Clinical%20Trials%20Market%20in%20Russia

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Clinical Trials Market in Russia

• 17 October 2008
• ROTOBO - ACTO

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Agenda

• ACTO objectives, structure, members
• CROs in Russia current status and perspectives
• Market of clinical trials in Russia current
  status and perspectives
• Regulatory system in Russia and its compliance to
  international guidelines (ICH GCP, FDA, EU)

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Association of Clinical Trials Organizations
(ACTO)

• non-commercial organization of the
  companies/legal entities and clinical research
  community engaged in clinical trials in Russia

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Areas of interest

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ACTO The main objectives

• Further development of Russia as a leading
  clinical research country/market by engaging in
  capacity building and activities to shape the
  professional environment
• Generation of awareness of clinical research as a
  specialty and establishing the high Industry
  reputation amongst the general public and
  governmental agencies

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ACTO The main objectives

• Representing the interests of the members of the
  Association
• Creating a favorable business environment for the
  companies conducting the clinical trials in
  Russia
• Maintaining constructive dialogue with regulatory
  authorities and general public aimed at the
  development of stable local legislative basis for
  the clinical trials conduct harmonized with the
  respective worldwide standards

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ACTO The main objectives

• Promoting an ethical business model
• Ensure a proper and effective balance between the
  interests of parties involved in clinical trials
  including the patients, the medical community,
  and the general public and governmental agencies.

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The members of ACTO

• Pharmaceutical Companies
• Bristol-Myers Squibb
• Janssen Pharmaceutica
• Pfizer
• Candidates
• Bayer Schering Pharma AG
• Eli Lilly Vostok S.A.
• AVINEX LLC

• Contract Research Organizations
• Almedis ClinStar
• Worldwide Clinical Trials (WCT)
• i3 MB Quest (POI)
• Parexel PharmaNet
• PRA International
• PSI Quintiles Synergy

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Association management structure
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Committees Workgroups

• Regulatory committee
• Logistic committee
• Legislative committee
• HR Working group

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Projects and Activities

• Analysis of initiatives in changing of
  legislation
• Monitoring of Regulatory procedures and timelines
  
• Standardization of documents and procedures
• Preparation of draft national standard Clinical
  Safety Data Management Definitions and Standards
  for Expedited Reporting (an analogue of the ICH
  E2A)
• Good Taxation Practice (VAT rate 10)
• Salary Survey

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Agenda

• ACTO objectives, structure, members
• CROs in Russia current status and perspectives
• Market of clinical trials in Russia current
  status and perspectives
• Regulatory system in Russia and its compliance to
  international guidelines (ICH GCP, FDA, EU)

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CROs in Russia

• About 60 CROs operating now
• Up to 5 new CROs appear every year
• 42 of trials have been initiated by CROs and 31
  by foreign pharmaceutical companies
  (Roszdaravnadzor)

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Types of CROs in Russia

• Global CROs established their own offices
  according to development plans (Quintiles, Icon,
  PharmaNet, MBQ/POI, PRA)
• Global CRO bought established local business
  (WCT, i3, Parexel, Kendle, AAIPharma)
• Joint venture (PSI)
• Local CROs (Almedis, Synergy Research Group)

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Agenda

• ACTO objectives, structure, members
• CROs in Russia current status and perspectives
• Market of clinical trials in Russia current
  status and perspectives
• Regulatory system in Russia and its compliance to
  international guidelines (ICH GCP, FDA, EU)

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Russia important clinical research (CR) market

• Developed Market
• Population 143 million
• Centralized healthcare system
• Pool of physicians eager to conduct CR
• Large untapped patient source
• Number of well established vendors
• High quality of data

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Main areas of operation
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2043 Clinical Trials in 2004-2007

Total
Global CT
Global CT
Local CT
Bioequivalence Studies
Source Roszdravnadzor
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Structure of CT market

Global CT
Local CT (Local Manufactures)
Local CT (Foreign sponsors)
Bioequivalence (Local Manufactures)
Bioequivalence (Foreign sponsors)
Source Roszdravnadzor
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Phases of CT (Foreign Sponsors)
2008, III quarters (Total 315)

I phase
II-III phase
IV phase
I-II phase
bioequivalence

III phase
II phase
III-IV phase
Source Roszdravnadzor
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Japan in CT in Russia in 2008

• Cardiology 3 studies
• Neurology 2 studies
• Psychiatry 1 study
• Infectious diseases 1 study
• Infectious diseases / pulmonology - 1 study
• Pulmonology 1 study
• Infectious / skin diseases 1 study
• Rheumatology 1 study

Source Roszdravnadzor
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Quality of studies

• Based on 36 FDA inspection 1995 - 2007
• No Actions Indicated (NAI) 18 inspections (50)
• Voluntary Actions Indicated (VAI) 17
  inspections (47)
• Official Actions Indicated (OAI) 1 inspection
  (3)

Source Applied Clinical Trials, Apr. 2008
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Agenda

• ACTO objectives, structure, members
• CROs in Russia current status and perspectives
• Market of clinical trials in Russia current
  status and perspectives
• Regulatory system in Russia and its compliance to
  international guidelines (ICH GCP, FDA, EU)

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Regulatory system (structure and timelines)
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Laws and Regulations

• Federal Law On Medicines 22.06.1998 ? 86-??
• National Standard of the Russian Federation GOST
  P 52379-2005 GOOD CLINICAL PRACTICE
• Order of Ministry of Health of Russian Federation
  of 19.06.2003 ? 266 Procedures of clinical
  practice in Russian Federation"
• Order of Roszdravnadzor of 17.08.2007 ?
  2314-??/07 Statement of Central Ethics Committee"

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NATIONAL STANDARD OF THE RUSSIAN FEDERATION GOST
P 52379-2005 GOOD CLINICAL PRACTICE

• The standard is identical to Consolidated
  Guideline on Good Clinical Practice, issued by
  the International Conference on Harmonisation of
  Technical Requirements to Registration of
  Pharmaceuticals for Human Use (ICH GCP)

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Questions Answers