Module 5 Presentations

18/07/2024

Presentation Outline

Market Dynamics

Drug Development Strategy

PMDA Consultation Strategy

Clinical Trials Strategy

Communication Strategy

Distribution to third parties is not allowed

15

Clinical Development Pathways in Japan

Global Clinical Development Without Japan

Global Phase II

Global Phase III

Phase I

NDA

Launch

Full Development

Phase II

Phase I

Phase III

NDA Launch

Bridging Concept

Phase I

Phase II NDA Launch

Global Phase II

Global Phase III

Global Clinical Development With Japan

Phase I

NDA Launch

Japan APAC Development

Phase I

Phase II

Phase III

NDA Launch

Distribution to third parties is not allowed

16

8