2013 Open. Clinica Global Conference: June 21, 2013 KSLION Open. Clinica Enterprise for Clinical Trial in Japan *Y Natsumeda, * T Osako and H Maniwa Mount Fuji Yokohama Mitsui Building * Key Support for Life Innovation (KSLION) Information Services International Dentsu (i. Si. D) Kanagawa Yokohama Kawasaki Tamagawa River Tokyo Haneda/Tokyo Airport Keihin Life Innovation Global Strategic Zone applied to the Government by Yokohama, Kawasaki, Kanagawa (Sep 2011)
The focus of my talk is to demonstrate the importance and value of the Open. Clinica Enterprise in Japan. Need: Japan has not fully addressed the promise of biotech, health and life innovation, especially in clinical trials. Value: Refinement of the clinical trial process in Japan will promote tremendous innovation and, therefore, value in the Japanese Health. Care System. I will describe recent efforts. Vision: Open. Clinica and related modification will streamline the critical path, eliminate drug lag and device lag and revive Japan in life innovation.
The focus of my talk is to demonstrate the importance and value of the Open. Clinica Enterprise in Japan. Need: Japan has not fully addressed the promise of biotech, health and life innovation, especially in clinical trials. Value: Refinement of the clinical trial process in Japan will promote tremendous innovation and, therefore, value in the Japanese Health. Care System. I will describe recent efforts. Vision: Open. Clinica and related modification will streamline the critical path, eliminate drug lag and device lag and revive Japan in life innovation.
Japanese Clinical Trial System 1. High cost per patient 2 ～ 6 times more expensive than either USA or EU 2. Poor performance Too many sites, too few patients per site per trial - requiring J-GCP to enforce each trial site have independent IRB (1997). 3. Pharma and Biotech exclude Japan from global development program until POC trial promising results. Nine out of 10 compounds in clinical trials fail to get approved. 4. Poor experience in FIH, POC or international collaborative clinical trials in Japan Difficult to develop clinical trial leaders and infrastructure 5. Many trials designed to confirm overseas trials Lack of enthusiasm of physicians
Reality of New Drug Development Safety POC Kola and Landis, Nature Review Drug Discovery, 2004 (3): 711 -715
Japan Lags behind Many Countries in International Collaborative Trials Japan ranked 60 th among 87 countries Total protocols: 413 Rank Country Protocol % 1 USA 264 63. 9 15 Hungary, Sweden 75 18. 2 2 Canada 175 42. 4 17 Argentina 73 17. 7 3 Germany 171 41. 4 18 South Africa 71 17. 2 4 Spain 133 32. 2 19 Brazil, Denmark 63 15. 3 5 France 132 32. 0 21 India 59 14. 3 6 England 124 30. 0 22 Korea, Taiwan 51 12. 3 7 Poland 110 26. 6 41 Hong Kong 27 6. 5 8 Italy 108 26. 2 47 Singapore 23 5. 6 9 Belgium 106 25. 7 50 China 18 4. 4 10 Australia 105 25. 4 54 Pakistan 10 2. 4 11 Mexico 86 20. 8 57 Indonesia 7 12 Czech Republic 83 20. 1 60 Japan 6 1. 5 13 Netherlands, Russia 79 19. 1 68 Vietnam 2 0. 5 ＜Data from 2008 European Federation of Pharmaceutical Companies, Ph. RMA＞
Japanese clinical trials are designed to replicate and validate previous studies, therefore, results cannot be published in top medical journals. Japan Phase I lag Phase I is initiated only after overseas POC shows promising. Submission Phase I High cost/Poor performance 1. 9 years Submission Approval USA Review 1. 8 years Clinical trials 6. 1 years Phase I Approval Clinical trials 4. 5 years Review 1. 1 years Drug lag 3. 8 years Asahi Newspaper June 9, 2010
