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Investing in Clinical Studies in Greece of Crisis: case study of ΑstraΖeneca Greece
Dora TourtoglouClinical Research ManagerArea Europe | Greece | Medical Dpt Athens,15 December 2016
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Clinical environment…in Greece
Source: 2016 clinicaltrial.govClinical Trials distribution:
- 265 open Clinical trials
- Covers 4% in patients medication needs
- 20% clinical trials increase in 2015
- Each new Clinical trial is an investment of 250k €
- Contribution on gross domestic product about
850k €
- Top product of export in country (352m €)
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Distribution of Clinical Trials in Greece
17095
Interventional Clinical trials
Univ.Hosp.Collabgroups
Pharma
Source: 2015 EOF/NEC
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Pharmaceutical Investment in R&D in Europe
4 Source: EFPIA member associations (official figures) “ThePharmaceutical Industry in Figures-Key Data 2015”
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AZ Clinical trial Journey…At a glance
5
2008‘’Lean and Agile’’ allocation
2010EXIT
Clinical trials
Country
2015ReSTART
2016Outperformance
2017Target other TAs and PhI
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GREECE : Case study
Vision
• Externally : Partners to HCPs and patients for healthcare improvement
• Internally : Top partners for trial placement and execution
• How : Working together
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HOW?• Continously align organisation and processes to fit costume and demand
• Align support and training through simplification/lean processes
• Support cross-border and cross function co-operation
• Support training in processes and in new compounds
• Medical Affairs department aligned and support
• CLIN OPS act as speakers person and communicator in/out of the country
Stop wishing… Start doing
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Key drivers for the modified allocation
Facts and Figures
Local health environment alliance
Main scientific capabilitiesExternal Input KOLEmphasize International KOL synergiesMaking Greece ONCO clinical hub
Be proactively STRATEGIC!!! Overage in Site Selection Study Specific Target Setting / Planning
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9
5 Global Ph III trials assigned
ONCO Lung-H&N-Bladder-Breast Respiratory CV / Metabolics
22 Sites45 Investigators
~120 patients
16 ESRs
71 Sites
260 patients1080 samples
5 NISs
200 Sites
1799patients
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AZ Investment past- current-future…
20102,1m €
2016-20176,2m €
20188,5m €
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Clinical Team, Medical Department, AstraZeneca
AZ GR Clinical
10
+
Internal roles: 40%
Employees with more 10 years
- AZ: 30%
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Achievements …
12
5 Global Top Recruiting Sites1 International Coordinator/PI
1 PI in Steering Committee
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Achievements …
Changed mindset
13
Overecruiting105-150% from initial target
QUALITY Audit findings: no observations
Screening Failure Rate 0,0%
1st Patient in
Europe!
1st EU country with
all sites activated!
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