INDIA AS AN EMERGING DESTINATION FOR CLINICAL TRIALS

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INDIA AS AN EMERGING DESTINATION FOR CLINICAL TRIALS

  1. 1. INDIA AS AN EMERGING DESTINATION FOR CLINICAL TRIALS Dr. S K GuptaDr. S K Gupta Dean & Director General Institute Of Clinical Research, India New Delhi-110037
  2. 2. REQUIREMENTS FOR GLOBAL RESEARCH  Infrastructure  Regulatory Environment  Patient Pool-Genetic Diversity  I.P Protection  Investigator Availability  Bioethics Regulation  Cost Advantage
  3. 3. CDSCO INFRASTRUCTURE AVAILABLE • Over 200 Medical Colleges • Over 22,000 graduates per year • 15,622 hosp., 903,952 hosp.beds >75% in urban area • 14000 diagnostic labs • 700,000 scientists and engineering graduates / year • World class medical / lab facilities at secondary / tertiary care centers • Skilled computer savvy biomedical work force • Highly developed IT / ITES • Motivated & committed personnel Clin. Res. Infrastructure IT Support Connectivity • High quality digital connectivity • Excellent air/surface transport facilities across country
  4. 4. CDSCO • Large No. of specialists in different therapy segments • Medical Training In English • 600,000 Eng. Speaking physicians • PG training from Europe/US • Treatment Protocols in line with West • Large no. of ICH/GCP compliant Investigators / sites • Large, Diverse, therapy-naïve • Advantage of having 6 out of 7 genetic varieties • Large pt. pool in acute/chronic disease segment • Increasing no. of pts in life style disorders segment, HIV, Oncology INDIA : ADVANTAGES Patient population Investigators
  5. 5. 200 1000 300 400 1000 6000 2000 4000 0 1000 2000 3000 4000 5000 6000 7000 Sponsor Staff CRO Staff Invigilator Other Site Staff Demand Supply Demand-Supply Gap of CR Professionals, 2010 in IndiaDemand-Supply Gap of CR Professionals, 2010 in India
  6. 6. HUMAN RESOURCE DEVELOPMENT Established in 2004Established in 2004 To meet the challenges 50,000 ProfessionalsTo meet the challenges 50,000 Professionals DELHI, MUMBAI, BANGALORE AHEMEDABAD AND HYDERABAD
  7. 7. DRUG DISCOVERY & DEVELOPMENTDRUG DISCOVERY & DEVELOPMENT R&D investment by Indian Pharma Companies Before patent protection implementation Process researchProcess research NDDSNDDS NCENCE After patent protection implementation -Expected ProcessProcess researchresearch NDDSNDDS NCENCE Process Research NDDS NCE
  8. 8. Amended Schedule Y Phase I clinical trial NCE from abroad in Pipeline Phase I trial for NCE developed in India: Yes Pharmacovigilanc e launch ICMR/ Bioethics Product patent regime Clinical Trial Registry launched ICH-GCP LANDMARK YEAR: 2005LANDMARK YEAR: 2005 CLINICAL RESEARCHCLINICAL RESEARCH
  9. 9. WHY INDIA IS BECOMING A HOT DESTINATION FOR CLINICAL RESEARCH? Clinical trials in India is growing at a 60% AAGRClinical trials in India is growing at a 60% AAGR •• Crossed USD 100 million in 2004.Crossed USD 100 million in 2004. •• By 2010, the industry will spend USD 300M+ on clinical trials inBy 2010, the industry will spend USD 300M+ on clinical trials in India.India. More than 150 CRO’s are conducting clinical trials complying Estimated market size of clinical trials in India (USD in mn)
