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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).

Mirai Miyahara

President of i Access Consulting Inc.

Main specialty areas

  • Medical devices
  • Regenerative medicinal products

Specialized support fields

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

Miyahara holds a Master's degree in Business Administration from the Graduate School of Economics at Tohoku University. She possesses 17 years of professional experience in Regulatory Affairs, QMS, business planning, and overseas marketing at a leading medical device company and Notified bodies in Japan. With a specific focus on multi-country regulatory compliance and extensive experience in overseas medical device markets, Miyahara has demonstrated proficiency in navigating the regulatory landscapes of diverse markets, including Japan, China, India, East Southern Asia, EU and the U.S. She has a proven track record of achieving success in supporting medical companies with regulatory compliance, facilitating international expansion, and establishing strategic partnerships with local entities. Miyahara is also an adviser for JETRO medical devices international expansion program.

Kazuhiro Ikumi

MEDICOLAB Co., Ltd.

Main specialty areas

  • Medical devices

Specialized support fields

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

Board-certified neurologist, CEO at MEDICOLAB, Co., Ltd. My initial job was a medical doctor at a tertiary care emergency hospital. I have 14 years of clinical experience in Parkinson's disease, dementia and other neurodegenerative diseases. MEDICOLAB, Co., Ltd. receives PR and development support from Fujitsu, NVIDIA, Amazon, and Microsoft. I am involved in business development in the CNS area and support researchers for their idea and trial products or services for commercialization.

Yutaka Kono

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

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Other

Eiichi Yamaguchi

Eiichi Yamaguchi, Ph.D. President A1 Partners

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy

Ph.D from Faculty of Pharmaceutical Sciences Kyushu University. Currently engaged in management and business development consulting for pharmaceutical companies, biotech ventures, and consulting firms. Over 20 years expertise of business development at Shionogi Co., Ltd., a major pharmaceutical company as well as bioventure companies. Senior Director, Business Development & Corporate Planning Dept., Shionogi. A lot of global business experience such as the first Managing Director, Shionogi Singapore, Vice President, Shionogi Qualicaps, Inc., North Carolina, and Shionogi New York. Board of Director & President & COO, a bioventure company. The first chairman, Japan Pharma Alliance Association. The Vice Chairman, Public Private Alliance Conference associated with Infectious diseases led by Dr. Shigeru Omi. Also engaged in Director, International Committee, JPMA. Last but not least, selected as Mentor for Blockbuster Tokyo 2021

Tomohito Suzuki

Tohoku University Knowledge Cast Co., Ltd.
Senior Consultant, Medical Device Development Support Division

Main specialty areas

  • Medical devices

Specialized support fields

  • Laws and
    regulations
  • Business
    planning
  • Fundraising

D. in Pharmaceutical Sciences from Kyoritsu Pharmaceutical University (now Keio University). Formerly a medical device reviewer at the Pharmaceuticals and Medical Devices Agency (PMDA). At PMDA, a member of the team in charge of the cardiovascular field and was in charge of approval review and consultation for many medical devices including new medical devices. Seconded from PMDA to the University of Tokyo Hospital as a Project Assistant Professor at the Translational Research Center, where supported the development of medical seeds in academia. Seconded from PMDA to Division of Medical Device Research of the Department of Industrial-Academic Collaboration of the Japan Agency for Medical Research and Development (AMED) as a manager in charge of overseeing projects with medical device-related budgets. He has been in his current position since 2020. Based on his experience in reviewing at PMDA and supporting R&D in academia and AMED, he supports efficient development of medical devices for many manufacturers including venture companies.

Masakazu Masujima

Partner, Mori Hamada & Matsumoto

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

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

Masa is a guru of startup legal advisory space in Japan. Based on the experiences at Palo Alto office of Wilson Sonsini Goodrich & Rosati, his advice is West Coast style; progressive, risk-base and proactive. Through more than 2 dacades of dedication to the startup space, he has advised IPOs, M&As and major cross-border fundraising for may startups, including biotech and healthcare ones, and have also worked with entrepreneurs through a variety of touch situation, such as disputes between founders, problems with investors as well as intellectual property disputes. Masa has served as a council member of numerous Government committees, such as Regulatory Reform Promotion Council, the Regulatory Sandbox Committee, the Digital Market Competition Council and the Industrial Structure Council. He is admitted to NY bar and Japan bar, and a licensed patent attorny in Japan.

