Clinical Trials Market in Russia

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

2. 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)

3. Association of Clinical Trials Organizations (ACTO) non-commercial organization of the companies/legal entities and clinical research community engaged in clinical trials in Russia

4. 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

5. 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;

6. 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;

7. 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.

8. 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:

9. Association management structure

10. Committees & Workgroups • Regulatory committee • Logistic committee • Legislative committee • HR Working group

11. 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

12. 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)

13. 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)

14. 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)

15. 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)

16. 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

17. Main areas of operation

18. 2043 Clinical Trials in 2004-2007 Total Global CT Global CT Local CT Bioequivalence Studies Source: Roszdravnadzor

19. Structure of CT market Global CT Local CT (Local Manufactures) Local CT (Foreign sponsors) Bioequivalence (Local Manufactures) Bioequivalence (Foreign sponsors) Source: Roszdravnadzor

20. 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

21. 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

22. 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

23. 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)

24. Regulatory system (structure and timelines)

25. 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"

26. 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)

27. Questions & Answers