2025 年 42 巻 3 号 p. 191-193
I had the opportunity to present at the DIA Japan Annual Meeting from November 5–7, 2023. DIA founded in the U.S., provides a platform for stakeholders―regulatory authorities, industry, academia, and patients―to exchange information. Although physician participation was limited, particularly among neurologists, the event was a large–scale conference supported by Japan's Ministry of Health, Labour and Welfare, AMED, and PMDA. The 2023 DIA Japan Annual Meeting, themed “Fusion of Knowledge and Skills Beyond Time and Space : Reconstructing Drug Development in Society 5.0,” covered diverse topics, including AI in healthcare, decentralized clinical trials, rare disease research, and regulatory science. While neurology–focused discussions were sparse, advanced initiatives in oncology and infectious diseases provided valuable insights applicable to neurology. I presented in a session on rare disease drug development alongside patient representatives, pharmaceutical companies, and MHLW officials. A patient's plea, “Are you truly committed to saving patients?” was deeply moving. Regulatory discussions included concerns about Japan's pharmaceutical competitiveness if Phase 1 trials were bypassed for global studies. The MASTER KEY Project for rare cancers demonstrated a sustainable registry model through industry–academia collaboration, providing a reference for neurological disorders like ALS. Strengthening ties between the Japanese Society of Neurological Therapeutics and DIA Japan could enhance collaboration with global regulators, industry, and patients, accelerating drug development in neurology.