Yoshiki Kawabata

President, MedX Inc.

Main specialty areas

  • Medical devices
  • Regenerative medicinal products

Specialized support fields

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

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

Nao Yoshizawa

GRiT Partners Law offices/Willsame.co.ltd/Cabinet office advisor for National bioecnomy strategy/Keio university Medical school

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

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

After leaving the law firm Nishimura Asahi, [the individual] established the law firm GRiT Partners and assumed the role of managing partner. They also serve as the representative of Willsame Corporation and hold qualifications as a lawyer, patent attorney, CFE (Certified Fraud Examiner), Applied Information Technology Engineer, Information Processing Security Support Engineer, and IT Strategist. They have served as a committee member for the formulation of standards in electronic commerce and related information transactions at the Ministry of Economy, Trade and Industry, as an expert in the Cabinet Office's bioecnomy strategy, and as an advisor to Biock. They have been involved in the establishment of the Japan Chapter of Aging2.0 in Silicon Valley and served as a mentor for Alchemist Accelerator. A graduate of the law faculty at Hitotsubashi University, they completed intellectual property and machine learning programs at Stanford University, as well as multiple AI programs at MIT. They serve as a program committee member for the Graduate School of Pharmaceutical Sciences at the University of Tokyo and the Medical Innovation Human Resources Development Course at Tokyo Medical and Dental University. With a deep understanding of international perspectives on digital health, they provide advisory support for startups and pharmaceutical companies' DX (Digital Transformation) programs. They founded the Life Science Incubation Council and focus on launching projects and connecting them with ecosystems both domestically and internationally.

Kiyoaki Kojima

Partner

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

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

Kiyo advises clients in corporate formation, governance, and compliance matters; mergers and acquisitions; joint ventures; leasing and licensing matters; distribution and franchise arrangements; and a wide range of commercial transactions.An important part of Kiyo’s practice includes his work with international companies in relocating and/or establishing ventures in the U.S. He assists companies and investors with incentives and site selection; real estate acquisitions and construction agreements; corporate formation and governance; asset purchases and joint ventures; regulatory compliance; and contracts of all types to help ensure a seamless U.S. launch or transition.He also counsels clients in virtually all areas of labor and employment law, including drafting and/or interpretation of employment agreements, company policies, and handbooks; union-avoidance training; countering discrimination and harassment claims; hire, fire and discipline issues; and dispute resolution procedures. Active in the community, Kiyo is a member of the Atlanta Bar Association, a board member of the Japan America Society of Georgia, and a board member of the Japanese Chamber of Commerce of Georgia. He also serves in “advisor” or “supporter” roles in various entities in Japan, such as InnoHub, MEDISO, and IDEC Yokohama.

Tomokatsu Hongo

Keio Innovation Initiative, Inc
Corporate Officer

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Business
    planning
  • Fundraising
  • Management
    Strategy

Ph.D. in Biological Chemistry from Nagoya University. At Summit Pharmaceuticals International Corporation, I was engaged in VC fund management, investment and sales support for bio-ventures, and domestic sales agency business for overseas bio-ventures. In 2016, I joined Keio Innovation Initiative (KII) as an investment manager in the medical and health field. I have been investing in drug discovery, regenerative medicine, and medical device ventures by leveraging his business experience in the pharmaceutical industry and career as a researcher, and providing a wide range of hands-on support, not only in terms of funding, but also in business development.

