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

Tomohisa Hayasaki

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

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.

Katsuhiro Fukunishi

Hitoshi Fujimaki

TMI Associates Attorney-at-law (admitted in Japan and New York)

Joined TMI Associates in 2016. Completed an LL.M. in National and Global Health Law at Georgetown University Law Center in 2023, earning the Food & Drug Law Certificate. Admitted to the New York State Bar in 2024. The practice focuses on pharmaceutical, medical device, and healthcare regulatory matters in both Japan and the United States, with extensive experience supporting R&D and commercial operations of Japanese companies domestically and abroad. Work includes licensing and collaboration agreements with overseas partners, joint research and development arrangements, CRO agreements, GCP compliance during clinical trials, promotional review, regulatory assessments (including medical-device classification), authority inspections, and broad advisories on pharmaceutical and medical-device regulations. Also advises on U.S. healthcare compliance issues, including the Anti-Kickback Statute, the Sunshine Act, and related federal and state requirements. Author of Introduction to U.S. FDA Drug and Medical Device Law and Regulation (Shojihomu, September 2024).

Akiyo Inoko Hewett

Attorney, Smith, Gambrell & Russell, LLP

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.

Taku Seriu

Seriu Medical Consulting Ltd. CEO
APCER Life Sciences. Senior Advisor to the Board
The Institute of Drug Development Career Promotion. Representative Director

A physician and Doctor of Medical Science, he began his career as an internist before leading clinical leukemia research at the Universities of Ulm and Heidelberg in Germany. After returning to Japan, he took on leadership roles including Head of Clinical Development at Nihon Schering, Executive Officer at Bristol-Myers Squibb, and Executive Vice President and Board Member at Otsuka Pharmaceutical, where he oversaw drug development, medical affairs, regulatory affairs, pharmacovigilance, and quality assurance.
He has led the development, approval, and post-marketing activities of more than 50 therapeutics and diagnostics across oncology, neuroscience, cardiovascular and renal diseases, infectious diseases, and rare diseases, contributing to global launches and appropriate-use initiatives.
He currently serves as President of Seriu Medical Consulting and Senior Advisor at APCER Life Sciences, supporting R&D strategy, safety and risk management, organizational development, and new business planning. He also advises startups on development strategy, TPP creation, and fundraising pitch preparation, and has a strong track record in post-acquisition organizational integration, aligning cultures, talent, and processes. He teaches pharmaceutical medicine at several universities and is an editor and contributing author of Introduction to Pharmaceutical Medicine, the first textbook of its kind published in Japan. He continues to practice clinical medicine and remains committed to supporting those driving pharmaceutical innovation in Japan, guided by the principle: “Learn Together, Grow Together.”