OVERVIEW Drug development in East Asia has become extremely vigorous as the interests of organizations related to drug development expand. Such organizations are now not only interested in the advancement of drug development, but also the maximization of generated value and the improvement of quality in new drug development. In order to facilitate drug discovery under the revised regulations for optimal regulatory circumstances, professionals involved in drug development face various challenges. Furthermore, collaboration to work towards drug discovery beyond each country’s boundaries is strongly desired in this era of globalization of drug development. In this conference, together with experts from industry and CRO, speakers from regulators and academia in Japan, China and Korea will share information and experiences regarding the current situation of new drug development in the emerging East Asia region, and provide advice on how to improve the value and quality of new drugs. The 8th DIA Annual Conference in Japan for Asian New Drug Development will feature discussion on all stages of drug development, with sessions focused on the following topics: • Latest regulatory information • Early phase clinical trial • Collaboration between academic organizations • Regulatory inspection • Regional study communications • Late phase development strategy We look forward to welcoming you to the conference. WHO SHOULD ATTEND • Clinical development professionals • Personnel involved in regulatory affairs • Personnel at clinical study sites • Personnel at CROs and SMOs • Personnel involved in medical affairs and marketing • Personnel at academic organization • Personnel at agency 8 th DIA Annual Conference in Japan for Asian New Drug Development Value and Quality of East Asian Clinical Trial in Drug Development May 22-23, 2014 | Sola City Hall | Ochanomizu, Tokyo PROGRAM CHAIR Hidetoshi Shuto, MS Astellas Pharma Inc. PROGRAM VICE-CHAIR Ari Fujishiro Daiichi Sankyo Co., Ltd. PROGRAM COMMITTEE Tomohisa Hayakawa, PhD EPS International Holdings Co., Ltd. Shii Man, MD, PhD Otsuka Beijing Research Institute, China Koichi Miyazaki, MSc, RPh Daiichi Sankyo Co., Ltd. Yasuto Otsubo Pharmaceuticals and Medical Devices Agency Min Soo Park, MD, PhD Yonsei University College of Medicine Republic of Korea Kihito Takahashi, MD, PhD GlaxoSmithKline K.K. Akio Uemura, PhD Allergan Japan K.K. Yoshiaki Uyama, PhD Pharmaceuticals and Medical Devices Agency Jisin Yang, MD AstraZeneca K.K. DIA Global Center 21 Dupont Circle NW, Suite 300 Washington, DC 20036 Worldwide Offices Basel, Switzerland | Beijing, China | Horsham, PA, USA Mumbai, India | Tokyo, Japan www.DIAhome.org or more information visit diahome.org/Japan-8thNewDrugDev Fo Simultaneous Translation Available Tabletop Exhibit Opportunity For information, contact DIA Japan Nisso 22 Bldg. 7F, 1-11-10 Azabudai, Minato-ku, Tokyo 106-0041 Japan Tel: 81-3-5575-2130 | Fax: 81-3-3583-1200 email: [email protected]
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DIA Annual Conference in Japan for Asian New Drug Development
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OVERVIEW
Drug development in East Asia has become extremely vigorous as the interests of organizations related to drug development expand. Such organizations are now not only interested in the advancement of drug development, but also the maximization of generated value and the improvement of quality in new drug development. In order to facilitate drug discovery under the revised regulations for optimal regulatory circumstances, professionals involved in drug development face various challenges. Furthermore, collaboration to work towards drug discovery beyond each country’s boundaries is strongly desired in this era of globalization of drug development.
In this conference, together with experts from industry and CRO, speakers from regulators and academia in Japan, China and Korea will share information and experiences regarding the current situation of new drug development in the emerging East Asia region, and provide advice on how to improve the value and quality of new drugs.
The 8th DIA Annual Conference in Japan for Asian New Drug Development will feature discussion on all stages of drug development, with sessions focused on the following topics:• Latest regulatory information• Early phase clinical trial• Collaboration between academic organizations• Regulatory inspection• Regional study communications• Late phase development strategy We look forward to welcoming you to the conference.
WHO SHOULD ATTEND
• Clinical development professionals• Personnel involved in regulatory aff airs• Personnel at clinical study sites• Personnel at CROs and SMOs• Personnel involved in medical aff airs and marketing• Personnel at academic organization• Personnel at agency
8th DIA Annual Conference in Japan for Asian New Drug DevelopmentValue and Quality of East Asian Clinical Trial in Drug Development
May 22-23, 2014 | Sola City Hall | Ochanomizu, Tokyo
PROGRAM CHAIR
Hidetoshi Shuto, MSAstellas Pharma Inc.
PROGRAM VICE-CHAIR
Ari FujishiroDaiichi Sankyo Co., Ltd.
PROGRAM COMMITTEE
Tomohisa Hayakawa, PhDEPS International Holdings Co., Ltd.
