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Clinical Rubik’s Cube
Opportunities and Challenges in Global R&D Studies: Example of Hungary
Dr. Aleksandar Skuban2009
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Opportunities multiply
as they are seized.
Sun Tzu
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Topics
Global trends in placement of clinical trialsGrowing opportunitiesExample of Hungary: tradition of researchContributionsHealth Atlas 2008Patient BenefitsFuture Prospects
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PharmaceuticalClinical Development PsychiatryIntl Clinical Trials Management
Clinical Research OrganizationsTop 10 Global Companies
HungarySemmelweis University Budapest
Background Europe and United States
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Placement of Clinical TrialsEmerging, Developing and Mature Markets
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Investigator Landscape
*Glickman S W. Ethical and Scientific Implications of the Globalization of Clinical research. N Engl J Med 2009;360:816-823Tufts Center for the Study of Drug Development
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CRO Market 2005
L10 MM SM
15.714.9
6.6
Annual Revenue Growth 2002-2007
80%
11%
9%
Largest 10 CROs Medium CROsSmall Companies
Applied Clinical Trials May 2007
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Globalization is a Tool(and two-way road)
Rapidly Changing environment
Definitions of Emerging, Developing or Developed Countries
Economy (GDP, IFC, World Bank)Scientific and Ethics Standards International Exposure
BRIC(M) and Beyond
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And a knowledge to use it(by all parties)
Regional Differences and Expectations
Benefit for Clinical Development Programs
New Enthusiasm for Problem-Solving
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Regional Considerations
Patient AccessCompetent SitesDisease PrevalenceRecruitment SpeedData QualityCostExperience
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Universal Challenges
EthicalScientificAccess to Health CareAccess to Tested TherapiesCommercializationLack of ExperienceExploitationData Quality
Glickman S W. Ethical and Scientific Implications of the Globalization of Clinical research. N Engl J Med 2009;360:816-823Shuchman M. Commercializing clinical trials-risks and benefits of the CRO boom. N Engl J Med 2007;357:1365-8
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Tailored SolutionsOpen Mind for a Changing Landscape
Value creation vs. Consumer ExpansionCountry Specific Consideration and AssessmentTraining InfrastructureICH-GCPRegulatory oversight
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Hungarian Example
CEE, EU, Emerging, DevelopingDiscovered, Re-discovered
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Strong Background in Science, Chemistry and Medicine
Tradition of Pharmaceutical Manufacturing
Pharmacology Research
Established Regulatory Framework
Centralized Health Care System
Comprehensive Public Health Policies
Traditional Strengths
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Albert Szent-Györgyi von Nagyrápolt Nobel Prize in Physiology or Medicine in 1937.
First to isolate Vitamin C which he found in abundance in Hungarian paprika.
Science, Chemistry and Medicine
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1965 First publication by Joseph Knoll in English
1967 Psychiatrist Ervin Varga observed antidepressant action
1971 Selective MAO-B inhibitor
1975 W Birkmayer (Wiena) Effect in PD
1996 Adjuvant Therapy in Parkinson’s Disease (US)
2006 Selegiline patch for depression (US)
Selegiline Story
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Am J Psychiatry 1979; 136:196-199 Copyright © 1979 by American Psychiatric Association Comparative efficacy of tofisopam and placeboHL Goldberg and RJ Finnerty
Tofisopam is a new agent marketed in Europe as a minor tranquilizer. The authors conducted a 4-week double-blind trial of this drug compared with placebo in 57 outpatients with anxiety and depression. They found that according to physician ratings and patient self-ratings tofisopam was an effective anxiolytic agent for subjects with anxiety and depression.
Twenty-one percent of the patients receiving tofisopam and 10% of those receiving placebo reported side effects. The drug was especially effective in the treatment of somatic difficulties.
1970s Tofisopam (Grandaxin®)
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Lawrenceville, NJ (June 14, 2002)
VelaPharm Advances Development of Tofisopam for the Treatment of Anxiety in the U.S.Preclinical Data Presented at NCDEU, a National Institute of Mental Health/New Clinical Drug Evaluation Unit (NCDEU) General Meeting in Boca Raton, Florida
March 14, 2006
Pharmos to buy Vela Pharmaceuticals for $29.7MOnce the deal is complete, the new company's lead product will be R-tofisopam, a drug that has demonstrated positive Phase II data for the treatment of diarrhea-predominant and alternating-type irritable bowel syndrome (IBS).
