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[V4-S4] Innovation in Development of Orphan Drugs (2) — Diversifying Type of Operation and Companies
Session Chair(s)
Satoru Hayata, MS
Sobi Japan, Japan
Yasuhiro Kanatani
Director, Dept of Health Crisis Management
National Institute of Public Health, Japan
Speaker(s)
Development of Orphan Drugs - Regulatory Viewpoints from PMDA
Ken Sakushima, MD, PhD, MPH
Hokkaido University Hospital, Japan
Specially Appointed Associate Professor, Research and Development Division
New Business Model for the Development and Market Launch of Orphan Drugs
Hiroshi Kosaku, MSc
CMIC HOLDINGS, Japan
Senior Corporate Officer, Non-clinical CRO Business, Bio-CDMO Business
Development of Ultra Orphan Drugs and It's Advancement
Shigeki Shimasaki
Nobelpharma Co., Ltd., Japan
Vice President & COO, Head of Research & Development
Orphan drug development in Genzyme Japan
Masaki Osawa
Genzyme Japan K.K., Japan
Regulatory Affairs
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