careers in clinical research 2009
DESCRIPTION
Opportunities in clinical research in IndiaTRANSCRIPT
![Page 1: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/1.jpg)
Careers in Clinical ResearchCareers in Clinical Research
Dr. Ashok Rattan,Chief Executive,
Fortis Clinical Research Ltd&
Adviser,Religare SRL Diagnostics,
Fortis / Escorts Hospitals, Delhi & NCR
![Page 2: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/2.jpg)
Dr. Ashok RattanMBBS, MD, MAMS
• 1st July 2009 : Present position• 1st July 2007 – 2009 : Director, SRL• 1st July 2005 – 2007 : CAREC/PAHO/WHO• 29 June 1998 – 2005 : Ranbaxy NDDR• 19 June 1987 - 1998 : AIIMS• June 1981 – 1987 : JNMC, AMU, Aligarh• June 1977 – 1981 : Naga Hospital, Kohima
MBBSMBBS
MDMD
MAMSMAMS
![Page 3: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/3.jpg)
Pick a job you like, Pick a job you like, and you will never have to work in your lifeand you will never have to work in your life
Either be so talented that you get what you want,Either be so talented that you get what you want,Or Or Accept what you get and act as though you always Accept what you get and act as though you always Wanted what you have been givenWanted what you have been given
![Page 4: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/4.jpg)
New Drug Discovery and Development(Timelines)
DIS
CO
VE
RY
/SC
RE
EN
ING
SYNTHESIS AND PURIFICATION
ANIMAL TESTING
PHASE II
PHASE I
SHORT-TERM
PHASE III
LONG-TERM
PHASE IV
ADVERSEREACTION
SURVEILLANCEPRODUCT DEFECT
REPORTING
PRE-CLINICALRESEARCH CLINICAL STUDIES NDA REVIEW POST-MARKETING
24 + 18 months. AVG: 5 YEARS AVG: 12 MOS.
IND NDA APPROVAL
![Page 5: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/5.jpg)
TARGET IDENTIFICATION
& VALIDATION
R&D Technology
HIT IDENTIFICATION LEAD SEARCH
& OPTIMIZATION
CANDIDATE SELECTION GLP PHASE
PHASE I-II PHASE II - III
EXPLORATORY RESEARCH
DRUG DISCOVERY
DRUG PROFILING PRE- DEVELOPMENT
DEVELOPMENT
GENOMICS
PROTEOMICS
PHARMACOGENETICS
BIOINFORMATICS
HTS
ASSAY DEVELOPMENT
SUBSTANCE LIBRARY
MOLECULAR MODELING
COMBINATORIAL CHEMISTRY
IN VITRO &
ANIMAL PHARMACOLOGY
TOXICOLOGY
NEW FORMULATION
PILOT PLANT
PHARMACOGENETICS
DATA MINING
DATA BASE
![Page 6: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/6.jpg)
5000 compounds evaluated
Phase-I
20-100 healthy volunteers
0 2 4 6 8 10 12 1614
Years
Phase-II100-500 patient volunteers
Phase-III
1000-5000 patient volunteers
Review and approval byFood & Drug Administration
1Compoundapproved
5 INDs
Discovery and preclinical testing
Source: Tufts Centre For Study Of Drug Development in C&EN, June 2000
Bringing a new drug to the market can take 15 years
![Page 7: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/7.jpg)
Cost of bringing a new drug to the market is 800M to 1B US$
![Page 8: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/8.jpg)
UnderstandDisease & Identify
unmet needs
SelectMechanism/
Target
DesignNCEs &Screens
Virtual Screening
Synthesize NCEs
ConvertLead-to-IND
Candidate
New Drug Discovery Road MapPreclinical work-up
IND directed regulatory studies
ConvertHit-to-Lead
Screen/Identify Hit
![Page 9: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/9.jpg)
IND ApprovalIND ApprovalInvestigator’s brochureInvestigator’s brochure
ProtocolProtocolApproval for Phase 1Approval for Phase 1
Select research siteSelect research site
![Page 10: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/10.jpg)
Activities
• Protocols writing• CRF designing• Clinical Trial Materials logistics• Selection of sites, investigators, Labs• Training of investigators, Investigators’ meet• Obtaining regulatory and IEC approvals• Monitoring of studies, ensuring reliable & regular
capture of correct data• Ensuring compliance with protocol
![Page 11: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/11.jpg)
Clinical Trials Win Win Relationship
CRO/ SMO/ AROFee for service,
expand research capacity, work satisfaction
Sponsors Regulatory approval,
Publication, Enhanced healthcare,
Sales & Profits
PatientsImproved care,
decreased expenses, new therapies
InvestigatorFee for service,
Expand Research capacity, Academic interest / publication
![Page 12: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/12.jpg)
![Page 13: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/13.jpg)
Career opportunities in Clinical Research
![Page 14: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/14.jpg)
Mr Umakant Sahoo
Why Join Clinical Research
• Sunrise Industry, Booming Market• Huge Demand & Supply Gap, Easy Entry• White Collared, Knowledge Intensive Job vis-à-vis
Boring Sales/Marketing/Production Jobs & Unstable and Uncertain Clinical Practice
• Good Career Prospects• Quickies (quick money, growth on the ladder)• National & International Travel, Cross-cultural
Exposure• Increased Contacts, Marketability • Understanding of Drugs, Diseases & Management• I Love Research, Documentation, Paper Work
![Page 15: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/15.jpg)
