New Publication: Strengthening Regulatory Science in Academia
'Strengthening regulatory science in academia: STARS – an EU initiative to bridge the translational gap' is the title of a new publication currently available in a pre-print version. It outlines what regulatory-related barriers hamper the translational development of novel products or new treatment paradigms initiated in academia, and proposes key steps towards improved regulatory dialogue among academia, funding bodies and regulatory authorities.
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.
A new publication – to be published in 'Drug Discovery Today' and currently available in its pre-print corrected proof stage – outlines how the STARS 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.