1. Q UINTILES INDIA Opportunities and Experiences in conducting Clinical Trials in India Narges Mahaluxmivala MD (Bom), DTM&H (Eng) Quintiles India September 25, 2003

2. Q UINTILES INDIA 2 Clinical Research in India Knowledge-based ‘service’ sector Enormous potential for growth (size, scale, range of services)  to Indian and overseas research organisations

3. Q UINTILES INDIA 3 Benefits to India Boosts exports earn foreign exchange Expands/enhances medical and research infrastructure

4. Q UINTILES INDIA 4 Major Enablers - 1 ‘Socio-economic changes’  Increasing urbanisation  Better education  Higher incomes  Better access to healthcare  Increasing life span (aging population)  Change in disease patterns Changing attitudesChanging demands

5. Q UINTILES INDIA 5 Need for new medicines Availability of trained manpower Well-equipped tertiary care hospitals Large patient population Usage of English for medical and scientific communication Major Enablers - 2

6. Q UINTILES INDIA 6 Healthcare Industry Rs.100,000 crores growing at 17% employing 60 lakhs people directly and 20 lakhs indirectly

7. Q UINTILES INDIA 7 Development Research Opportunities First Wave  Phase III – IV Clinical Studies to international standards  Well equipped hospitals and qualified investigators  English speaking population  No-fault connectivity  Data Management / Statistics  Trained manpower  Accredited laboratories  Preclinical support services

8. Q UINTILES INDIA 8 Opportunities Second Wave - overlapping  Phase I Clinical Studies to international norms  Bioinformatics  Health economics-related (health insurance liberalization)  RDE eDC Development Research IT-related back office services to development research

9. Q UINTILES INDIA 9 Development Research Opportunities Third Wave - overlapping Genomics Tailored medicine research Diagnostics (new generation) Clinical trial management systems eDC (web-based)

10. Q UINTILES INDIA 10 India Inherent Advantages Scientific Manpower Scientific Knowledge Global Exposure IT development Globalization of Trade To evolve Business in a ‘patients’ regime Healthcare delivery improvement Greater industry/academia collaborations Regulatory framework harmonization with global requirements Resources – Manpower/Monetary/Material Inexperience Experience

11. Q UINTILES INDIA 11 Today’s Realities

12. Q UINTILES INDIA 12 Drug Development Costs

13. Q UINTILES INDIA 13 Drug Discovery accelerating more drugs in the pipeline 1996 - 2853 drugs in development 1997 -3102 drugs in development 1998-3278 drugs in development 2002-5387 drugs in development !!! Why ? High throughput screening Molecular modeling Genomics

14. Q UINTILES INDIA 14 Growing Realization vThe Cost of Pharma Research has to decrease internal - efficiencies external - outsourcing More R & D will be done outside the USA & Europe - cost - enrollment - time-to-market

15. Q UINTILES INDIA 15 Clinical Trials

16. Q UINTILES INDIA 16 Contradictions in Clinical Research Clinical Trials are global but Controls are local Clinical research is part of a ‘knowledge industry’ but responses to it are ‘emotional’ Clinical research is based on science but influenced by political/cultural sensitivities and economic backgrounds Clinical trials are ‘experiments’ but may be viewed as therapeutic options

17. Q UINTILES INDIA 17 Interpretation / Implementation of GCP Scientific Influences - minimal Cultural Influences - significant Acclimatization – slow Complete cultural integration not the answer but differences to be appreciated and accepted by both parties Evolving standards of performance  Drive the drug development process forward  Prevent exploitation of the subject / patient

18. Q UINTILES INDIA 18 Clinical Trial aspects affected by culture Ethical Review Consent procedures Standards of Care for control groups Intervention offered or not after trial ends? Placebo controls - yes or no? Is the trial considered a treatment option?

19. Q UINTILES INDIA 19 Ethical Review Medical Ethics in General vs Ethics within a protocol (Risk/benefit analysis) Perception of Risks and Priorities e.g. confidentiality Absence of continuous oversight Clinician vs investigator (conflict of roles) ECs need to make special efforts to understand and comply with international standards

20. Q UINTILES INDIA 20 Subject Consent Differing Doctor / Patient Relationship ? Differences in understanding of study- related factors by subjects ? Procedure meaningful or routine ? Consent after discussions with family / others

21. Q UINTILES INDIA 21 Managing Relationships - 1 Differing scientific and societal compulsions Role of Monitor - very important Cooperation / Coordination / Cross-cultural Communication Researchers - culturally knowledgeable - culturally sensitive Investigator Clinical Trial SponsorRegulatory

22. Q UINTILES INDIA 22 Managing Relationships - 2 Use of IT IT Strategy for Investigator-facing activities e.g. databases integrated tools IT - great equaliser records and processes information as programmed “Innovation opportunities occur when new technologies and a fresh perspective converge”

23. Q UINTILES INDIA 23 Conclusions India is well placed to provide solutions for contemporary and future clinical research  Can facilitate affordable drug research  Has required patient populations and quality scientists and clinicians  Has the information technology competitive advantage  Has a regulatory framework which is moving towards regulatory harmonization  The socio-economic transformation in urban India understands contemporary GCP requirements  Rapid urbanisation and exposure to developed world facilitates cross-cultural understanding

24. Q UINTILES INDIA 24