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

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 €)

Distribution of Clinical Trials in Greece

17095

Interventional Clinical trials

Univ.Hosp.Collabgroups

Pharma

Source: 2015 EOF/NEC

Pharmaceutical Investment in R&D in Europe

4 Source: EFPIA member associations (official figures) “ThePharmaceutical Industry in Figures-Key Data 2015”

AZ Clinical trial Journey…At a glance

5

2008‘’Lean and Agile’’ allocation

2010EXIT

Clinical trials

Country

2015ReSTART

2016Outperformance

2017Target other TAs and PhI

GREECE : Case study

Vision

• Externally : Partners to HCPs and patients for healthcare improvement

• Internally : Top partners for trial placement and execution

• How : Working together

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

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

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

AZ Investment past- current-future…

20102,1m €

2016-20176,2m €

20188,5m €

Clinical Team, Medical Department, AstraZeneca

AZ GR Clinical

10

+

Internal roles: 40%

Employees with more 10 years

- AZ: 30%

Achievements …

12

5 Global Top Recruiting Sites1 International Coordinator/PI

1 PI in Steering Committee

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!