Advantage India
LanguageLanguage
Patient poolPatient pool
CostCost
SpeedSpeed
English speaking staffEnglish speaking staff
Large pool of treatment naiive patientsLarge pool of treatment naiive patients
30 – 50% of USA or EU cost30 – 50% of USA or EU cost
Fast recruitmentFast recruitment
RegulatoryRegulatory
International Quality International Quality
Parallel Studies Schedule Y 2005Parallel Studies Schedule Y 2005
QualityQuality
![Page 16: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/16.jpg)
Success
SpeedSpeed CostCost QualityQuality
![Page 17: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/17.jpg)
People involved in clinical trial in USA
Sponsor staffSponsor staff
CRO staffCRO staff
InvestigatorsInvestigators
Other site staffOther site staff
78,00078,000
44,00044,000
50,00050,000
35,00035,000
![Page 18: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/18.jpg)
Supply & Demand Manpower 2010
Sponsor staffSponsor staff
CRO staffCRO staff
InvestigatorsInvestigators
Other site staffOther site staff
1,0001,000
6,0006,000
2,0002,000
4,0004,000
200200
1,0001,000
300300
400400
![Page 19: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/19.jpg)
Career Pathways• Project Management• Site management• Contract management• Data management• Clinical• Bio-analytical• Laboratory• Bio-statistics• Quality• Pharmaco-vigilance• Medical writing• Regulatory• Business Development
![Page 20: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/20.jpg)
Where ?
• Pharmaceutical companies• CRO• BA BE centres• SMO• ARO• IT• Central Labs• Logistics• Training centres
![Page 21: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/21.jpg)
Roadmap to success
![Page 22: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/22.jpg)
Roadmap 1 For medical graduates
• If you are: MBBS/ MD (Pharmacology)
Join as CRA, CRC, Study coordinator
In 2 to 5 years expect to be:
Medical Adviser, Regulatory Affairs Manager,Medical Monitor, Medical Writer
In 5 to 15 years to be:
Medical Director,Head (Clinical Operations)
![Page 23: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/23.jpg)
Roadmap 2 for Pharma / graduates• If you are: B Pharm/ M Pharm/ Graduate / PG
(Biotech, Nursing, Science) / MBA / Ph D
Join as CRA, Data Manager, QA executive, Pharmacy Executive
In 5 to 15 years expect to become:
Clinical Team leader, Project Manager, Manager (Clinical Operations), Manager (QA), Clinical Study manager, Regulatory manager
In 2 to 5 years you may become
Head (Operations), Head (Projects), GM, CEO
![Page 24: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/24.jpg)
Roadmap 3
– If you are: Graduate / PG/ PhD in Maths & Statistics, SAS Programmer etc
–Data base designer, statistical programmer,
–Data Validation/ QC executive
In 2 to 5 years expect to become
Data Manager, Statistician, SAS programmer, QC manager
In 5 to 15 years you will be
Head Data Management, Biostatistician
![Page 25: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/25.jpg)
Roadmap 4
– If you are Graduate / PG, MBA including HR, Finance
Accounts/ HR executive,
Business Development executive
In 2 to 5 years time, expect to become
Manager BD, Manager (Clinical Trial supplies), Manager (Accounts), Manager (HR), Manager (Training)
Head (HR), Head (BD), CFO, Head (Training & QA)
In 5 to 15 years time, you could be
![Page 26: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/26.jpg)
• Industry does not work on the years of experience basis alone
• What is more important is what you have achieved in these years
• Careers can be aborted for non achievers & they can and are shown the door
• Fast track for the high achievers & excessive rewards
• Individuals get rewards though team work is hall mark of success
![Page 27: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/27.jpg)
Always remember we can not spell success without “U”
![Page 28: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/28.jpg)
EducationChange of behavior
CognitionCognition PsychomotorPsychomotor Affective AffectiveAct of knowingAct of knowing Skills Skills Attitude, Motivation Attitude, MotivationKnowledge is powerKnowledge is power Skills come from drill Skills come from drill “I can” is more important than IQ“I can” is more important than IQ
DOMAINSDOMAINS
![Page 29: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/29.jpg)
• Think not of yourself as An architect of your career• But as a sculpture• Expect to have to do a lot of hard hammering & chiseling & scraping & polishing
BC Forbes
![Page 30: Careers In Clinical Research 2009](https://reader035.vdocuments.net/reader035/viewer/2022070313/554b6942b4c90564168b48ad/html5/thumbnails/30.jpg)
“It is not the strongest of species that survive, nor the most intelligent,
but the ones most responsive to changes”Charles Darwin (1809-1882)
Life's battles don't always goTo the stronger or faster man,
But sooner or later the man who wins Is the one who thinks he can.
Attributed to Author Napoleon Hill circa 1973