Translating Academic Drug Discovery Into Clinical Development: A Survey of the Awareness of Regulatory Support and Requirements Among Stakeholders in Europe. Issue 2 (21st November 2022)

• Record Type: Journal Article
• Authors: Kallio, Marko J.; Starokozhko, Viktoriia; Agricola, Eleonora; Burggraf, Manja; Heß, Anne; Ballensiefen, Wolfgang; Löbker, Wiebke; Nuevo, Yoana; Pasmooij, Anna M.G.; Mol, Peter G.M.
• Is Part Of: Clinical pharmacology & therapeutics. Volume 113:Issue 2(2023)
• Page Start: 349
• Page End: 359
• Publication Date: 2022-11-21
• Subjects: Pharmacology -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1002/cpt.2789
• Languages: English
• ISSNs: 0009-9236

Abstract

Abstract : Important discoveries by academic drug developers hold the promise of bringing innovative treatments that address unmet medical needs to the market. However, the drug development process has proved to be challenging and demanding for academic researchers, and regulatory challenges are an important barrier to implementing academic findings in clinical practice. European regulators offer varying degrees of support services to help drug developers meet regulatory standards and requirements. "Strengthening Training of Academia in Regulatory Sciences and Supporting Regulatory Scientific Advice" (STARS) is a European Commission–funded consortium aiming to strengthen the training of academics in regulatory science and requirements. Here, we report the results of four surveys that investigated the awareness and utilization of support tools offered by European regulators and identified the regulatory challenges and support needs of researchers. The surveys targeted four main European stakeholders in academic medicines research: academic research groups (706 respondents), academic research centers (99), funding organizations (49), and regulators (22). The results show that while European regulators provide various regulatory support tools, less than half of the responding academic researchers were aware of these tools and many experienced challenges in reaching a sufficient level of regulatory knowledge. There was a general lack of understanding of the regulatory environment that was aggravated by poor communication between stakeholders. The results of this study form a foundation for an improved European medicines regulatory network, in which regulatory challenges faced by academia are tackled.