1. Advanced and Global Drug Development Techniques: Brigding Strategies and Pharmacogenomics Simltaneous/ Worldwide Development Strategies: Overview Thomas K ue rner, M.D. Nippon Boehringer Ingelheim Co., Ltd.

2. The 3rd Kitasato-Harvard Symposium Key success factor for bridging Clarify influence of extrinsic and intrinsic factors Careful analysis of PK/PD in different populations Confirmation of dose-response relationship in different ethnic groups Confirmation of safety profile in submitted region

3. The 3rd Kitasato-Harvard Symposium Example from Asian Trials in mild to moderate essential hypertension using ARB

4. The 3rd Kitasato-Harvard Symposium Conclusions Past Little experiences among regulatory agencies with Asian multi-center trials Mostly retrospective bridging strategies applied by the sponsors Future Prospective Asian collaborative registration trials Ensuring of compliance to ICH agreed standards Competitive enrollment will enhance performance in different Asian countries