Session Details
[S12★☆]Frontiers of Emerging Research in Regulatory Science
Fri. Mar 27, 2026 1:10 PM - 3:10 PM JST
Fri. Mar 27, 2026 4:10 AM - 6:10 AM UTC
Fri. Mar 27, 2026 4:10 AM - 6:10 AM UTC
Room 07 (F403, Bldg. 4, Area 2 [4F])
Organizer: Ryosuke Nakamura (Fac. Pharm. Sci., Teikyo Univ.), Minoru Tada (NIHS), Masataka Tsuda (AMED), Masuo Kondoh (Grad. Sch. Pharm. Sci., U Osaka)
The top-selling new drugs are shifting from small molecules to new modalities such as biopharmaceuticals, regenerative and cell therapies, and gene therapies. The development of emerging modalities, including nucleic acid drugs, antibody drugs, and microbiome-based therapies has been accelerating. To deliver these next-generation drugs to patients, it is essential to advance regulatory science (RS) research that integrates new technologies and perspectives. As the saying goes, "He who controls regulation controls innovation." (Kusakabe T., Pharmacia, 54, 798, 2018)
Accordingly, the execution of world-leading RS research will determine the outcome of globalized drug development. Nurturing young RS researchers with fresh perspectives and flexible thinking—who will lead the next generation—is key to fundamentally strengthening Japan's drug discovery capabilities. Since 2017, the Japan Agency for Medical Research and Development (AMED) Pharmaceutical Regulatory Harmonization and Evaluation Research Project has supported young RS researchers, funding 42 projects to date and fostering Japan's RS infrastructure.
In this symposium, we will invite promising young RS researchers who have completed this program's support to share their achievements, offering an opportunity to experience the innovative spirit of RS research in Japan.
Accordingly, the execution of world-leading RS research will determine the outcome of globalized drug development. Nurturing young RS researchers with fresh perspectives and flexible thinking—who will lead the next generation—is key to fundamentally strengthening Japan's drug discovery capabilities. Since 2017, the Japan Agency for Medical Research and Development (AMED) Pharmaceutical Regulatory Harmonization and Evaluation Research Project has supported young RS researchers, funding 42 projects to date and fostering Japan's RS infrastructure.
In this symposium, we will invite promising young RS researchers who have completed this program's support to share their achievements, offering an opportunity to experience the innovative spirit of RS research in Japan.
Opening Remarks
Ryosuke Nakamura1 (1. Fac. Pharm. Sci., Teikyo Univ.)
[S12-1]Empowering Drug Innovation through Regulatory Science<br/>- Master the regulations, master innovation -
○Tetsuya Kusakabe1 (1. AMED)
[S12-2]Development of single-particle analysis for quality assessment of lipid nanoparticle formulations
○Yuki Haraya1 (1. NIHS)
[S12-3]Development of PROTAC off-target evaluation system using liquid chromatograph mass spectrometer
○Masashi Watanabe1, Shigetsugu Hatakeyama1 (1. Grad. Sch. Med., Hokkaido Univ.)
[S12-4]Enhancement of Intestinal Epithelial and Hepatocyte Functions Using Genome Editing Technology and Development of an Intestine-Liver-on-a-Chip
○Ryosuke Negoro1 (1. Courage Pharm. Rits. Univ.)
[S12-5]Development of predictive methods for the chronic transition of drug-induced kidney injury
○Kohei Matsushita1 (1. Div. Pathol., NIHS)