Clinical Research ICRI

8/8/2019 Clinical Research ICRI

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Overview of the Presentation

• Healthcare Players• Drug Development Process

• Clinical Trials : Definition• Players in Clinical Research• Regulatory, Phases, Roles in Clinical Research• Benefits & risks of Clinical research• Regulations in Clinical research

• Thoughts to Consider • Clinical Research Market• CRO Market, revenues, job opportunities

• Summary



Healthcare Industry Players

PharmaceuticalIndustry

PatientCare

Physician

Hospital

InsuranceCompany



Drug Development Process

CompoundSelection

Proof of ConceptOutcome2 – 4 Years

4 – 7 YearsMarketing

Introduction

*Key variable guidingdevelopment time

Target SelectionTarget Validation

& leadoptimization

Proof of Concept

Clinical Trials

Pre-clinical

Phase

Clinical Phases I, IIIII, IIIB*

DrugRegistration

FDA Approval

Marketing(Phase IV

Clinical Trials)

(5,000 – 10,000)(250)

(5)(1)



Clinical Trials: What Are They?

• An organized research study designed to investigatenew methods of preventing, detecting, diagnosing, or treating an illness or disease (such as cancer).Clinical: Pertaining to humans (subjects volunteers, patients)Research: The study of material & sources in order to establish facts

& reach new conclusions (analysis, enquiry, examination,experimentation, exploration, fact-finding, inquiry, investigation,probe, scrutiny, searching, study)

Source: Concise Oxford Dictionary



The Players in ClinicalResearch

Sponsor Investigator Site Patient

CRO

SMO

IRB/IEC



What is Involved in a ClinicalTrial?

File IND application

Develop protocolSubmit to FDA for comment or

no action

Select investigational sitesbased on # of patients

needed for the studyRegulatory requirements for each trial at each site•PI’s CV•Financial disclosure forms•Informed consent•IRB approval

Initiate site(s)

Sites enroll patients

Write study report

Patients cycle through studyCapture: Adverse events, vitalsigns, study drug adherence,QOL questionnaires capturedon Case Report Forms

Patients exit study

Data collected and cleaned

Sites closed

Add study to NDA



Clinical Trials Process andAssociated Regulatory Process

Phase IIIPre-NDAMeeting

PhaseIV

File NDA DrugApproval

Pre-IND MeetingIND Application

PhaseI

PhaseII

Phase IIEnd of Phase IIMeeting



Phases of Clinical Trials

For marketing purposes, to compare theeffectiveness of two therapies already on themarket or to study new uses of therapies

VariesPhase IV

Compares new therapy exam or preventive optionto a standard one

100-1000+Phase III

Test patients responses to a new therapy, exam, or preventive option

30-40Phase II

Tests how to administer a new therapy, exam, or preventive option

Less than 10Phase I

Purpose# of ParticipantsCategory



Tasks Involved in ClinicalTrials

• Protocol development• Volunteer recruitment• Project Management• Monitoring• Data management• Assurance of Drug safety• Clinical statistics• Medical writing• Quality assurance• Technology support



•

Clinical Trials Benefits & Risks

Patients may not receive the therapyunder investigation (may receive aplacebo – inactive pill – instead)

• The new therapy may not be moreeffective than the standard, thoroughlytested therapy

• In Phase I trails, not knowing the safetyconsequences of the new therapy (risk isless in Phase III trials)

• New therapy may have unexpected,

possibly severe side effects or may beless effective than standard of care

• Insurance companies may not cover allcosts of clinical trials

• Having access to potentially moreeffective therapies than those currentlyavailable

• Receiving quality medical care fromleading physicians

• Being closely monitored for possiblenegative effects• Sometimes receiving treatment at a

reduced rate or free of charge• Helping to further new research that may

result in significant medical advances• For patients in cancer therapy trials

assigned to control groups, they stillreceive the top standard therapy availabletoday

Possible Risks of TrialsPossible Benefits of Trials



History Behind Regulationsof Clinical Trials

• Regulations often result in response to abuse of human researchsubjects and concerns about the validity of data and conclusionsfrom clinical trials.

• The primary vehicles for human subject protection are IRBs andinformed consent.

• The Declaration of Helsinki and the Belmont Report are criticaldocuments for the protection of human subjects in research.

• The FDA, by means of PDUFA and FDAMA, has made significantgains in speeding the process of making new drugs available for patients who need them.

• Current problems with clinical trials and trial oversight may well leadto increased regulation.



Regulations for Clinical Trials

• The FDA regulations pertaining to clinical trials are found in 21 CFRParts 11, 50, 54, 56, 312 and 314.

