concurrently serving in the basic and clinical departments of Hyogo College of Medicine.

Kazuhide Hasegawa

Director, Bristol-Myers Squibb Company

Main specialty areas

  • Medicines
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Management
    Strategy

After graduating with a doctoral degree from the Graduate School of Pharmaceutical Sciences, University of Tokyo, he was in charge of drug discovery research, management planning, and public relations at Kyowa Hakko Kogyo Co., Ltd. (Kyowa Hakko Kirin Co., Ltd.), external corporate communications for Bristol-Myers Squibb Company, and then from 2018, public relations for overseas research at the Tokyo Institute of Technology. Regarding studies, he participated in the establishment of the Bessel Research Laboratory, which was established by joint investment by the Organization for Pharmaceutical Safety and Research, where as a project leader, he conducted many collaborative studies with research institutions, including Tokyo University, leading to the commercialization of a diagnostic agent for heart diseases. Regarding management planning, he conducted technology assessments of candidate companies for M&As. Regarding public relations-relating experience, he was involved in the post-merger integration of Kyowa Hakko Kirin, internal and external public relations activities, and corporate branding. He started communications with digital media in a pharmaceutical company before others by using characters, new cartoons, and media arts, thereby their technologies could be communicated in an easy-to-understand way. As a result, the company received the bronze Cannes Lions Health. At the Bristol-Myers Squibb Company, he earned a reputation because he explained the features of an immune checkpoint inhibitor, which is a drug with a novel mechanism of action, to media in an easy-to-understand way. He desires to create new business from the standpoints of technology and communication.

Yasuhiro Kubo

Representative, Yasuhiro Kubo Professional Engineer Office

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Business
    planning
  • Fundraising
  • Management
    Strategy

He graduated with a bachelor’s degree in engineering from the Department of Biological Science and Technology, Faculty of Engineering, Tokushima University, and with a degree of Master of Arts from the Department of Material and Life Information Science, Graduate School of Human Information Science, Nagoya University. He was involved in industrial technology engineering and response to various laws and regulations (GMP, QMS, and ISO) related to multiple areas, including medical products, medical devices, test and diagnostic agents, cosmetics, and functional foods in a domestic pharmaceutical company.

He contributed to the development of injection drugs for knee osteoarthritis and adjuvant agents in ophthalmic surgery, which were staple products, in Europe and (North) America. In venture capital firms (bank-affiliated and finance-related), he provided technology-based venture companies with hands-on investment and consulting services, as well as inspections to determine whether or not an investment was appropriate. He also has experience in supporting business management as an outside director for two invested companies. One of them had successfully completed a merger and acquisition. He was involved in constructing a portfolio of a biotechnology and life science fund with a total value of ten billion yen. In a management counseling firm, he supported management in the planning and implementation of R&D strategies for publicly traded companies. He also has experience in debt payment rescheduling reaching a total of 4 billion yen for a middle-ranking IT company in cooperation with a lawyer's office, which led to a successful result. As a professional engineer (biotechnology) and management consultant, he is currently providing technological management innovation consulting services for the growth of mainly middle-ranking, small and medium enterprises, and venture companies.

Atsushi Usami

University of Tokyo Edge Capital (UTEC)

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated with a doctoral degree from the Graduate School of Pharmaceutical Sciences, University of Tokyo. He is a licensed pharmacist. He was involved in consulting services at Mitsubishi Research Institute, Inc. Subsequently since October 2013, he has participated in the University of Tokyo Edge Capital (UTEC) program. He is currently involved in investment activities in seed and early-stage venture companies focusing on the life science fields as a partner. He provides support for commercialization as a project promoter of JST START and a mentor for NEDO TCP, as well as serving as a lecturer of Education Seminar for Collaboration Between Industry and Academia at the University of Tokyo Life Innovation Leading Graduate School.

Kazushi Kamitani

Representative, JPRO Consulting Office

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Management
    Strategy

He played a wide range of roles, including product development, marketing, public relations and IR, overseas operation, business development, and clinical development at large life science companies in Japan and overseas for over 20 years. He participated in the development of a variety of products, including consumer healthcare products, OTC, generic drugs, prescription drugs, medical devices, and dental materials. He has a wealth of experience in managing international businesses, for example, serving as a representative of the overseas operations of a Japanese pharmaceutical company and a foreign venture company. Since starting his own business, he has providing consulting services and support for the whole range of management to investment and consulting firms, life science companies, and small and medium enterprises in Japan and overseas. He is trying to provide practical support based on his practical experience of the product and business lifecycle ranging from product development to commercialization and business management.

Michiko Echizenya

Assistant Chief, RIKEN Cluster for Innovation, RIKEN

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

She received the degree of doctor of medicine form Kyoto University. After serving as a postdoctoral researcher at the Institute of Regenerative Medical Science, she was involved in obtaining patents on medicines and biotechnologies and promoting technology transfer at the Office of Society Academia Collaboration for Innovation. Since 2012, she has been in her current role. She is working on supporting research promotion and putting into practical use the research results from academia, including consultation about inventions, intellectual property licenses, support for acquirement of external funds, and coordinating the conclusion of each contract for collaborative research. She completed the NEDO Technology Startup Supporters Academy (SSA) (the first generation).

Daisuke Sugiyama

Vice Head of the Center (Professor), Advanced Fusion Medical Creation Center of Kyushu University

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated with a doctoral degree in medicine from the Graduate School of Medicine, University of Tokyo. After working for a hospital as a clinician, he studied under a scholarship for studying in France from the French government and worked as an Overseas Research Fellow of the Japan Society for the Promotion of Science. After that and since 2006, he had worked for Kyushu University. Since 2012, he has been at the Center for Clinical and Translational Research (CCTR) of Kyushu University Hospital, where he has promoted translational research projects of identifying and fostering drug seeds and collaboration among industry, government, and academia. Making use of his experience in serving as a TLO advisor and starting a business, he is also fostering BIO entrepreneurships.