Ranking of Basic and Clinical Research Basic Research Nature Med, Cell, J. Exp. Med. 1993~97 1998~2002 2003~07 USA Clinical Research NEJM, Lancet, JAMA 1993~97 1998~2002 2003~07 3, 097 (1) 2769 (1) 2674 (1) 3314 (1) 3695 (1) 2677 (1) Germany 321 (3) 404 (2) 442 (2) 253 (6) 511 (3) 343 (4) Japan 236 (6) 371 (3) 369 (3) 122 (12) 183 (12) 74 (18) UK 365 (2) 352 (4) 314 (4) 920 (2) 1484 (2) 873 (2) France 239 (5) 256 (5) 269 (5) 274 (5) 432 (5) 300 (5) Canada 227 (7) 209 (6) 204 (6) 377 (3) 502 (4) 462(3) Switzerland 244 (4) 209 (6) 166 (7) 166 (8) 261 (9) 252 (9) Italy 132 (8) 155 (8) 236 (7) 374 (7) 279 (7) Holland 109 (9) 114 (9) 127 (9) 277 (4) 410 (6) 294 (6) Australia 97 (10) 106(10) 120(10) 155 (9) 282 (8) 260 (8) China 1 (36) 8 (25) 53 (13) 20 (30) 59 (21) 102 (15) 15 (22) 39 (18) － － S. Korea － －
2011 Rankings 1 Hong Kong 1 USA World Competitiveness Rankings by IMD* 3 Singapore 4 Sweden 5 Switzerland World Competitiveness Rankings 6 Taiwan 7 Canada Where is innovative Japanese Industry? 8 Qatar USA (1) 9 Australia Toyota, Honda, Nissan, Isuzu, Mitsubishi, 10 Germany Mazda, Subaru, Panasonic, SONY, Toshiba, Germany (8) 11 Luxemburg 12 Denmark Hitachi, SANYO, Fujitsu, Shiseido, Kikkoman, 13 Norway UK (15) 14 Holland Kirin, Nintendo, Tamagocchi, Seiji Ozawa, 15 Finland Japan (17) 16 Malaysia Tonegawa, i. PS by Yamanaka, Ichiro, Gozzila, 17 Israel 18 Austria etc? 19 China France (19) 20 UK 21 New Zealand 22 South Korea China (31) 23 Belgium 24 Ireland 25 Chile 26 Japan 27 Thailand IMD*: International Institute for Management Development 28 UAE 29 France Announcement started in 1989 30 Czech Republic
The focus of my talk is to demonstrate the importance and value of the Open. Clinica Enterprise in Japan. Need: Japan has not fully addressed the promise of biotech, health and life innovation, especially in clinical trials. Value: Refinement of the clinical trial process in Japan will promote tremendous innovation and, therefore, value in the Japanese Health. Care System. I will describe recent efforts. Vision: Open. Clinica and related modification will streamline the critical path, eliminate drug lag and device lag and revive Japan in life innovation.
High cost Poor performance Excluded and isolated Lack of global experience Lack of leaders Immature infrastructure Drug lag & Device lag 2008 Education for clinical research GCP training & seminars PMDA/YCU joint graduate course Public Private Partnership International workshop Revive Japan in Life Innovation 2012 Eliminate drug lag and device lag KSLION High performance High quality Low cost Paperless Remote 2013 Pre-PMDA consultation Networking & Grouping Central IRB ICH-GCP CDISC FDA 21 CFR Part 11
Current Activities & Future Vision of DCRI: Global Collaborations Such as HBD Yokohama City University: Clinical Research Seminar December 20, 2008 Mitchell W. Krucoff MD, FACC Professor of Medicine / Cardiology Duke University Medical Center Director, Cardiovascular Devices Unit Duke Clinical Research Institute
Duke Clinical Research Institute • > 1, 000 faculty & staff (205 faculty) • > $100 M annual activity (2/3 from industry) • world’s largest ARO • not for profit • faculty interest-driven mission: • academic & scientific integrity • clinical care for unmet medical needs • public health • different culture from big CROs
CBMI Palaver Seminars: Members u Center for Biomedical Informatics, Harvard Medical School u Laboratory for Personalized Medicine, Harvard Medical School u Harvard Molecular Technology Group & Lipper Center for Computational Genetics, Harvard Medical School Dr. P. Tonellato u Regenerative Biology, Wisconsin University u Great Lakes WATER Institute, Wisconsin University u National Center for Biomedical Computing, USA u The School of Biomedical Science, Tokyo Medical and Dental University u Recombinant Data Corp. , USA u Johnson & Johnson Corp. , USA u The Partners Health. Care Center for Personalized Genetic Medicine, Harvard Medical School
