careers in clinical research 2009
DESCRIPTION
Opportunities in clinical research in IndiaTRANSCRIPT
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
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
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
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
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
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
Cost of bringing a new drug to the market is 800M to 1B US$
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
IND ApprovalIND ApprovalInvestigator’s brochureInvestigator’s brochure
ProtocolProtocolApproval for Phase 1Approval for Phase 1
Select research siteSelect research site
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
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
Career opportunities in Clinical Research
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
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
Success
SpeedSpeed CostCost QualityQuality
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
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
Career Pathways• Project Management• Site management• Contract management• Data management• Clinical• Bio-analytical• Laboratory• Bio-statistics• Quality• Pharmaco-vigilance• Medical writing• Regulatory• Business Development
Where ?
• Pharmaceutical companies• CRO• BA BE centres• SMO• ARO• IT• Central Labs• Logistics• Training centres
Roadmap to success
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)
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
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
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
• 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
Always remember we can not spell success without “U”
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
• 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
“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