Department for Advancing Translational ScienceMedicine and Medical Science

M.D., Ph.D. Professor Sumimasa Nagai

Department for Advancing Translational Science is a new research field in Graduate School of Medicine, which is constituted of staff members of Department of Medical Development, Institute for Advancement of Clinical and Translational Science (iACT), Kyoto University Hospital. We collaborate with internal departments and external institutions to support researchers developing drugs, medical devices, diagnostics, and regenerative medical products. We comprehensively support researchers by planning development strategy and managing patents, technology transfer, and regulatory affairs. Our research and educational activities aim for production of many experts who can sufficiently support researchers.

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Research and Education

Our research field in Graduate School of Medicine is unique in terms of specialty in translational science. We define translational science as research activity whose goal is to translate results of basic research into clinical application as drugs, medical devices, in vitro diagnostics, or regenerative medical products.
Promoting translational science and producing innovative medical products in cooperation with industry is one of the most important missions of academia.
In Japan, there are few experts who can understand the value of basic research, unmet medical needs, and regulatory affairs and who can sufficiently support researchers.
We provide on-the-job training, seminars, and lectures to produce many experts who can promote and support innovative translational science.
Regulatory science plays an important role in development of new medical products as well as the advancement of patient safety.
We conduct regulatory science research to propose better pharmaceutical regulations that can promote translational science adequately.

Recent Publications

  1. Matsuda K, Nagai S, Sugimoto K. Drug approval delays in hematologic malignancies between Europe and the US and between Japan and the US: a clinical perspective. Japanese Journal of Clinical Oncology 53(12):1125-1129, 2023
  2. Nagai S, Nishihara H, Suzuki T, Nishio K, Taniguchi H, Tsuchihara K, Nakamura K, Takamatsu R, Ueno T, Aburatani H, Kohno T, Kohsaka S. Recommendations related to the analytical equivalence assessment of gene panel testing. Cancer Science 113(10):3282-3290, 2022
  3. Yang YT, Nagai S (co-first), Chen BK, Qureshi ZP, Lebby AA, Kessler S, Georgantopoulos P, Raisch DW, Sartor O, Hermanson T, Kane RC, Hrushesky WJ, Riente JJ, Norris LB, Bobolts LR, Armitage JO, Bennett CL. Generic oncology drugs: are they all safe? The Lancet Oncology 17(11):e493-e501, 2016
  4. Nagai S, Urata M, Sato H, Mikami M, Kuga W, Yanagihara R, Miyamoto D, Suzuki Y, Shikano M. Evolving Japanese regulations on companion diagnostics. Nature Biotechnology 34(2):141-144, 2016
  5. Nagai S, Ozawa K. Clinical trial designs to obtain marketing authorization of drugs for haematological malignancy in Japan, the EU and the US. British Journal of Haematology 174(2):249-254, 2016

Department for Advancing Translational Science

Professor and Director: Sumimasa Nagai, M.D., Ph.D.
Program-Specific Professor: Hiroyuki Nakahira, Ph.D.
Associate Professor: Ryo Nishino, M.D., Ph.D.
Program-Specific Senior Lecturer: Kayo Hattori
Assistant Professor: Mika Ushimaru, Ph.D , Erika Yamamoto, M.D.,Ph.D., Kumiko Tatsumi

TEL : +81-75-751-4749
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