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Faculty Members


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

Kondoh MasuoProfessor

Ph.D. (Pharmaceutical Sciences) from Osaka University
Research Assistant, Pharmaceutical Sciences, Tokushima Bunri University, Tokushima, Japan.
Assistant Professor, Pharmaceutical Sciences, Showa Pharmaceutical University, Tokyo, Japan.
Associate Professor, Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, Japan.
Technical official, Ministry of Health, Labour and Welfare, Japan
Professor, Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, Japan.

Research theme

Development of novel diagnoses based on tight junctions and their application to precision medicine

During the evolution of mono-cellular organisms to multi-cellular organisms, cellular barrier systems developed that separate the inside of the body from the outside environment and also separate the internal and external tissues. Dysregulation of barrier functions occurs in many malignant diseases, including cancer, neurogenerative disease, inflammatory bowel disease, renal disease, and pulmonary disease. In this theme, we will develop novel diagnostic methods based on tight junction dysregulation and apply these to medical therapies.

Development of a system for drug delivery to the central nervous system and its application to drug development

Increasing numbers of people suffer central nervous system (CNS)-related diseases such as Alzheimer disease and psychiatric disorders; however, development of CNS drugs has been delayed partly because of the lack of a drug delivery system to the brain. In this theme, we will develop drug delivery systems to the CNS, evaluate the balance of risks and benefits, and propose a regulatory concept for CNS drugs used with the drug delivery system.

Development of transdermal and mucosal permeation-enhancing probes and their application to design considerations for non-invasively administered biologics

The development of innovative biologics, such as mRNA, peptide, antibody, and oligonucleotide therapeutics, continues to accelerate. Most innovative biologics are parenterally administered to patients. Although non-invasive routes such as transdermal and oral administration are ideal, the skin and the mucosal barrier prevent an influx of biologics. Therefore, a combination of permeation enhancers is essential for non-invasive administration of biologics. In this theme, we will generate transdermal and mucosal permeation enhancers, use these as a probe for estimating risk of non-specific influx of xenobiotics, and propose design considerations and premarket submission recommendations for administration of non-invasive drugs.

Design considerations and premarket submission recommendations for innovative medical product candidates

The generation of innovative medical product and medical therapy platforms, including recent progress in wearable devices and Internet of Things technologies, has provided novel modalities for drugs and digital pharmaceuticals. In addition, on-demand aqueous chlorine dioxide solution (or matching transformation system [MA-T]), has gained attention as a promising disinfectant agent. Guidance for design considerations and premarket submission recommendations are required prior to their clinical application to patients. In this theme, we will develop and prepare regulatory considerations for the safe and efficient provision of innovative medical products to patients.

Representative achievements

A Japanese regulatory consideration for medical device interoperability (in preparation for publication)


Tachibana, K.; Hashimoto, Y.; Shirakura, K.; Okada, Y.; Hirayama, R.; Iwashita, Y.; Nishino, I.; Ago, Y.; Takeda, H.; Kuniyasu, H.; Kondoh, M. 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, 2021, 336, 105-111.

Castro Dias, M.; Quesada, A.O.; Soldati, S.; Boesch, F.; Gruber, I.; Hildbrand, T.; Soenmez, D.; Khire, T.; Witz, G.; McGrath, J.L.; Piontek, J.; Kondoh, M.; Deutsch, U.; Zuber, B.; Engelhardt, B. Brain endothelial tricellular junctions as novel sites for T-cell diapedesis across the blood-brain barrier. J Cell Sci, 2021, 134, jcs253880.

Matsushita, S.; Tachibana, K.; Kusakabe, T.; Hirayama, R.; Tsutsumi, Y.; Kondoh, M. Overview of the pre- and post-marketing requirements for drugs granted Japanese conditional marketing approval. Clin Transl Sci, 2021, 14, 806-811.

Kohno, T.; Konno T.; Kikuchi, S.; Kondoh, M.; Kojima, T. Translocation of LSR from tricellular corners causes macropinocytosis at cell-cell interface as a trigger for breaking out of contact inhibition. FASEB J, 2021, 35, e21742.

Ohwada, K.; Knno, T.; Kohno, T.; Nakano, M.; Ohkuni, T.; Miyata, R.; Kanuki, T.; Kondoh, M.; Takano, K.; Kojima, T. Effects of HMGB1 on tricellular tight junctions via TGF-β signaling in human nasal epithelial cells. Int J Mol Sci, 2021, 22, 8390.

Shimizu, Y.; Shinoda, T.; Shirasago, Y.; Kondoh, M.; Shinya, N.; Harada, K.; Yagi, K.; Suzuki, T.; Wakita, T.; Kimura-Someya, T.; Shirouz, M.; Fukasawa, M. Occludin-binding single-chain variable fragment and antigen-binding fragment antibodies prevent hepatitis C virus infection. FEBS Lett, 2021, 595, 220-229.

Takamura, K.; Tachibana, K.; Kusakabe, T.; Nakai, K.; Tsutsumi, Y.; Kondoh, M. New Japanese Regulatory Frameworks for Post-marketing Management of Pharmaceutical Products. Pharm Res, 2020, 37, 122.

Ota, N.; Tachibana, K.; Kusakabe, T.; Sanada, S.; Kondoh, M. A concept for a Japanese regulatory framework for emerging medical devices with frequently modified behavior. Clin Transl Sci, 2020, 13, 877-879.

Matsushita, S.; Tachibana, K.; Kusakabe, T.; Hirayama, R.; Tsutsumi, Y.; Kondoh, M. The roadmap to approval under Japan’s two track regulatory system: comparing six regenerative medical products. Cell Stem Cell, 2020, 27, 515-518.