Shii Man, MD, PhDOtsuka Beijing Research Institute, China
Koichi Miyazaki, MSc, RPhDaiichi Sankyo Co., Ltd.
Yasuto OtsuboPharmaceuticals and Medical Devices Agency
Min Soo Park, MD, PhDYonsei University College of MedicineRepublic of Korea
Kihito Takahashi, MD, PhDGlaxoSmithKline K.K.
Akio Uemura, PhDAllergan Japan K.K.
Yoshiaki Uyama, PhDPharmaceuticals and Medical Devices Agency
Jisin Yang, MDAstraZeneca K.K.
DIA Global Center21 Dupont Circle NW, Suite 300
Washington, DC 20036
Worldwide Offi cesBasel, Switzerland | Beijing, China | Horsham, PA, USA
Mumbai, India | Tokyo, Japanwww.DIAhome.org
or more information visit diahome.org/Japan-8thNewDrugDevFo
10:00-10:10 WELCOME AND OPENING REMARKSKo SekiguchiRepresentative Director, DIA Japan
10:10-11:30 KEYNOTE SESSIONKeynote 1SESSION CHAIR
Ari FujishiroAssociate Director, Regulatory Leader, Regulatory Aff airs Group, Asia Development Dept., Daiichi Sankyo Co., Ltd.
New Drug Development in Asian Region - from Japanese
Company Perspective
Hidetoshi ShutoCorporate Executive, Astellas Pharma Inc.
Keynote 2SESSION CHAIR
Hidetoshi ShutoCorporate Executive, Astellas Pharma Inc.
Strategies for Asia Drug Development: An Integrated
Approach
Mark Bach, MD, PhDVice President and Head, Asia Pacifi c Medical SciencesJanssen Pharmaceuticals, Pharmaceutical Companies of Johnson and Johnson, Singapore
11:30-13:00 LUNCH BREAK
13:00-14:30 SESSION 1Early Phase and Regional Clinical Trials in Asia / Academia Collaboration in East AsiaIn recent years global clinical trials in East Asia have been increasing with the globalization of drug development. However, most of those trials are conducted as Phase 3 study. Prior suffi cient evaluation of the PK/PD similarities of drugs among East Asian regions and between US/EU and other regions is needed for more effi cient conduct of global clinical trials in East Asia. Therefore the im-portance of global clinical trial in Asia from an early stage is becoming higher.
In this session speakers from industry and academia will provide their strate-gies and future visions of new drug development and the role of academia collaboration in East Asia. Finally, the future direction of drug development in East Asia and the issues to be addressed will be discussed.
Part 1: Academia Collaboration in East AsiaSESSION CO-CHAIRS
Yasuto OtsuboReviewer, Offi ce of New Drug II, Pharmaceuticals and Medical Devices Agency
All Session 1 speakers; Part 1 & Part 2 andMin Soo Park, MD, PhDDirector, Clinical Trials Center, Yonsei University College of Medicine, Republic of Korea
17:30-19:00 NETWORKING RECEPTION
DAY 1 | THURSDAY, MAY 22, 2014
OCTOBER 23-24
5th DIA Cardiac Safety WorkshopKFC Hall | Ryogoku, Tokyo
SEPTEMBER 10-11
3rd DIA Basic Statistical Concept Workshop for All Clinical Research Professionals in JapanNomura Conference Plaza | Nihonbashi, Tokyo
OCTOBER 27-28
4th DIA Project Management Training Course in JapanUrbannet Kanda Conference | Tokyo
NOVEMBER 16-18
11th Annual Meeting DIA Japan 2014Tokyo Big Sight | Ariake, Tokyo
DECEMBER 8
2nd DIA Advanced Regulatory Aff airs Training CourseUrbannet Kanda Conference | Tokyo
Nisso 22 Building 7F1-11-10 Azabudai Minato-ku Tokyo 106-0041 Japan
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JUNE 30
3rd CMC Forum in JapanKFC Hall | Ryogoku, Tokyo
JUNE 10-11
3rd FDA IND/NDA Training in JapanKyoto Research Park | Shimogyo, Kyoto
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8:15-8:30 REGISTRATION
8:30-9:30 SESSION 2Part 1: East-Asian Regulatory Update on Global Clinical TrialsWith increasing global drug development, regulatory agencies have taken several measures to approve a drug more appropriately. In this session, East Asian regulatory agencies form China, Korea, and Japan will present the latest situation of global clinical trials and regulatory perspectives relating to global drug development. In the panel discussion at the end, various topics will be discussed such as regulatory challenges to evaluate foreign clinical data and to promote Asian regulatory collaboration and global drug development. Ques-tions and comments from participants will be very much appreciated.