Takahiro Mizumoto

UTokyo Innovation Platform Co., Ltd.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

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

Completed a Master's Program in Intellectual Property Management at Kyoto University Graduate School of Medicine. After passing the patent attorney examination, experienced venture investment in the IT and healthcare high-tech sectors at NIFSMBC Capital (currently split into Daiwa Corporate Investment and SMBC Capital). Later, at Showa Shell Sekiyu, led the planning and development of various new services including settlement, new electricity, and application development. With the establishment of the University of Tokyo IPC fund, joined the company and founded 1stRound, the largest university incubation program in partnership with the University of Tokyo, Tokyo Institute of Technology, Tokyo Medical and Dental University, and Tsukuba University. Subsequently, led the establishment of an open innovation promotion fund of approximately 25 billion yen and served as the CIO (Chief Investment Officer) of the fund.

Chia-Feng Lu

Shareholder(Senior Partner), Greenberg Traurig, LLP

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

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

Chia-Feng Lu represents life sciences companies and industry associations in strategic regulatory and legislative worldwide to guide and develop new legislation and policy, to frame effective approaches to working with the various agencies on compliance and investigation issues. He has intensive experience in provision of the guidance to companies introducing novel technology products, such as AI, block chain, 3D-printing, cancer immunotherapy, digital health, cell / gene therapy, precision medicine-related products and services, RNAi drug, as well as SMART device. In his past experience, he has already assisted companies in translating the scientific ideas from Nobel Laureates into the successful commercial launch of at least two products. In addition, he advises investment banks, private equity firms, and venture capital groups on their evaluations of the technologies, deal structures, and the resulting business impacts, as well as regulatory uncertainty with respect to novel technology and compliance. He specializes in various issues in connection with biotech investors or life sciences companies’ research & development strategy, portfolio management, corporate strategy planning, partnerships, licensing, project finance, auction, investment, and M&A. He has also served as an adjunct faculty member of a number of leading academic institutions in the U.S. and Japan, and an advisor to numerous government agencies.

Jun Yamadera

Eyes, JAPAN co. ltd.

Main specialty areas

  • Medical devices

Specialized support fields

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

Jun Yamadera founded Eyes, JAPAN co. ltd. in 1995, the first IT startup from the University of Aizu, Fukushima. In the past 20 years, he has been working on various cutting edge projects such as exporting Fukushima rice via web in 1995, making world’s first virtual pottery system, making CG of historical archives of national treasure of Japanese castles, temples, traditional dances and medical motions using motion capture. He is a pioneer in Augmented Reality wearable technologies, Medical x IT and has been organizing world’s first medical security hackathon since 2012. His team won the the championship in Developers Challenge 2013 Health 2.0 in Silicon Valley. He is the Health 2.0 Fukushima Chapter Leader and a TEDxKobe 2015 Speaker. He started a project called “FUKUSHIMA Wheel” in the aftermath of the terrible disaster caused by the earthquake and nuclear accident in Fukushima, JAPAN in March 11, 2011. More than 24 years experience in Cutting Edge Technologies such as AI, Blockchain and Cyber Security. He is also advisor of Safecast and LivingAnywhere.

Yumi Kawata ,MD, PhD

Hedgehog MedTech, Inc.

Main specialty areas

  • Medical devices

Specialized support fields

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

She is Founder and CEO of Hedgehog MedTech, Inc, a start-up Digital Therapeutics (DTx) company. Previously, she was a manager with SoftBank Corp, where she evaluated new Healthcare & Life Science investment opportunities, managed relationships with strategic partners. Prior to SoftBank, she was a Government Relations specialist with Medley, Inc, where she built and maintained the relationships with Ministry of Health, Labour and Welfare and Academia. She launched researches and POCs, contributing to the spread of telemedicine in Japan. She also served as a technical officer for MHLW. she was involved in the management of researches on Rare and Intractable diseases and Infectious Diseases.

Hitoshi Takuma

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

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

Masashi Matsunaga

Biospire Japan Ltd. / Biospire UK Ltd.
CEO

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy

As an experienced global business development strategist, Dr Masashi Matsunaga provides business soft-landing, clinical and regulatory support to the UK and European market. He also enables to support IP management, marketing and pitch-deck brush-up in the MEDISO support package. He is based at Harwell Science & Innovation Campus, a core UK innovation hub located near Oxford.