  10. 10. TREATMENT NAIVE PATIENTS (DISEASE WISE)TREATMENT NAIVE PATIENTS (DISEASE WISE)  45 million asthmatics45 million asthmatics  30 million diabetics30 million diabetics  18 million hypertensive18 million hypertensive  13 million hepatitis C13 million hepatitis C  10 million or more HIV10 million or more HIV patientspatients  8 million epileptics  3 million cancer  1.5 million Alzheimer's  one million schizophrenics
  11. 11. CLINICAL DATA MANAGEMENTCLINICAL DATA MANAGEMENT ADVANTAGE INDIAADVANTAGE INDIA Capabilities of Vendors  HR capabilities to support large work force  well capitalized & willing to invest  committed to innovation  long term high level relationship Opportunity From Deals  Strategic outsourcing of a global function  Seek more than cost saving  Long term contracts  Board level oversight  Scale & Scope to effect a “Tipping Point”
  12. 12. Study Average US cost (in millions) Indian cost Phase I 20 50% less than the average cost in US Phase II 50 60%less than the average cost in US Phase III 100 60%less than the average cost in US Cost of Clinical trials in USA vis-à-vis in IndiaCost of Clinical trials in USA vis-à-vis in India CLINICAL TRIALS
  13. 13. CROS CONTRIBUTING FOR OUTSOURCINGCROS CONTRIBUTING FOR OUTSOURCING CLINICAL RESEARCHCLINICAL RESEARCH CROs Can Deliver Quicker and More Efficient Trials CROs Can Deliver Quicker and More Efficient Trials • Specialized in clinical research and can generate economies of scale • Utilize latest data management tools & technologies as well as other technologies (e.g., patient recruitment) • Can conduct trials in lower cost regions • Reduce time to complete trials* – CROs complete trials 30% faster than pharma companies* – CROs complete trials in less time across phases • Specialized in clinical research and can generate economies of scale • Utilize latest data management tools & technologies as well as other technologies (e.g., patient recruitment) • Can conduct trials in lower cost regions • Reduce time to complete trials* – CROs complete trials 30% faster than pharma companies* – CROs complete trials in less time across phases 140139 89 978166 Phase I Phase II Phase III Sponsor CRO
  14. 14. ADVANTAGE INDIA OVER OTHER COUNTRIES
  15. 15. DISEASE WISE CLINICAL TRIALS DONE IN INDIA
  16. 16. THE PERCENTAGE OF CRO REVENUES FROM BIOTECHTHE PERCENTAGE OF CRO REVENUES FROM BIOTECH FIRMS IS RAPIDLY INCREASINGFIRMS IS RAPIDLY INCREASING 70% 68% 66% 64% 62% 60% 30% 32% 34% 36% 38% 77% 73% 40% 23% 26% 0% 25% 50% 75% 100% 2000 2001 2002 2003 2004 2005 2006 2007 Biotech Pharma % of Expenditure CRO R&D Expenditure Forecast (2000–2007) Source: Frost & Sullivan, 2003.
  17. 17. PHASE IV TRIAL MARKET INCREASING DUE TOPHASE IV TRIAL MARKET INCREASING DUE TO SAFETY CONCERNSSAFETY CONCERNS 20.2% 20.6% 23.4% 22.2% 39.3% 37.2% 34.2% 31.1% 15.5% 18.8% 22.2% 26.1% 19.7%19.0% 24.3%26.2% 0% 25% 50% 75% 100% 2001 2003 2005 2007 Phase IV Phase III Phase II Phase I % of Revenue CRO Revenues by Clinical Phase (2001–07) Source: Frost & Sullivan, 2003.
