Reducing the risk and increasing the probability of success in drug development
10 Sept 2026
Clinical Development
- How can using established, regulator-accepted endpoints help derisk development and clarify the regulatory pathway?
- What lessons can be learned from programmes that failed after using novel or creative endpoints, including biomarkers?
- How early should endpoint alignment with FDA and EMA expectations occur to reduce risk before Phase 2?
- Why is it important to avoid changing endpoints between Phase 2 and Phase 3?
- How can Phase 3 registration studies confirm Phase 2 learnings and improve the probability of success in psychiatry and neurology drug development?
Industry Expert
