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Why Does Drug Loss Occur? Challenges to be Addressed for Patients, and Japan's Contribution to Globalized Drug Development
Session Chair(s)
Toshiharu Sano, RPH
Associate Vice President
MSD, Japan
This forum will address need for a global development strategy aimed at enhancing patient access to new drugs and maximizing business opportunities in Japan. The panelists will consist of members from pharma industry associations, agency and academia
Learning Objective : Discuss maximizing value of innovative products for the global market including Japan; Apply learnings to clinical development strategy to expand target patients and market effectively; Describe need to enhance access to innovative drugs for children and patients with rare diseases; Discuss influencing regulators, industry, and trial sites to improve the local environment and reduce burdens in global simultaneous development.
Speaker(s)
Initiatives of Medical Institutions - Introduction to High-Quality Trials Using Networks
Kenichi Nakamura, MD, PHD, MBA
National Cancer Center Hospital, Japan
Chief, Department of International Clinical Development
Changes in Japan's Pharmaceutical Regulations and Clinical Environment
Akihiro Ishiguro, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Head of PMDA, Washington D.C. Office
What is Drug Lag and Loss: Challenges for Globalization in Japan
Nobutaka Kobayashi, MPHARM
Mitsubishi Tanabe Pharma Corporation, Japan
Deputy Director
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