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Careers In Clinical Research Industry Gp 06 Nov11
 

Careers In Clinical Research Industry Gp 06 Nov11

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  • 16 We take pride in our integrity as a company that improves people’s lives. We are devoted to maintaining top performance through teamwork . We value innovation in our products and leadershi p in our groups. We are committed to serving the communities around us. We are a corporation with a high respect for people and a sharp customer focus . These are our values at Pfizer.

Careers In Clinical Research Industry Gp 06 Nov11 Careers In Clinical Research Industry Gp 06 Nov11 Presentation Transcript

  • A quick road map Gopal Pai, Ph.D. Head, Clinical Operations, Clinigene International Limited (A Biocon Company), Bangalore
  • Out-sourced / In-sourced / Combination Customer Focus Respect for People Integrity Innovation Teamwork Leadership Performance Community
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  • In Vitro Screening Tests
  • In Vitro Screening Tests Animal Model Screening Tests
  • In Vitro Screening Tests Animal Model Screening Tests Pre-clinical Animal Toxicity Studies
  • In Vitro Screening Tests Animal Model Screening Tests Pre-clinical Toxicity Studies Sub-Acute & Acute Chronic Animal Safety Studies
  • Sub-Acute, Acute & Chronic Animal Safety Studies
    • Reproductive
    • Fertility
    • Fetal
    • Perinatal
    • Post-natal
    • Carcinogenicity
    • Teratogenicity
    • Mutagenicity
    • Topical toxicity
  • Acute Sub-Acute & Chronic Animal Safety Studies Pharmaceutical Development
    • Preformulation
    • Formulation
    • Process development
    • Stability & shelf-life
    • Scale-up
  • Acute & Sub-Acute Chronic Animal Safety Studies Pharmaceutical Development Clinical Development
    • Biography of a drug from its inception in the lab to its introduction to the consumer market and beyond.
    • Tests the drug for its efficacy and toxicity in humans
    • It continues throughout the lifetime of the drug to include post marketing surveillance where a periodic 'progress report' is submitted to the regulatory authorities once every 2 years after the drug is released into the market and also into Pharmacovigilance where safety of marketed drugs, biologics or medical devices are monitored.
  • Clinical Development Phase I Phase II Phase III Phase IV
    • Marketing permission
    • New indications
    • Post-marketing surveillance (PMS)
    • Pharmacoepidemiology
    • Pharmacoeconomics
    • Pharmacovigilance
    • Risk complexity
    • Scientific rigor
    • First trials of drugs in humans (healthy volunteers)
    • Preliminary evaluation of safety & toxicity
    • Establishes pharmacokinetic and pharmacodynamic profile
    • Various dosage forms/strengths may be tested
    • Limited number of volunteers are usually used (12-32)
    • Establishes efficacy for proposed diseases or conditions
    • Assesses short term safety
    • Determines appropriate route of administration, dose range & frequency
    • Small number of subjects (generally exceeding 24-30 subjects)
    • Large scale trials to obtain efficacy & safety data
    • Evaluates the therapeutic values of drug
    • May also involve differentiation from other existing therapies
    • Establish pharmaco-economic importance
    • Generally comparative studies are common
    • Number of subjects could exceed 300
    • Conducted after the drug route, dose & frequency are established
    • Studies performed according to approved labeling only
    • Post-marketing surveillance (safety/toxicity)
    • To differentiate from other existing therapies
    • Pharmacoeconomic evaluation
    • Increase usage and awareness in practice
    • Range exceeds 1000 subjects
  • International Scientific & Ethical quality Standard DESIGN REPORT RECORD COLLECT Patient Safety Credibility of Data Execute Verify Analyze Publish / market Services Audits & Inspections
  • Declaration of Helsinki ICH-GCP Local regulations Protocol, SOPs
    • Conduct of study per Declaration of Helsinki, GCP and applicable local regulations
    • Research, only if benefits justify risks
    • Focus on Patients rights & Safety
    • Adequate supporting information
    • Scientifically sound protocol
    • EC approval
    • Medical care of subjects by physician
    • Training
    • Informed Consent
    • Recording & storing of information
    • Confidentiality of subjects
