| Preface | Takeuchi M Lagakos SW |
iii |
| Faculty Members | iv-vi | |
| Program | vii-xi | |
| Opening Remarks and Welcoming Address | Sato T | 1 |
| Doogan DP | 3 | |
| Congratulatory Remarks: What is Expected of the Symposium? |
Kurokawa T | 5 |
| SESSION 1: BRIDGING STRATEGIES: OVERVIEW | Chaired by Yazaki Y |
7-69 |
| ICH-E5: Overview and Current Topics | Narukawa M | 9-18 |
| Bridging-Current Asian Practices | ||
| Japanese Experience on Bridging Studies through PMDEC's Reviews of NDAs |
Fujiwara Y | 19-33 |
| Experiences in Other Asian Countries | ||
| Bridging Studies in the Asian Pacific Region -The Singapore Experiences- |
Tan SF | 35-9 |
| Implementation of Bridging Studies -The Taiwan Experiences- |
Tzou MC | 41-8 |
| Development of Evaluation and Consultation on Bridging Studies -The Thailand Experiences- |
Chongprasert S | 49-57 |
| Comments from Academia | ||
| Bridging: Extrapolating Evidence of Efficacy and Safety to New Populaions |
Ware JH | 59-69 |
| SESSION 2: BRIDGING STRATEGIES: THE WEST EXPERIENCE WITH BRIDGING |
Chaired by Doogan DP |
71-106 |
| Regulatory System in Europe | Kuerner T | 73-8 |
| Practical Issues in Conducting Multi-country Studies |
Stanley KE | 79-88 |
| Racial Differences in the Response to Drugs? | Wood AJJ | 89-101 |
| Panel Discussion | 103-6 | |
| SESSION 3: REGIONAL/GLOBAL CLINICAL TRIALS | Chaired by Lagakos SW |
107-44 |
| Developing an Asian Regional Strategy | ||
| Significance of Extrapolation of Foreign Clinical Data to Asian Countries |
Takeuchi M | 109-16 |
| Challenge in Conducting Global Clinical Trials | ||
| What Impact will Globalization have on Bridging Studies? |
Shimatani K | 117-25 |
| Panel Discussion | ||
| Discussants | ||
| Asian Multinational Clinical Trials -Current Status and Future Direction- |
Iwasaki M | 127-9 |
| Panel Discussion | 131-44 | |
| TV CONFERENCE: TOKYO-WASHINGTON, D.C. | ||
| SESSION 4: ICH: PRACTICAL IMPLEMENTATION OF E5 GUIDELINES |
Chaired by Lagakos SW |
145-66 |
| Regulatory Experience with ICH E5 | ||
| ICH E5 Guidance: A Regulatory Perspective on its Evolution and Implementation |
O'Neill RT Temple RJ |
147-53 155-6 |
| Panel Discussion | ||
| Discussants | ||
| Toward Regional Multi-Centered Trials | Sato D | 157-8 |
| Feasibility of Doing Regional Clinical Trials across Several Countries |
Tasaki T | 159-60 |
| Panel Discussion | 161-6 | |
| SESSION 5: PHARMACOGENOMICS: ADVANCES IN UNDERSTANDING |
Chaired by Imura H |
167-208 |
| Typical Example for an Approval of Genome Research Compound |
||
| Accelerated Approval of Imatinib Mesylate for Leukemia Treatment-Approval Summary or Imatinib Mesylate Capsules in the Treatment of Chronic Myelogenous Leukemia- |
Cohen MH | 169-76 |
| Genome Sequencing and Analysis (DNA, cDNA) | ||
| Application of Whole Genome Shotgun Sequencing and Analysis |
Woodage TJ | 177-90 |
| Drug Discovery and Early Development Research/ Translational Research |
||
| Translation of Genomic Information into Drug Discovery and Early Clinical Development |
Arai K | 191-208 |
| SESSION 6: PHARMACOGENOMICS: IMPACTS-CLINICAL & REGULATORY |
Chaired by Kurokawa K |
209-40 |
| Implication of New Genetic Science (Future for Tailor-made Therapy) |
||
| Pharmacogenomics: Implications for Post-Genome Science (Future for Tailor-made Medicine) |
Kurokawa K | 211-8 |
| Applications of Clinical Genetics | ||
| The Future of Genetics in Clinical Medicine | Power A | 219-26 |
| Panel Discussion | ||
| Discussant Speechs | ||
| A Correlative Study for POP of Target-based Drugs Using Gene Expression cDNA Array |
Nishio K | 227-9 |
| Is it Possible to Apply Results of Microarray Method Prospectively? |
Nagamura F | 231-3 |
| Pharmacogenomics in Japan | Gushima H | 235-6 |
| Panel Discussion | 237-40 | |
| SUMMARY AND CONCLUSION | 241-9 | |
| Summary and Conclusion | Lagakos SW | 243-7 |
| Closing Remarks | Takeuchi M | 249 |