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| 序 文 | 竹内正弘（Masahiro Takeuchi） Stephen W. Lagakos | iii |
| Faculty Members | iv-xix | |
| Program | xx-xxiii | |
| Opening Remarks | 柴 忠義（Tadayoshi Shiba） | 1-2 |
| Congratulatory Remarks | 川原 章（Akira Kawahara） | 3-4 |
| Welcoming Address | Stephen W. Lagakos | 5-6 |
| Plenary Lecture | Chairperson: 竹内正弘（Masahiro Takeuchi) | 7-16 |
| Emerging science and the challenges of the new century | 黒川 清（Kiyosi Kurokawa） | 9-16 |
| Session 1 : Changes of the Development Strategies during 5 years and Envisaged in the upcoming 5 years: Retrospective and Prospective Bridging，Simultaneous Worldwide Development， Multinational Trials (Global/Regional) | Chairperson: 井村裕夫（Hiroo Imura） | 17-70 |
| 1) What has been achieved int the past 5 yeas? | 竹内正弘（Masahiro Takeuchi） | 19-26 |
| 2) What is the future? | ||
| Strategic changes from bridging design to global/regional studies | 魚井 徹（Tohru Uwoi） | 27-32 |
| e-Patient's medical records and the network conception -The ubiquitousinformation network for the community based health services may offer optimal health care and welfare for every citizen by tailor-made form- | 北岡有喜（Yuki Kitaoka） | 33-9 |
| Genotyping: Impact on a trial design and labeling | 宇山佳明（Yoshiaki Uyama) | 41-8 |
| Regulatory perspectives of simultaneous global development | 森 和彦（Kazuhiko Mori） | 49-56 |
| Panel Discussion | 57-70 | |
| Session 2 : R&D Competitiveness of the Japanese Pharmaceutical Industry | Chairperson: Delcan P. Doogan | 71-111 |
| Pharmaceutical industry; METI's perspective Overview of Biotechnology-present and future- | 多喜田圭二（Keiji Takita） | 73-80 |
| Comparison of new drug development in Japan and overseas | 中村 洋（Hiroshi Nakamura） | 81-6 |
| What is driving cost in clinical trials? -How can we contain costs?- | 島谷克義(Katsuyoshi Shimatani） | 87-99 |
| Panel Discussion | 101-11 | |
| Session 3-1 : New Challenges-Disease Areas- | Chairperson: 高久史麿（Fumimaro Takaku) | 113-54 |
| Recent topics of cancer therapy:
Investigator initiated clinical trials, combination therapy of anticancer agents, etc. | 藤原康弘（Yasuhiro Fujiwara) | 115-22 |
| Society and aging related diseases: | ||
| 1) Alzheimer disease: The cardiovascular link | Deborah Blacker | 123-32 |
| 2) Optimal trial designs in depression | 樋口輝彦(Teruhiko Higuchi) | 133-40 |
| Cardiovascular diseases: Hypertension: From genetic study to clinical trials | Chao A. Hsiung | 141-8 |
| Panel Discussion | 149-54 | |
| Session 3-2 : New Challenges-Global Trial Strategies- | Chairperson: Lee-Jen Wei | 155-223 |
| Using SNPs data to characterize patients in global trials
-How to drive the hardest part of studying human genetic variation- | Isaac S. Kohane | 157-65 |
| Critical factors in conduct of global studies -An update on bridging studies, and a perspective on their future in international drug development- | Robert T. O'Neill | 167-74 |
| PGx: Regulatory perspective -Use of pharmacogenomics in drug development and in product labels: A clinical pharmacology perspective- | Atiqur N. Rahman | 175-80 |
| Challenges in conducting multinational trials in HIV and in extrapolating results from different regions | Stephen W. Lagakos | 181-90 |
| Global development strategies: Industry perspective -The use of prior information in medical research- | Gordon Lan | 191-201 |
| Use of SNP data and responder analyses in clinical trials: The drug against viral hepatitis type C | 八橋 弘（Hiroshi Yatsuhashi) | 203-12 |
| Panel Discussion | 213-23 | |
| Session 3-3 : New Challenges -Other Novel Technologies: Biomarkers, etc.- | Chairperson: 竹内正弘(Masahiro Takeuchi) | 225-60 |
| Introduction of more objective endpoints into clinical trials:
Biomarker best practice and reality in US | Stephen A. Williams | 227-36 |
| Biomarker opportunities for Japanese clinical development | 芝田英生(Hideo Shibata) | 237-41 |
| Research of human ES cells and its application to the future R&D
of New drugs | 中辻憲夫（Norio Nakatsuji) | 243-51 |
| Panel Discussion | 253-60 | |
| Session 4 : Review System and Discussion on Good Review Practice(GRP) | Chairperson: 白神 誠（Makoto Shiragami） | 261-311 |
| NDA review and relationship between reviewer, academia and industry | 小野俊介（Shunsuke Ono） | 263-73 |
| FDA review system Considerations for conduct of bridging studies | Ralph Harkins | 275-83 |
| EMEA regulatory up-to-date topics | Nikolaus Mueller | 285-93 |
| Training of clinical trials and reviewers | 高橋希人（Kihito Takahashi） | 295-9 |
| Panel Discussion | 301-11 | |
| Conclusion & Closing Remarks | 313-22 | |
| Conclusion | Lee-Jen Wei | 315-20 |
| Closing Remarks | 竹内正弘（Masahiro Takeuchi） | 321-2 |