2013 openclinica global conference: june 21, 2013
DESCRIPTION
2013 OpenClinica Global Conference: June 21, 2013 OpenClinica Enterprise for Clinical Trial in Japan *Y Natsumeda, * T Osako and H Maniwa. KSLION. * Key Support for Life Innovation (KSLION). Mount Fuji. Information Services International Dentsu (iSiD). Yokohama Mitsui Building. Kanagawa. - PowerPoint PPT PresentationTRANSCRIPT
2013 OpenClinica Global Conference: June 21, 2013OpenClinica Enterprise for Clinical Trial in Japan
*Y Natsumeda, * T Osako and H Maniwa
Mount Fuji
Yokohama
KawasakiTokyo
Haneda/Tokyo AirportTamagawa
River
KanagawaYokohama Mitsui Building
KSLION
Keihin Life Innovation Global Strategic Zone applied to the Government by Yokohama, Kawasaki, Kanagawa (Sep 2011)
Information Services International Dentsu (iSiD)* Key Support for Life Innovation (KSLION)
The focus of my talk is to demonstrate the importance and value of the OpenClinica 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 HealthCare System. I will describe recent efforts.
Vision: OpenClinica 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 OpenClinica 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 HealthCare System. I will describe recent efforts.
Vision: OpenClinica and related modification will streamline the critical path, eliminate drug lag and device lag and revive Japan in life innovation.
1. High cost per patient
2. Poor performance
3. Pharma and Biotech exclude Japan from global development program until POC trial promising results.
4. Poor experience in FIH, POC or international collaborative clinical trials in Japan
5. Many trials designed to confirm overseas trials
2 ~ 6 times more expensive than either USA or EU
Nine out of 10 compounds in clinical trials fail to get approved.
Too many sites, too few patients per site per trial - requiringJ-GCP to enforce each trial site have independent IRB (1997).
Lack of enthusiasm of physicians
Difficult to develop clinical trial leaders and infrastructure
Japanese Clinical Trial System
Reality of New Drug Development
0102030405060708090
100
Su
cces
s R
ate
(%)
Phase I Phase II Phase III NDA Approval
Stage of Development
Kola and Landis, Nature Review Drug Discovery, 2004 (3):711-715
POC
Safety
Japan Lags behind Many Countries in International
Collaborative Trials
<Data from 2008 European Federation of Pharmaceutical Companies, PhRMA>
Japan ranked 60th among 87 countries Total protocols: 413
Rank
CountryProtoco
l%
1 USA 264 63.9
2 Canada 175 42.4
3 Germany 171 41.4
4 Spain 133 32.2
5 France 132 32.0
6 England 124 30.0
7 Poland 110 26.6
8 Italy 108 26.2
9 Belgium 106 25.7
10 Australia 105 25.4
11 Mexico 86 20.8
12Czech
Republic83 20.1
13Netherlands,
Russia79 19.1
Rank
CountryProtocol
%
15Hungary, Sweden
75 18.2
17 Argentina 73 17.7
18 South Africa 71 17.2
19 Brazil, Denmark 63 15.3
21 India 59 14.3
22 Korea, Taiwan 51 12.3
41 Hong Kong 27 6.5
47 Singapore 23 5.6
50 China 18 4.4
54 Pakistan 10 2.4
57 Indonesia 7 1.7
60 Japan 6 1.5
68 Vietnam 2 0.5
Phase I Submission
Approval
Clinical trials 6.1 years
Phase I
Clinical trials 4.5 years Review1.1 years
Drug lag3.8 years
SubmissionApproval
Review1.8 years
1.9 years
Japan
USA
Phase I lag Phase I is initiated only after overseas POC shows promising.
Asahi Newspaper June 9, 2010
High cost/Poor performance
Japanese clinical trials are designed to replicate and validate previous studies, therefore, results cannot be
published in top medical journals.
Ranking of Basic and Clinical Research Basic Research Clinical Research
Nature Med, Cell, J. Exp. Med. NEJM, Lancet, JAMA 1993~97 1998~2002 2003~07 1993~97 1998~2002 2003~07
USA 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) 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)
S. Korea - 15 (22) 39 (18) - - -
World Competitiveness Rankings by IMD*
IMD*: International Institute for Management DevelopmentAnnouncement started in 1989
World Competitiveness Rankings USA
(1)Germany (8) UK (15)
Japan (17)
France (19) China (31)
2011 Rankings 1 Hong Kong 1 USA 3 Singapore 4 Sweden 5 Switzerland 6 Taiwan 7 Canada 8 Qatar 9 Australia10 Germany11 Luxemburg12 Denmark13 Norway14 Holland15 Finland16 Malaysia17 Israel18 Austria19 China20 UK21 New Zealand22 South Korea23 Belgium24 Ireland25 Chile26 Japan27 Thailand28 UAE29 France30 Czech Republic
Where is innovative Japanese Industry?Toyota, Honda, Nissan, Isuzu, Mitsubishi,
Mazda, Subaru, Panasonic, SONY, Toshiba, Hitachi, SANYO, Fujitsu, Shiseido, Kikkoman,
Kirin, Nintendo, Tamagocchi, Seiji Ozawa, Tonegawa, iPS by Yamanaka, Ichiro, Gozzila,
etc?
