Unlocking Japan’s CNS Advantage: Strategies for Successful CNS Drug Development
As global investment in CNS therapies grows, sponsors are taking a closer look at Japan as a strategic destination for clinical development.
The country offers strong specialist networks, high-quality clinical execution, and a regulatory environment that is increasingly supportive of international development. However, successful CNS development in Japan requires an understanding of its unique regulatory landscape, patient pathways, and operational considerations.
In this roundtable, experts will explore how sponsors can leverage Japan’s strengths, navigate common challenges, and optimize CNS trial planning and execution.
Key Takeaways
- The strategic advantages Japan offers for CNS drug development.
- Key differences between Japan and US/EU clinical development models.
- Regulatory and operational considerations that shape trial success.
- How to optimize feasibility, site selection, and patient recruitment.
- Why partnering with local experts can accelerate development.
Roundtable Panelists:
- Dr. Karan Dixit, Assistant Professor of Neuro-oncology, Northwestern Medicine
- Dr. Masahisa Katsuno, Dean & Professor, Department of Neurology, Graduate School of Medicine, Nagoya University
- Rie Kawahara, Clinical Leader/Clinical Research Associate (CRA), Clinical Operation Division, Neuroscience
Department, CMIC - Joseph Palumbo, Chief Medical Officer & Executive Head of Research and Development, BioVie
- Takeshi Sakata, Senior Consultant, Development Strategy and Regulatory Consulting Group, Regulatory Consulting
Department, Consulting Division, CMIC - Midori Yenari, Professor of Neurology, University of California San Francisco School of Medicine
- Moderator: Meredith Landry, Managing Editor, Custom Content, Citeline
Download the full executive summary to learn more.
