Opportunities in clinical research in India

1. Dr. Ashok Rattan, Chief Executive, Fortis Clinical Research Ltd & Adviser, Religare SRL Diagnostics, Fortis / Escorts Hospitals, Delhi & NCR Careers in Clinical Research

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

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

13. Career opportunities in Clinical Research

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

21. Roadmap to 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

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