SESSION CO-CHAIRS
Yasuto OtsuboReviewer, Offi ce of New Drug II, Pharmaceuticals and Medical Devices Agency
Min Soo Park, MD, PhD Director, Clinical Trials CenterYonsei University College of Medicine, Republic of Korea
Global Clinical Data Evaluation for Drug Approval in
China
Tao WangDeputy Director, Division II of Clinical Trial for Pharmaceuticals, Center for Drug Evaluation, China Food and Drug Administration, China
Global Clinical Data Evaluation for Drug Approval in
Korea
Myung-Jung KimDirector, Clinical Trials Management Division, Pharmaceutical Safety Bureau, Ministry of Food and Drug Safety, Republic of Korea
Global Clinical Data Evaluation for Drug Approval in
Japan
Yasuto OtsuboReviewer, Offi ce of New Drug II, Pharmaceuticals and Medical Devices Agency
9:30-9:50 SESSION 2 - CONTINUEDPart 2: Trend of GCP InspectionWith progress of global clinical development of new drug, numerous clinical trials have been conducted in many countries. Agencies have been conducting GCP inspections in those countries, to ensure the subject’s right and safety, and to demonstrate data reliability of clinical trial. In this session, offi cers in agencies and experts from Japan, China, Korea, and United State who make eff orts for ensuring reliable clinical trialdata will present the inspection process, points of their attention during inspection, and effi cient model for building reli-ability into scientifi c and operating processes.
In panel discussion, the speakers in part 1 and 2 will then discuss recent trend in pharmaceutical regulations and systemic approach for improvement of clinical trial qualitywhich is major issue for industry and clincial site.
SESSION CO-CHAIRS
Ari FujishiroAssociate Director, Regulatory Leader, Regulatory Aff airs Group, Asia Development Dept., Daiichi Sankyo Co., Ltd.
Akio Uemura, PhDSenior Director, Head of Global Drug Development and Regulatory Aff airs Japan, Allergan Japan K.K.
An Overview of the FDA GCP Inspection Process and Key
Trends Remote Presentation via Internet
Ann Meeker-O’ConnellSenior Director, Clinical Strategy Team Lead, R&D Quality Assurance – Pharma R&D Q&C, Janssen Pharmaceuticals, Inc., United States
9:50-10:20 COFFEE BREAK
10:20-12:30 SESSION 2 - CONTINUED
PMDA’s Experiences on Foreign GCP Inspection:
Focusing on Asian Region
Tomoko Ohsawa, PhDDirector for Personnel Coordination, Offi ce of General Aff airs, Pharmaceuticals and Medical Devices Agency
MFDS’s Perspective of Regulatory Inspection in Korea
Ho-Jin OhAssistant Director, Clinical Trials Management Division, Pharma-ceutical Safety Bureau, Ministry of Food and Drug Safety,Republic of Korea
Situation of Regulation and GCP Inspection in China
Jiangping DongDivision Head, Division of Pharmaceuticals, Department of Drug Registration, China Food and Drug Administration, China
Panel Discussion
PANELISTS
All Session 2 speakers; Part 1 & Part 2
12:30-14:00 LUNCH BREAK
Private Social Function Policy
DIA does not allow hospitality functions to be held during any DIA meeting sessions, scheduled exhibit hours, or social events. There-fore, the hours noted below are the only hours that are acceptable for hospitality functions.
Wednesday, May 21 All times are acceptable
Thursday, May 22 Before 8:00 and after 20:00
Friday, May 23 Before 8:00 and after 19:00
DAY 2 | FRIDAY, MAY 23, 2014
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14:00-15:30 SESSION 3Optimal Development Strategies Based on Diff erences in Culture and Healthcare SettingAsia has received a lot of attention as a place for multinational clinical studies, with hope for little diff erence in ethnicity and physical size. It is critical, howev-er, to have a comprehensive understanding of the broad medical environment surrounding health care services such as medical practice, culture, insurance, or drug pricing for smooth execution of clinical studies. Better mutual under-standing will minimize the eff ect of extrinsic factors on drug evaluation.
In the fi rst part, we will listen to suggestions on eff ective communication for smooth clinical studies in Asia from the viewpoints of sponsor and CRO. In the second session, speakers introduce their experience of post-marketing study in Korea and the health care system in China. A panel discussion by all speak-ers will provide an opportunity for exchanging opinions on diff erences in the broad health care environment in Asia, and for a constructive discussion about development strategies that speed the access of patients to medicines.
Part 1: Eff ective and Effi cient Communication in Asia Regional StudiesSESSION CO-CHAIRS
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8th DIA Annual Conference in Japan for Asian New Drug DevelopmentValue and Quality of East Asian Clinical Trial in Drug Development
Event #14302 • May 22-23, 2014 • Sola City Hall | Ochanomizu, TokyoAddress: 4-6 Kandasurugadai, Chiyoda-ku, Tokyo 101-0062
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