| The 13th Kitasato University-Harvard School of Public Health Symposium Advanced Drug Development Strategy and Technology －Moving beyond the Comfort Zone－ | ||
| Preface | Takeuchi M，Wei LJ | iii |
| Faculty Members | iv-xvii | |
| Program | xviii-xxi | |
| Opening | ||
| Opening Remarks | Kobayashi H | 3-4 |
| Congratulatory Remarks 1 | Takaku F | 5-6 |
| Congratulatory Remarks 2 | Sato T | 7-8 |
| Welcome Address | Gruttola VD | 9-10 |
| Keynote Speech 1 | Chairperson：Takeuchi M | 11-24 |
| From Basic Research to Practical Use in Life Sciences －Current Situation and Future Prospects in Japan | Saruta T | 13-24 |
| Session 1 Real World Data Collection, Evaluation and its Implication | Chairperson：Narukawa M | 25-67 |
| Computerization of Medical Information and their Active Use | Nakayasu K | 27-36 |
| Moving beyond the Comfort Zone for Clinical Trials－Application of Big Data | Takeuchi M | 37-44 |
| Analytics of Clinical “Big Data”－Toward Applications for Pharmaceutical Industry－ | Hisamitsu T | 45-54 |
| Application of Real World Data to Clinical Development | Onogi H | 55-9 |
| Panel Discussion | 61-7 | |
| Session 2 Japan in Global Drug Development as a Key Role | Chairperson：Harada A | 69-136 |
| Learn from the Case Where Approval was obtained in Japan before the Rest of the World | Sugita M | 71-5 |
| Simultaneous Filing in US/EU/JPN | Nakamura T | 77-85 |
| New Drug Development of Japan Origin through Industry-Academia Collaboration －Trials in Academia and in PMDA | Yamori T | 87-100 |
| Current Post-Marketing Safety Measures of Japan | Yamamoto H | 101-11 |
| Drug Discovery－Role and Significance of Academia－ | Miyata T | 113-26 |
| Panel Discussion | 127-36 | |
| Keynote Speech 2 | Chairperson：Takeuchi M | 137-48 |
| Kanagawa Model Changing Japan ‒ Healthcare New Frontier Conception | Kuroiwa Y | 139-48 |
| Session 3 Collaboration without Barrier of Business-to-Business | Chairperson：Takeuchi M | 149-85 |
| Open Innovation AK project | Aramori I | 151-8 |
| Open Innovation in National Strategic Special Zone | Shuto K | 159-65 |
| New Initiative for Medical Research and Development in Japan | Hishiyama Y | 167-77 |
| Panel Discussion | 179-85 | |
| Session 4 How to generate and transmit valuable evidence from Japan | Chairperson：Sato T | 187-218 |
| Mission of the Foundation Sponsored Clinical Trial General Managing Center in Vitalization of the Clinical Trial | Hayashi S | 189-94 |
| Overseas IIR and Support from Pharmaceutical Companies | Kostek A | 195-9 |
| Efforts in Clinical Research and Clinical Trials Activation and Revision
of the Ethical Guidelines for Clinical Studies | Minamikawa K | 201-7 |
| Patient Expectations and Perspectives on Issues in Clinical Research | Suzuki N | 209-12 |
| Panel Discussion | 213-8 | |
| Closing | ||
| Closing Remarks | Takeuchi M | 221 |