R-Tofisopam in Development Today
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1901
1912
1913
Pharmaceutical Industry
1990 Hungarian Pharmaceutical Manufacturers Association (MAGYOSZ)
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Ministry of Health (2005)
OGYI (National Institute of Pharmacy)
ETT (Medical Research Council)
TUKEB (Scientific and Research Ethics Committee)
KFEB (Clinical Pharmacology Ethics Committee)
ECRIN ( European Clinical Research Infrastructures
Network)
Regulatory Framework Professional Networks
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11-12 meetings per year
414 new clinical trials reviewed
1294 “amendments” reviewed
Decisions taken
70% approved15% declined (68 % scientific, 18% ICF, 17%
both)15% withdrawn
Clinical Pharmacology Ethics Committee (2008)
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1994 GCP in Hungary
2001 Clinical Trial Management Society Hungary
Founding assembly 23 organizations
2004 Membership in IFAPP International Federation of
Association of Pharmaceutical Physicians
2004 CRA accepted as a profession
2004 Hungary EU member
Professional NetworksRegulatory Framework
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Health care expenditure
United Kingdom*
Hungary
Switzerland
Russian Federation
Greece
8.1
7.9
11.5
6
7.9
2560
1308
4011
583
2179
US$ PPP2 % of GDP
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Number of nurses and physicians and hospital beds
United Kingdom*
Hungary
Switzerland
Russian Federation
Greece
213
304
397
431
500
499
896
833
806
338
390
792
568
966
473
Hospital beds Nurses Physicians
Per 100 000 population (* UK data from 2002)
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Leading physicians and Institutions
Early adoption of GCP guidelines
Excellent Data Quality
High Patient recruitment
Skilled clinical research professionals
Lower cost
Enthusiasm for novel drug development
Contributions in the ‘90s
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Clinical Trials in Hungary 1992-2008
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
0
50
100
150
200
250
300
350
Phase I Phase II Phase III Phase IV Bioequiv.Courtesy of Janos Antal, MD, MBA (Parexel Hungary)
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New Global Trials Initiated in CEE*
Hungary Poland Russia Romania Ukraine
146213 196
62 47
204
573
725
212
375
2002 2007
Center Watch Data August 2008 (*selected countries)
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Atlas of Health 2008 in Europe
(WHO Europe)
Benefit for patients and patient access benefits
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Atlas of Health 2008 in Europe Hungary
1st All Cancer , Lung cancer & New Cases
2nd Digestive system
3rd Colon
4th Total alcohol consumption
5th Suicide
Russian Federation (life expectancy at birth, death from all causes, circulatory system, ischaemic heart disease (25-64), suicide)
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Deaths from diseases of the circulatory system
Russian Federation
Hungary
France
301.2
175.3
28.6
157.1
47.8
4.9
Females Males
Per 100 000 population (25-64 years)
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Deaths from cancer
Russian Federation
Hungary
Sweden
224.5
301.2
86.8
123.3
157.1
102.5
Females Males
Per 100 000 population (25-64 years)
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Deaths from lung cancer
Poland
Hungary
Sweden
72
99.7
16.9
20.9
35.3
19.7
Females Males
Per 100 000 population (25-64 years)
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Deaths from GI system diseases
Norway
Hungary
Moldova
19.3
105.4
156.9
15
42.4
115.4
Females Males
Per 100 000 population (25-64 years)
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Hungary Activity Map(www.clinicaltrials.gov) October 2009
278 active studies
89 cancer studies
21 lung cancer studies
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Prospects for clinical research in Hungary
Slightly smaller than Indiana- population 9.9 M
Local, Regional CROs and Pharmaceutical Companies
Competition for Qualified Sites and Patients
Restrictions for Placebo-Controlled Studies
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Opportunities
European Integration
Government Support for Clinical Research
Expanding Research Networks and Quality Sites
Accreditation of Phase I (Clinical Pharmacology) sites
Need for more qualified, English speaking personnel
Adjustment to new trends
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Expansion Maturing Saturation Migration
Future scenarios
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Other (New)Countries and Regions
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Growth Rate of New Global Trials Initiated in CEE*
Center Watch Data August 2008 (*selected countries)
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Unique
1.1B
2%221 trials in 2007 (Reuters Jan 21,2009)
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Technology
Competition
Integration
Outsourcing
Relationships
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choice integrity
knowledge
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National Institute of Pharmacy http://www.ogyi.huMinistry of Health http://www.eum.hu/main.php Medical Research Council http://www.ett.hu/ Clinical Trial Management Society Hungaryhttp://www.mkvt.hu/http://www.mkvt.hu/admin/data/file/177_clinical_trial_managementsociety_hungary.pdfHungarian Pharmaceutical Manufacturers Organization http://www.magyosz.org/ European Clinical Research Infrastructures Networkhttp://www.ecrin.org/
Useful Links
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Thank You
Questions