    • Supplies in conformity with GMP, Protocol
    • Quality systems
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  • CR Training Institute
    • choose a specialty
    • like academics
    • possesses some industry experience
    • understand and appreciate the difference in academic and industrial standards of CR
    • skills of teaching and motivating students
  • Synopsis Reg. approval pre-study inv. meet Idea Idea Final Protocol Final CRF Drug Supply Inv. & site selection Final Report Safety Monitoring Data processing & analysis Close-out Inv. Meet & EC approvals Site Initiation Monitoring Audits & inspection
  • Project Manager SPONSOR REGULATORY BODY Senior mgmt approval Study Monitor Investigator Central Laboratory Patients Labs / Services Data management & Biometrics Vendors CRA CRA CRA CRA Ethics Committee
  • Hospital / Institute Investigator Contract Research Organization Sponsor
    • Highly Experienced & skilled researchers
    • clinical scientists, clinicians
    • project planners, market researchers
    • Voracious readers and analyzers
    • Forward thinkers
    • Converting theory into practice
    Product development team Very senior positions (MD, PhD or higher) Synopsis Reg. approval pre-study inv. meet Idea Idea
    • Experienced
    • clinical scientists, clinicians
    • project planners, clinical writers, statisticians
    • Voracious readers and writers
    • Forward thinkers
    • Converting theory into practice
    Dept: Clinical Writing Junior – Senior positions (min. Masters/ PhD) Synopsis Regulatory approval Idea Idea
    • Experienced
    • Regulatory specialists / writers
    • (needs knowledge of international drug and CR laws in various countries)
    • Specialized in understanding and strategizing
    • Liaison with drug and health authorities
    • Liaison with academecians and practitioners
    • Compile submissions for regulatory authorities
    Dept: Regulatory Affairs Junior - Senior positions Min: Sc/Ph G/PG Synopsis Regulatory Strategies & approval Idea Idea
    • Experienced
    • clinical specialists / writers
    • (needs team skills and negotiation skills)
    • Specialized in understanding and strategizing
    • Liaison with other specialities and departments
    • good team player and negotiator
    • good clinical writing skills & experience
    Dept: Clinical Writing Junior - Senior positions Min: Sc/Ph PG Final Protocol Final CRF Drug Supply Inv. & site selection
    • Experienced
    • IT professionals in CRF designing and forms
    • (needs team skills and negotiation skills)
    • specialized in layout and designing forms
    • expert in flow of data collection instruments
    • understanding of database and data validation rules
    • good team player and negotiator
    • good IT skills & experience
    Dept: Data Management Junior - Senior positions Min: G/PG (IT specialists) Final Protocol Final CRF/ eCRFs Drug Supply Inv. & site selection
    • Pharma mfg (cGMP), storage & distribution
    • Experience in packaging and labeling
    • Experience in randomization and blinding supplies
    • specialized manufacturing in cGMP for CR supplies
    • knowledge of inventory management
    • storage & distribution logistics management
    • specialization in randomization and blinding techniques
    Dept: Clinical supplies Junior - Senior positions Min: Pharm/B.tech G/PG Final Protocol Final CRF/ eCRFs Drug Supply Inv. & site selection
    • Experienced Project managers
    • Regulatory documentation specialists
    • Site start-up specialists / site auditors
    • knowledge of infrastructure and capabilities mapping
    • knowledge of GCP documentation requirements
    • thorough with GCP compliance and medical records
    • detection of deficiencies and negotiation skills
    • requires travel about 50-60%
    Dept: Investigator services Junior - Senior positions Min: G/PG (Bio) Final Protocol Final CRF/ eCRFs Drug Supply Inv. & site selection
  • Dept: Administration Junior - Senior positions Min: G/PG (event managers/ travel agents) Dept: Ethics Committee Very senior positions Min: composition per ICMR guidelines (highly qualified and experienced individuals only) Inv. Meet & Ethics Committees Site Initiation Monitoring Quality Audits & Govt. inspection
    • Project managers
    • Clinical Research Associates
    • specialized in setting up sites for projects
    • assessing sites for GCP compliance, facilities and capabilities
