| The 12th Kitasato University-Harvard School of Public Health Symposium Advanced and Global Drug Development Techniques: Next Steps and Actions as one of the Leading Countries | ||
| Preface | Takeuchi M，Wei LJ | iii |
| Faculty Members | iv-xv | |
| Program | xvi-xix | |
| Opening | ||
| Opening Remarks | Okayasu I | 3-4 |
| Congratulatory Remarks 1 | Shimajiri A | 5 |
| Congratulatory Remarks 2 | Akagawa H | 7-12 |
| Welcome Address | Wei LJ | 13-4 |
| Keynote Speech 1 | Chairperson：Takeuchi M | 15-27 |
| Prospects for Medicine and Medical Devices in Japan | Takaku F | 17-27 |
| Session 1 Activate Upstream of New Drug R&D | Chairperson：Iwasaki M | 29-73 |
| Drug Discovery Support Network in Japan | Kurebayashi Y | 31-4 |
| Drug Discovery and Clinical Development: Role of Academia and Global Perspective | Miyata T | 35-9 |
| Bioventures: Growth Strategies and Importance for Innovation | Kneller R | 41-52 |
| Patent Pools as Public Health Meta-Collaborations: The Experience of NIH and the Medicines Patent Pool | Ferguson SM | 53-66 |
| Panel Discussion | 67-73 | |
| Session 2 For Enhancement and Utilization of Clinical Research | Chairperson：Harada A | 75-142 |
| Activities and Grand Design as a Country within the New 5-Year Plan | Yamada M | 77-91 |
| Activities of ARO in Japan | Hanaoka H | 93-102 |
| Current Structure and Status of an Academic Research Organization | Handler AJ | 103-11 |
| Proposals for Establishing a Compendium System for Anticancer Drugs in Japan | Fujiwara Y | 113-24 |
| Examples of Utilizing Japan’s Clinical Research Data for Submitting Application for Approval | Sawada T | 125-33 |
| Panel Discussion | 135-42 | |
| Session 3 Review of Past Effort and Exploring the Future Possibilities in New Drug Development | Chairperson：Fujieda T | 143-203 |
| Japan’s Clinical Trial Environment and Capabilities ‒ Things We should Do from Now on ‒ | Kobayashi K | 145-58 |
| What is Japan’s Quality as seen from Medical Institutions? ‒ from a Physician’s Standpoint | Ohtsu A | 159-74 |
| What is Japan’s Quality as seen from Medical Institutions? ‒ from a Clinical Research Staff’s Standpoint | Ushirozawa N | 175-84 |
| Quality as seen from Regulatory Authorities | Osawa T | 185-95 |
| Panel Discussion | 197-203 | |
| Keynote Speech 2 | Chairperson：Takeuchi M | 205-16 |
| New Trends of Medicine and Importance of Science of Translation | Imura H | 207-16 |
| Session 4 Learning from New Approaches for Activation of New Drug Development | Chairperson：Takeuchi M | 217-287 |
| Introduction to Japanese Regulatory Agencies and Japanese Government’s
Recent Policies on Early Phase Clinical Trials in Japan | Miyata T | 219-30 |
| The Japanese Review Authorities’ Research Setup and Future Outlook | Uyama Y | 231-39 |
| Interconnected R&D: A Future Direction for Pharmaceutical Research and Development | Tardiff BE | 241-8 |
| FDA’s Model-Based Strategies in the ICH-E14 Guidelines | Garnett CE | 249-61 |
| Enhancing Technology Transfer for Neglected Tropical Disease (NTD) | Ferguson SM | 263-70 |
| Revitalizing Clinical Trial Methodology and Translational Statistics | Wei LJ | 271-81 |
| Panel Discussion | 283-7 | |
| Closing | ||
| Closing Remarks | Takeuchi M | 291 |