Clinical Trials in India

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    Clinical Trials in India - Presentation Transcript

    1. Introduction to clinical research
    2. India has become an attractive destination for outsourced pharmaceutical services.
      • Drive for increased productivity & efficiency in the pharmaceutical industry
      • Growth of the biotech sector and the virtual pharma model
      • Proven success of other outsourcing plays
      • Established track record in Business Process & IT outsourcing
      • World leader in the generic and API sectors
      • Intellectual Property protection enforcement has evolved
      • Well trained, English speaking and computer savvy biomedical workforce
      • Cost effective workforce willing and able to adhere meticulously to protocols and processes
      • Large heterogeneous “urban centric” patient populations
      Global Trends Indian Industry Core Competencies
    3. The clinical development sector in India is enjoying rapid growth.
      • Revenues from contract R&D for international sponsors was USD 100 M in 2005
      • Sector enjoying a 40% annual growth rate
      • Nascent but dynamic CRO sector
        • Quintiles India has been in operation for the past 5 years, with multiplication of resources
        • Most global CROs have a presence in or alliance to access India
        • Local CROs are gaining momentum but consolidation is inevitable
      • Pharmaceutical sponsors are ramping up their clinical operations in India
        • Pfizer, Aventis and Eli Lilly are ahead of the rest
        • Altana, Merck & Co and GSK are catching up
      - India’s Clinical Development Sector -
    4. What is clinical research?
      • Organized research on human beings
      • intended to provide adequate information on the drug use as a therapeutic agent on its safety and efficacy.
      • Also referred to as Clinical trial management
    5. Clinical research - position in drug development
      • Drug development
      • Discovery research
      • Formulation and development
      • Clinical development(trials)
      • Commercialization
    6. India offers pharmaceutical services at various stages of the value chain. Target Identification & Validation Lead Generation & Optimisation Pre-Clinical Development Ph I Ph II & III Contract Manufacturing
      • Less developed academic expertise
      • Investment incongruity
      Pharmaceutical Value Chain with Offshoring Opportunities
      • Medicinal Chemistry
      • Custom chemical synthesis
      • Molecular Modelling
      • Virtual Screening
      • Pharmaco-kinetics
      • Animal Testing
      • Toxicology
      • Bioequival-ence
      • Limited first in man studies
      • Clinical Trials
      • Data Management
      • Central Lab
      • Biostats
      • APIs
      • Formulations
      • Finished product
      • Clinical trial supplies
    7. Why do we need clinical trials?
      • new drugs
      • for new uses of existing drugs,
      • medical devices,
      • new drug delivery systems etc.
    8. Why do we need clinical trials?
      • Evidence to prove the efficacy and safety in human beings.
      • Only a well designed clinical study on a defined population can give meaningful results- (positive or negative) about any therapeutic intervention
    9. Scope of clinical research?
      • Total cost of the drug development
      • 750-900 million US $
      • Total time taken for the drug development
      • 9-10 years
      • 2/3rds of the drug development cost and time is spent on clinical trials development
    10. Regulatory guidelines today
      • Drugs and cosmetics act 1947
      • SCHEDULE-Y
      • Indian GCP GUIDELINES
      • ICMR Guidelines
      • WHO Guidelines
      • ICH-GCP Guidelines
    11. Clinical research -a multi-disciplinary approach
      • Sponsor
      • Investigators
      • Monitors
      • Auditors and the quality control personnel.
      • Biostatisticians.
      • Data management group.
      • Regulatory Affairs.
      • Reporting and Documentation medical writing.
      • Business development group
    12. Players in Clinical Research Industry
      • Pharma companies
      • Clinical/contract research organisations(CROs)
      • Biotech companies
      • Central diagnostic laboratories
      • Clinical research training institutes
    13. NEW DRUG DEVELOPMENT PROCESS
      • Drug discovery
      • Synthesis
      • Drug designing
      • Target validation(Preliminary in-vitro screening)
      • Pharmacological assays
    14. PRECLINICAL STUDIES
      • Include studies conducted on Experimental animals for safety and efficacy
      • .
    15. Toxicity studies
      • Acute toxicity studies LD50
      • Sub- acute toxicity studies
      • Chronic toxicity studies
      • Special toxicity studies-carcinogenecity,teratogenecity
      • genotoxicity,
      • effects on fertility and reproduction
    16. PRECLINICAL STUDIES
      • Efficacy studies
      • In- vitro assays
      • Studies conducted using only animal tissues or cells or enzyme systems
      • In- vivo assays
      • Experiments using whole animals
    17. CLINICAL TRIAL PHASES
      • Phase-I- Clinical pharmacology,safety of new drugs
      • Phase-II -safety and efficacy of new drug in patients,exploratory trial.
      • Phase-III -multicentric confirmatory trial.
      • Phase-IV -post- marketing surveillance
    18. Who conducts the clinical trial?
      • Investigators
      • Principal investigator
      • Co-investigator
    19. Who participates in the trial?
      • Subjects
      • Patients
      • Healthy human volunteer
    20. Regulatory requirements
      • Drugs and cosmetics act
      • Schedule-Y
      • DCGI Drug controller General of India
      • US-FDA United states-Food and drug administration act.
      • MHRA Medicinal and health care products regulatory agency
    21. MONITORING
      • Overseeing the progress of a clinical trial
      • Ensuring that it is conducted according to the protocol,GCP,SOPs and the regulatory requirements.
      • Usually conducted by Clinical research associates.
    22. SUMMARY
      • Clinical research is an integral part of drug development
      • Unlike the past, today the process has gained a unique position due to the regulatory requirements and ethical guidelines available globally.
      • Designing, conducting,monitoring, appropriate quality assurance and data management determine the success of the clinical research.
    23. Major Players
    24. Career Path
    25. Career Pipeline

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