Strengthening regulatory science in academia: STARS, an EU initiative to bridge the translational gap

STARS consortium, Viktoriia Starokozhko, Marko Kallio, Åsa Kumlin Howell, Anna Mäkinen Salmi, Gunilla Andrew-Nielsen, M Goldammer, Manja Burggraf, Wiebke Löbker, Anne Böhmer, Eleonora Agricola, Corinne S de Vries, Anna M G Pasmooij, Peter G M Mol*

*Corresponding author for this work

    Research output: Contribution to journalArticleAcademicpeer-review

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    Truly disruptive medicine innovation and new treatment paradigms tend to start in non-commercial research institutions. However, the lack of mutual understanding between medicine developers and regulators when it comes to medicine development significantly delays or even prevents the access of patients to these innovations. Here, we outline what regulatory-related barriers hamper the translational development of novel products or new treatment paradigms initiated in academia, and propose key steps towards improved regulatory dialogue among academia, funding bodies and regulatory authorities. Moreover, we briefly describe how the STARS (Strengthening Training of Academia in Regulatory Science) project aims to reach out to medicine innovators in academia to bridge the regulatory knowledge gap and enhance this dialogue to facilitate the implementation of academic research findings in clinical practice.

    Original languageEnglish
    Pages (from-to)283-288
    Number of pages6
    JournalDrug Discovery Today
    Issue number2
    Early online date2020
    Publication statusPublished - Feb-2021

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