Opportunities in Clinical Research

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Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development

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Opportunities in Clinical Research

  1. 1. Clinical Research Industry & Opportunities in CR
  2. 2. Clinical Research- An Overview What is Clinical Research? • Is an organized research conducted on human beings • Intended to provide adequate information on the use of drugs as a therapeutic agent, with regard to –Usefulness –Safety –Adverse effects
  3. 3. Clinical Research RESEARCH DRUGS BIOLOGICS MED. DEVICES – To test its – Efficiency – Efficacy – Toxicity BEFORE MANUFACTURING AND MARKETING
  4. 4. The Pharmaceutical Enterprise Discovery Pre-clinical Clinical CMC Labeling (Chemistry, Mfg, & Regulatory Control) Manufacturing Sales & Marketing Safety & Surveillance
  5. 5. New Drug Development is... 500 Million US $(235) Expensive Time consuming 12 years Cumbersome 1 out of 10,000 NCE becomes a marketable drug … and what will the Marketing outcome be?
  6. 6. Compound Success Rates by Stage Years 0 5,000–10,000 Discovery Screened (2-10 Years) 2 Preclinical Testing 250 Laboratory and Enter Preclinical Testing 4 Animal Testing 6 Phase I 5 20-80 Healthy Volunteers Enter Used to Determine Safety 8 Phase II 100-300 Patient Volunteers Clinical And Dosage Used to Look for Efficacy Testing 10 and Side Effects Phase III 1,000-5,000 Patient Volunteers Used to 12 Monitor Adverse Reactions 1 to Long-term Use Approved 14 FDA Review/Approval by the FDA Additional Post-marketing 16 Testing Source: Tufts Center for the Study of Drug Development
  7. 7. PHARMA- THE R&D PIPELINE • IND - Investigational New Drug Application Production • NDA - New Drug Application & Marketing
  8. 8. Stake Holders in Clinical Research – Pharmaceutical companies – R&D department – Contract/ Clinical Research Organizations – Clinical research managers – Research coordinators – Regulatory affairs managers – Data managers – Medical writers – DCGI – Ethics committee – Hospitals – Accredited laboratories – Doctors ( Clinicians)
  9. 9. Job positions in Clinical Research – Entry level • Clinical Research Coordinator • Business Development Executive(BDE) • Regulatory Affairs Executive(RAE) • Co- Investigator • Drug Safety Associate – Middle level • Clinical Research Associate (CRA) • Study Coordinator • Investigator – Senior level • Director Projects • Director Clinical Research • Data Manager • Director Regulatory Affairs
  10. 10. Who are involved in the process of Clinical research? • Pharmaceutical Companies - Sponsors of the trial • CRO - Implementers of trial • Drugs - Objects of the trial • Patients/ Volunteers - Subjects of the trial • Doctors - Investigators in the trial • Clinical Research Managers - Manage the trial • DCGI - Regulatory Authority of the trial • IEC - Monitors compliance of ethics • Hospital - Site of the trial • Accredited Laboratories - Lab Investigation of the trial • Regulatory Affairs Managers - Ensures compliance of regulatory Guidelines • Data Managers - Develops Statistical Models & Methodology for Clinical Studies • Medical Writers - Develops the Study Documents, Reports & Publications
  11. 11. Mc Kinsey Reports on Clinical Research • “India will need over 50,000 Clinical Research Professionals & Globally 250,000 Clinical Research Professionals by 2012” • “The global clinical trial outsourcing opportunity to India is expected to grow to Rs.5,000 crores by 2010”
  12. 12. Exponential Growth of CR industry GROWTH OF THE CLINICAL 2003: Rs. 100 Cr RESEARCH 2004: Rs. 250 Cr INDUSTRY 2010: Rs. 5000 Cr McKinsey Report (50 times)
