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