Original data on some of the clinical studies conducted

1. Manipal Acunnova/Bioridge/20090402V1.0
EMERGING MARKETS: CLINICAL
TRIALS, INDIA
Krathish Bopanna PhD, DSc
Senior Vice President
Manipal Acunova Limited
Bangalore
krathish.bopanna@ecronacunova.com
2nd April, 2009
Bangalore, India

2. India: A Snap Shot
India constitutes about 17% of the world’s By 2015, the number of ailments is expected to
population increase by 30%
Manipal Acunnova/Bioridge/20090402V1.0
Pharma Market Clinical Trial Market
•Second only to China in real GDP growth •In 2002, clinical trials in India generated $70 million*
•Crowded pharma market with 20,000 firms, 60,000 •It is predicted to grow by $200 million by 2007 and
distributors, 70,000 retailers* between $500 million to $1 billion by 2010*
•Top 10 companies control 30% of market
•Expected to grow at 10-12% annually to reach $20
billion by 2015**
•Generics will continue to dominate
Source: * Confederation of Indian Industry (CII)
Source: * Deloitte
** McKinsey & Co
India is tipped to be a hot destination for clinical trials!

3. Estimated Ailments & Hospitalizations
Every Year, an estimated 115 Crore ailments are reported
Manipal Acunnova/Bioridge/20090402V1.0
Every Year, an estimated 3 Crore cases of hospitalization are reported
Fourteen diseases contribute to 76% of approximately 3 Crore hospitalized
cases

4. Estimated NCD Projections
By 2015, the share of non-communicable diseases (NCD) such as mental health, COPD, diabetes, CVD,
blindness and cancers is expected to rise
Manipal Acunnova/Bioridge/20090402V1.0
Increase in NCD’s may be due to rising population, increasing
urbanization and better access to health care

5. Prevalence: Diabetes & Asthma
5 states have one-third of population but 55% of diabetes cases
Manipal Acunnova/Bioridge/20090402V1.0
6 states have almost half the population but 62% of asthma cases
Most of these diseases have a skewed regional/state distribution

6. Prevalence: Diarrheal Diseases & Mental Diseases
5 states have one-third of population but 55% of diabetes cases
Manipal Acunnova/Bioridge/20090402V1.0
More than 70% of prevalence is accounted for by 2 zones alone
Data sometimes gives a picture of a country in the continent!

7. Manipal Acunnova/Bioridge/20090402V1.0
Unlocking India's Potential in Clinical
Research
- A Comparison

8. Comparison : Feasibility Versus Actual
Recruitment in Experienced Site (Endocrinology)
Case Study: 3 competitive well established sites, having experience of conducting trials for more
than 6 years
Manipal Acunnova/Bioridge/20090402V1.0
# of Subjects
Deviation is minimal across different sites

9. Comparison : Feasibility Versus Actual
Recruitment in Experienced Site (Neurology)
Case Study: 3 competitive well established sites, having experience of conducting trials for more
than 6 years
Manipal Acunnova/Bioridge/20090402V1.0
# of Subjects
Deviation was varied across three different settings!

10. Comparison : Feasibility Versus Actual Recruitment in
Little Experienced Site or No Experience (Diabetes)
Case Study: By taking 3 sites in tier 2 cities , having experience of 2 to 3 trials
Manipal Acunnova/Bioridge/20090402V1.0
# of Subjects
Classical example of variability across different sites

11. Regulatory Approval Times
• Competitive regulatory approval timelines & faster recruitment
• Lac of knowledge among the clients about timelines for category A
US
Singapore
Hong Kong
Korea
Manipal Acunnova/Bioridge/20090402V1.0
Taiwan
Russia
South Africa
Australia / NZ
Poland
Czech Republic
India
Brazil
China
0 30 90 270 Days
Source: FastTrack Systems Global Cost Databases, 2006
Indian is in timelines with the rest of the World!

