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

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.

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.

Hikaru Saito

Saisei Ventures LLC Partner

As a partner of Saisei Ventures, a newly established global venture capital firm that invests in advanced biotech companies in cell and gene therapy, Dr. Saito is responsible for Japan operations including company creation, integrating Japanese science and technology with the Western ecosystem. Prior to joining Saisei, he started career as a research scientist at Astellas Pharma Inc. and then as a Senior Manager of Business Development and as a Senior Investment Manager at Astellas Venture Management, a CVC arm based in Silicon Valley, USA, where he was a lead role for deal process, due diligence and transactions for venture investments in RNA therapeutics, cell and gene therapy. He was providing business support to portfolio companies based on the expertise, experience, and global network. He also led the development of strategic partnerships with venture capital funds, accelerators, and institutional investors based in the U.S. and Europe. Prior to joining Astellas, he was a Visiting Fellow at the Institute of Medical Science, University of Tokyo, and a Research Fellow of the Japan Society for the Promotion of Science. He received his B.S. in Biotechnology and M.S. and Ph.D. in Biomolecular Molecularl Engineering from Tokyo Institute of Technology.

Shin-ichi Kamachi

CRO-K Co.,Ltd

Completed doctoral course at Kyushu University Graduate School of Pharmaceutical Sciences. After joining Chugai Pharmaceutical Co., Ltd. Research Institute in 1977, he worked consistently on pharmaceutical research and development. He has experience in approving one small molecule drug and four biopharmaceuticals. He also has the experience of being the first Japanese company to recommend approval for a central review of EMA. He took early retirement in 2004 and mainly assists with biopharmaceutical CMC and non-clinical testing. After establishing the Japanese branch of an American biopharmaceutical consulting company (Biologic Consulting Group, BCG), he currently serves as a senior consultant for CLOCK Co., Ltd., providing support and advice on the development of biopharmaceuticals.

Hitoshi Takuma