CBMI Palaver Seminars on Translational Medicine, 2009 Date Speaker Title 1 2009/9/28 2 2009/10/5 Takako Takai Activities in education and research on translational research at Tokyo Medical and Dental University, Japan. 3 2009/10/19 Vince Fusaro Using Existing Data to Improve Translational Research 4 2009/10/26 Mark Boguski 5 2009/11/2 Dennis Wall 6 2009/11/16 7 8 9 10 Peter J. Tonellato Methodology and Infrastructure for Translational Science Clinical and Educational Genomics -Personal experiences with direct-to-consumer genotyping. Disentangling autism through cross-disease computational analysis Sa'ndor Szalma Tran. SMART - data warehouse for translational research Virtual Patient Population Convergence: A New Framework for Translational Biomedical Informatics 2009/11/23 Structure of protein interaction network and their implication Hiroshi Tanaka on drug design Status of translational and clinical research in Japan and 2009/11/30 Yutaka Natsumeda YCU's vision Akihiko Konagaya 2009/12/7 Vikas P. Sukhatme Promoting Translational Medicine 11 2009/12/14 Vince Fusaro Peter J. Tonellato Closing Remarks on the Fall '09 Palaver
Joint International Conferences on Translational Research and Personalized Medicine in Yokohama Feb 1, 2010 by YCU and HMS/CBMI To Translate Extensive Basic Research Data into Clinical Research and Practice Feb 2, 2010 by TMDU, YCU and HMS/CBMI The Opening of the Next Generation in Omics-based Medicine Feb 3, 2010 by FDA, DCRI, HMS/CBMI, YCU Strategy and Scientific Tools to Facilitate Processing Basic Discovery Seeds to Meet Medical Needs Minatomirai, Yokohama
Harvard Medical School, Mallinckrodt Professor of Pathology, Dr. Jeffrey Saffitz March 3, 2010
Duke Clinical Research Institute, Chief Operating Officer, Ms. Miriam Donohue March 5, 2010
PMDA・YCU Joint Graduate Course Started on April 1, 2010 http: //www. pmda. go. jp/ Pharmaceuticals and Medical Devices Agency
A Test Trial to Implement Intra. Links (Highly Secure Cloud Storage System) into Clinical Trial Sites and Central IRB February ～ April, 2011 Name Sponsor Shionogi CRO LINICAL Sites Fukui General Hospital, other 10 sites in Fukui prefecture SMO Sehma IT Services i. Si. D Achieved in the trial 1. 2. 3. 4. 5. 6. Feasibility search for the sites for the trial Paperless IRB review and approval Prompt and secure delivery of safety information Remote source document verification (R-SDV) Secure storage of the document Delivery of the information only to the authorized members
Keihin Life Innovation Global Strategic Zone KSLION Adopted by the Japanese Government (Dec. 2011) Mount Fuji Yokohama Mitsui Building Kanagawa Yokohama Kawasaki Tamagawa River Tokyo Haneda/Tokyo Airport
Keihin Life Innovation Global Strategic Zone adopted by the Japanese Government (Dec, 2011) The goals are to develop innovative medicines and devices to achieve personalized medicine. Strategic aims (selected): • International collaborative clinical trials to eliminate drug/device lag • Pre-PMDA functions Founded in June, 2012 • Efficacious clinical trial network • Partnering and Matching between discovery seeds and medical needs • Construct a biobank integrated with the clinical information database
Collaborations among 4 Major Sites Tonomachi Suehiro RIKEN Fukuura YCU Regenerative Medicine YCU Cancer/ Lifestyle diseases YCU Preventive Medicine YCU Medicine/Technology Minatomirai Conferences, Exhibitions KSLION 26
Personalized preventive medicine/Innovative drugs and medical devices/Creating new industries Basic Research Pre-PMDA KSLION Academic Pharmas Bioventures Devices Clin trial NW Central IRB CRC support PMDA Joint graduate course YCU 2 YCU hospitals Adv Med Res Center Clin Pharm Center GCP trainings Seminars & workshops FIH/Phase I Low cost High performance Global standards POC International collaborative trials FDA/EMA Keihin NW Japan NW Asian NW US NW EU NW Keihin Life Innovation Global Strategic Zone
