2013 Fiscal Year Final Research Report
Developing strategies to obtain regulatory approval for therapies from Japanese universities and startups
| Project/Area Number |
23590126
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Drug development chemistry
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| Research Institution | The University of Tokyo |
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Principal Investigator |
KNELLER RobertW 東京大学, 先端科学技術研究センター, 教授 (20302797)
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| Co-Investigator(Renkei-kenkyūsha) |
KIMURA Hiromichi 東京大学, 薬学系研究科生命薬学専攻, 教授 (08039684)
CHUNG Ung-il 東京大学, 工学系研究科バイオエンジニアリング専攻, 教授 (30345053)
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| Project Period (FY) |
2011 – 2013
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| Keywords | 新薬発見 / レギュラトリーサイエンス / バイオベンチャー / 臨床試験 / 新薬開発 / 産学連携 / 医療機器開発 / 知的財産 |
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| Research Abstract |
This project has focused on the development of appropriate strategies for Japanese bio-ventures to commercialize their technologies. It has involved extensive discussions with biomedical scientists, early stage companies and larger companies who might become alliance partners. Obtaining regulatory approval of these technologies from PMDA, FDA or EMA, is a key goal of these strategies. Much case by case data has been collected through these strategy development activities. We are in the process of putting these findings to practical use and generalizing results so that we can benefit other scientists and policy makers.
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