Takis Zervakakis Bucharest, October 2014

Clinical Research,

an Important Contributor

to the Scientific & Financial Development

of a country

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

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

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

Global Distribution of Clinical Trials

Source: www.clinicaltrials.gov 16 April 2013

143,583 trials in 184 countries

Distribution of Clinical Trials in Europe

38,901 registered studies in Europe

Source: www.clinicaltrials.gov 16 April 2013

Distribution of Clinical Trials in MET

5853 registered studies in ME & Turkey

Source: www.clinicaltrials.gov 16 April 2013

Clinical Trials for Rare Diseases

• World 1,744

• USA 776

• Europe 496

• S-E Europe 55

• Middle-East 53

Clinical Trials for Rare Diseases

• World 1,744

• USA 776

• Europe 496

• S-E Europe 55 --- Romania 5

• Middle-East 53 --- Israel 41

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

Leadership Examples !!!

Attracting More Clinical Trials

Distribution of Clinical Trials in Europe

38,901 registered studies in Europe

Source: www.clinicaltrials.gov 16 April 2013

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

Clinical Trials :Cornerstone of Belgian Economy

Source: PWC Report – Clinical Research Footprint and Strategic Plan to Promote

Clinical Trials in Belgium - June 2012

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

Source: Rx&D, CIHR and ACAHO 2011 Clinical Trials Summit Action Plan

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

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

Critical Objective of Government Initiatives

• Significant improvement in the regulatory set-ups with major emphasis for time of approvals

Slovenia case!!! ( 1 month)

• 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

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)

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

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

Constant & Increased Risk….

25

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

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

• 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)

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

Steve Jobs, Cofounder/CEO Apple Computers

Innovation is the distinction between

the leader and the follower

Key Stakeholders for Clinical Trials

Hospitals/Universities

PIs & ResearchTeams

Society

Regulators/Insurance payers

Volunteer/Patients

Industry

Thank You for your patience !!