12. Speed of Enrolment
# of Patients Enrolled Per Month Per Site
Manipal Acunnova/Bioridge/20090402V1.0
Case Study of a Major Multinational Phase III Respiratory

13. Total Patient Enrolment Per Country
US had fixed plan percentage of patients.
Manipal Acunnova/Bioridge/20090402V1.0
Case Study of a Major Multinational Phase III Respiratory

14. Quality: Planning Accuracy
% of Planned Recruitment (Enrollment)
N. America W. EU5 CEE
Manipal Acunnova/Bioridge/20090402V1.0
Case Study of a Major Multinational Phase III Respiratory

15. Quality of Clinical Trials in India
Case Study: Considering 3 well developed sites with more than 6 years of experience in conducting
trials
Manipal Acunnova/Bioridge/20090402V1.0
No major finding in all the audits performed

16. Site Quality And Efficiency
Site Randomization Loss
Manipal Acunnova/Bioridge/20090402V1.0
Case Study of a Major Multinational Phase III Respiratory

17. Ethics Committee Approval Timelines
Case Study: 6 sites where chosen
Manipal Acunnova/Bioridge/20090402V1.0
# of Days Required
For Approval
Majority of the centers are in the range of 15-30 days

18. Clinical Study Cost Comparisons by Country
Clinical trials in cost ~44% lower than in the US
Manipal Acunnova/Bioridge/20090402V1.0
Source: FastTrack Systems Global Cost Databases, 2006
Clinical trial cost drives study in developing countries!

19. Manipal Acunnova/Bioridge/20090402V1.0
Efficiency: % Active/Total Sites
Case Study of a Major Multinational Phase III Respiratory

20. Cost Advantage: Relative Investigator Fees
CEE
Manipal Acunnova/Bioridge/20090402V1.0
W. EU5
N. America
Case Study of a Major Multinational Phase III - Respiratory

21. Efficiencies, Speed and Costs
Patients/Month/Site Estimated Monitoring Cost/100 Patients (in USD)
Manipal Acunnova/Bioridge/20090402V1.0
Case Study of a Major Multinational Phase III Respiratory

22. Ethics Committees Working Dilemmas Are Being
Addressed
• Local Ethics Committee exist in > 200 clinical centers
• ICMR (Indian Council for Medical Research) to review & audit the
functioning of ECs
Manipal Acunnova/Bioridge/20090402V1.0
• Introduce a national accreditation system for ECs
• Develop the ‘Independent Forum’ for ‘Ethics Review Committees’, a
training body
• Revised Schedule Y of ‘Drugs and Cosmetics Act’ governing clinical trial
conduct has prescribed roles and responsibilities of ECs
• Composition as per ICH GCP guidelines formats for the EC approval
letter
• Provisions for inspection

23. India- Hot spot for Data Management
• Large and growing resource pool
Highly developed process innovation skills
Credible data quality
Manipal Acunnova/Bioridge/20090402V1.0
Operational flexibility to manage “crunch” periods
Cost-effectiveness
• Software options
Established data management software e.g. Oracle Clinical, Clintrial, PRA Flex DMS™
• Range of services available
Data entry & verification
Statistical analysis, medical writing, software programming

24. Clinical trials in India: Summary
Advantages Challenges
• Faster Recruitment • Set up procedure for central lab and
• Treatment naïve subjects logistic services takes time
• Good Regulatory environment • Perception by foreign clients India
Manipal Acunnova/Bioridge/20090402V1.0
being non GCP compliant
• Category A Trials are approved faster
• Perception of falsification of data or
• High quality of education amongst corruptions
Investigators
• Awareness of the subjects about
• High Standard of care comparable to clinical trials and consenting
UK in all the developed cities like:
Mumbai, Delhi, Bangalore, Calcutta, • Many no of languages and translation
Hyderabad, Chennai, Trivandrum of ICFs
• Cost of Investigators Grant is 70% to
50% lower to US and UK
• ICHGCP trained sites