Leveraging Prior Quantitative Knowledge to Guide Drug Development Decisions and Regulatory Science Recommendations: Impact of FDA Pharmacometrics During 2004–2006

TLDR

The study proposes End‑of‑Phase 2A meetings to accelerate product availability and improve drug application quality, and is developing draft guidance to be issued in 2008. The authors review 11 pilot End‑of‑Phase 2A meetings held since 2004, illustrating the process through four detailed case studies of quantitative analyses and decision‑making. Industry and FDA scientists rated the meetings as very helpful (average 4/5), and sponsors altered their development plans afterward, supporting the creation of the forthcoming guidance.

Abstract

The End-of-Phase 2A meetings are proposed to identify opportunities to make innovative medical products available sooner and to increase the quality of drug applications through early meetings between sponsors and the FDA. This article summarizes the overall experience across 11 pilot End-of-Phase 2A meetings since 2004. Four case studies are presented in more detail to demonstrate the various issues and methods encountered at these meetings. Overall, industry and FDA scientists ranked these meetings to be "very helpful" (average score of 4 on a scale of 1 to 5). In almost all the instances the sponsors changed their drug development plans subsequent to these extensive quantitative analyses-based meetings. A draft Guidance is being developed to be issued in 2008, and we hope this initiative will be resourced by then.