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Careers In Clinical Research 2009

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Opportunities in clinical research in India

Opportunities in clinical research in India

Published in: Business, Health & Medicine

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  • 1. Dr. Ashok Rattan, Chief Executive, Fortis Clinical Research Ltd & Adviser, Religare SRL Diagnostics, Fortis / Escorts Hospitals, Delhi & NCR Careers in Clinical Research
  • 2. Dr. Ashok Rattan MBBS, MD, MAMS
    • 1 st July 2009 : Present position
    • 1 st July 2007 – 2009 : Director, SRL
    • 1 st July 2005 – 2007 : CAREC/PAHO/WHO
    • 29 June 1998 – 2005 : Ranbaxy NDDR
    • 19 June 1987 - 1998 : AIIMS
    • June 1981 – 1987 : JNMC, AMU, Aligarh
    • June 1977 – 1981 : Naga Hospital, Kohima
    MBBS MD MAMS
  • 3. Pick a job you like, and you will never have to work in your life Either be so talented that you get what you want, Or Accept what you get and act as though you always Wanted what you have been given
  • 4. New Drug Discovery and Development (Timelines) DISCOVERY/SCREENING SYNTHESIS AND PURIFICATION ANIMAL TESTING PHASE II PHASE I SHORT-TERM PHASE III LONG-TERM PHASE IV ADVERSE REACTION SURVEILLANCE PRODUCT DEFECT REPORTING PRE-CLINICAL RESEARCH CLINICAL STUDIES NDA REVIEW POST-MARKETING 24 + 18 months. AVG: 5 YEARS AVG: 12 MOS. IND NDA APPROVAL
  • 5. TARGET IDENTIFICATION & VALIDATION R&D Technology HIT IDENTIFICATION LEAD SEARCH & OPTIMIZATION CANDIDATE SELECTION GLP PHASE PHASE I-II PHASE II - III EXPLORATORY RESEARCH DRUG DISCOVERY DRUG PROFILING PRE- DEVELOPMENT DEVELOPMENT GENOMICS PROTEOMICS PHARMACOGENETICS BIOINFORMATICS HTS ASSAY DEVELOPMENT SUBSTANCE LIBRARY MOLECULAR MODELING COMBINATORIAL CHEMISTRY IN VITRO & ANIMAL PHARMACOLOGY TOXICOLOGY NEW FORMULATION PILOT PLANT PHARMACOGENETICS DATA MINING DATA BASE
  • 6. 5000 compounds evaluated Phase-I 20-100 healthy volunteers 0 2 4 6 8 10 12 16 14 Years Phase-II 100-500 patient volunteers Phase-III 1000-5000 patient volunteers Review and approval by Food & Drug Administration 1 Compound approved 5 INDs Discovery and preclinical testing Source: Tufts Centre For Study Of Drug Development in C&EN, June 2000 Bringing a new drug to the market can take 15 years
  • 7. Cost of bringing a new drug to the market is 800M to 1B US$
  • 8. Understand Disease & Identify unmet needs Select Mechanism/ Target Design NCEs & Screens Virtual Screening Synthesize NCEs Convert Lead-to-IND Candidate New Drug Discovery Road Map Preclinical work-up IND directed regulatory studies Convert Hit-to-Lead Screen/ Identify Hit
  • 9. IND Approval Investigator’s brochure Protocol Approval for Phase 1 Select research site
  • 10. Activities
    • Protocols writing
    • CRF designing
    • Clinical Trial Materials logistics
    • Selection of sites, investigators, Labs
    • Training of investigators, Investigators’ meet
    • Obtaining regulatory and IEC approvals
    • Monitoring of studies, ensuring reliable & regular capture of correct data
    • Ensuring compliance with protocol
  • 11. Clinical Trials Win Win Relationship CRO/ SMO/ ARO Fee for service, expand research capacity, work satisfaction Sponsors Regulatory approval, Publication, Enhanced healthcare, Sales & Profits Patients Improved care, decreased expenses, new therapies Investigator Fee for service, Expand Research capacity, Academic interest / publication
  • 12.  
  • 13. Career opportunities in Clinical Research
  • 14. Why Join Clinical Research
    • Sunrise Industry, Booming Market
    • Huge Demand & Supply Gap, Easy Entry
    • White Collared, Knowledge Intensive Job vis-à-vis Boring Sales/Marketing/Production Jobs & Unstable and Uncertain Clinical Practice
    • Good Career Prospects
    • Quickies (quick money, growth on the ladder)
    • National & International Travel, Cross-cultural Exposure
