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Emerging Markets India V1 0

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Original data on some of the clinical studies conducted

Original data on some of the clinical studies conducted

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    Emerging Markets India V1 0 Emerging Markets India V1 0 Presentation Transcript

    • 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
    • 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!
    • 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
    • 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
    • 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
    • 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!
    • Manipal Acunnova/Bioridge/20090402V1.0 Unlocking India's Potential in Clinical Research - A Comparison
    • 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
    • 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!
    • 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
    • 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!
    • Speed of Enrolment # of Patients Enrolled Per Month Per Site Manipal Acunnova/Bioridge/20090402V1.0 Case Study of a Major Multinational Phase III Respiratory
    • 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
    • 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
    • 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
    • Site Quality And Efficiency Site Randomization Loss Manipal Acunnova/Bioridge/20090402V1.0 Case Study of a Major Multinational Phase III Respiratory
    • 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
    • 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!
    • Manipal Acunnova/Bioridge/20090402V1.0 Efficiency: % Active/Total Sites Case Study of a Major Multinational Phase III Respiratory
    • Cost Advantage: Relative Investigator Fees CEE Manipal Acunnova/Bioridge/20090402V1.0 W. EU5 N. America Case Study of a Major Multinational Phase III - Respiratory
    • 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
    • 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
    • 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
    • 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