    • training site staff for implementation of protocol requirements
    • helping site staff to upgrade documentation skills
    • help understanding of protocol logically & scientifically
    • helper, supervisor, negotiator, motivator
    Dept: Clinical Operations Junior - Senior positions Min: G/PG (Bio) Inv. Meet & Ethics Committees Site Initiation Monitoring Quality Audits & Govt. inspection
    • Clinical Research Associates
    • helper, supervisor, negotiator, motivator
    • takes care of staff changes and ongoing training
    • continued assessment for
      • GCP, ethical and protocol compliance
      • authenticity of data collection
      • facilities and capabilities
      • training site staff (turn-over)
      • travel 75-85%
    Dept: Clinical Operations Junior - Senior positions Min: G/PG (Bio) Inv. Meet & Ethics Committees Site Initiation Monitoring Quality Audits & Govt. inspection
    • Internal auditor
    • (generalist and experienced)
    • independent observer & reporter
    • assesses the compliance to
      • standard operating procedures (SOP)
      • GCP, ethical and protocol compliance
      • quality of monitoring by study team
      • Verify data generation, facilities, capabilities
      • training site staff (turn-over)
      • travel 60-75%
    Dept: Quality Assurance / Govt drug inspector Senior positions Min: G/PG (Bio) Inv. Meet & Ethics Committees Site Initiation Monitoring Quality Audits / Govt. inspection
    • Medical officer / Safety officer
    • (experienced)
    • medical terminology & knowledge
    • assesses the safety of all participating subjects
      • follow regulatory reporting guidelines
      • follow up and manage AE / SAEs
      • make medical decisions on continuation of subjects
      • make medical decisions on continuation of protocol
      • documentation requirements
      • analysis skills in drug development
    Dept: Drug Safety / Pharmacovigilance Junior - Senior positions Min: MD / G/PG (Bio) Final Report Safety Monitoring Data processing & analysis Close-out
    • Database designer / Database programmer
    • Data entry / Data manager / Medical coders
    • (experienced)
    • IT specialists
      • (range : computer operator – programmers)
    • Database (generally clinical Oracle / Oracle
      • system admin, database builder, database programming
      • web-page programmers and linking databases
    • Data entry
      • basic keyboard, medical terminology skills
    Dept: Data management (Database team) Junior - Senior positions Min: IT skills (G) + nursing Final Report Safety Monitoring Data processing & analysis Close-out
    • Data manager / Medical coders
    • IT specialists (range : database programmers )
      • Knowledge of CDISC standards
      • Knowledge of programming
      • validation of the database structure
      • validation of edit check programs
    • Medical knowledge with IT skills
      • knowledge of WHO / Medra dictionary
      • mapping of diverse terms to standard terms
    Dept: Data management (Data Cleaning & Validation) Junior - Senior positions Min: IT skills / G / BDS / MBBS / Nursing Final Report Safety Monitoring Data processing & analysis Close-out
    • SAS programmers / Biometricians
    • IT specialists (range : SAS programmers )
      • Knowledge of CDISC standards
      • Knowledge of programming & validations
      • Generation of tables and listings
    • Biometrics knowledge with IT skills
      • generate a Statistical Analysis plan
      • decide methods and validate programs
      • approve tables and listings generated
    Dept: Biometrics (Data analysis, Tables and listing ) Junior - Senior positions Min: IT skills + Nursing / PG/PhD Biostats Final Report Safety Monitoring Data processing & analysis Close-out
    • Data managers & CRAs
    • Generate queries
        • Clean database for database lock and release for analysis
        • Generation of Final tables and listings (100% accurate)
    • Resolve queries
        • Help resolve queries and verify data at site
        • Collection of essential documents
        • Close site
    Final Report Safety Monitoring Data processing & analysis Close-out
    • Clinical Writers / Medical Advisors / Project Managers / Biometricians
    • use Final tables & listings for reports/publications
    • have a good knowledge of regulatory submission requirements internationally
    • analytical skills to interpret data and make conclusions