Naoko Machida

Main specialty areas

  • Medicines
  • Regenerative medicinal products

Specialized support fields

  • Fundraising
  • Intellectual
    property
    management

She graduated with a doctoral degree in engineering from the Graduate School of Engineering, University of Tokyo. After performing roles related to patents at public agencies and institutions, she was involved in obtaining patents on research and technology seeds from national and public universities. She is involved in application strategies and contracts on intellectual property for commercializing. She specializes in the medicinal products, biotechnology, and regenerative medical technology fields. She completed the 2017 NEDO Technology Startup Supporters Academy.

Junichi Imoto

Senior Venture Capitalist, Nissay Capital Co., Ltd.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated with a master’s degree from the Division of Material Chemistry, Graduate School of Engineering, Kyoto University. He was involved in research and development of medicinal products at the Synthetic Organic Chemistry Laboratories of Fujifilm Corporation. Subsequently, he performed duties relating to patent and bibliographic information at Thomson Reuters. Since 2015, he has worked on investment activities mainly in research and development-driven venture companies at Nissay Capital Co., Ltd. He invested in more than 20 companies. Among them, he holds the position of outside director in nine companies. He is working on providing active support for venture companies, for example, performing a project promoter of New Energy and Industrial Technology Development Organization (NEDO) and Japan Science and Technology Agency (JST).

Miyuki Shimizu

Medical Lab Partners Corporation

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Management
    Strategy
  • Intellectual
    property
    management

She graduated from the Graduate School of Natural Science, Chiba University. She holds the degrees of doctor of medicine and master of management in information technology. She worked on the development of medical devices and medicinal products in a wide range of fields related to blood, surgical operations, general-purpose medical devices, dialysis, and rehabilitation at Terumo Corporation. She also has experience in a series of project developments from planning a theme to commercializing at a medical practice, as well as experience in management. Since 2015, she has provided consulting services to more than 100 companies entering the medical industry as her current role. She is trying to provide consulting services with the viewpoint of the individual company in mind.

Takato Noumi

Representative Director, FORESIGHT&LINX Cp., Ltd.

Main specialty areas

  • Medicines

Specialized support fields

  • Business
    planning
  • Fundraising
  • Management
    Strategy

At his consulting company, he is currently providing practical support for constructing research strategies, business development, and licensing regarding to drug discovery to pharmaceutical companies and biotech venture companies in Japan and overseas. After completing his postgraduate course, he worked in basic research in molecular biology for 10 years followed by joining the Research Division of the headquarters of Novartis. Subsequently he served as the head of theTsukuba Research Laboratories of GlaxoSmithKline K.K. He had engaged in drug discovery research from a global point of view for 15 years. After that, he has been involved in searching for and evaluating drug discovery seeds and technologies and developing international businesses and licensing at Sanofi S.A. in France and his own consulting company for 10 years. He has a broad network of connections with pharmaceutical companies, biotech venture companies, academia, and venture capital firms in Japan and overseas.

Yusuke Shinozawa

Head of the Investment and Fostering Research Center, Real Tech Fund (Leave a Nest Co., Ltd.)

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated with a master's degree in agriculture from the Graduate School of Agricultural and Life Sciences, University of Tokyo. After working at a PR firm, in 2009, he joined Leave a Nest Co., Ltd. In the same year, he launched a Silicon Valley training project for graduate students, which was the first overseas project for Leave a Nest Co., Ltd. In 2012, he also established a media development project, and from 2013, he established the seed acceleration project Tech Planter. He became growth manager at the Real Tech Fund in 2015, where he limited his target fields to biotechnology and marine fields, and he offered business support in these fields. In 2018, he became manager of the Frontier Development Division. He is doing his activities with “starting business operation” as his theme, not “starting a business.”

Hajime Oshita

Representative Director, MedVenture Partners, Inc.

Main specialty areas

  • Medical devices

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

After working on a negotiation at Japan Lifeline Co., Ltd., with medical device venture companies in 1997, at a venture capital firm in Japan, he was responsible for investing in medical device venture companies in the USA. Companies in which he invested enjoyed record success at the time. Therefore, he was employed by a local venture capital firm in Silicon Valley and since then, he has been involved in investment activities with medical device venture companies in the USA for about five years. He was involved in many invested companies as a leading investor in the USA, most of which reached the exit. Chestnut Medical developed the Pipeline Stent, which became the most cutting-edge product in the world for treatment of cerebral arterial aneurysms. He invested in Chestnut Medical from the early phase of development. He held the position of lead investor, and at the same time, he was deeply involved in management. In 2013, he established MedVenture Partners, Inc., a venture capital firm specialized in medical devices. He performed successful cases such as Biomedical Solutions Inc., C2 Therapeutics Inc., etc., with a find of 1 of 6 billion yen.

Satoshi Fukushima

Globis Capital Partners & Co.

Main specialty areas

  • Medical devices

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy

He graduated from the Faculty of Economics, University of Tokyo. He was involved in investment activities in reformed fields of existing industries, including digital health, at Globis Capital Partners & Co. (GCP). He served as an outside director of several companies, including Medley, Inc., Kakehashi Inc., and Yoriso. Co. Ltd., and provided support to their management personnel mainly in strategy formulation, development of the organization, and finance. In addition to investigation activities, he provided support for fund structuring and open innovations provided by large companies in healthcare fields.

Before joining GCP, he was serving as an M&A advisor mainly in the technology, media, and telecommunication fields and worked on financing at the general headquarters of German Securities Finance Corporation.

