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

Chia-Feng Lu

Shareholder(Senior Partner), Greenberg Traurig, LLP

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.

Yumi Kawata ,MD, PhD

Hedgehog MedTech, Inc.

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.

Mineki Takechi

Cardio Intelligence Inc. Chief Development Officer
Director

After working at Fujitsu Ltd. on the development of products and services such as image processing system and cloud information service for home healthcare, as well as research and development in information retrieval and AI, and new business development, I engaged in the construction of a pulmonary hypertension patient registry at the International University of Health and Welfare Mita Hospital. Since 2020, I have been serving as CDO at Cardio Intelligence Inc., responsible for the development of software medical devices for arrhythmia analysis and regulatory affairs. Since 2021, I have also been serving as COO, overseeing overall business planning and execution.

Mirai Miyahara

President of i Access Consulting Inc.

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.

Yasuhisa Matsukawa