Clinical Research In Russia

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Clinical Research In Russia

  1. 1. Overview of Clinical Research in Russia and Development Plan 8 January 2009 Tatiana Postnikova
  2. 2. Main objectives <ul><li>Overview of Clinical Research </li></ul><ul><li>Clinical Research Market in Russia </li></ul><ul><li>Development plan </li></ul>Tatiana Postnikova
  3. 3. Overview of Clinical Research Market Players : - Pharmaceutical companies -Biotech companies -CROs Source : Winter, J and Baguley, J.,(2006), ‘Outsourcing Clinical Development’, Gower Publishing Company, USA Tatiana Postnikova
  4. 4. Clinical Research Market <ul><li>CR Market is an attractive area </li></ul><ul><li>Number of small R&D companies is expected to grow by 43% in 2018 </li></ul><ul><li>(Pharmaceutical Market Outlook, 2018) </li></ul><ul><li>Opportunities </li></ul><ul><li>Increase of outsourced services and CROs </li></ul><ul><li>Globalization - Opportunities for emerging markets </li></ul><ul><li>Threats </li></ul><ul><li>Competition from generics </li></ul><ul><li>Challenging regulatory requirements </li></ul><ul><li>The downturn in credit market </li></ul>Source : Winter, J and Baguley, J.,(2006), ‘Outsourcing Clinical Development’, Gower Publishing Company, USA Tatiana Postnikova
  5. 5. Clinical Research Market in Russia Clients Pharmaceutical/ Biotech Companies and CROs Local Regulatory Requirements Candidates Competitors Recruitment agencies Tatiana Postnikova Clinical Research
  6. 6. Local Regulatory Requirements <ul><li>The National regulations regarding drug development and Clinical Trials </li></ul><ul><li>in Russia are similar to European countries : </li></ul><ul><li>ICH Good Clinical Practice – OST No 42-511-99(Russian version) </li></ul><ul><li>Main legislation governing Clinical Research in Russia: </li></ul><ul><li>&quot; Good Laboratory Practice in Russian Federation &quot;( Decree of the Minister of Health of RF #267 dated 19.06.2003) </li></ul><ul><li>‘ Good Clinical Practice in Russian Federation &quot;( Decree of the Minister of Health of RF #266 dated 19.06.2003) </li></ul><ul><li>Federal Law &quot; On Medicinal Products &quot; # 86-FZ dated 22 June 1998 </li></ul><ul><li> ( with amendments dated 2 January 2000, 30 December 2001) </li></ul><ul><li>Resolution of Ministry of Health of Russian Federation # 103 </li></ul><ul><li> &quot; On Decision Making about Clinical Trials Conduct &quot; dated 24 March 2000 </li></ul>Tatiana Postnikova
  7. 7. Main Competitors <ul><li>Local RAs – indirect competitor </li></ul><ul><li>( Cornestone, Selectum, Yappi Group and etc) </li></ul><ul><li>Focus on local biotech and pharmaceutical companies, main functional areas – pharmaceutical distribution/sales/marketing </li></ul><ul><li>Global RAs – direct competitor </li></ul><ul><li>(Kelly Scientific, HaysPharma, Manpower and etc) </li></ul>Strengths -Global scope -Well-known in Russian market Weaknesses -Broad functional areas -Lack of focus on CR Source: www.hh.ru Tatiana Postnikova
  8. 8. Candidate’s profile Source : Kelly Services, (2008) ‘Recruitment for pharmaceutical companies’ www. kellyservices.ru <ul><li>Excellent academic knowledge </li></ul><ul><li>Team working skills </li></ul><ul><li>Underdeveloped language skills </li></ul><ul><li>Lack of knowledge of international legal requirements </li></ul><ul><li>Insufficient level of international qualifications </li></ul><ul><li>‘ Lost generation of scientists’: </li></ul><ul><li>60% - over 55 years </li></ul><ul><li>25% - under 30 years </li></ul><ul><li>15% - between 30 and 45 years </li></ul>Strengths Weaknesses
  9. 9. Client’s profile and Skill Demand <ul><li>Client’s profile </li></ul><ul><li>- International biopharmaceutical companies – 66% of all CTs (2008) </li></ul><ul><li>-Local biopharmaceutical companies -34% of all CTs (2008) </li></ul><ul><li>-Significant increase in the proportion of CROs – 75% of all CTs (2008) </li></ul><ul><li>Skill Demand </li></ul><ul><li>-Technical Skills (qualifications, ‘soft’ skills, cross-functional skills) </li></ul><ul><li>-Social Skills – significant skills shortage: </li></ul><ul><li>-language skills </li></ul><ul><li>-commercial awareness </li></ul>Source: Synergy Research Group , (2008), ‘Clinical Research in Russia’, www.cra-club.ru
  10. 10. Business opportunities in Russia Table 1 Table 2 Tatiana Postnikova 3200 Annual n umber of jobs in Clinical Research 100 Number of bio/pharmaceutical companies with R&D and CROs in Russia 125 Average number of employees per company 25% Global Employee Turnover in CROs 38,400,000 r/ £920,000 23,040,000 r/ £552,000 Annual Revenue 240,000 r/ £5,750 240,000 r/ £5,750 Revenue per candidate 960,000 r/ £23,000 960,000 r/ £23,000 Average salary per candidate 160 96 Annual number of jobs processed by Clinical Professional 3200 3200 Annual number of jobs in Clinical Research 5% 3% Clinical Professional’s projected market share in Russia Year 2 2010 Year 1 2009
  11. 11. Development plan Tatiana Postnikova Talent Tracker Strategy plan for the next 6 months. Clinical Market Information (analyse main competitors) Pipeline watch Clinical Market Information (analyse candidates and clients) Career Clinic (CV clinic and Interview Tips) Service development Introduce Clinical Professional to 40 new biotech/pharmaceutical companies and CROs Overall: 120 Introduce Clinical Professional to 40 new biotech/pharmaceutical companies and CROs Introduce and promote service to 40 biotech/pharmaceutical companies and CROs Client’s development Attract and build relationships with candidates: -senior level – 40 -middle level – 100 -entry level - 80 Overall: 660 Attract and build relationships with candidates: -senior level – 40 -middle level – 100 -entry level -80 Attract and build relationships with candidates: -senior level – 40 -middle level – 100 -entry level -80 Candidate’s development 3 month 2 month 1 month
  12. 12. <ul><li>Any questions? </li></ul><ul><li>Thank you for your attention </li></ul>Tatiana Postnikova

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