Strengthening regulatory science in academia: STARS, an EU initiative to bridge the translational gap. Issue 2 (February 2021)

• Record Type: Journal Article
• Authors: Starokozhko, Viktoriia; Kallio, Marko; Kumlin Howell, Åsa; Mäkinen Salmi, Anna; Andrew-Nielsen, Gunilla; Goldammer, M.; Burggraf, Manja; Löbker, Wiebke; Böhmer, Anne; Agricola, Eleonora; de Vries, Corinne S.; Pasmooij, Anna M.G.; Mol, Peter G.M.
• Is Part Of: Drug discovery today. Volume 26:Issue 2(2021)
• Page Start: 283
• Page End: 288
• Publication Date: 2021-02
• Subjects: Drugs -- Design -- Periodicals; Drugs -- Research -- Periodicals; 615.1
• DOI: 10.1016/j.drudis.2020.10.017
• Languages: English
• ISSNs: 1359-6446

Abstract

Highlights: Current dialogue between academic researchers and regulators is inadequate. The STARS project aims to bridge the regulatory knowledge gap in academic research. Early exchange of information between academic researchers and regulators is crucial. Regulatory science should be implemented in (bio)medical educational programmes. Abstract: 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.