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

Akiko Yamamoto

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

Graduated from the Department of Pharmacy at Kyoritsu Collage of Pharmacy (currently Keio University) and received a Ph.D. from Gifu Pharmaceutical University. Engaged in work related to each process of pharmaceutical life cycle (research and development, sales promotion, licensing/alliance, quality assurance and Good Vigilance Practice(GVP)) at Nissan Chemical Corporation. Especially, as the corporate quality assurance department leader, managed the company's pharmaceutical quality system, and maintained and improved appropriate quality assurance systems for API manufacturing sites, manufacturing contractors, and contract testing facilities. Specifically, provided support during FDA inspections and global pharma quality audits, and advised on improvements and response policies for issues raised. Also has experience in implementing regulations and change processes when adding starting material, intermediate and API manufacturing sites, and testing facilities. In addition, has reviewed documents such as license and quality assurance-related contract contents, change applications and master files to be submitted to authorities.

Hiroyuki Kajiyama

Graduated from Kyoto University Faculty of Pharmaceutical Sciences. Worked at Tanabe Mitsubishi Pharma Corporation in pharmaceutical research and development, primarily handling clinical development tasks. Since 2016, employed at the Pharmaceuticals and Medical Devices Agency (PMDA), Review Management Department, as a Technical Expert in Regulatory Science Strategy Consultation. Engaged primarily in providing consultation services on pharmaceuticals, medical devices, regenerative medicine products, focusing on academia and venture companies.

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.

Aiko Kato Sullenberger

RykoTECH　President

Aiko Kato Sullenberger, CEO of RykoTECH, a significant contributor within the Boston startupecosystem for several years, brings a wealth of experience in various roles, spanning investor,startup, and accelerator. She provides specialized advisory services comprehensive strategicconsultation and facilitation of market entry into the US across diverse sectors, including drugdiscovery, medical devices, digital health, digital therapeutics and biotech. Aiko can help 　 • Fundraising • Strategic Partnership Development • Create Deal Flow (Connecting with Potential Investors) • Identifying Partners and Advisors • Assistance in Facilitating Clinical Trials • Corporate Strategy: Investment Thesis, Portfolio Analysis • Market / Trend Research & Analysis • Go-to-Market Strategy • Academic Business Liaison: Interdisciplinary Project Lead • Cross-Functional Team Building

Masakazu Masujima

Partner, Mori Hamada & Matsumoto

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.