KCR: CEE Market for Clinical Trials

IS Central and Eastern Europe still an emerging market?

Anna Baran MdChief medical Officer, KCR S.A.

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AGENDA

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Geopolitical status

European Commission and EMA adherence

CEE submission reality

CE bioequivalent studies – regional considerations

Cultural aspect – don’t assume

Conclusions

Kcr seminar / stockholm, 18Jun / Anna Baran

Geopolitical situation (2004)

Kcr seminar / stockholm, 18Jun / Anna BaranPage / 4


Geopolitical situation (current)

EC directives and EMA adherence

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EU Directive 2001/20 – implemented, Ukraine and Serbia

to follow

EU Directive 2005/28 – predominantly implemented

Approach to new CT regulation – under discussion

Adherence to EMA SA – case by case basis

EudraVigilance – implemented with few gaps


CEE Submission reality

Region-wide adherence to EU Directives

Strong focus on patients’ wellbeing

Increasing awareness of quality/pre-clinical data within

authorities

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Description of feedbacks

Complexity of feedback from CEE authorities is increasing year by year, focusing now on subject matter review

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Till 2010 2011 and on

Administrative deficiencies Stability data

Placebo related considerations Toxicology data

Irrelevant protocol Previous clinical data

Protocol design (medium level)


Regulatory process duration (kcr retrospective data)

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0

20

40

60

80

100

120

140

160

180

200

RA average

approval

duration

EC average

approval

duration

Sequential

submission


Recommended approach

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Include regulatory

perspective into study

feasibility

Design set up

timelines based

on retrospective

data

and recent

intelligence

Keep quality of the file

and stay conscious for

the next 60 days plus


Recently observed trends


Local agencies/study authorization

• Different level of recognition of clinicaldevelopment concept

Healthcare professionals

• Gradually increasing value recognition

Patients

• Open for change

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Generic drugs – special cases

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Bioequivalence to be proved based on non-PK data

Clinical endpoints often patient-reported

Placebo control as one of reference arms

Low treatment effect resulting in significant number of

subjects per group

Lack of ‚prejudice’ at drug agencies


CE bioequivalence development –benefits of stakeholders

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•Ability to realize full program within single region

• Mastering CRO capability

•Access to non-reimbursed drugs under clinical trial

•Ability to join clinical research at relatively low complexity

•Lack of study type recognition

•Decreasing role of India

Regulatory landscape

Physicians perspective

CEE benefits

Patients perspective


Communication and conflict resolution style


Risk propensity


conclusions

CEE region is and will remain significant research market,

however ’emerging’ term is gradually moving East and

South

Upcoming laws can paradoxically prolong start-up

timeline

CE bioequivalence studies will challenge the standard

classification of research phases

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QUESTIONS& ANSWERS

IS Central and Eastern Europe still an emerging market?Contact:

Anna Baran MD, Chief Medical Officer

Email: [email protected]

About KCR

KCR is a European Contract Research Organization (CRO) with a dynamic team of nearly

300 professionals operating across 18 countries in Europe as well as the U.S.

With 17 years of experience, more than 350 trials executed, over 30,000 patients recruited

and almost 3,000 sites contracted, KCR is a strategic solutions provider and a reliable

alternative to global CROs, delivering the all-important flexibility.

We provide services on long standing global or local contracts to 12 out of the Top 20

Global Pharma companies, and have been granted by 3 of them with the Preferred

Provider certification.

KCR offers clinical development support via 3 types of professional services:

- Full Service Model for Clinical Development Services (Phase I-IV)

- Functional Service Provider (FSP)

- Post-Marketing Clinical Services

For more information about the KCR offer, please visit www.kcrcro.com or contact us at

[email protected].

KCR

CORPORATE HEADQUARTERS.

6 Postepu str.

02-676 Warsaw, Poland

Phone: +48 22 313 13 13

Fax: +48 22 313 13 14

Email: [email protected]

www.kcrcro.com

http://www.kcrcro.com/

mailto:[email protected]

Health & Medicine

KCR: CEE Market for Clinical Trials