New paradigms in drug development

Orateur : Matthieu ROUSTIT (CHU, Grenoble)

Drug development is a complex and costly process, and few drug candidates eventually become effective medicines. To prevent late-phase failure and reduce uncertainty, developers aim at establishing the proof-of-concept (POC) as early as possible during drug development. The « quick win, fast fail » model has been proposed at the beginning of this decade. It consists in shifting the POC from phase II studies to early clinical studies, occuring at the beginning of development. This approach also fosters two-way communication between scientists and developers, to transition from the traditional bench-to-bedside model. In this context, academic research and small companies have played a more prominent role in drug development in recent years. Close collaboration between scientists, clinicians, and drug developers is required to design such early, small studies. Specific regulatory and funding issues also need to be addressed.

Télécharger dans mon agenda