| Preface | Takeuchi M Lagakos SW | iii |
| Faculty Members | iv-xvii | |
| Program（English） | xviii-xxi | |
| Program（Japanese） | xxii-xxv | |
| Keynote 1（The 7th KH-symposium） | ||
| Keynote 1： | Chairperson： Lagakos SW | 1 |
| Critical Path Initiative: What, Why and Future Direction？ | Woodcock J | 3-10 |
| KH-JST/CRDS Workshop | ||
| Integrative Celerity Research | Chairperson：Takeuchi M | 11 |
| Opening Remarks | Kitazawa K | 13-4 |
| Keynote Lecture: ICR Clinical Research Initiative | Imura H | 15-23 |
| Panel Discussion: Ikeda C, Araki K, Campbell G, Ono S Lagakos SW, Doogan DP, Takahashi K | 25-52 | |
| Closing Remarks | Imura H | 53-5 |
| The 7th KH-symposium | ||
| The 7th KH-symposium - Harvard School of Public Health Symposium on Advanced and Global Drug Development Techniques: Japan's Critical Path Opportunities | 57 | |
| Opening Remarks | Mizumoto K | 59-60 |
| Congratulatory Remarks | Nakagaki T | 61-2 |
| Welcome Address | Doogan DP | 63 |
| Session 1：Future of Japan Life Science | Chairperson: Takeuchi M | 65 |
| National Perspective：Structual Problems Inhibiting the innovation in the Medical Field | Tokumtsu Y | 67-77 |
| Media Perspective：Future of Life Science in Japan from the viewpoint of the Media | Nakamura M | 79-84 |
| Industry Perspective | Doogan DP | 85-92 |
| Keynote 2：Future of Clinical Research and Issues in Japan | Imura H | 93-106 |
| Session 2-1：Japan's Critical Path Opportunities -1 Reforming the Clinical Trial Process for Trial Conduct; Environment and Infrastructure of Clinical Research and Trials | Chairperson: Ono S | 107 |
| Promotion of Translational Research in Japan： Present Status and Future Prospects of Translational Research Center at Kyoto University Hospital | Shimizu A | 109-19 |
| A Survey of Investigator's Motivation to Conducting Clinical Trials | Uno H | 121-9 |
| Survey Results; Current Status of EDC Use in Japan | Sekine E | 131-8 |
| Clinical Trial Performance and Cost Survey | Shimatani K | 139-54 |
| Panel Discussion | 155-72 | |
| Session 2-2：Japan's Critical Path Opportunities -1 (Cont.) Introduction of Critical Path Science | Chairperson: Azuma J | 173 |
| Biomedical Application of Metabolome Analysis；Exploring New Metabolic Pathways and Surrogate Markers | Suematsu M | 175-82 |
| FDA Critical Path; Where Does It Lead? | Weiner D | 183-90 |
| Session 3：Japan's Critical Path Opportunities - 2 Reforming the Clinical Trial Process for Novel Trial Design, Trial Conduct and Introduction of Other Novel Technologies (Biomarkers etc.) | Chairperson: Wei LJ | 191 |
| Some Considerations in Use of Adaptive Disign for Global Clinical Trial Program | Hang HMJ | 193-6 |
| An Update on Critical Path Opportunities: Streamlining Clonical Trials to Improve Their Success Rate and Efficiency | O'Neill RT | 197-202 |
| Pharmacometrics | Gobburu JV | 203-10 |
| Japan Development Approach | Takeuchi M | 211-7 |
| Panel Discussion | 219-26 | |
| Session 4：Japan's Critical Path Opportunities - 3 New Challenges in Disease Areas | Chairperson: Takaku F | 227 |
| Society and Aging Related Disease: Smoking Cessation | Azoulay S | 229-36 |
| Cancer Therapy; Recent Topics | Fujiwara Y | 237-44 |
| Cardiovascular Disease -Urgent Needs for Japanese Version of NIH's Roadmap and FDA's Critical Path Initiatives to Re-engineer Clinical Research and Development- | Sase K | 245-53 |
| Clinical Study Design for Medical Devices | Campbell G | 255-60 |
| Japan is lagged from Other Countries in Clinical Use of New Medical Devices: Industry Perspective on Critical Path Opportunities | Trunzo JE | 261-5 |
| Panel Discussion | 267-74 | |
| Session 5：Japan's Critical Path Opportunities - 4 Tracking Innovation through New Critical Path Tools in the Regulatory Process | Chairpersons:Ono S, Kusuoka H | 275 |
| The Possibility of Japanese Critical Path Initiative(Reviewer's perspective) | Mori K | 277-84 |
| What can we do as a Regulatory Body to Provide New Drugs with Efficacy and Safety for Patients Earlier? | Narukawa M | 285-90 |
| Critical Path in Taiwan | Chern HD | 291-7 |
| Industry Perspective and Proposal | Harada A | 299-305 |
| Panel Discussion | 307-21 | |
| Academic Effort for Innovative Clonical Research | Ikeda Y | 323-6 |
| Clinical Trial Promotion for Medical Devicesて | sato D | 327-39 |
| Conclusion and Closing Remarks | 341 | |
| Conclusion | Lagakos SW | 343-7 |
| Closing Remarks | Takeuchi M | 349 |