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Takis Zervakakis Bucharest, October 2014
Clinical Research,
an Important Contributor
to the Scientific & Financial Development
of a country
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Towards the Ultimate Goal for Health !!
Clinical Trials
Essential to the development of innovative medicines,
vaccines and medical devices that treat and prevent illnesses and more importantly unmet
needs of patients
Pharmaceutical Industry
A key asset to scientific and medical progress by turningfundamental research into
innovative treatments that are widely available and accessible
to patients
Source: Efpia, The Pharmaceutical Industry in Figures, 2012
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Pharma R&D Investment Remains Significant
• around €90 billion on R&D in 2012
• 15% (the ratio of R&D spend to net sales)
Highest investment on R&D
than any other industrial sector !!!
Source: Pharma tops global R&D spend in 2012, www.separationsnow.com
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Top R&D budgets (2011)
CompanyNumber of drugs approved
R&D Spending Per Drug ($Mil)
Total R&D Spending 1997-2011 ($Mil)
AstraZeneca 5 11,790.93 58,955
GlaxoSmithKline 10 8,170.81 81,708
Sanofi 8 7,909.26 63,274
Roche Holding AG 11 7,803.77 85,841
Pfizer Inc. 14 7,727.03 108,178
Johnson & Johnson 15 5,885.65 88,285
Eli Lilly & Co. 11 4,577.04 50,347
Abbott Laboratories 8 4,496.21 35,970
Merck & Co Inc 16 4,209.99 67,360
Bristol-Myers Squibb Co. 11 4,152.26 45,675
Novartis AG 21 3,983.13 83,646
Amgen Inc. 9 3,692.14 33,229
Sources: InnoThink Center For Research In Biomedical Innovation; Thomson Reuters
Fundamentals via FactSet Research Systems - www.forbes.com 2/10/2012
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Global Distribution of Clinical Trials
Source: www.clinicaltrials.gov 16 April 2013
143,583 trials in 184 countries
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Distribution of Clinical Trials in Europe
38,901 registered studies in Europe
Source: www.clinicaltrials.gov 16 April 2013
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Distribution of Clinical Trials in MET
5853 registered studies in ME & Turkey
Source: www.clinicaltrials.gov 16 April 2013
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Clinical Trials for Rare Diseases
• World 1,744
• USA 776
• Europe 496
• S-E Europe 55
• Middle-East 53
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Clinical Trials for Rare Diseases
• World 1,744
• USA 776
• Europe 496
• S-E Europe 55 --- Romania 5
• Middle-East 53 --- Israel 41
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How Industry Select Trial Locations ??
Criterion Relative importance Key elements
Strategic relevance High Market opportunity and role of KOLs
Quality High Expertise and protocol adherenceTracking and data systems
Time High-Medium Approval time (Regulatory, EC)Site set-up time
Reliability Medium Delivery against targets
Cost Medium-Low Trial and site costsR&D tax incentives
Source: Mc Kinsey Report August 2005
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Leadership Examples !!!
Attracting More Clinical Trials
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Distribution of Clinical Trials in Europe
38,901 registered studies in Europe
Source: www.clinicaltrials.gov 16 April 2013
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Belgium, Leading by example
• Belgium represents only 2.7% of the European GDP
• Its pharmaceutical industry represents a comparatively larger share of employment (4.9%) and R&D investments (6.6%) within Europe
• In 2010, pharma companies invested an estimated
€1.8 billion in R&D in Belgium
Source: PWC Report – Clinical Research Footprint and Strategic Plan to Promote
Clinical Trials in Belgium - June 2012
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Clinical Trials :Cornerstone of Belgian Economy
Source: PWC Report – Clinical Research Footprint and Strategic Plan to Promote
Clinical Trials in Belgium - June 2012
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Strategic Plan to Promote Clinical Trials in Belgium• Source: PWC Report – Clinical Research Footprint and Strategic Plan to Promote Clinical Trials in Belgium - June 2012
Source: PWC Report – Clinical Research Footprint and Strategic Plan to
Promote Clinical Trials in Belgium - June 2012
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Source: Rx&D, CIHR and ACAHO 2011 Clinical Trials Summit Action Plan
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From the Canadian Action Plan...
