Clinical Research as a Contributor to the Scientific & Financial Development of the Country

Transcription

1 Clinical Research as a Contributor to the Scientific & Financial Development of the Country Takis Zervakakis Vice President Marketing & Business Development

2 Short CV 2.5 years med rep 2.5 regulator affairs mgr 3.5 regulatory affairs mgr / product mgr cns 2.0 group product mgr 2.5 marketing mgr 9.0 managing director 1998 responsibility for cyprus 2002 responsibility for turkey & cyprus responsibility for balkan countries

3 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 turning fundamental research into innovative treatments that are widely available and accessible to patients Source: Efpia, The Pharmaceutical Industry in Figures, 2012

4 Pharma R&D Investment Remains Significant around 90 billion on R&D in % (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,

5 Pharma R&D Spend over Time Source: Efpia, The Pharmaceutical Industry in Figures, 2012

6 Optimistic Outlook!! Worldwide R&D Spend by Pharma & Biotech Companies ( ) WW Prescription Sales ($bn) per year Pharma R&D Spend Growth per Year 9.1% 0.8% (0.3%) 1.7% 2.0% WW Prescription (Rx) Sales Growth per Year 8.2% 2.8% (0.9%) 3.7% 4.3% R&D as % of WW Rx Sales 20.3% 19.0% 18.9% 18.2% 17.4% Source: June 18, 2012

7 Global Distribution of Clinical Trials 143,583 trials in 184 countries Source: 16 April 2013

8 Distribution of Clinical Trials in Europe 38,901 registered studies in Europe Source: 16 April 2013

9 Distribution of Clinical Trials in TME 5853 registered studies in ME & Turkey Source: 16 April 2013

10 How Industry Select Trial Locations?? Criterion Relative importance Key elements Strategic relevance High Market opportunity and role of KOLs Quality High Expertise and protocol adherence Tracking 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 costs R&D tax incentives Source: Mc Kinsey Report August 2005

11 How Turkey Compares Internationally?? Criterion Relative importance Key elements Strategic relevance High Market opportunity and role of KOLs 75+ M population 16th worldwide by market value Quality High Expertise and protocol adherence Tracking and data systems Nice track record & Adequate supervision Time High-Medium Approval time (Regulatory, EC) Site set-up time Despite improvements can still improve Reliability Medium Delivery against targets Must improve in pts recruitment & time Cost Medium-Low Trial and site costs R&D tax incentives Competitive costs

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13 Leadership Examples!!! Attracting More Clinical Trials

14 Distribution of Clinical Trials in Europe 38,901 registered studies in Europe Source: 16 April 2013

15 Distribution of Clinical Trials in Europe Belgium!!! 38,901 registered studies in Europe Source: 16 April 2013

16 Belgium, Leading by example Belgium represents only 2.7% of the European GDP Source: PWC Report Clinical Research Footprint and Strategic Plan to Promote Clinical Trials in Belgium - June 2012

17 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 Source: PWC Report Clinical Research Footprint and Strategic Plan to Promote Clinical Trials in Belgium - June 2012

18 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

19 Clinical Trials, Cornerstone of Belgian Economy Source: PWC Report Clinical Research Footprint and Strategic Plan to Promote Clinical Trials in Belgium - June 2012

20 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

21 Australia attracts more than $1 billion/year in pharmaceutical R&D investment! Source: - Interview with Mr. G. Combet, Minister for Industry and Innovation Oct 2012

22 Leading by Example, Australia...our processes... need reform! Key issues including: Timelines of approvals Benefits of e-health Improving patients recruitment Support clinical trials networks

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

24 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

25 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

26 Critical Objective of Government Initiatives Significant improvement in the regulatory set-ups with major emphasis for time of approvals Slovenia case!!! ( 1 month)

27 Economic Value of R&D In 2011 research-based pharmaceutical industry invested an estimated 27,500 billion in R&D in Europe It directly employs 660,000 people Generates 3-4 times more indirect employment Source: EFPIA, Key Data 2012