    • data organization, language and writing skills
    Final Report Safety Monitoring Data processing & analysis Close-out
    • Clinical writers
      • SOP writing and administration (re/training, implementation and archival)
    • Project Management
      • Tracking large projects with MS-Projects (Gantt charts, critical path and mile stones)
      • Productivity and resourcing (use of timesheets, costs, tasks and activities, P&L for each project)
      • Financial tracking (Project finance)
    • Legal & Contracts mgmt (vendors and sites)
    • CRF / label printing & QA
    • Central Laboratory business
    • Business development
    • IVRS
    • Translations
    • Rater training and certifications
    • GCP training and certification
    • Consultant ……
  • Pull Push
    • Team members
    • Competencies
    • Systems Processes
    Push
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  • CHALLENGES IN DRUG DEVELOPMENT GLOBALLY
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  • Once a very noble profession……
    • Gene therapies, Stem cell therapies
    • GM products for human consumption
    • Cloning
    • Blood donations, transfusions
    • Organ transplants
    • Contraception
    • HIV testing , counseling
    • Clinical laboratory testing
    • In vitro fertilization / sperm banking
    • Abortions / euthanasia / sex determination
    • Consents provided by patients and their relatives at all hospitals
    • Insurance coverage in medical care
    • Narcotic drug use/abuse
    • Taste enhancers
    • Artificial sweeteners
    • Pollution control
    • Exposure to sunlight
    • Daily dietary components (pediatric, adult)
    • Smoking…
    Is Clinical Research any different ?!
  • … NOW PERCEIVED AS A GUINEA PIG SYNDROME ! Help !!! Help !!!
  • Pre-World War II Empiric Rx Evidence-Based Medicine Personalized Medicine Post-World War II … the future?
  • as much “ art ” as it is “ science ” much of evidence-based medicine is a “ gold-standard in treatment approaches”, keeping the "art" aspect in mind … is as good an approach as any to determining whether evidence-based medical study results are useful to you as you and your doctor consider possible treatment for whatever your medical problem is. “ Art” factor
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    • * Regulatory status of the drug / device / treatment (Approval by CDSCO)
    • * Data of past exposure with human and/or animal (Sch Y, Y1 - CDSCO)
    • * Insurance cover for study-drug related injury to subjects (CDSCO)
    • * Investigational sites with Regulatory & GCP training (ICH & Indian GCP)
    • * Inspections of CROs, Sponsors and Sites by CDSCO
    • * CRO registration with CDSCO
    • * Informed Consent Process and documentation of the process
    • * Use Pharmacovigilance network development
    • * CTRI registration (Public information enabled by CDSCO)
    • * Ethics /Scientific committee approvals (ICMR guide, OHRP Registered?)
  • … More patient PROTECTIVE MEASURES available
    • Protective mechanisms in place to allow continuation of studies:
      • DMC (Data monitoring committee)
      • DMEC (Date monitoring and ethical committee)
      • DSMBs (Date Safety Monitoring Board)
      • Regular and periodic IRB safety reviews
    • So what is missing in Clinical Research today ?
      • Regular surveillance mechanisms from CDSCO and other audit firms
      • Training in medical schools on ethics in EBM
      • Community involvement and awareness of clinical research
      • Patient protection groups (with balanced views)
      • Research societies / specialty bodies (with balanced views)
      • Accreditations for ECs, CROs and CR personnel (various skill sets)
      • Control and register SMOs (many sub-standard ones mushrooming!)
    • Hospitals: Largely no-health care regulations
      • laws for registration in some states
      • no standards set
      • no universal accreditation mechanism
      • proposed national law (awaited)
    • Like in other walks of life,
    • nothing works more than the restraint on the continued temptation
    • to get on to the wrong side of the law to make a quick buck!
    • (Ethics rule our lives, others ruin them !)
    • … so far as the law is around,
    • the police will be around,
    • … so far as the police are around,
    • the criminals will also be around !
    • Is this ANY different in other professions & spheres of life ?
    • … so is only Clinical research profession in a dilemma?!
  •