• «Clinical trial contracts are worth millions of dollars and thousands of jobs.»
• «By improving cost, quality, speed and relationships as they pertain to clinical trial start-ups times, we can increase the profitability and attractiveness of Canada as a CT business partner.»
Source: Rx&D, CIHR and ACAHO 2011 Clinical Trials Summit Action Plan
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Leading by Example, UK
• UK already attracts a healthy share of the global industry R&D
• But its share of clinical research spend is declining
• The aim is now to reverse this trend!
Source: Mc Kinsey Report August 2005
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Critical Objective of Government Initiatives
• Significant improvement in the regulatory set-ups with major emphasis for time of approvals
Slovenia case!!! ( 1 month)
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• In 2011 research-based pharmaceutical industry invested an estimated € 27,500 million in R&D in Europe
• It directly employs 660,000 people
• Generates 3-4 times more indirect employment
Economic Value of R&D
Source: EFPIA, Key Data 2012
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Employment & Job Growth
1 direct job in biopharmaceutical sector supports 3.7 other jobs!!!
Source: The Biopharmaceutical Sector’s Impact on the US Economy,
Archstone Consulting LLC, March 2009
Growth of Multiplier for U.S. Biopharmaceutical Sector Employment (1996-2006)
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Research as a Powerful Economic Engine
• NIH investing more than $31 billion annually in medical research
• In 2011, NIH-funded research supported an estimated 432,000 jobs all across the US
• Every $1 of NIH funding generates about $ 2.21 in local economic growth
Source: www.nih.gov – Our Economy
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24
Research Efforts must continue….
Note: Death rates are global as estimated by the WHO
Sources: Mortality - World Health Organization: “The World Health Report 2002”;
Wyeth Analysis; New Medicines in Development, PhRMA
Cancer
Stroke
AIDS
Diabetes
Alzheimer’s
One person
dies every…
4 sec
6 sec
11 sec
35 sec
86 sec
Drugs under
development….
83
395
18
22
53
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Constant & Increased Risk….
25
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Cost of bringing a new drug to market
is estimated at $1.3 B
Sources: Truly Staggering Cost Of Inventing New Drugs - www.forbes.com 2/10/2012
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Recent Deals History
GSK and AstraZeneca
(March 2011)
o seting up the Manchester Collaborative Centre for Inflammation Research
o contribution of $5m over a three-year period
Sanofi
(February 2010)
o partnership with AVIESAN,the French Life Sciences and Healthcare Alliance
Sanofi
(April 2011)
o partnership with Stanford University, to fund five research programs/year
Pfizer o investing $100m/5years in a Center for Therapeutic Innovationscientists from the 8 Universities
Eisai
(March 2010)
o alliance with the John Hopkins Brain Science Institute
Source: www.pharmaceutical-technology.com – Can increased collaboration between
big pharma and academia counter industry issues? December 2011
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• Importance & Benefits coming from Clinical Research may not be apparent to all stakeholders
• The Government has a Leading role in building & promoting a Culture of Clinical Research
• Awareness about clinical trials needs to occur at all levels
• This shouldn’t rely only on enthusiastic individuals
Source: A.R. Baer , Journal of Oncology Practice, May 2011 vol.7 no:3 188-192
Concluding Remarks(1)
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Concluding Remarks(2)
• Encouraging growth in healthcare and life-sciences sectors should be a government priority and clinical research is a critical factor in achieving this goal.
• It drives innovation, generates income and gives rise to more effective and cheaper treatments
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Steve Jobs, Cofounder/CEO Apple Computers
Innovation is the distinction between
the leader and the follower
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Key Stakeholders for Clinical Trials
Hospitals/Universities
PIs & ResearchTeams
Society
Regulators/Insurance payers
Volunteer/Patients
Industry
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Thank You for your patience !!