Taiki Ishikura

Japanese Organization for Medical Device Development, Inc.

Main specialty areas

  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy

He specialized in startups and the development of starting businesses in the medical area. Aqumen Biopharmaceuticals K.K., a drug discovery venture company, of which he participated in its establishment personally, commercialized a university-launched technology for the first time in Japan and succeeded in placing it in the European market.
After that, at M3, a medical IT venture company, he led the development of a new project for IT services to accelerate clinical trials conducted by pharmaceutical companies and medical device manufacturers. During the time when he was studying for the master of business administration (MBA) degree at Stanford Graduate School of Business, he investigated the investment in start-ups of mHealth and Health Tech, as well as gaining experience in the Biodesign program. He is currently serving as a director of P5, Inc., and a member of Biocamp Judging Committee of Novartis Pharma K.K.

In 2015, he became a part-time lecturer at the Graduate School of Pharmaceutical Sciences, University of Tokyo.
In 2017, he held the positions of a TCP mentor for the New Energy and Industrial Technology Development Organization (NEDO) 2017 and an advisor for MIRAI 2018.

Masakatsu Noguchi

Japanese Organization for Medical Device Development, Inc.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Management
    Strategy

He graduated from the Faculty of Science, Kyoto University. He also graduated with a doctoral degree from the Graduate School of Biostudies, Kyoto University. He also engaged in basic research in intractable neurological diseases under the Research Fellowship for Young Scientists (DC2) of the Japan Society for the Promotion of Science. Before the above position, he worked for the Japanese and Singapore subsidiaries of Abbott USA. He was responsible for product marketing of diagnostic agents and devices, medicinal products, and for area marketing of Asia & Pacific of medical IT. He was the only Japanese among 15 employees who were selected from Asian countries for the Asian countries Management Development Program of this company. Before his previous job, he worked for Dream Incubator Inc., where he was in charge of support for collaboration between industry and academia and for technology-based start-ups, and support for large companies implementing new businesses, as well as being in charge of large projects undertaken by public agencies.

In 2014, he served as a member of a committee asking for ideas from the public in the Kanagawa Prefecture Healthcare Planning Promotion Council and was involved in project management for developing medicinal products and diagnostic agents and devices.

Masahiro Shinoda

Japanese Organization for Medical Device Development, Inc.

Main specialty areas

  • Medical devices

Specialized support fields

  • Intellectual
    property
    management

He specialized in business development based on his experience in intellectual property. He has experience in launching a start-up as a sideline while pursuing research in nanotechnology from his time at a university. After that, he contributed to out-licensing a system developed by Transcosmos Inc. in the early days of the Internet to a large company. He provided support for gaining over 100 patents, ranging from vehicle to medical care, at the Tokyo Central Patent Firm. He was providing support to the Institute of Immunology, a traditional biotechnology-based company. At the company, as an intellectual property director of a related company, he promoted the development of research and business with patents from Japan and the USA, which were in-licensed from a doctor. In addition, he settled disputes about patents of medical devices and antibody drugs there. After that at Astamuse Company, Ltd., which is a Tokyo University-launched venture company, he participated in a project for patent analysis and a distribution platform from the planning stage. There he also contributed to launching a new project for consulting about R&D and new business. He is an IT strategist sanctioned by the Ministry of Economy, Trade and Industry.

Koji Matsushima

Main specialty areas

  • Medical devices

Specialized support fields

  • Laws and
    regulations
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated from the Department of Communication Engineering, Faculty of Electro-Communications, University of Electro-Communications.

Since entering Konishiroku Industry Ltd. (current Konica Minolta, Inc.), he has been involved in the research and development of optical instruments and printing systems for over 20 years. Subsequently, he provided responses to laws and regulations about healthcare projects and QMS system management, thereby being involved with laws and regulations about medical devices in various countries, as well as the acquisition and maintenance of safety standards. From 2015, as a medical-industrial cooperation coordinator from a public support organization, he provided support for matching, responses to laws and regulations, funding and intellectual property strategy in support programs for small and medium enterprises (SME), and venture companies entering the medical devices industry. He is currently a freelance consultant.

Hiroyuki Hasegawa

Director of Life Science, Mitsubishi UFJ Capital Co., Ltd.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy

He graduated with a master’s degree from the Faculty of Pharmaceutical Sciences, Hokkaido University. In 1994, he joined Daiichi Seiyaku Company (current Daiichi Sankyo Company, Limited) and was in charge of the areas of infectious diseases and cancers in the Department of Post-marketing Surveillance. In 2004, he joined UFJ Capital Co., Ltd. (current Mitsubishi UFJ Capital Co., Ltd.), where he served as an analyst and capitalist. From 2013, he made an attempt to use open innovation for the Development of Emerging Technologies (OiDE) Fund for the purpose of nurturing outcomes from academia-launched research to become the fundamental technology for drug discovery in collaboration with Daiichi Sankyo Company Limited. He promoted investment activities using Mitsubishi UFJ Life Science Number 1 Fund (10 billion yen) established in 2017.

Currently, he holds the position of outside director at OiDE CapiSEA Company, OiDE Adjubilee Company, and Kamuipharma Co. JP., as well as serving as a fellow for collaboration between industry and academia at Kyoto University Medical Science and Business Liaison Organization.

Hiroaki Kato

Visiting Professor, The Graduate School of the Digital Hollywood University

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy

He is a former government official of the Ministry of Health, Labour and Welfare and is working as a doctor specialized in digital health, including telemedicine, AI, and IoT. As an ophthalmologist, he has experience in more than 1,500 surgical operations. He developed instruments for cataract operations and ophthalmic consultation services.

