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Developing strategies to obtain regulatory approval for therapies from Japanese universities and startups

Research Project

Project/Area Number 23590126
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Drug development chemistry
Research InstitutionThe University of Tokyo

Principal Investigator

KNELLER RobertW  東京大学, 先端科学技術研究センター, 教授 (20302797)

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)
Project Period (FY) 2011 – 2013
Project Status Completed (Fiscal Year 2013)
Budget Amount *help
¥3,380,000 (Direct Cost: ¥2,600,000、Indirect Cost: ¥780,000)
Fiscal Year 2013: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2012: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2011: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
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 / 国際研究者交流 / アントレプレナーシップ / ベンチャー企業 / 知的財産権
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.

Report

(4 results)
  • 2013 Annual Research Report   Final Research Report ( PDF )
  • 2012 Research-status Report
  • 2011 Research-status Report
  • Research Products

    (25 results)

All 2014 2013 2012 2011 Other

All Journal Article (8 results) (of which Peer Reviewed: 3 results) Presentation (12 results) (of which Invited: 9 results) Book (3 results) Remarks (1 results) Patent(Industrial Property Rights) (1 results) (of which Overseas: 1 results)

  • [Journal Article] Industry-university collaborations in Canada, Japan, the UK and USA–with emphasis on publication freedom and managing the intellectual property lock-up problem2014

    • Author(s)
      Kneller, Robert, Marcel Mongeon, Jeff Cope, Cathy Garner, Philip Ternouth
    • Journal Title

      PLOS ONE

      Volume: 9 (3)

    • Related Report
      2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] Industry-university collaborations in Canada, Japan, the UK and USA - with emphasis on publication freedom and managing the intellectual property lock-up problem2014

    • Author(s)
      Kneller, Robert; Mongeon, Marcel; Cope, Jeff; Garner, Cathy; Ternouth, Philip
    • Journal Title

      PLOS ONE

      Volume: 9 Issue: 3 Pages: 1-21

    • DOI

      10.1371/journal.pone.0090302

    • Related Report
      2013 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Commercializing promising but dormant Japanese industry-university joint discoveries via independent, venture capital funded spin-offs. In Hishida, K (Ed.)2013

    • Author(s)
      Kneller, Robert
    • Journal Title

      Fulfilling the Promise of Technology Transfer : Fostering Innovation for the Benefit of Society Springer

      Pages: 23-33

    • Related Report
      2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] Umemura, The Japanese Pharmaceutical Industry : Its Evolution and Current Challenges (Review)2013

    • Author(s)
      Kneller, Robert
    • Journal Title

      Journal of Japanese Studies

      Volume: 39 (no. 1) Pages: 253-240

    • Related Report
      2013 Final Research Report
  • [Journal Article] The Japanese Pharmaceutical Industry: Its Evolution and Current Challenges (review)2013

    • Author(s)
      Kneller, Robert
    • Journal Title

      Journal of Japanese Studies

      Volume: 39 Issue: 1 Pages: 235-240

    • DOI

      10.1353/jjs.2013.0023

    • Related Report
      2012 Research-status Report
  • [Journal Article] イノベーションにおけるベンチャー企業の役割―アントレプレナーシップの環境改善に向けて―2011

    • Author(s)
      ロバート・ケネラー
    • Journal Title

      渡部俊也(編)『イノベーションシステムとしての大学と人材』第3章(東京大学知的資産経営総括寄付講座シリーズ第3巻)(白桃書房)

      Pages: 173-200

    • Related Report
      2013 Final Research Report
  • [Journal Article] The importance of new companies for innovation, and ways to improve Japan's environment for science based entrepreneurship. Chapter 3 in Watanabe, Toshiya (ed)2011

    • Author(s)
      Kneller, Robert
    • Journal Title

      University and Human Resource Development in Innovation Systems Tokyo : Hakuto-Shobo Publishing Co

      Pages: 173-200

    • Related Report
      2013 Final Research Report
  • [Journal Article] Invention Management in Japanese Universities and its Implications for Innovation : Insights from the University of Tokyo. Chapter 3 in Wong PK (ed)2011

    • Author(s)
      Kneller, Robert
    • Journal Title

      Academic Entrepreneurship in Asia : The Role and Impact of Universities in National Innovation Systems Cheltenham UK : Elgar

      Pages: 69-85

    • Related Report
      2013 Final Research Report
  • [Presentation] Bioventures: Growth strategies and importance for innovation 日本の製薬企業の世界戦略としてのバイオベンチャー活用の道2013

    • Author(s)
      Kneller, Robert
    • Organizer
      12th Kitasato University - Harvard School of Public Health Symposium on Advanced and Global Drug Development 第12回北里‐ハーバードシンポジウム
    • Place of Presentation
      東京千代田区大手町・日経ホール
    • Related Report
      2013 Annual Research Report
    • Invited
  • [Presentation] Does France Need a Bayh-Dole Act? [panel discussion]2013

    • Author(s)
      Kneller, Robert
    • Organizer
      Congres Curie 2013, Valorisation de la Recherche Publique
    • Place of Presentation
      Palais des Congres, Ajaccio, Corse, フランス
    • Related Report
      2013 Annual Research Report
    • Invited
  • [Presentation] Alternative strategies to promote Japanese science-based entrepreneurship2013

