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Clinical Trials Market in Russia. 17 October 2008 ROTOBO - ACTO. Agenda. ACTO: objectives, structure, members CROs in Russia: current status and perspectives Market of clinical trials in Russia: current status and perspectives

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Clinical Trials Market in Russia

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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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Society

Developing and introduction of high standards for clinical trials

Developing and forming of public opinion of the industry branch

Association

Participation in

legislative process

(dialog with

legislative

establishment and

representing for the industry)

  • Self-control of the branch

Legislative Authority

Executive Authority

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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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

The members of ACTO:


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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

III phase

bioequivalence

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-ФЗ

  • 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-Пр/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


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