He is a rare person who has experience in three areas—medical practice, medical systems, and business—which are required for medical care and the healthcare business, and he understands these areas, providing support for the development of new business covering the full range of medical care. He is also familiar with Japanese medical venture companies and works as a consultant, advisor, and director for large enterprises and venture companies. He wrote 41 books, including Medical Care 4.0 — Medical Care in the Fourth Industrial Revolution Era—.

Tsutomu Uchiyama

Head of the Office, Tsutomu Uchiyama Intellectual Property Strategy Office

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Intellectual
    property
    management

Patent Attorney/Doctor of Pharmacology After working as a researcher in molecular biology for Daiichi Pharmaceutical Co., Ltd., he passed the examination for patent attorneys in 1996. He worked in the intellectual property departments of three companies—Takeda Pharmaceutical Company Limited, SoftBank Investment, and Eisai Co., Ltd.—for a total of 20 years, where he was involved in patent practice and the direction, supervision, establishment, and implementation of patent strategies, as well as patent applications and acquisition of rights patent clearance, and intellectual property due diligence. In April 2017, he established Tsutomu Uchiyama Intellectual Property Strategy Office. Making use of his previous experience, he is currently providing support for mainly venture companies, small and medium enterprises, and academia regarding patent strategies and agreements for research in drug discovery, regenerative medicine, and biotechnology fields.

Ayuko Nemoto

Lawyer, Sonderhoff & Einsel Low and Patent Office

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

She graduated from the Faculty of Law, University of Tokyo. She received her LLM from Georgetown University Law Center. A lawyer (Japan and New York State). She worked for foreign-affiliated lawyer's offices (Clifford Chance LLP and K&L Gates Foreign Laws Joint Enterprise Lawyer's Office) and was temporarily transferred to other company, during which she was involved in public relations and corporate law. She provides advice on laws and regulations for medical devices, pharmaceutical products, and regenerative medicine and is involved in legal audits and contract negotiations for investment in and acquisition of healthcare-related venture companies. She also provides general legal support for healthcare-related venture companies (corporate, intellectual property, labor, response to M&A, contract, personal information, pharmaceutical affairs and advertising regulation, response to dispute and accident).

Takayuki Hirose

Patent attorney, Hirose International Patent Firm

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Intellectual
    property
    management

He graduated with a master’s degree from the Graduate School, University of Tokyo. Patent attorney. After working in the intellectual property department in a major company, he was involved in lawsuit-, adviser- and application-relating services at a lawyer's office, followed by establishing his own international patent attorney's office in 2017. He offers intellectual property strategies in cooperation with companies as an adviser for multiple companies, including the Japanese Organization for Medical Device Development, Inc., (JOMDD) and Shin Nippon Biomedical Laboratories, Ltd. Furthermore, he applies for patent rights and trademarks in a wide variety of areas. He is involved in intellectual property-related services that include medical devices and pharmaceutical products. When he applies for a patent in foreign countries, he offers application strategies by placing the most importance on client’s profit, for example, to give advice to receive a subsidy or to select a foreign agent at a reasonable price depending on the company’s size.

Tomoko Nakatani

Prezio IP Firm

Main specialty areas

  • Medicines
  • Regenerative medicinal products

Specialized support fields

  • Intellectual
    property
    management

She graduated from the Department of Life Science and Technology, School of Bioscience and Biotechnology, Tokyo Institute of Technology. After working at a research institute of Sankyo Company, Limited, she gained experience in intellectual property about low molecular weight compounds and biopharmaceuticals in the Intellectual Property Department. Subsequently, she was in charge of intellectual property assessment and investment and intellectual property consulting about investment destinations at biotechnology venture capital firms. For the purpose of providing support for strengthening intellectual property in biotech venture companies, she moved to a patent attorney's office, where she supported intellectual property strategies and human resources development in addition to application and procedures at the Japan Patent Office of biotech venture companies and universities. She has more than 10 years of experience supporting intellectual property of venture companies and universities with her strong interest in putting into practical use research seeds by effectively gaining patent rights.

Katsuya Hashizume

Leader of the Group for Investment Through Collaboration Between Industry and Academia, JAFCO Co., Ltd.

Main specialty areas

  • Medical devices

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

After graduating with a master’s degree from the Graduate School of Media and Governance, Keio University, he joined JAFCO Co., Ltd. Since he joined the company, he has consistently engaged in investment in university-launched venture companies. He made several investments in life science companies (gene analysis, diagnostic devices such as POCT, surgery support robots, medical devices such as those for cerebrovascular thrombectomy, regenerative medicine, and bioinformatics) at the seed or early stage in the company’s lifecycle. He also holds the positions of outside director of multiple university-launched venture companies. He is working on commercializing the technology seeds possessed by research institutes such as universities as a representative project promoter of the Program for Creating Start-ups from Advanced Research and Technology (START) operated by the Japan Science and Technology Agency (JST).

Kenji Harada

Principal of the Investment Group of Life Science Investment Division, JAFCO Co., Ltd.

Main specialty areas

  • Medicines
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated with a doctor of pharmacy degree in immunology from the Faculty of Pharmaceutical Sciences, Tokyo University. He is also a licensed pharmacist and first class radiation protection supervisor.
After obtaining his degree, he performed a wide range of tasks from basic research to development research as a team leader at Toray Basic Research Laboratories (current Pharmaceutical Research Laboratories) during which he developed drugs with anti-inflammatory action and drugs with central action. Subsequently, at the headquarters, he was involved in planning and promoting collaborative research with universities, as well as making assessments from the aspect of technology and intellectual property of fundamental technologies and drug candidates of biotech venture companies in the US and Europe. Furthermore, he conducted and permitted manufacturing GMP inspections in pharmaceutical products and medical care areas multiple times. After joining JAFCO Co., Ltd., he consistently made investments in biotech venture companies in the US and Japan. He took part in the management of invested companies in the US as a director. He is still the director of an invested company in the US. He was appointed a promoter of the Program for Creating Start-ups from Advanced Research and Technology.

