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*

*Bijbehorende auteur voor dit werk

    OnderzoeksoutputAcademicpeer 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.

    Originele taal-2English
    Pagina's (van-tot)283-288
    Aantal pagina's6
    TijdschriftDrug Discovery Today
    Volume26
    Nummer van het tijdschrift2
    Vroegere onlinedatum2020
    DOI's
    StatusPublished - feb-2021

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