The focus of my talk is to demonstrate the importance and value of the OpenClinica 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 HealthCare System. I will describe recent efforts.
Vision: OpenClinica and related modification will streamline the critical path, eliminate drug lag and device lag and revive Japan in life innovation.
High cost Poor performanceExcluded and isolatedLack of global experienceLack of leaders Immature infrastructure Drug lag & Device lag
Pre-PMDA consultationNetworking & GroupingCentral IRBICH-GCPCDISCFDA 21 CFR Part 11
Education for clinical researchGCP training & seminarsPMDA/YCU joint graduate coursePublic Private Partnership International workshop
High performanceHigh qualityLow cost PaperlessRemote
Eliminate drug lag and device lag
Revive Japan in Life Innovation
KSLION
2008
2012
2013
Current Activities & Future Vision of DCRI: Global Collaborations Such as HBD
Current Activities & Future Vision of DCRI: Global Collaborations Such as HBD
Mitchell W. Krucoff MD, FACC
Professor of Medicine / Cardiology
Duke University Medical Center
Director, Cardiovascular Devices Unit
Duke Clinical Research Institute
Mitchell W. Krucoff MD, FACC
Professor of Medicine / Cardiology
Duke University Medical Center
Director, Cardiovascular Devices Unit
Duke Clinical Research Institute
Yokohama City University: Clinical Research Seminar
December 20, 2008
Yokohama City University: Clinical Research Seminar
December 20, 2008
Duke Clinical Research InstituteDuke Clinical Research InstituteDuke Clinical Research InstituteDuke 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: MembersCBMI Palaver Seminars: Members
Center for Biomedical Informatics, Harvard Medical School
Laboratory for Personalized Medicine, Harvard Medical School
Harvard Molecular Technology Group & Lipper Center for Computational Genetics, Harvard Medical School
Regenerative Biology, Wisconsin University
Great Lakes WATER Institute, Wisconsin University
National Center for Biomedical Computing, USA
The School of Biomedical Science, Tokyo Medical and Dental University
Recombinant Data Corp. , USA
Johnson & Johnson Corp. , USA
The Partners HealthCare Center for Personalized Genetic Medicine, Harvard Medical School
Center for Biomedical Informatics, Harvard Medical School
Laboratory for Personalized Medicine, Harvard Medical School
Harvard Molecular Technology Group & Lipper Center for Computational Genetics, Harvard Medical School
Regenerative Biology, Wisconsin University
Great Lakes WATER Institute, Wisconsin University
National Center for Biomedical Computing, USA
The School of Biomedical Science, Tokyo Medical and Dental University
Recombinant Data Corp. , USA
Johnson & Johnson Corp. , USA
The Partners HealthCare Center for Personalized Genetic Medicine, Harvard Medical School
Dr. P. Tonellato Dr. P. Tonellato
Date Speaker Title
1 2009/9/28 Peter J. Tonellato Methodology and Infrastructure for Translational Science
2 2009/10/5 Takako TakaiActivities 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 BoguskiClinical and Educational Genomics -Personal experiences with direct-to-consumer genotyping-
5 2009/11/2 Dennis WallDisentangling autism through cross-disease computational analysis
6 2009/11/16 Sa'ndor Szalma TranSMART - data warehouse for translational research
72009/11/23
Akihiko KonagayaVirtual Patient Population Convergence: A New Framework for Translational Biomedical Informatics
8 Hiroshi TanakaStructure of protein interaction network and their implication on drug design
9 2009/11/30 Yutaka NatsumedaStatus of translational and clinical research in Japan and YCU's vision
10 2009/12/7 Vikas P. Sukhatme Promoting Translational Medicine
11 2009/12/14Vince Fusaro
Closing Remarks on the Fall '09 PalaverPeter J. Tonellato
CBMI Palaver Seminars on Translational Medicine, 2009CBMI Palaver Seminars on Translational Medicine, 2009
Joint International Conferences on Translational Research and Personalized Medicine in Yokohama
Feb 1, 2010 by YCU and HMS/CBMITo Translate Extensive Basic Research Data into Clinical
Research and PracticeFeb 2, 2010 by TMDU, YCU and HMS/CBMI
The Opening of the Next Generation in Omics-based MedicineFeb 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