    • Increased Contacts, Marketability
    • Understanding of Drugs, Diseases & Management
    • I Love Research, Documentation, Paper Work
  • 15. Advantage India Language Patient pool Cost Speed English speaking staff Large pool of treatment naiive patients 30 – 50% of USA or EU cost Fast recruitment Regulatory International Quality Parallel Studies Schedule Y 2005 Quality
  • 16. Success Speed Cost Quality
  • 17. People involved in clinical trial in USA Sponsor staff CRO staff Investigators Other site staff 78,000 44,000 50,000 35,000
  • 18. Supply & Demand Manpower 2010 Sponsor staff CRO staff Investigators Other site staff 1,000 6,000 2,000 4,000 200 1,000 300 400
  • 19. Career Pathways
    • Project Management
    • Site management
    • Contract management
    • Data management
    • Clinical
    • Bio-analytical
    • Laboratory
    • Bio-statistics
    • Quality
    • Pharmaco-vigilance
    • Medical writing
    • Regulatory
    • Business Development
  • 20. Where ?
    • Pharmaceutical companies
    • CRO
    • BA BE centres
    • SMO
    • ARO
    • IT
    • Central Labs
    • Logistics
    • Training centres
  • 21. Roadmap to success
  • 22. Roadmap 1 For medical graduates
    • If you are: MBBS/ MD (Pharmacology)
        • Join as CRA, CRC, Study coordinator
      • In 2 to 5 years expect to be :
    Medical Adviser, Regulatory Affairs Manager, Medical Monitor, Medical Writer In 5 to 15 years to be:
        • Medical Director,
        • Head (Clinical Operations)
  • 23. Roadmap 2 for Pharma / graduates
    • If you are: B Pharm/ M Pharm/ Graduate / PG (Biotech, Nursing, Science) / MBA / Ph D
        • Join as CRA, Data Manager, QA executive, Pharmacy Executive
    In 5 to 15 years expect to become: Clinical Team leader, Project Manager, Manager (Clinical Operations), Manager (QA), Clinical Study manager, Regulatory manager In 2 to 5 years you may become
        • Head (Operations), Head (Projects), GM, CEO
  • 24. Roadmap 3
      • If you are: Graduate / PG/ PhD in Maths & Statistics, SAS Programmer etc
          • Data base designer, statistical programmer,
          • Data Validation/ QC executive
    In 2 to 5 years expect to become
          • Data Manager, Statistician, SAS programmer, QC manager
    In 5 to 15 years you will be
          • Head Data Management, Biostatistician
  • 25. Roadmap 4
      • If you are Graduate / PG, MBA including HR, Finance
          • Accounts/ HR executive,
          • Business Development executive
    In 2 to 5 years time, expect to become Manager BD, Manager (Clinical Trial supplies), Manager (Accounts), Manager (HR), Manager (Training) Head (HR), Head (BD), CFO, Head (Training & QA ) In 5 to 15 years time, you could be
  • 26.
    • Industry does not work on the years of experience basis alone
    • What is more important is what you have achieved in these years
    • Careers can be aborted for non achievers & they can and are shown the door
    • Fast track for the high achievers & excessive rewards
    • Individuals get rewards though team work is hall mark of success
  • 27. Always remember we can not spell success without “U”
  • 28. Education Change of behavior Cognition Psychomotor Affective Act of knowing Skills Attitude, Motivation Knowledge is power Skills come from drill “I can” is more important than IQ DOMAINS
  • 29.
    • Think not of yourself as
    • An architect of your career
    • But as a sculpture
    • Expect to have to do
    • a lot of hard hammering &
    • chiseling & scraping &
    • polishing
    • BC Forbes
  • 30. “ It is not the strongest of species that survive, nor the most intelligent, but the ones most responsive to changes” Charles Darwin (1809-1882) Life's battles don't always go To the stronger or faster man, But sooner or later the man who wins Is the one who thinks he can. Attributed to Author Napoleon Hill circa 1973