1. Summary of Discussion

2. l Issues –Practical use of ICH E5 guideline –Simultaneous global drug development

3. Practical use of ICH E5 guideline l Bridging strategies – two issues –Clinical aspects: Intrinsic factors Intrinsic factors Genomic information – individual variability Genomic information – individual variability Extrinsic factors: Extrinsic factors: Medical practice – impact on therapeutic effects Medical practice – impact on therapeutic effects

4. Practical use of ICH E5 guideline l Bridging strategies – two issues –Design aspects: Statistical issues – under investigation Statistical issues – under investigation Def.of similarity, sample size ??? Def.of similarity, sample size ??? Design aspects: Design aspects: Double blind placebo control ??? Double blind placebo control ???

5. Simultaneous global drug development l Global development strategies – two issues –Scientific based evidence: Surrogate markers Surrogate markers Dose response, individual variation (PK/PD) Dose response, individual variation (PK/PD) Quick and objective measurement, unvalidated Quick and objective measurement, unvalidated Genomic information Genomic information Design issue – selection of target population by pharmacogenomics approach Design issue – selection of target population by pharmacogenomics approach

6. Simultaneous global drug development l Global development strategies – two issues –Regulatory dialogue: Asian collaboration Asian collaboration APEC meetings in Taipei, 2001, and Tokyo 2002 APEC meetings in Taipei, 2001, and Tokyo 2002 Asian countries can be considered as one region Asian countries can be considered as one region Evaluation and review systems Evaluation and review systems Transparent drug development strategies and review system between regulatory bodies and sponsors, ex. Merge of KIKO and PMDEC Transparent drug development strategies and review system between regulatory bodies and sponsors, ex. Merge of KIKO and PMDEC