Europe can help speed up drug development in 3 key ways: 1) Access to greater patient populations in rare diseases can help with faster recruitment. 2) Certain areas have highly motivated patients with lack of treatment options, traveling long distances to participate in trials. 3) Lower cost of trials, around 80% of US costs in Western Europe and 50% in Eastern Europe.

1. Presentation
by Dr. med. Karl-Peter Klein
Dip Pharm Med RCP UK, FFPM RCP UK
Managing Director
AtoZ-CRO GmbH
Clinical Research
Leyenhaus 29, 51491 Overath/Germany
e-mail: kp.klein@atoz-cro.de
www.atoz-cro.de
Presented at the Marcus Evans Evolution Summit
Conference
Westin Chicago North Shore - Wheeling, IL, USA
on May 1, 2012
2012‐05‐01 1

2. How can Europe help to speed up
your drug development
Conditions,
Rules and Cost of doing clinical
trials in Central and Eastern
Europe
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4. Content
• Patients with rare diseases
• Availability of motivated patients
• Drug naive patients
• Motivated investigators
• Very experienced investigators
• Quality of data
• Fast Marketing Autorisation
• Fast Marketing Success
• Cost for clinical trials is lower in Europe
• Conditions to start trials in Europe
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5. How can Europe help to speed up your drug development
Rare Diseases
Europe can help to speed up recruitment
by having access to greater patient
populations in rare diseases
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6. How can Europe help to speed up your drug development
Availability of motivated patients
Esp. in Eastern Europe for certain patients
there is a lack of medical treatment; this
causes a high motivation to enter clinical
trials
Patients travel long distances to meet the
investigators
Patients are highly motivated and show a
high compliance
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7. How can Europe help to speed up your drug development
Drug Naive Patients
In some areas in Europe patients are not
overloaded with other drugs as they are in the
US or Germany, this means drug effects may be
seen clearer and earlier, this is of incredible
value and may speed up development process or
allow earlier decisions
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8. How can Europe help to speed up your drug development
Many motivated Investigators
In Europe there are many highly
motivated investigators and trial sites
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9. How can Europe help to speed up your drug development
Very experienced Investigators
In Europe there are many very
experienced investigators and trial sites
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10. How can Europe help to speed up your drug development
Quality of Data
Most inspection results by the US FDA in
Europe have shown a good quality of data
Based on experience of inspectors from the
US FDA, the number of findings in Europe
are about the same as in the US
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11. How can Europe help to speed up your drug development
The cost for clinical trials is lower in
Europe compared to US
In Western Europe cost is about 80%
In Eastern Europe about 50%
of the cost in the US
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12. How can Europe help to speed up your drug development
Fast Marketing Autorisation
Involvement of study sites in Europe in
early drug development supports the later
appoval process in Europe
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13. How can Europe help to speed up your drug development
Fast Marketing Success
Involvement of study sites in Europe in
the drug development later on supports
the marketing of these drugs
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14. Conditions, Rules of doing clinical trials in Europe
Conditions to start trials in Europe
• There is a certain hormonization in the EU
countries
• Offices in Europe or a legal representative
• Qualified Person for PV within the EU
• Approval of the Clinical Trial Application by
the Competent Authority
• Positive vote by the Ethics Committee (EC)
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15. Conditions, Rules of doing clinical trials in
Europe
CTA Review
- Applicaton is validated
- 30 (or 60) days review
- Deficiency letter may be issued
- After the response an additonal
review is completed
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16. The ICH-GCP compliance, the
availability of subjects, the quality of
investigators, the time-reduced and the
low costs are by far the important
criteria for choosing Eastern Europe
countries to conduct clinical trials.
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17. Conclusion
Conducting trials in Europe may help to
- accelerate development
- reduce costs
- support international registration
- support international marketing
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18. Thank you
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