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Regulatory Science for Pharmaceuticals and Medical Devices(Medical and Health Sciences)

Tachibana KeisukeAssociate professor / Lecturer

I am working on the advancement of regulatory science by utilizing my experience in academic drug discovery at Osaka University, new drug application at a pharmaceutical company, and new drug review at PMDA.

Research theme

A study of clinical effects prediction in the real world

Our aim is to establish a new academic system of regulatory science that will contribute to the clinical development of innovative drugs, medical devices, and regenerative medicine in Japan, and to develop human resources that combine basic research capabilities and clinical development capabilities.

Representative achievements

K. Tachibana, Y. Hashimoto, K. Shirakura, Y. Okada, R. Hirayama, Y. Iwashita, I. Nishino, Y. Ago, H. Takeda, H. Kuniyasu, M. Kondoh, Safety and efficacy of an anti-claudin-5 monoclonal antibody to increase blood-brain barrier permeability for drug delivery to the brain in a non-human primate, J Control Release. 336 (2021) 105–111.

K. Tachibana, M. Kondoh, A Method to Prepare a Bioprobe for Regulatory Science of the Drug Delivery System to the Brain: An Angulin Binder to Modulate Tricellular Tight Junction-Seal, Methods Mol Biol. 2367 (2021) 291–304.

K. Tachibana, Y. Iwashita, E. Wakayama, I. Nishino, T. Nishikaji, M. Kondoh, Tight Junction Modulating Bioprobes for Drug Delivery System to the Brain: A Review, Pharmaceutics. 12 (2020) E1236.

K. Tachibana, M. Kondoh, A Method to Prepare Claudin-Modulating Recombinant Proteins, Methods Mol. Biol. 2109 (2020) 251–260.

S. Matsushita, K. Tachibana, T. Kusakabe, R. Hirayama, Y. Tsutsumi, M. Kondoh, The Roadmap to Approval under Japan’s Two-Track Regulatory System: Comparing Six Regenerative Medical Products, Cell Stem Cell. 27 (2020) 515–518.

F. Wada, T. Yamamoto, T. Kobayashi, K. Tachibana, K.R. Ito, M. Hamasaki, Y. Kayaba, C. Terada, A. Yamayoshi, S. Obika, M. Harada-Shiba, Drug discovery and development scheme for liver-targeting bridged nucleic acid antisense oligonucleotides, Mol Ther Nucleic Acids. 26 (2021) 957–969.

T. Shimo, K. Tachibana, Y. Kawawaki, Y. Watahiki, T. Ishigaki, Y. Nakatsuji, T. Hara, J. Kawakami, S. Obika, Enhancement of exon skipping activity by reduction in the secondary structure content of LNA-based splice-switching oligonucleotides, Chem. Commun. (Camb.). 55 (2019) 6850–6853.

T. Yoshida, H. Oki, M. Doi, S. Fukuda, T. Yuzuriha, R. Tabata, K. Ishimoto, K. Kawahara, T. Ohkubo, H. Miyachi, T. Doi, K. Tachibana, Structural Basis for PPARα Activation by 1H-pyrazolo-[3,4-b]pyridine Derivatives, Sci Rep. 10 (2020) 7623.

K. Tachibana, T. Yuzuriha, R. Tabata, S. Fukuda, T. Maegawa, R. Takahashi, K. Tanimoto, H. Tsujino, K. Nunomura, B. Lin, Y. Matsuura, T. Tanaka, T. Hamakubo, J. Sakai, T. Kodama, T. Kobayashi, K. Ishimoto, H. Miyachi, T. Doi, Discovery of peroxisome proliferator-activated receptor α (PPARα) activators with a ligand-screening system using a human PPARα-expressing cell line, J Biol Chem. 293 (2018) 10333–10343.

K. Tachibana, S. Fukuda, J. Fukushima, K. Ishimoto, M. Sakata, Y. Nishimori, T. Doi, Exploring Compounds to be used as Cosmetic Agents that Activate Peroxisome Proliferator-Activated Receptor Alpha, Int J Cosmet Sci. (2022), in press.

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