| Preface | Takeuchi M, Lagakos SW | iii |
| Faculty Members | v | |
| Program | xviii | |
| ●Opening | ||
| Opening Remarks | Shiba T | 3-4 |
| Congratulatory Remarks | Narita M | 5-7 |
| Welcoming Address | Zelen M | 9 |
| ●Key Note 1 | Chairperson : Imura H | 11 |
| Development of Pharmaceuticals Industry in China and International Cooperation | Ruan X | 13-7 |
| ●Session 1 | ||
| Japanese Government Measures for Enhancement of New Drug Development in Japan | Chairperson : Imura H | 19 |
| R&D Challenges at MEXT in Developing Innovative Medicines and Pharmaceuticals | Watanabe M | 21-9 |
| Measures for Enhancing New Drug Development by Ministry of Health, Labour and Welfare | Chimura H | 31-40 |
| Issues around the Promotion of Pharmaceutical Development in Japan | Araki Y | 41-7 |
| Approach for Promoting Clinical Research by Cabinet Office | OritaT | 49-56 |
| ●Session 2 | ||
| Issues on Acceptance of Foreign Clinical Data in Each Region from Regulatory Perspective | Chairperson : Takeuchi M | 57 |
| Acceptance of Foreign Clinical Data: A U.S. Perspective | Justice RL | 59-64 |
| Issues on Acceptance of Foreign Clinical Data in Europe from a Regulatory Perspective | Dunder K | 65-76 |
| Biostatistics Consideration on Clinical Trials in China | Tang JY | 77-80 |
| Acceptance of Foreign Clinical Data in KFDA | Chang JY | 81-8 |
| Future Directions of Global Drug Developments on the basis of Japanese Regulatory Experience to Accept Foreign Clinical Data | Uyama Y | 89-97 |
| Dose-Response Study for Bridging Data Generation | Lim HS | 99-109 |
| Panel Discussion | 111-8 | |
| ●Session 3 | ||
| Translational/Clinical Research in Academia | Chairperson : Zelen M | 119 |
| Translational/Clinical Research in Japan | Narukawa M | 121-32 |
| Translational Research in Korea | Jang IJ | 133-40 |
| Clinical Research in Academia: A Viewpoint from Indonesia | Setiabudy R | 141-6 |
| The Clinical Utility Index (CUI): An Aid to Rational Dose Selection in Asian Global Studies? | Hodge L | 147-62 |
| Regulatory Harmonization Initiative in APEC LSIF (Life Science Innovation Forum) | Chern HD | 163-70 |
| Panel Discussion | 171-81 | |
| ●Key Note 2 | Chairperson : Takeuchi M | 183 |
| Induction of Pluripotency by Defined Factors | Yamanaka S | 185-201 |
| ●Session 4 | ||
| Challenges by Industry and Proposals for the Future | Chairperson : Harada A | 203 |
| Clinical Trial Environment for Asian Countries Including China | Man S | 205-13 |
| The Challenges of Drug Development in Emerging Markets | Marchant B | 215-21 |
| Challenges Facing Japanese Biotech Companies | Yoshida F | 223-34 |
| Sentinel Initiative in Japan: Utilization of Electronic Health Information in Pharmacovigilance | Misawa K | 235-45 |
| ●Session 5 | ||
| Clinical research in Japan | Chairperson : Takahashi K | 247 |
| Investigator Initiated Trial by Clinical Oncology Group | Nakamura S | 249-56 |
| Clinical Research in the National Hospital Organization | Ito S | 257-68 |
| From Academic Research Organization | Sato Y | 269-74 |
| Clinical Research Infrastructure: From the Perspectives of Medical Care, Law, and Legislation | Furukawa T | 275-82 |
| Panel Discussion | 283-92 | |
| ●Conclusion & Closing Remarks | ||
| Conclusion | Zelen M | 295-6 |
| Closing Remarks | Takeuchi M | 297-8 |