Hidehiro Ando

President & Representative, Andy Pharma Partners Inc.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Marketing
  • Fundraising
  • 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 40 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.

Atsushi Usami

The University of Tokyo Edge Capital Partners Co., Ltd. (UTEC)
Partner and Board Director

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

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

He holds a Ph.D. in pharmaceutical sciences from the University of Tokyo and is a licensed pharmacist. Prior to joining UTEC in October 2013, he worked as a consultant at Mitsubishi Research Institute. Currently serving as a Partner and Board Director, he oversees venture investments and provides management support primarily in the life sciences sector for seed and early-stage startups. He has played a key role in investments in companies such as OriCiro Genomics, Inc. (acquired by Moderna, Inc.) and Repertoire Genesis, Inc. (acquired by Eurofins Scientific SE). In recognition of his contributions, he was awarded the Encouragement Award for Venture Capitalists at the 23rd Japan Venture Awards in 2023.

Kazushi Kamitani

JPRO CONSULTING OFFICE, FOUNDER

Main specialty areas

  • Medicines
  • Medical devices

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising
  • Management
    Strategy
  • Other

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

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

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

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.

Junichi Imoto

Chief Venture Capitalist, Nissay Capital Co., Ltd.

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Business
    planning
  • Fundraising

He was involved in research and development of medicinal products at 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.

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.

Hiroaki Kato

Visiting Professor, The Graduate School of the Digital Hollywood University

Main specialty areas

  • Medical devices

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—.

Ayuko Nemoto

Aquaxis Law Office

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

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

My practice focuses on legal and compliance matters related to healthcare and life science companies. I have been advising on healthcare related laws and regulations, working on legal due diligence for investment, M&A, contract negotiation, and all the other general corporate matters (including domestic and international corporate matters, intellectual properties, labour laws, M&A, JV, IPO support, contract review, personal data, pharmaceutical and advertisement regulations, commercial dispute, accident, communication with relevant authority). Also act as an Advisor of the International Affairs Working Group and MA & Clinical Trial Working Group of Japan Pharmaceutical Industry Legal Affairs Association, Supporter of HealthcareInnovationHub held by Ministry of Economy, Trade and Industry and a member of IRB of the Council for Industrial use of Biological and Environmental Repositories (CIBER). Previously at international law firms.

Katsuya Hashizume

Beyond Next Venutes Inc.

Main specialty areas

  • Medical devices

Specialized support fields

  • Marketing
  • Business
    planning
  • Fundraising

For over 10 years, he has been consistently involved in investing in academia startups. Joined BNV in 2020, focusing on investments in startups in the medical device and digital health sectors. Appointed as an Executive Officer in August 2021. Leads the investment department while also overseeing the community management of portfolio companies. Prior to BNV, he has served as the leader of industry-academic investment group at JAFCO and the chief promoter of JST START. While investing in startups, he has been involved in the company creation of several acedemia startups, including Microwave Chemical (IPO), Biomedical Solutions (M&A) and Bly Medical (M&A). Completed graduate studies at the Keio University Graduate School of Media and Governance.

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.

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.

keiji Asada

Amenichi Consulting, LLC, CEO

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

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

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.

Teppei Konishi

Biomy Inc. CEO

Main specialty areas

  • Medical devices

Specialized support fields

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

He completed his graduate studies at the Graduate School of Engineering Science, Osaka University. At NTT DOCOMO, he specialized in big data analysis and AI-driven video analysis research, contributing to new business development. After leaving NTT DOCOMO, he served as CTO at an IT venture before founding Biomy Co., Ltd. There, he led the development of a personalized medical platform utilizing AI technology, collaborating with domestic and international pharmaceutical companies and research institutions. He also secured a Class II medical device manufacturing and sales license.