    • Author(s)
      Kneller, Robert
    • Organizer
      5th Annual Conference of the Stanford Project on Japanese Entrepreneurship (STAJE)
    • Place of Presentation
      米国スタンフォード大学
    • Related Report
      2013 Annual Research Report
    • Invited
  • [Presentation] Bioventures: Growth strategies and importance for drug discovery and development2013

    • Author(s)
      Kneller, Robert
    • Organizer
      The 11th International Symposium for Future Drug Discovery and Medical Care Current strategy for development of biopharmaceuticals and small molecule drugs
    • Place of Presentation
      北海道大学大学院理学院
    • Related Report
      2013 Annual Research Report
    • Invited
  • [Presentation] 日本の製薬企業の世界戦略としてのバイオベンチャー活用の道 -ハイブリッドベンチャーという選択-2013

    • Author(s)
      Kneller, Robert
    • Organizer
      医薬ライセンシング協会第249回月例会
    • Place of Presentation
      東京学士会館
    • Related Report
      2012 Research-status Report
    • Invited
  • [Presentation] 日本発の研究成果を商業化するための戦略 [Two strategies to mobilize Japanese discoveries for international markets]2013

    • Author(s)
      Kneller, Robert
    • Organizer
      文部科学省 大学発新産業創出拠点プロジェクト, 第2回つくば国際会議
    • Place of Presentation
      つくば国際会議場
    • Related Report
      2012 Research-status Report
    • Invited
  • [Presentation] What industry appreciates from interactions with universities: case studies of 90 companies in Japan, Canada, the UK and USA2012

    • Author(s)
      Kneller, Robert
    • Organizer
      The 4th annual conference of SPRIE-Stanford Project on Japanese Entrepreneurship (STAJE) : Japan at the Entrepreneurial Crossroads - What Lies Ahead?
    • Place of Presentation
      米国、スタンフォード大学
    • Related Report
      2012 Research-status Report
    • Invited
  • [Presentation] Commercializing university joint-research discoveries by independent spin-offs2012

    • Author(s)
      Kneller, Robert
    • Organizer
      Technology transfer fostering innovation for the benefit of society
    • Place of Presentation
      慶應大学三田キャンパス
    • Related Report
      2012 Research-status Report
    • Invited
  • [Presentation] 日本発の研究成果を商業化するための戦略 [Two strategies to mobilize Japanese discoveries for international markets]2012

    • Author(s)
      Kneller, Robert
    • Organizer
      AETフォーラム「eHealthビジネスの行方を探る」
    • Place of Presentation
      秋葉原アキバプラザ
    • Related Report
      2012 Research-status Report
    • Invited
  • [Presentation] 研究成果商業化のために米国・シリコンバレー活用を考える「Starting Companies in America to Commercialize Japanese Discoveries」2012

    • Author(s)
      ロバート・ケネラー
    • Organizer
      東京大学知的資産経営研究プロジェクト・新ビジネス塾
    • Place of Presentation
      東京丸の内三菱ビルコンファレンススクエア
    • Related Report
      2011 Research-status Report
  • [Presentation] University IP management and science-based entrepreneurship in Japan: impact on innovation and questions for America2011

    • Author(s)
      Robert Kneller
    • Organizer
      Office of Technology Licensing, Stanford University (USA)(招待講演)
    • Place of Presentation
      Stanford University (U.S.A.)
    • Related Report
      2011 Research-status Report
  • [Presentation] 日本の大学とシリコンバレーをつなぐために (Linking Japanese University Science to Silicon Valley (or other overseas entrepreneurial regions))2011

    • Author(s)
      ロバート・ケネラー
    • Organizer
      第84回日本生化学会大会セッション 4B 13: バイオ・イノベーションにかかる知的財産とアカデミック研究
    • Place of Presentation
      京都国際会館
    • Related Report
      2011 Research-status Report
  • [Book] Commercializing promising but dormant Japanese industry-university joint discoveries via independent, venture capital funded spin-offs. In Hishida, K (Ed.). Fulfilling the Promise of Technology Transfer: Fostering Innovation for the Benefit of Society2013

    • Author(s)
      Kneller, Robert
    • Publisher
      Springer
    • Related Report
      2012 Research-status Report
  • [Book] イノベーションにおけるベンチャー企業の役割―アントレプレナーシップの環境改善に向けて― (渡部俊也(編) 「イノベーションシステムとしての大学と人材」に収録)2011

    • Author(s)
      ロバート・ケネラー
    • Total Pages
      28
    • Publisher
      白桃書房
    • Related Report
      2011 Research-status Report
  • [Book] Invention Management in Japanese Universities and its Implications for Innovation: Insights from the University of Tokyo. (In S. Shane (ed). Academic Entrepreneurship in Asia: The Role and Impact of Universities in National Innovation Systems.)2011

    • Author(s)
      Robert Kneller
    • Total Pages
      17
    • Publisher
      Elgar (Cheltenham, UK)
    • Related Report
      2011 Research-status Report
  • [Remarks] Homepage of Robert Kneller!

    • URL

      http://www.kneller.asia/index.htm

    • Related Report
      2013 Annual Research Report
  • [Patent(Industrial Property Rights)] Voice messages displayed as text2012

    • Inventor(s)
      Kneller, Robert
    • Industrial Property Rights Holder
      Kneller, Robert
    • Industrial Property Rights Type
      特許
    • Filing Date
      2012-05-09
    • Related Report
      2012 Research-status Report
    • Overseas

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Published: 2011-08-05   Modified: 2021-04-07  

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