  13. 13. Opportunities for CR professionals • Starting salaries are expected to range from Rs.15,000 - Rs.20,000/ month onwards depending on the basic qualification & experience • At 30 years one could be a Director – Operations / Regulatory Affairs, earning a salary of Rs.1 Lakh per month
  14. 14. Average Salaries for CR professionals Country Average Salary for 1 to 2 year experienced CR professionals USA USD 5000 / month Canada CDN 3500/ month UK GBP 1500 – 1800/month India INR 15,000 - 20,000/month
  15. 15. Market Scenario-Worldwide Internationally, the demand for clinical research specialists is even stronger than in India. The shortage globally traverses all continents including most notably North America, Europe, as well as Asia. Most EU, Canadian, and US employers are outsourcing the majority of the clinical research work to India. These employers from the US, EU and Canada, though, have thousands of jobs available across India, which has become one of the world's leading centers for clinical research. World wide vacant positions estimated to be 250,000 by year 2010
  16. 16. Advantage - India • India signatory to TRIPS • New Patent Law since April 2005 • Clinical trials - mandatory for new drugs • Clinical trials - to be based on ICH-GCP norms • Patient enrollment – the key advantage • Tax concession for R&D expenditure by Govt. of India consistent with WTO guidelines • Clinical research spending in India to increase by 30% (5000 Crores) annually through 2010
  17. 17. Advantage - India • Large and diverse patient pool • Availability of Medical, Pharmacy/ Science graduates • Highly developed IT Industry • English speaking Medical/ Research professionals • Higher prevalence of diseases • Comparative cost advantages • Changes in Patent law w.e.f April 2005 (Product based patency V/S procedures based patency)
  18. 18. Pharmaceutical companies & CROs in India
  19. 19. Your Pathway to Clinical Research Industry
  20. 20. CR Industry is looking for • Qualified, Competent & Committed people • Professionals with relevant education & experience • Hands on experience • Good Communication Skills • ATTITUDE
  21. 21. Industry is in search of…………….. Relevant Education Relevant Experience Professional
  22. 22. Clinical Research Administration/Management VIII. ENGLISH I. LITERATURE PHARMACOLOGY II. MEDICINE VII. BIOSTATISTICS CRM VI. III. NURSING INFORMATION TECHNOLOGY V. MANAGEMENT IV. LAW
  23. 23. Head Medical Quality Other CR Project Biometry Regulatory Services Mgmt Medical Auditor Data Mgt Finance Project advisor manager Quality Study Statistics Human Medical control Mgr Res monitor Clinical Medial Training Team writing Trial Leader Pharmaco- supplies vigilance Sr CRAs CRAs CRCs
  24. 24. Basic Qualification required to enter the CR Industry Career Fields Qualification MSc Biochemistry, Clinical Research Btech Biotechnology, MSc Microbiology Management MSc Zoology BSc Nursing, MSc Nursing Pharmacovigilance Doctors (MBBS, BDS, BAMS, BVMS) B Pharm, M Pharm MCA, B Tech Computer Science Clinical Data Management/ MSc Computer Science, MSc Bioinformatics Biostatistics MSc Mathematics, MSc Statistics MSc Biostatistics
  25. 25. Way Forward • Research Aptitude Test (Aptitude/ Interest) • Academic/ Industry Evaluation (Employability) • Internships with Stipends • Training with scholarships
  26. 26. Research Aptitude Test Evaluation
  27. 27. Reference Books & Internet 1. All that you wanted to know about Clinical Research By Samir Malhotra MD, DM/ Nusrat Shafiq MD, DM/ Promila Pandhi MD/DM- PGIMER, Chandigarh, India) 2. Death By Prescription , Magna Books By Dr Ray D Strand, MD www.wikipedia.org/wiki/Clinical_research http://www.accenture.com/careers http://www.novartis.com/careers/index.shtml http://www.ppdi.com/careers
  28. 28. There is a no punishment for asking Questions!!!
  29. 29. Q&A Thank you

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