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.

Saho Murakami

VISIONEO LLC CEO

After gaining clinical experience as an ophthalmologist, I served at the Pharmaceuticals and Medical Devices Agency (PMDA), where I was responsible for reviewing and providing consultations on pharmaceuticals, medical devices, and regenerative medical products in the fields of CNS, sensory organs, and anesthesiology. My work included designation reviews for Sakigake (pioneering) and orphan drugs, as well as post-marketing safety activities. Currently, I support business and clinical development across the healthcare and life sciences sectors, offering strategic and R&D advisory services to major corporations, startups, and venture capital firms.

Yasuo Sasaki

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 regulatory 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.

Katsuya Hashizume

Beyond Next Venutes Inc.

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.

Miyuki Nagao

Globizz Japan Corporation　Tokyo Office Director

After working at U.S. headquarters as an assistant for FDA registrations, FDA filings, and regulatory investigations for medical devices, pharmaceuticals, and food products, she moved to GLOBITS' Tokyo office to work as a project coordinator. While proposing and coordinating projects related to Japanese companies' entry into the U.S. market, she also provides support for attending and responding to FDA inspections in various fields, advises on FDA registration, conducts brief investigations, and teaches seminars.