  18. 18. INDIA BUILDING A TRACK RECORDINDIA BUILDING A TRACK RECORD Clinical Trial Data From India to Achieve an FDA NDA Drug Company Compound Researched Indication US Launch Canagene Hepagam Hepatitis B Jan 06 Eli Lilly Alimta Cancer Feb-04 Eli Lilly Cialis Erectile dysfunction Nov-3 Jannsen Risperidal Psychosis Oct-03 Wyeth Flumist Influenza May-03 Alcon Vigamox Ophthalmic Infections Jan-03 Glaxo Lamictal Epilepsy Jan-03 Novrtis Zelcorm Irritable Bowel Syndrome Jul-02 Pfizer Vfend Fungal Infection May-02 Eli Lilly Xigris Septicemia Nov-01 Santen Quixin Ophthalmic Infections Oct-00
  19. 19. Sr. No. Company Clinical Trial in India CLINICAL Trial in China 1 Astra Zeneca 10 10 2 BMS 17 6 3 Eli Lilly 17 12 4 GSK 22 14 5 J&J 20 13 6 Merck 8 5 7 Novartis 9 6 8 Pfizer 16 5 9 Roche 5 14 10 Sanofi Aventis 15 13 Total 139 98 GLOBAL CLINICAL TRIALSGLOBAL CLINICAL TRIALS COMPARISON INDIA : CHINACOMPARISON INDIA : CHINA
  20. 20. 1 10 100 1000 10000 100000 Phase of trial No.Trials(Logtransformed) India 32 165 394 63 USA 6324 11305 5683 2474 All 8540 16878 11662 6142 Phase-1 Phase-2 Phase-3 Phase-4 Clinical Trials from IndiaClinical Trials from India ((www.clinicaltrials.govwww.clinicaltrials.gov.: 15Apr08).: 15Apr08)
  21. 21. CLINICAL TRIAL ACTIVITIES IN ASIACLINICAL TRIAL ACTIVITIES IN ASIA ALL STUDIESALL STUDIES Country All Studies % Industry Sponosred Australia 1572 62.72 Chinese Taipei 903 45.29 Japan 732 67.76 Korea 674 72.26 China 643 53.50 India 582 72.16 Singapore 335 68.36 Thailand 327 69.42 Chinese Hong Kong 250 82.00 Philippines 206 93.20 Malaysia 180 93.33 www.clinicaltrials.gov-snapshot: 7 Feb 2008 Countries with more than 100 studies listed
  22. 22. YEAR No. of Trials 2003 30 2004 50 2005 100 2006 143 2007 264 2008( upto August) 115 Total 702 CDSCO Global Clinical Trials Permitted
  23. 23.  No import duty on clinical trial supplies (2003)  Exemption from registration requirements for clinical trial supplies (2003)  Export of clinical trial related biological specimens allowed, based on protocol approval (2005)  Exemption from Service Tax on new Drug testing (2007) GOVERNMENT’S INITIATIVES INCENTIVES
  24. 24. RECENT INITIATIVES BY CDSCO FOR PROMOTING ETHICAL CLINICAL RESEARCH Review of proposal- Time lines Phase O, Phase-1 and Micro dosing trial- initiatives Registration CRO’s Registration of Clinical Trials
  25. 25.  Establish Single Window clearance for approvals  Fix timelines for each application (2-6 Weeks)  New Drug application status on the web – Update fortnightly  Subject Experts-reviewers – Internal / External  Staff & Infrastructure at one site  Training PRIORITIES SET BY CDSCOPRIORITIES SET BY CDSCO
  26. 26. Short Term Goals Year – 2008 Guidelines for Registration of CROs Meeting timelines Registration of CROs Mandatory registration of clinical trials in centralized clinical trial registry Allow Phase 0 (micro dosing) studies and phase 1 studies in the country in controlled manner CDSCO CDSCO GOALS FOR CLINICAL TRIALS REGULATION
  27. 27. CDSCO ** LAN / WAN connectivity of CDSCOLAN / WAN connectivity of CDSCO campuscampus ** Online submission of all the formsOnline submission of all the forms ** Digitalized interactive portalDigitalized interactive portal ** Digitalization of recordsDigitalization of records ** Online approvals with Digital signatureOnline approvals with Digital signature ** Inbuilt feature would administerInbuilt feature would administer spontaneous and randomspontaneous and random ** Checks to ensure quality ethical standards.Checks to ensure quality ethical standards. Vision : Paperless CDSCO officeVision : Paperless CDSCO office CDSCO INITIATIVES E-GOVERNANCE- DRUG REGULATORY SYSTEM
  28. 28. “India’s business and regulatory climates have undergone dramatic change in the past 18 months through passage of a patent bill, regulations updated to harmonize with TRIPs and international standards, and plans for a more US FDA-like regulatory body.” CenterWatch (July 2007) CLINICAL TRIALS IN INDIACLINICAL TRIALS IN INDIA
  29. 29. CHALLENGES AHEAD Improvement in Regulatory Framework Expanding Investigators Pool Moving from Metro to Mini Cities Scale up Competence Building Making India a Vibrant Destination
  30. 30. THANK YOUTHANK YOU www.icriindia.comwww.icriindia.com

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