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

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.

Automated summary

Truly disruptive medicine innovation often starts in non-commercial research institutions, but lack of mutual understanding between medicine developers and regulators can delay patient access. Regulatory barriers hinder the translational development of novel products or treatment paradigms initiated in academia. The STARS project aims to bridge the regulatory knowledge gap and enhance dialogue to facilitate implementation of academic research findings in clinical practice.