Akiyo Inoko Hewett

Attorney, Smith, Gambrell & Russell, LLP

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

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

Akiyo Inoko Hewett is a bilingual and double-licensed attorney based in Atlanta, Georgia, United States. She graduated from Tokyo University of Foreign Studies and earned her J.D. at Keio Law School. After passing the Japanese bar exam and completing her legal training in Kushiro, Hokkaido, Akiyo relocated to the United States. She earned an LL.M. from Emory University School of Law in Atlanta, Georgia. Currently, Akiyo serves as an attorney at Smith, Gambrell & Russell, LLP, where she provides legal services to Japanese companies doing business in the United States and supports clients across a broad range of corporate matters. Her practice areas include international and domestic commercial transactions, regulartory compliance, healthcare law, and immigration law.

Tomohisa Hayasaki

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

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Marketing
  • Fundraising
  • Intellectual
    property
    management
  • Other

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.

Tomokazu Ichikawa

Director, TM Research and Investments Pte. Ltd.

Main specialty areas

  • Medical devices

Specialized support fields

  • Laws and
    regulations
  • Business
    planning
  • Fundraising

Leveraged cross-functional expertise in business strategy and legal to work on strategy development, M&A, and investments in the medical device sector. Practiced law at Nagashima, Ohno and Tsunematsu, handling M&A and other corporate matters. Worked for McKinsey & Company and Hoya Corporation. Completed several acquisitions and investments in the US and Europe in the medical device business. Experienced managing a healthcare service operator in India. Currently, helping AI Medical Service, an artificial intelligence software startup for endoscope and CUC, a healthcare service provision related company. Spent more than 10 years in Singapore and familiar with business in Southeast Asian countries. Graduated from Waseda University, London Business School's Masters in Finance, and Cambridge's MBA. Attorney at law admitted in Japan.

Kunishige Masui

Managing Partner

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

  • Laws and
    regulations
  • Fundraising
  • Intellectual
    property
    management

Graduated from Kyoto University Faculty of Law, University of Tokyo Law School, and University of California, Irvine LLM. 2014 - 2021 at Nagashima Ohno & Tsunematsu; 2020 - 2021 at Smith, Gambrell & Russell, LLP (US law firm). Established Masui & Partners in December 2021. Mr. Kunishige Masui assisted numerous startups, from angel rounds to companies nearing IPO, and has also assisted in the launch of many new businesses, including cross-border localization. He is well versed in the legal and financing issues that arise for startups and new business development, and provides support as a mentor for JETRO, Healthcare Innovation Hub, Kawasaki-NEDO Innovation Center (K-NIC), Venture Café Tokyo, and IDEC. In addition to providing easy-to-understand explanations of foreign legal systems in comparison to those in Japan, he also specializes in removing obstacles to business growth by not only providing answers to "points that clients have actually consulted with" but also by digging into "points that need attention that clients are not yet aware of.”

Kensuke Suzuki

Nagashima Ohno & Tsunematsu
Partner, Attorney-at-law

Main specialty areas

  • Medicines
  • Medical devices
  • Regenerative medicinal products

Specialized support fields

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

Kensuke Suzuki is a partner at Nagashima Ohno & Tsunematsu. He represents both domestic and international clients, with a special focus on cross-border transactions, with respect to pharmaceutical, medical and healthcare business, M&A and corporate transactions, fund formation and management, and financial regulations. With expert knowledge of the Japanese medical, pharmaceutical, medical device, and other various healthcare-related regulations, he advises on a wide variety of business activities in the broad healthcare sector, such as regulatory compliance, data protection, mergers and acquisitions, alliances, business startups, financing, licensing and other commercial transactions. He was admitted to the Japan Bar in 2000 and worked as visiting attorney at Kirkland & Ellis (Chicago) from 2006 to 2007. He served as a special adviser to the Ministry of Health, Labour and Welfare from 2014 to 2015. He is fluent in Japanese and English.

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(liquidated in 2023).Since the first fund in 2017, we have been promoting investment activities using a total of 50 billion yen, including the "Mitsubishi UFJ Life Science Fund No. 4" (20 billion yen).Currently, he holds the position of outside director at Kamuipharma, GAIA Biomedicine, and Luxonus Co. Ltd., as well as serving as a fellow for collaboration between industry and academia at Kyoto University Medical Science and Business Liaison Organization.