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.

keiji Asada

Amenichi Consulting, LLC, CEO

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.

Masashi Matsunaga

Biospire Japan Ltd. / Biospire UK Ltd.
CEO

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.

Yuki Yamakage

Representative Director, Takashi Shimada Office Co., Ltd.
Managing Partner, BD Consulting Ltd.

I have experience working for a global medical device company in insurance strategy development and insurance applications for products in a wide range of medical specialties and disease areas, as well as market access work (relevant academic societies, patient groups, government agencies and industry associations). I have now set up my own private practice and provide support to medical device and pharmaceutical companies and new entrants in terms of healthcare and care systems and insurance strategies. I have experience in the insurance application category (C1/C2 applications) for innovative medical devices. I also have a lot of experience in training employees and conducting seminars, most recently on SaMD insurance applications. My motto is to provide consulting services that address the concerns of my clients after explaining information on insurance applications for medical devices in a way that is easy to understand for beginners.

Masaho Ishino

After engaging in medical research for 25 years, I became a patent attorney (JAPAN). Over the next 20 years, I have supported medical researchers in creating intellectual property and planning research strategies, as well as engaged in contract practice and technology transfer of university IP. Intellectual property strategies for regenerative medicine and other new modalities require not only a high level of expertise in both cutting-edge medical research and intellectual property rights, but also comprehensive knowledge covering clinical development and regulations. Utilizing my experience of contributing to the development research and practical application of university-originated seeds as a representative of an institution responsible for the AMED's Project of Translational and Clinical Research Core Centers and an organizer of nationwide academia intellectual property networks, I aim to contribute to raising the potential of intellectual property of academia/venture.