| Preface | iii | Takeuchi M Lagakos SW |
| Faculty Members | iv-xix | |
| Program | xx-xxvii | |
| Opening Remarks | 1-2 | Shiba T |
| Congratulatory Remarks | 3-4 | Kawahara A |
| Welcoming Address | 5-6 | Doogan DP |
| Session 1 : Performance of New Drug Research and Development in Japan and its International Competitiveness | 7-70 | Chairperson: Doogan DP |
| Clinical Research to be Delivered to Patients | 9-17 | Sasazuki T |
| Japanese Pharmacutical Industry from the Viewpoint of National Policy | 19-28 | Watanabe T |
| International Competitiveness of the Japanese Pharmaceutical Industry | 29-35 | Odagiri H |
| The Plan for Promotion of Biotechnology as a Science Technology in Industry | 37-44 | Takita K |
| International Competitiveness of the Japanese Clinical Trials on Cost and Performance | 45-58 | Shimatani K |
| Panel Discussion | 59-70 | |
| Session 2 : New Challenges-Enhancement of Productivity and Performance- | 71-118 | Chairperson: Imura H |
| The Impact of Critical Path Initiative on R&D in Japan | 73-83 | Takeuchi M |
| The Development and Use of Translational Models and Biomarkers in Clinical Development of New Medicines | 85-99 | Gale J |
| Innovation of Web-based Registration System for an International Collaboration Study on Clear Cell Carcinoma of the Ovary | 101-8 | Fujiwara K |
| Panel Discussion | 109-18 | |
| Session 3 : New Challenges-Disease Areas- | 119-57 | Chairperson: Takaku F |
| Vaccination Therapy for Alzheimer's Disease | 121-9 | Tabira T |
| Prevention of Cardiovascular Diseases: Aggresive Management of Cardiovascular Risk Factors | 131-40 | Yamada N |
| Investigator Initiated Trial (IIT): Future for IIT from the Past Experience | 141-6 | Teraoka A |
| Panel Discussion | 147-57 | |
| Session 4 : New Challenges-Innovative Study Design, along with Mathematical Approch and Simulation of Global/Regional Clinical Studies- | 159-215 | Chairperson: Zelen M |
| Design Considerations in Global Clinical Trials: Keys in Newly Disigning of Global Studies and Validation Study Designs of Novel Biomarkers | 161-6 | Hung HMJ |
| Design Issues in Anti-infective Trials: Opportunities and Challenges for Innovative Study Designs | 167-74 | Lin D |
| Explore and Develop Modeling/Simulation: "RALES" Design Kitasato-Harvard-Pfizer-Hitachi Project | 175-89 | Uno H |
| Data Mining Approach to Improve the Accuracy of AE Analysis: Establishment of Key Medical Institute Network, Collection of AE Information and its Analysis | 191-7 | Kojima C |
| Panel Discussion | 199-215 | |
| Session 5 : Regulatory-based Dialogues-Global Trials, Asian Trials- | 217-85 | Chairperson: Takeuchi M |
| A Trial to Assess Ethnicity and Hint on How to Design Global/Asian Studies | 219-32 | Keith D. Wilner |
| Regulatory Aspect of Asian Trials Regulatory-based Dialogues in Taiwan for Global and Asian Trials | 233-8 | Chern HD |
| Regulatory Perspectives and Clinical Trial Situation in Korea | 239-44 | Jang IJ |
| Regulatory-based Dialogues: Regulatory Aspect of Asian Trials | 245-55 | Foo YT |
| Regulatory Aspect of Asian Trials: Whither (and Whether) Bridging? | 257-63 | Kobayashi K |
| Challenge of a Global Trial and an Asian Trial | 265-74 | Nihira S |
| Panel Discussion | 275-85 | |
| Session 6 : Regulatory-based Dialogues-Performance of Regulatory Review- | 287-333 | Chairperson: Ono S |
| Opening Remarks at Session 6 | 289-90 | Ono S |
| Current Status and Future Perspectives of Clinical Trial Consultation and NDA Review Performance | 291-9 | Uyama Y |
| Proposal from industry eg. Quality, Performance and Training | 301-6 | Takahashi K |
| Review System for NDA Approval in the USA and Japan and their Performance of Review | 307-14 | Asaka O |
| Eary Approval and Launch of New Drugs: Dissolution of Drug Lag | 315-9 | Narukawa M |
| Panel Discussion | 321-33 | |
| Conclusion & Closing Remarks | 335-42 | |
| Conclusion | 337-40 | Wei LJ |
| Closing Remarks | 341-2 | Takeuchi M |