Clinical Trials Market in Russia 17 October 2008 ROTOBO - ACTO.

Clinical Trials Market in Russia

17 October 2008ROTOBO - ACTO

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)

Association of Clinical Trials Organizations (ACTO)

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

Areas of interest

Self-control of the branch

Self-control of the branch

Participation inlegislative process (dialog with legislative establishment and representing for the industry)

Participation inlegislative process (dialog with legislative establishment and representing for the industry)

SocietySociety

Legislative AuthorityLegislative Authority Executive AuthorityExecutive Authority

Developing and introduction of high standards for clinical trials

Developing and forming of public opinion of the

industry branch

AssociationAssociation

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;

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;

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.

The members of ACTO:Pharmaceutical Companies:Bristol-Myers Squibb;Janssen Pharmaceutica;PfizerCandidates: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

Association management structure

General Meeting

Board (collective executive body)

Committees & Workgroups

Executive Director (sole executive body)

Committees & Workgroups

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

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

Agenda





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)

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)

Agenda





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

Main areas of operation

2043 Clinical Trials in 2004-2007

525

253

447

279

508

324

563

369

2004 2005 2006 2007495 - 24%

323 - 16% 1225 - 60%

Global CT

Local CT Bioequivalence StudiesGlobal CT

Total

Source: Roszdravnadzor

Structure of CT market

2007 (Тotal - 563)

66%1%4%

11%18%

Global CT

Local CT (Foreign sponsors)

Bioequivalence (Foreign sponsors)

Bioequivalence (Local Manufactures)

Local CT (LocalManufactures)

I-III quarters 2008 (Total - 474)

59%1%

6%

11%23%


Phases of CT (Foreign Sponsors)

2% 1%

27%

3%

1% 6% 1%

59%

I phase

I-II phase

II-III phase

bioequivalence

III phase

2008, III quarters (Total – 315)


II phase III-IV phase

IV phase

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


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

Agenda





Regulatory system (structure and timelines)

Total~ 122,6 days (147,7)

FINAL APPROVAL (Roszdravnadzor)

~ 25, 2 days

Ethics Approval (Central

Ethics Committee)~ 44,7 days

Import/Export License

(Roszdravnadzor)~ 23,7 days

Expertise of Application for Rzd.

(FGU)~ 73,7 days

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"

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)

QuestionsQuestions & Answers & Answers

Clinical Trials Market in Russia 17 October 2008 ROTOBO - ACTO.

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