1. Points for Discussion Panelists: Drs.Iwasaki, Takahashi, Wood

2. Current Situation Issues –Bridging is one way –Disappearance of clinical trials –Costs –Speed –Approval Procedure Agreement –No –very expensive –very speedy –Not transparent

3. Bridging Studies Issues –Intrinsic factors –Extrinsic factors Agreement –individual variation p450 DNA information genetic disease –cultural issues affects both targeted population conductivity of trails

4. Bridging Studies Issues –Industry perspective –Regulatory bodies –Stat. concerns Agreement –willingness speed, cost regulatory system –successful bridging studies speed of review time type of bridging studies –def. Of similarity non-standard stat.practice sample size

5. Global Studies Issues –Regulatory acceptance –Public health care –Medical practice –Surrogate markers Agreement –yes based on scientific evidence –depends on regions –recruited/targeted population education GCP –more likely to be applied not necessarily validated

6. Ethnicity Issues –Definition –Intrinsic factors –Extrinsic factors Agreement –no clear definition –individual variation basic science P450 genomic information how to apply in NDA submission –Cultural factor medical practice conductivity placebo vs active target population

7. Design Issues Issues –Clinical Aspects –Statistical Aspects Agreement –modified global protocol in each region intrinsic and extrinsic surrogate marker safety concern pharmacoeconomics –Extended concept from bridging study no hypothesis test between regions sample size calculation