28 Employment & Job Growth 1 direct job in biopharmaceutical sector supports 3.7 other jobs!!! Growth of Multiplier for U.S. Biopharmaceutical Sector Employment ( ) Source: The Biopharmaceutical Sector s Impact on the US Economy, Archstone Consulting LLC, March 2009

29 Collateral Benefits & Type of Employment Profile for Direct Jobs in U.S. Biopharmaceutical Sector (2006) Source: The Biopharmaceutical Sector s Impact on the US Economy, Archstone Consulting LLC, March 2009

30 Economic Impact & Contribution to GDP Contribution to GDP Supported by U.S. Biopharmaceutical Sector (2006) Source: The Biopharmaceutical Sector s Impact on the US Economy, Archstone Consulting LLC, March 2009

31 Cancer Stroke AIDS Diabetes Alzheimer s One person dies every 4 sec 6 sec 11 sec 35 sec 86 sec Drugs under development Note: Death rates are global as estimated by the WHO Sources: Mortality - World Health Organization: The World Health Report 2002 ; Wyeth 31 Analysis; New Medicines in Development, PhRMA

32 Research Efforts must continue. Cancer Stroke AIDS Diabetes Alzheimer s One person dies every 4 sec 6 sec 11 sec 35 sec 86 sec Drugs under development Note: Death rates are global as estimated by the WHO Sources: Mortality - World Health Organization: The World Health Report 2002 ; Wyeth 32 Analysis; New Medicines in Development, PhRMA

33 33 Constant & Increased Risk.

34 Economic Potential Cost of bringing a new drug to market is estimated at $1.3 B Sources: Truly Staggering Cost Of Inventing New Drugs - 2/10/2012

35 Economic Value for the Academia Academic institutions face increasingly tight budgets Source: Can increased collaboration between big pharma and academia counter industry issues? December 2011

36 Economic Value for the Academia Academic institutions face increasingly tight budgets Synergy in terms of funding and technology from Pharma Source: Can increased collaboration between big pharma and academia counter industry issues? December 2011

37 Economic Value for the Academia Academic institutions face increasingly tight budgets Synergy in terms of funding and technology from Pharma Collaboration between large Pharma Co s and Academic Institutions creating a trend Source: Can increased collaboration between big pharma and academia counter industry issues? December 2011

38 Powerful partners: Pharma and Academia 225 different research groups from 23 major pharma 298 academic teams 47 small and mediumsized companies 11 patient organisations EMEA Source:

39 Recent Deals History GSK and AstraZeneca (March 2011) Sanofi (February 2010) Sanofi (April 2011) Pfizer Eisai (March 2010) o seting up the Manchester Collaborative Centre for Inflammation Research o contribution of $5m over a three-year period o partnership with AVIESAN, the French Life Sciences and Healthcare Alliance o partnership with Stanford University, to fund five research programs/year o investing $100m/5years in a Center for Therapeutic Innovation scientists from the 8 Universities o alliance with the John Hopkins Brain Science Institute Source: Can increased collaboration between big pharma and academia counter industry issues? December 2011

40 Leading by Example, Turkey becoming one of the global R&D and production hubs and a regional management center by 2023 Source: Turkey s Pharmaceutical Sector Vision 2023 Report

41 Concluding Remarks Importance & Benefits coming from Clinical Research may not be apparent to all stakeholders All stakeholders should be appropriately aware about Clinical Research This shouldn t rely only on enthusiastic individuals Source: A.R. Baer, Journal of Oncology Practice, May 2011 vol.7 no:

42 Concluding Remarks Importance & Benefits coming from Clinical Research may not be apparent to all stakeholders Awareness about clinical trials needs to occur at all levels This shouldn t rely only on enthusiastic individualsthe Government has a Leading role in building & promoting a Culture of Clinical Research Source: A.R. Baer, Journal of Oncology Practice, May 2011 vol.7 no:

43 Concluding Remarks Clinical Research drives innovation, generates income and brings more effective and affordable treatments to patients!!!

44 Key Stakeholders for Clinical Trials Society Volunteer/ Patients Hospitals/ Universities PIs & ResearchTeams Regulators/ Insurance payers Industry

45 Thank You for your patience!! Takis Zervakakis Vice President Marketing & Business Development