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Drug Discovery, Development & Clinical trials: Current status and the way forward


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Why India is growing up in \'Clinical Research\'.

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Drug Discovery, Development & Clinical trials: Current status and the way forward

  1. 1. Drug Discovery, Development & Clinical trials: Current status and the way forward Presented By Mr Jeetu Gangil M. Pharm (Pharmacy Practice) Manipal College of Pharmaceutical Sciences Manipal University , Karnataka 26-27 June 2010, Solan (Himachal Pradesh)
  2. 2. Introduction <ul><li>Clinical trials are studies performed with human subjects to test new drugs or combinations of drugs, new approaches to surgery or radiotherapy or procedures to improve the diagnosis of disease and the quality of life of the patient. </li></ul><ul><li>In this presentation, we analyses the career prospects for the professionals in the clinical research industry and discusses how India would meet the growing demand for quality and trained professionals to support local and global pharmaceutical companies for the conduct of international standard clinical research. </li></ul>
  3. 3. Indian Scenario <ul><li>The Indian market is expected to double to nearly $10 billion by 2010 from the existing $5 billion. According to McKinsey & Company's latest report &quot;India Pharma 2015: Unlocking the Potential of the Indian Pharmaceuticals Market&quot; the country's pharma market is all set to provide the third leading growth opportunity globally. It is expected to triple in size and touch $20 billion by 2015 , becoming one of the world's top 10 markets and the global pharmaceutical markets will more than double to $1.3 trillion by 2020. India is likely to be in the league of top 10 pharma markets by 2020. </li></ul>Source; The Times of India,
  4. 4. Drug Discovery & Development
  5. 5. Percentage of Different Models Emerged in Clinical Research A Evolution in India Source; Chiltern International Private Limited, India
  6. 6. Recruitment in Clinical Research: Indian Perspective Demand-Supply Gap 2010 in India Source: Chiltern International Estimates
  7. 7. Evolution Clinical Trials Source: Clinical Trial Registry, January 2007
  8. 8. Is Clinical Research an attractive Pitch? <ul><li>Today India has produced 300 GCP trained investigators and approximately 600 trained CR professionals . </li></ul><ul><li>McKinsey estimated that the Indian CR market will grow to US$ 1.5 billion in value by 2010. </li></ul><ul><li>The market will triple to $20 billion by 2015 and move into the world’s top 10 pharmaceutical markets. </li></ul>Source: McKinsey’s Report
  9. 9. Clinical Research; India Vs World <ul><li>India Vs Western Countries </li></ul><ul><li>Cost Competitiveness of Indian R&D </li></ul>Source: Business Week, Pharmabiz, Cygnus Research Positive Factor <ul><li>Patient enrollment </li></ul><ul><li>Diversity </li></ul><ul><li>Costs </li></ul>Equality • English competency • Medical infrastructure • Western medicine familiarity • Companies with international standards Has to be Improved • IPR reputation • Industry standards • Less established infrastructure Clinical Phase US Costs Indian Costs I US$ 20 million <50% of US cost II US$ 50 million <60% of US cost III US$ 100 million <60% of US cost
  10. 10. India overtakes China as No.1 destination for clinical trials <ul><li>India has piped China to become Asia's most popular destination for conducting clinical trials. According to the Planning Commission, around 139 new trials were out sourced to India recently compared to 98 in China. </li></ul>Source; The Times of India
  11. 11. Is Recession Can Hit Indian Clinical Trials: CROs ? <ul><li>Indian clinical research organizations (CROs) do not see any near-term impact of recession as large pharma customers where these trials could be conducted at one-fifth of the US cost. </li></ul><ul><li>The cost of clinical trials vary on the basis of complexity and disease segment, a simple trial in India can cost 15-20% of the US price, while a more sophisticated trial involving imaging systems may be 50-60% of the US price. Studies suggest that R&D expenditure is increasing by 15% per year, making global biopharmaceutical companies look for cheaper options. </li></ul>Source; The Economic Times
  12. 12. Conclusion ‘ India is the Best’ for clinical Trials’ <ul><li>India has availability of a large population of treatment-naive patients with multiethnic and multiracial backgrounds. India has Wide spectrum of diseases in India. In India the cost of conducting trials can be reduced up to 30-50% in India. </li></ul><ul><li>India is identified as a major resource center for conducting clinical trials and data management services. With its large patient populations, well-trained and enthusiastic investigators, and per-subject trial costs considerably lower than those in developed nations, it is widely recognized as a major center for conducting clinical trials. Its increased regulatory control and its acceptance of the ICH guideline for GCP further enhance India's reputation as a place to conduct clinical trials. </li></ul>