Masaki Sato

Principal of the Investment Group of Life Science Investment Division, JAFCO Co., Ltd.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated with a doctoral degree from the Graduate School of Pharmaceutical Sciences, Hokkaido University. He received a doctor of pharmacy in immunology and is a licensed pharmacist. After joining the Medical Department of Mitsubishi Kasei Co., Ltd., he worked mainly in the clinical development and development planning of medicinal products in areas of central nervous system. After working in the departments of Management Strategies and Business Administration at Mitsubishi Pharma Corporation, from 2006 at JAFCO Co., Ltd., he has been involved in investment in unlisted Japanese biotech venture companies (drug discovery, medical devices and regenerative medicine) and post-investment financial support. He currently holds the post of a project promoter of the Program for Creating Start-ups from Advanced Research and Technology (START) operated by the Japan Science and Technology Agency (JST).

Miwa Toyoda

Principal of the Investment Group of Life Science Investment Division, JAFCO Co., Ltd.

Main specialty areas

  • Medicines
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy

She graduated with a master’s degree from the Faculty of Pharmaceutical Sciences, Tokyo University. She is a licensed pharmacist. In 2014, she joined JAFCO Co., Ltd., where she was involved in investment in biotechnology and medical device venture companies in Japan and overseas. In her former job at Ono Pharmaceutical Co., Ltd., she was involved in a series of departments from research, development and planning, and clinical development to business development. At the period when she was in the department of business development, she worked on a lot of compound evaluations and evaluations of clinical needs. Based on that experience, she can offer advice from the perspective of pharmaceutical companies in consideration of a possible future business partnership.

Bumhwan Lee

The Third Investigation Department, Mitsubishi UFJ Capital Co., Ltd.

Main specialty areas

  • Medical devices

Specialized support fields

  • Business
    planning
  • Fundraising
  • Management
    Strategy

He graduated with a doctoral degree in engineering from the Department of Chemistry & Biotechnology, School of Engineering, University of Tokyo. He had several roles, including research and development, national project management, product development, and technology sales, in venture companies and universities. He worked on development planning, business planning, and planning of new business in the diagnosis division at a leading chemical manufacturer. He provided support for the potential IPO process at a securities company and took part in the establishment of university-related funds. Currently, he is working on investments in university-launched venture companies and medical devices- and medical care service-relating venture companies at a venture capital.

Shigeru Yasue

Mitsubishi UFJ Capital Co., Ltd.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated from the Department of Economics, School of Political Science and Economics, Waseda University.
He was involved in investments in biotech venture companies in Japan, the USA and Europe at Mitsubishi UFJ Capital Co., Ltd. for 18 years.
He has accumulated experience in reviewing presentations given by hundreds of companies and conducting due diligence by discovering cases of biotech venture companies in Japan and overseas, which are developing cutting-edge technologies, including regenerative medicine, nucleic acid drug discovery, and antibodies.
A pharmaceutical company, even a domestic one, searches for the best business partner from among many counterparts of the negotiation all over the world.
To make it possible to expand an excellent science business, various types of skills, including those in intellectual property, business planning, negotiation for a partnerships, and presentations, need to be improved to levels that are not lower than those of foreign venture companies.

Achievements
Support for biotech venture companies’ activity aiming at obtaining license from foreign pharmaceutical companies.
Support for biotech venture companies’ activity aiming at obtaining license from Japanese pharmaceutical companies.
Planning and support for financing from venture capital firms

Koji Yoshida

Representative Director, Luminov Inc.

Main specialty areas

  • Medical devices

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

After graduation from university, he was involved in marketing at the world's biggest foreign-affiliated manufacturer of artificial joint for 20 years. After he experienced the role of a leader of unit with a budget of 15 billion yen, he launched his own business in 2014. He established Luminov Inc., which specializes in the development, manufacturing, and sales of medical devices. In 2017, he planned a medical-industrial cooperation event on consignment from a public entity. He held workshops for companies who entered this industry from different industries. Products newly developed at these workshops were highly regarded, having won a second prize in an international event associated with medical care devices. Furthermore, the unique strategy for developing medical devices that uses workshops and medical care products originated from these workshops were frequently quoted in the media.

Kiyoshi Kanazawa

Janssen Pharmaceutical K.K.

Main specialty areas

  • Medicines

Specialized support fields

  • Laws and
    regulations

He graduated with a doctoral degree in science and engineering from the Graduate School, Tokyo Institute of Technology. He has worked at several pharmaceutical companies, during which he had engaged in drug discovery research as a pharmacological researcher (at Japanese-affiliated companies and venture companies for eight years) and after that he has been involved in portfolio management (as his current position at a foreign-affiliated company for five years). At venture companies, he contributed to concluding some types of contracts, contracts of collaborative research with pharmaceutical companies, and contracts for collaborative development and research with university hospitals as a person responsible for pharmacology. He is willing to contribute to formulation of study plans based on medical needs at the worldwide scale, not on a domestic scale, in this project. He has experience in areas of cancer, auto-immune disease, respiratory disease, and chronic kidney disease.

