| The 11th Kitasato University-Harvard School of Public Health Symposium Advanced and Global Drug Development Techniques: Innovative Strategies for Enhancing Regional Drug Development as a Global Drug Development | ||
| Preface | Takeuchi M，Wei LJ | iii |
| Faculty Members | v-xv | |
| Program | xvi-xxi | |
| Opening | ||
| Opening Remarks | Shiba T | 3-4 |
| Congratulatory Remarks | Akagawa H | 5-8 |
| Welcome Address | Takeuchi M | 9-10 |
| Keynote Session | Chairperson：Imura H | 11-34 |
| How Japan can Contribute More to Facilitate Global Development? | Teshiroge I | 13-34 |
| Session 1 Can We Find a Way to be an Outstanding Country in Drug Development? | Chairperson：Harada A | 35-74 |
| The Role and Expectations of Japan in Global R&D Strategies | Erb DM | 37-42 |
| Japan's Role in Global Clinical Development－Viewpoints from a Japan-based Company－ | Kobayashi K | 43-8 |
| Japanese Policy for Early-Phase Clinical Trial | Miyata T | 49-57 |
| Governmental Approach in Creating more Japan-origin Drugs | Okamoto M | 59-66 |
| Panel Discussion | 67-74 | |
| Session 2 The Role and Future of Modeling and Simulation for Drug Development in Asia | Chairperson：Kumagai Y，Uyama Y | 75-115 |
| Pharmacometrics 2020 | Gobburu J | 77-86 |
| Modeling & Simulation Approach for Bridging Sub-population | Kaibara A | 87-93 |
| Bridging Ethnic Factors in Pharmacometric Modeling and Simulation of Clinical Trials | Wagg JK | 95-105 |
| Panel Discussion | 107-15 | |
| Session 3-1 Regional Development, Global Development, Simultaneous Development‒ The Best Way to Faster Access for Patients | Chairperson：Narukawa M | 117-34 |
| Simultaneous Delivery of Innovative Drugs to Patients－Eli Lilly’s Strategy | Fujimoto T | 119-24 |
| PMDA's International Strategic Plan and Its Implementation | Tadano K | 125-34 |
| Session 3-2 Regional Development, Global Development, Simultaneous Development‒ The Significant Role of Japanese R&D in Asia | Chairperson：Gordon Lan KK | 135-72 |
| Quality of Data Generated from Japan from the Perspective of Companies | Uden S | 137-45 |
| Surrogate Endpoints in Cardiovascular Trials | Solomon SD | 147-52 |
| What is the Best Strategy of Drug Development to Provide an Innovative Drug to Patients? －An Importance of Regulatory Contribution－ | Uyama Y | 153-60 |
| Regulatory Perspectives and Experiences on Data Monitoring & New Challenges in MRCTs | Wang SJ | 161-6 |
| The Significance and Role of IDMC in Asia | Takeuchi M | 167-72 |
| Session 4 Roundtable Discussion | Chairperson：Takeuchi M | 173-94 |
| The Significant Japanese Role in Research and Development －Proof of Concept (from seeds to bed side) －Quality of Clinical Trial in Japan (Sample size) －Scientific Drug Development Strategy (Biomarker, Surrogatemarker and IDMC) | 175-94 | |
| Closing | ||
| Closing Remarks | Takeuchi M | 197 |