CDISC : Clinical Data Interchange Standards Consortium • Paper work to electronic system • Better, Faster, Cheaper • Global standards Global standard EDC (Electronic Data Capture) Commercial source ・ ・ ・ Open source ・ 28
Open. Clinica Training Seminar Dates: January 30 - February 1. 2013 Wednesday 9: 30 -13: 00 - Business Administration 14: 00 -17: 00 - Data Management Thursday 9: 30 -12: 30 - Data Management (con’t…) 13: 30 -14: 30 - Monitoring 15: 30 -17: 00 - Clinical Research Coordination / Data Entry Friday 9: 30 -12: 00 - Investigators / Data Specialists 12: 00 -17: 00 - CRF Design/ Additional questions/tutoring 29
Influence of Nuclear Power Plant Disaster to the Residents in Fukushima • A cohort study should be done and exact data should be collected on how the residents are affected with the exposure. • Japan is responsible for reporting the data to the world. • Open. Clinica could be used for the cohort study. • Opportunity for the EDC to be implemented in the clinical trial networks all over Japan 60, 000 people moved out from Fukushima. A total of 94 Red Cross hospitals in Japan
Even if Japan closes all nuclear power plants; • There are many nuclear power plants in East Asia. • Fukushima data will tell how to reduce the risk. Natural disasters in the world (1978 – 2008) Nuclear Power Plants in East Asia 年代別 Natural disasters in Asia (1978 – 2008) Disasters Asia ３６６ （３７％） Deaths Asia 1. 34 M （59％） Victims Asia 977 M （89％） Damage Asia $605 B （45％） 被災者数（百万人） 被害額（億ドル） （資料）CREI, アジア防災センター(内閣府） 31
A Project to Build Large Hospital Ships Be ready for Natural Disaster Activities at Non-Emergency Situation • Medical Patrol around Medical Depopulated Area • Extend the Medical Patrol to South Asian Countries • Domestic/International Contributions • Downsize/Reduce Weight of Therapeutic and Diagnostic Devices • Promote Industry for Medical and Nursing Devices • Training Young Talents • Creating jobs Yokohama Mercy (USA) 70, 000 tons, 273 m x 32 m 1, 000 beds, 12 operation rooms 32
Building Realistic, Predictive Models of Disease: Drug Repositioning and Personalized Medicine
Pharmacodiagnostics can Streamline Clinical Development and Increase Value. Traditional clinical trials Broad patient population Responders only 10 -12 years Cost of Development Success Rate Patients Per NDA Value Pharmacogenomicsbased trials 5 -7 years >$1, 000 Million 5 -10% >2, 000 Good <＄500 Million 25 -50% >600 Better Source: Pharma 2010: The Threshold of Innovation.
History of Metformin 1922 Synthesized 1927 Shown blood sugar reducing effect in rabbit 1957 Shown anti-diabetic effect in diabetic patients 1958 Approved 2001 Mechanism to reduce blood sugar is shown to activate AMPK
Effect of Metformin on Colorectal Aberrant Crypt Foci K Hosono et al. Cancer Prev Res 3: 1077 -1083, 2010
Plans to implement Open. Clinica • YCU oncology group working in 6 major hospitals in Keihin area agreed to use it for their studies. • Several other local clinical trial networks such as red-cross, Shikoku, Kyushu, Tokyo metropolitan are under consideration. • Fukushima cohort study is under discussion. • Yokohama city now supports financially KSLION. • US-Japan collaborative clinical trials could be run with Open. Clinica. • Japan needs close collaborations with Open. Clinica for training and Enterprise supports.
The focus of my talk is to demonstrate the importance and value of the Open. Clinica Enterprise in Japan. Need: Japan has not fully addressed the promise of biotech, health and life innovation, especially in clinical trials. Value: Refinement of the clinical trial process in Japan will promote tremendous innovation and, therefore, value in the Japanese Health. Care System. I will describe recent efforts. Vision: Open. Clinica and related modification will streamline the critical path, eliminate drug lag and device lag and revive Japan in life innovation. Thank you!
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