Background: Antimicrobial drug resistance is an urgent problem. There are relatively few agents in developmental pipelines. Traditional pathways for drug development are expensive and slow. Both the EMA and FDA have recognized some of these obstacles for drug development. New regulation now enables accelerated drug development, with adaptive licensing until larger definitive phase III studies are completed. Such an approach enables access to drugs for patients with unmet medical needs.
Challenges: There is uncertainty regarding what constitutes reasonable pathways for accelerated drug development. There is a reliance on very robust preclinical studies, innovative clinical trial design, strong academicindustrial partnerships, and a requirement for early engagement with regulatory bodies.