Makoto Nakagawa

Head of the Department of Planning Technology for Home Medical Care, Teijin Pharma Limited

Main specialty areas

  • Medical devices

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated with a master’s degree from the Department of Medical and Biological Engineering, Graduate School of Science and Technology, Keio University. In the Business Division for Home Medical Care of Teijin Pharma Limited, he was involved in planning research and development of home medical care devices, development project management, creating medical innovation by using the BioDesign strategy, collaborative research and development with venture companies, application for approval and certification for medical devices, and establishing a medical device manufacturing plant in a foreign country. He currently supervises the department of research, development, manufacturing, and after-sales service as the head of the Department of Planning Technology for Home Medical Care. He has wide range of knowledge about research and development management, ranging from proposing a concept of medical devices and services to business viability evaluations, feasibility studies, prototyping, nonclinical and clinical assessments, product design, obtaining approval and certification, and manufacturing.

Bunsei Kawakami

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated with a master’s degree from the Division of Agricultural Chemistry, Graduate School of Agriculture, Kyoto University. He holds a doctoral degree in agriculture. He was in a department for healthcare project in a private company for 31 years, where he was involved in product development and marketing of chemical reagents and devices for life science research and in vitro diagnostic reagents and devices. After retirement, he worked for a public industry support organization for five years, where he supported product development (including intellectual property and response to laws and regulations) and sales channel development (including overseas) promoted by companies aiming to newly enter the healthcare business. He hopes to provide support for product development and sales channel development of medical venture companies by using his knowledge, experience, and human network of connections that he has gained through these business activities.

Kazuhiro Takekita

Specially Appointed Lecturer, Surgery Course, Department of Cardiovascular Surgery, Graduate School of medicine, Osaka University

Main specialty areas

  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Intellectual
    property
    management

He was involved in launching a project of regenerative medicine by using autologous skeletal muscle-derived cell sheets in the Department of Cardiovascular Surgery, Graduate School of Medicine, Osaka University. Subsequently, he was involved in the evaluation of regenerative and biological devices at the Pharmaceuticals and Medical Devices Agency (PMDA). He performed several duties related to the Health Labour Sciences Research Grant, clinical study of human stem cells, and advanced medical care at the Research and Development Division, Health Policy Bureau, Ministry of Health, Labour and Welfare. After that, he led the regenerative medical product evaluation unit as chief of the Office of Review for Regenerative Medical Product, PMDA. Also, he was involved in improving the legislation for regenerative medical products in the revision of the Pharmaceutical Affairs Law in 2014. From August 2017, he has been serving as a specially appointed lecturer in the Department of Cardiovascular Surgery, Graduate School of Medicine, Osaka University, where he promotes projects to develop various products derived from human-induced pluripotent stem cells.

Nobutaka Tani

Coordinator for Collaboration Between Industry and Academia, “Compass to Healthy Life” Research Complex program of the Institute of Physical and Chemical Research

Main specialty areas

  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated with a master’s degree from the Department of Synthetic Chemistry, Graduate School of Engineering, University of Tokyo. He led the research and development and the launching new project for medical devices, including blood purification system and brain and heart catheters, at Kaneka Corporation. After that, he was involved in RD of the whole life science, including biopharmaceuticals, as the head of the Life Science RD Center, while investing in medical venture companies such as DDS and establishing joint ventures. He then moved to JSR Corporation and established JSR Life Sciences. He led the launch of the life science project for M&A as the first president since JSR Life Sciences was established. As a part of open innovation, he established a CVC and invested in or acquired venture companies in Japan and overseas, while successively holding the positions of president of the invested companies.

Koichi Kanemoto

Part-time Lecturer, The Jikei University

Main specialty areas

  • Medical devices

Specialized support fields

  • Marketing
  • Business
    planning
  • Management
    Strategy

He graduated from the Department of the Electronics, School of Engineering, Tohoku University. He graduated with a doctoral degree in engineering form the Graduate School of Systems and Information Engineering, University of Tsukuba. At a manufacturer specialized in medical devices, he was involved in the research and development of biometric devices, as well as response to safety standards and quality management of medical devices. He launched a medical device project at a general electronic manufacturer, where he worked to develop diagnostic imaging devices and managed the medical device project. He worked on the research and development of medical devices and management at welfare equipment manufacturers and medical venture companies. Subsequently, he conducted research in medical engineering and medical devices as an associate professor of a medical school. JRCA QMS judge (sub).

Makoto Shigematsu

Representative Director, Kai Fostering Partners Inc.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

He worked on a new project research and development, trial manufacture, mass production, and commercializing of glass delay line element for VTR at Asahi Glass Co., Ltd. He moved to CSKVC by making use of his relevant experience. As a venture capitalist, he engaged mainly in establishing, financing, fostering, and managing venture companies. He practiced monetizing of novel technologies, timely financing, establishing organization and management, sharing an exit strategy as a milestone, active use of intellectual property rights (open and close), and business talks and negotiations (not bargaining) hated by engineers. He has providing support for company’s growth fostered by competition and cooperation, while being employed by traditional companies for 20 years and by venture companies for 20 years with an understanding exactly the opposite of the corporate culture of both.

Shin-ichi Kamachi

CRO-K Co.,Ltd

Main specialty areas

  • Medicines
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Business
    planning
  • Management
    Strategy

He graduated with a doctoral degree from the Graduate School of Pharmaceutical Sciences, Kyushu University. After joining General Research Laboratories of Chugai Pharmaceutical Co., Ltd., in 1977, he consistently contributed to the research and development of medicinal products. He has experience in gaining marketing approval for one low molecular drug and four biopharmaceuticals. He has also experienced recommendations under the centralized procedure in the European Union for the first time for a Japanese company. Since 2004 of early retirement, he has been involved in consulting services about the development of biopharmaceuticals targeting a wide range of companies from leading pharmaceutical companies to venture companies, focusing on the CMC of biopharmaceuticals. At the time, he established the Japanese branch of a consulting company specializing in biopharmaceuticals (Biologic Consulting Group, BCG) but now provides support for development and advice as a senior consultant of CRO-K Co., Ltd.