Pharmaceuticals and Medical Devices Agency
http://www.pmda.go.jp/
PMDA ・ YCU Joint Graduate Course Started on April 1, 2010
February ~ April, 2011
Name
Sponsor Shionogi
CRO LINICAL
Sites Fukui General Hospital, other 10 sites in Fukui prefecture
SMO
IT Services
Sehma
iSiD
Achieved in the trial1. Feasibility search for the sites for the trial2. Paperless IRB review and approval 3. Prompt and secure delivery of safety information4. Remote source document verification (R-SDV) 5. Secure storage of the document6. Delivery of the information only to the authorized members
A Test Trial to Implement IntraLinks (Highly Secure Cloud Storage System) into Clinical Trial
Sites and Central IRB
Mount Fuji
Yokohama
KawasakiTokyo
Haneda/Tokyo AirportTamagawa
River
KanagawaYokohama Mitsui Building
KSLION
Keihin Life Innovation Global Strategic ZoneAdopted by the Japanese Government (Dec. 2011)
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• Efficacious clinical trial network• Partnering and Matching between discovery seeds and
medical needs• Construct a biobank integrated with the clinical
information database
Founded in June, 2012
26
Regenerative Medicine
Cancer/ Lifestyle diseases
Preventive Medicine
Collaborations among 4 Major SitesTonomachi Suehiro Fukuura
YCU
YCU
MinatomiraiMedicine/Technology
KSLION
YCU
YCU
Conferences, Exhibitions
RIKEN
Personalized preventive medicine/Innovative drugs and medical devices/Creating new industries
Keihin Life Innovation Global Strategic Zone
YCU 2 YCU hospitalsAdv Med Res Center Clin Pharm CenterGCP trainingsSeminars & workshops
Joint graduatecourse
PMDAFDA/EMA
Pre-PMDA
KSLIONClin trial NWCentral IRB
CRC support
FIH/Phase I
POC
Keihin NW
Japan NWAsian NW
US NW
EU NW
Low costHigh performanceGlobal standards
Inte
rnat
ion
al
coll
abo
rati
ve t
rial
s
Devices
Basic Research
Academic
Bioventures
Pharmas
・Open source・・
Commercial source
・
Global standard EDC (Electronic Data Capture)
• Paper work to electronic system• Better, Faster, Cheaper• Global standards
CDISC : Clinical Data Interchange Standards Consortium
28
OpenClinica Training Seminar
Dates: January 30 - February 1. 2013
Wednesday9:30-13:00 - Business Administration14:00-17:00 - Data Management Thursday 9:30-12:30 - Data Management (con’t…)13:30-14:30 - Monitoring15:30-17:00 - Clinical Research Coordination / Data Entry Friday 9:30-12:00 - Investigators / Data Specialists12:00-17:00 - 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. • OpenClinica 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.
年代別
(資料) CREI,アジア防災センター( 内閣府)
Disasters
Asia 366(3
7%)
DeathsAsia
1.34 M( 59%)
VictimsAsia 977
M( 89%)
DamageAsia
$605 B ( 45%)
被災者数(百万人)
被害額(億ドル)
Nuclear Power Plants in East AsiaNatural disasters in the world (1978 – 2008)
31
Natural disasters in Asia (1978 – 2008)
32
A Project to Build Large Hospital ShipsBe ready for Natural DisasterActivities 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 m1,000 beds, 12 operation rooms
Building Realistic, Predictive Models of Disease: Drug Repositioning and Personalized Medicine
Pharmacodiagnostics can Streamline Clinical Development and Increase Value.
Broad patient population
Responders only
Cost of DevelopmentSuccess RatePatients Per NDAValue
>$1,000Million5-10%>2,000Good
< $ 500Million25-50%>600Better
Source: Pharma 2010: The Threshold of Innovation.
Traditional clinicaltrials
Pharmacogenomics-based trials
10-12 years 5-7 years
History of Metformin 1922 Synthesized 1927 Shown blood sugar reducing effect in rabbit 1957 Shown anti-diabetic effect in diabetic patients1958 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 OpenClinica• 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 OpenClinica.• Japan needs close collaborations with OpenClinica
for training and Enterprise supports.
The focus of my talk is to demonstrate the importance and value of the OpenClinica 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 HealthCare System. I will describe recent efforts.
Vision: OpenClinica and related modification will streamline the critical path, eliminate drug lag and device lag and revive Japan in life innovation.
Thank you!