| Project/Area Number |
15K08016
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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 Robert 東京大学, 先端科学技術研究センター, 教授 (20302797)
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| Research Collaborator |
Kiyono Hiroshi
Yuki Yoshikazu
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| Project Period (FY) |
2015-04-01 – 2019-03-31
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| Project Status |
Completed (Fiscal Year 2018)
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| Budget Amount *help |
¥3,380,000 (Direct Cost: ¥2,600,000、Indirect Cost: ¥780,000)
Fiscal Year 2017: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2016: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2015: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
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| Keywords | 医薬品開発 / 臨床試験 / 薬事承認 / レギュラトリーサイエンス / バイオベンチャー / 海外ネットワーク / 知的財産権 / 特許 / 治験 |
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| Outline of Final Research Achievements |
This research adopted a case study approach to exploring ways overseas research networks can assist Japanese bioventures to conduct clinical trials for regulatory approval. Clinical trials outside Japan are often necessary to obtain approval from overseas regulatory agencies such as the US FDA, European EMA and the UK MHRA. Contract research organizations (CROs) can perform such trials. However, overseas trials can also be performed in collaboration with academic institutions. This research found that academic collaborators can offer valuable scientific expertise, innovative testing methods, and access to affiliated hospitals that can hasten patient recruitment. Sometimes academic institutions can leverage public research funds, thus reducing overall costs. They can often help select appropriate CROs that conduct some of the research. They often have close ties to regulators who can provide valuable feedback on study design from a regulatory perspective.
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| Academic Significance and Societal Importance of the Research Achievements |
治験に伴う時間や費用は新薬開発にとって大きな障壁であり、治験を有効かつ迅速に行えることは新薬を患者に届けるために極めて重要である。様々な制約を受けている日本のバイオベンチャーにとっては海外ネットワークの存在を無視することは賢明とは言えず、海外の学術機関とどのような協力関係を築くことが治験のプロセスに有効であるかを知るのは喫緊の課題である。特許や資金調達に関する理論は当然ながら重要だが、現実的な側面には対処できない。本研究では海外ネットワークがもたらす極めて現実的な側面をケーススタディーを通じて示したが、このような詳細なモデルを知ることは創薬ベンチャーにとっては大きな一歩を踏み出す助けになる。
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