Tamaki Nara

Director, Olvis Planning Co., Ltd.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

She graduated from the Department of English Literature, School of Humanities, Kansei Gakuin University (English and Sociology) and graduated from Business Breakthrough University (Management and Marketing). She worked in the international department of a city bank, lived in the UK, and then worked for a leading precision equipment maker. She devoted almost five years to making plans for new project and management for digital equipment and then devoted almost ten years to providing planning and development and making plans for management for new field products in medical devices and healthcare (medical IT) projects. Especially during this period, she felt great significance in establishing a collaborative development system with medical-based researchers while experiencing the bodily sensations of strength, weakness, joy, a feeling of achievement, and challenges in developing new business in medical devices and healthcare in companies. This experience made her give guidance about medical device development and open innovation establishment. Since then about four years have passed and her role has not changed.
Paper: Cancer and Chemotherapy, 2015, joint work
Title: Development of Support System for Breast Cancer Patients,
Managing Side Effects Through an Internet-based System, etc.
Lecture:
A Symposium for innovation through collaboration between industry and academia in Waseda University and Kobe University
Collaboration Between Industry and Academia in the Development of Medical Devices in Our Company—from an experience of accepting an internship of a doctor from the School of Medicine, Kobe University.

Hiroshi Akimoto

Representative Director, Intellectual Property Strategy Network, Inc.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

In 1970, he graduated with a doctoral degree in pharmacology from the Faculty of Pharmaceutical Sciences, the Tokyo University.

He was research staff at the Department of Chemistry, University of Pennsylvania. In 1972, he joined Takeda Pharmaceutical Company Limited, where he was involved in research on antibiotics and cancer areas at the chemical laboratory. He successfully developed two new drugs (Pansporin and Alimta). He successively held the following positions of director of the Third Drug Discovery Research Institute in 1992, director of the Intellectual Property Department in 1994, company director in 2000, managing director in 2003, and a member of the management conference from 2005. In 2008, he retired from his position. After that, he was the leader of a project for iPS cell intellectual property support as a counselor on intellectual property from the Japan Pharmaceutical Manufacturers Association. In July 2009, he established Intellectual Property Strategy Network, Inc., and became the Representative Director. In August 2010, he established LSIP Fund Management Limited liability Company and became Functional Manager, which is his current role today.

Hirofumi Usami

Intellectual Property Strategy Advisor, Intellectual Property Strategy Network, Inc.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Intellectual
    property
    management

Work Experience: He successively held the following positions: Patent License GM in Intellectual Property Department of Takeda Pharmaceutical Company Limited; a permanent member of Industrial Property Right Committee of Osaka Pharmaceutical Industries Association; a visiting professor at the Graduate School of Law, Kyoto University; Director Responsible for Industry of Japan Intellectual Property Association; a visiting professor in the Dept. of Science and Technology Law, National Yunlin University of Science and Technology (Taiwan); and a professor at the Graduate School of Intellectual Property, Osaka Institute of Technology. From 2013, he became an advisor at Intellectual Property Strategy Network, Inc.

His book: Patent Strategies Necessary to Develop Your Company
His Paper: Yakugaku Zasshi, Patent Management, Pharm Stage, International pharmaceutical intelligence, Research on Intellectual Property, Tokugikon, Intellectual property management, Pharm Tech Japan, Science & industry, etc.

Katsuhiko Hiwatashi

Representative Director, SynX Inc.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy

Regarding company strategy, business management, business transformation, business development and alliances, he has over 20 years of experience in the consumer digital field and about 5 years of experience in the medical care and healthcare field.
In June 2017, he established SynX Inc. to provide support for development of novel business and business innovation focusing on medical care, healthcare, and wellness areas and became the Representative Director.

Major Work Experience
・Business Innovation Director at MSD K.K.
・General Manager of Facebook Japan
・A Responsible Person for Electronic Commerce (EC) Project in President's Office and other positions at Rakuten, Inc.
・Producer for New Business Development at M3, Inc.
・Planning Office and other departments at Recruit Co., Ltd.

Satoshi Konishi

President and Representative, KHE Consulting and KHE International Patent Office

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated with a doctoral degree in engineering from the Graduate School of Engineering Science, Osaka University. He worked on research and development and the business development of medical devices in multiple companies, including Toshiba Corporation and Schlumberger Limited. He served as the director of the research institute and the project leader and promoted collaborative research and collaborative business with enterprises and universities in Japan and overseas. After his retirement, he established KHE Consulting and the KHE International Patent Office. He provides guidance on technology and regulatory to healthcare-related venture companies in Japan and overseas, support for management and commercializing, business liaison services in Japan and overseas, incubations based on intellectual property, and patent applications and right acquisitions of patents. He sponsors seminars on medical device industries, intellectual property rights, and international technology standards.

He was registered as a patent attorney, certified as a foreign certified vocational training instructor by the former Ministry of Labor, and registered as an international business partner in Alberta, Canada. Other than that, he is serving as a counselor on public support for management.

Ikuhisa Sawada

Representative, Intergenome Limited liability Company

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Business
    planning
  • Fundraising
  • Management
    Strategy

He graduated with a doctor of philosophy degree from the graduate school, University of California, Davis. He experienced the early stages of biotech venture companies in the 1980s. After coming back to Japan, at Yamanouchi Pharmaceutical Co., Ltd. (current Astellas Pharma Inc.), he was in charge of research and development strategy for developing new drugs and drug formulations and was involved in strategy formulation and project promotion. Furthermore, he set up multiple projects for collaboration between academia and biotech venture companies in Japan and overseas and collaboration among academia, industry, and government, leading to the promotion of innovative research in drug discovery. After retirement, he joined the New Energy and Industrial Technology Development Organization (NEDO), where he planned and managed biotechnology-related national projects from the government’s point of view. He has consistently promoted the research and development of epoch-making drugs and medical technologies via cutting-edge biotechnology. In 2015, he was a Senior URA (specially appointed professor) at Tokyo Medical and Dental University. In 2016, he established Intergenome Limited liability Company, where he provides support for the research and development of biopharmaceuticals.

Jun Utsumi

CEO, TIR Research Consulting, LLC. and Senior Advisor, Japanese Foundation for Cancer Research

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated from the Graduate School of Veterinary Medicine, Hokkaido University. He has a Doctor of Science degree and an MBA; he is a professional engineer (biotechnology), PMRJ-certified regulatory science expert, and veterinarian (DVM). He was in charge of pharmaceutical research and clinical development at Toray Industries, Inc., and successfully developed a novel antipruritus drug (received the Pharmaceutical Society of Japan Award for Drug Research and Development and the Annual Okochi Memorial Technology Prize). After the business career, he engaged in services for collaboration between industry and academia at Hokkaido University and Kyoto University (professor). Then he consecutively held positions as an expert consultant on pharmaceutical affairs strategy in the Pharmaceuticals and Medical Devices Agency (PMDA) and a senior consultant for intellectual property at the Japan Agency for Medical Research and Development (AMED). Based on more than 30 years of experience in the areas of industry, government, and academia, he established a consulting company in 2018. He is providing commercialization strategies in which the essential three factors of medical R & D—technology (T), intellectual property (I) and pharmaceutical affairs (R)—are integrated. He wrote and published “A Guide to Integrated Strategy in Drug Discovery” (Nanzando Co., 2015).

Miyuki Tanabe

Technical Expert

Main specialty areas

  • Medical devices

Specialized support fields

  • Laws and
    regulations
  • Business
    planning
  • Management
    Strategy

He is a licensed pharmacist (a master's degree in Medicinal Chemistry from Gifu Pharmaceutical University) He is specialized in pharmaceutical regulatory affairs about medical devices and in vitro diagnostics, QMS, and quality assurance. He was involved in research and development, clinical development, and quality assurance of medical devices and in vitro diagnostics as an employee of Asahi Kasei Pharma Corporation. After retirement, he provided consultations on the regulations for university academia or venture companies as a technical expert for the Innovation Practical Application Support and Strategy Consultation Section, Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA). From April 2018, he has been working as a freelance consultant in pharmaceutical regulatory affairs.

Yasuo Sasaki

(Former) A Community Cooperation Coordinator of the Public Interest Incorporated Foundation Shizuoka Industrial Promotion Foundation Pharma Valley Center, Former Pharma valley

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Business
    planning
  • Management
    Strategy
  • Intellectual
    property
    management

He graduated with a doctoral degree in science from the Department of Chemistry, Graduate School of Science, Hokkaido University. He was involved in the research and development of pharmaceutical products as an employee of Asahi Kasei Pharma Corporation. He was mainly in charge of preclinical studies and pharmaceutical affairs. From 2013, he provided support for research and development by academia, drug discovery venture companies, and small and medium enterprises centering on the eastern part of Shizuoka Prefecture. Since 2018, he has been providing support services as a freelance advisor or coordinator in the life science field.

By participating in an investigation conducted by the Japan Health Sciences Foundation, he was also involved in investigations and the planning and management of various types of seminars on medical needs and drug discovery technologies from 2005.

Yukari Kume

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Other

She graduated with a master’s degree from the Graduate School of Philosophy, Sophia University. After studying in the US for three years, she returned to Japan to work as an interpreter and translator of English at a semiconductor manufacturer and an IT company for more than 10 years. In 2012, she joined Mitsubishi Research Institute, Inc., to translate technology into English and was involved in surveys of overseas laws and regulations and the technical regulations governing suitability assessment and authorizations in the fields of railways, aircrafts, and consumer products. From November 2015, she has provided various types of surveys as a freelance consultant.

Rirei Chin

Representative, C-suite Limited liability company

Main specialty areas

  • Medicines
  • Medical devices

Specialized support fields

  • Marketing
  • Business
    planning
  • Management
    Strategy

She graduated with a master’s degree from the Graduate School of Medicine, Keio University. She is a licensed pharmacist and a certified pharmacist in Chinese herbal medicines and crude drugs. At Mitsubishi Research Institute, Inc., she was involved in medical device projects and led clinical needs assessments and product evaluations. As a consultant, she has extensive experience in marketing support for medical devices and pharmaceutical companies. In particular, her strengths are providing advice from the perspective of medical users based on her experience in hospital consultancy. Taking advantage of her knowledge of pharmacology, she provides support for local economic development projects using medicinal crops. In 2017, she established the C-suite limited liability company.

Main article: “How should the hospital/medical industry consider medical technology assessment? – Evaluation of medical economic effects of measures against infectious diseases using AEP –“ (Mitsubishi Research Institute Report No. 56, 2013).

Masaya Nakano

Global Business Development Institute, Inc.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Management
    Strategy

He graduated with a master's degree in applied chemistry from the Department of Applied Chemistry, Graduate School of Science and Engineering, Waseda University. He provided survey and consulting services, such as marketing surveys, business planning, and overseas business development support, as an employee of Mitsubishi Research Institute, Inc. In 2012, he became independent and established the Global Business Development Institute, Inc., serving as the representative director. As a small and medium enterprise (SME) management consultant, he provided survey and consulting services in support of SMEs and venture companies.
Work experience
・ Survey and analysis services related to overseas medical needs and the status of overseas business development by domestic companies
・ Formulation of management corrective action programs for small and medium enterprises and monitoring of the implementation
・ Support for overseas business development by venture companies
・ Miscellaneous achievements in marketing surveys and business planning