• The ICH Guidelines for Good Clinical Practice should be followed inclinical trials.

• The FDA publishes many guidelines and information sheetspertaining to the appropriate conduct of clinical trials.

• Good clinical practices are the ethical and clinical standard for

designing, conducting, analyzing, monitoring and reporting onclinical trials.



R&D Investment is highThere is pressure on companies to performThe pipeline is exploding

Sales growth is strong

How do all these positive factors impact employment in our industry?

Thoughts to Consider



Clinical Research Market

50,0001,000 [2 %]45002010

26,500 US + Rest600 [2.26% of US]27002007

10,000180 [1.80 %]8102005

9,000100 [1.11 %]4502004

5000 - 600070 [1.16 %]3152003

Global Market(million $)

Indian Market(million $) [% of global]

Indianmarket(Rs. in cr.)

Year

est McKinsey 2003 Assumption USD = Rs. 45



3-Year Employment GrowthGlobal Pharmaceutical Industries

6.0%

4.2%

2.0%1.7% 1.5%

0%

2%

4%

6%

8%

Asia Latin

America

US Canada W. Europe

Growth rate

Source: PhRMA, CenterWatch analysis

Allocation of R&D



Allocation of R&DPersonnel by Function

54%Discovery

/ Preclinical

23%Clinical

15%Regulatory

8%Other

49%Discovery /Preclinical

29%Clinical

7%Other15%

Regulatory

Source: PhRMA, CenterWatch analysis





CRO - Revenues

Source: SMA Report, 2003



CRO - Industry Analysis

Source: SMA Report, 2003



Top 20 CROs in India

40

16.3

203

264.22

72

52

350

478.7

80

225

72.41

80.99

Stage 1

Stage 2

Stage 3

Overall

GR

CYREV

LYREV

Source: Data on File



Staff Distribution in IndianCROs

18.9

46.39

4.06

22.68

14.83

7.9

0 10 20 30 40 50

Corporate

Clin Ops

Bus.Dev

Lab. Serv

Data Mgmt

IT




MNC Pharmacos in ClinicalResearch

• GSK, Glaxo SmithKline PharmaceuticalsLtd,Mumbai

• Novartis International ClinicalDevelopment Center, Mumbai

• Novartis Pharma, Mumbai• Roche,Mumbai• Sandoz, Mumbai• Wyeth, Mumbai• BMS, Mumbai

• Novo Nordisk, Bangalore• Lundbeck, Bangalore• Eisai Pharmaceuticals, Mumbai• LG Life Sciences, Delhi• Bayer, Mumbai• GE, Delhi• Johnson & Johnson, Jansenn Cilag,

Mumbai,• CordiBaxter, Delhi• BD Biosciences, Delhi

•Abbott, Mumbai•Chiron, Mumbai

•Astra Zeneca Pharma India Ltd,Bangalore•AstraZeneca Foundation, Bangalore•Aventis Pasteur, Delhi

•Pfizer Ltd,Mumbai•Pfizer Biometrics, Mumbai•Altana (Zydus), Mumbai•Lilly, Delhi•Boston Scientific, Delhi

Hospira, Delhi•Merck ,Delhi•Sanofi Aventis Syntho Lab, Mumbai

These sponsors outsource work from the parent clinical development headquarters aswell as have a clinical development unit located in India. Several have entered 2003-05and many more are setting up at brisk pace.

Synergy, 2005

Indian Pharmacos in Clinical



Indian Pharmacos in ClinicalResearch

• Bharat Biotech, Hyderabad•Bharat Serum,Mumbai• Cadila Pharmaceuticals• Cipla,Mumbai• Emcure, Pune• Fulford IndiaMumbai• Indus Biotherapeutics,Ahmedabad• IPCA, Mumbai• Shreya Biotech,Pune• Shant ha Biotechnics Pvt. Ltd. Hyderabad• Sun Pharma, Mumbai• Torrent Pharmaceutical Ltd, Gandhi nagar,• USV Ltd. Mumbai• Wockhardt, Mumbai• Zydus Cadilla, Ahmedabad

• Biocon,Bangalore• Cadila Pharmaceuticals, Ahmedabad• Intas Pharmaceuticals Ltd.Ahmedabad• Glenmark Pharmaceuticals Ltd.• Himalaya Drugs ,Bangalore• Lupin Ltd. Pune• Nicholas Piramal,Mumbai•Panacea Biotech ,Delhi

•Ranbaxy Research Laboratories Delhi

•Ranbaxy Research Laboratories,

Gurgaon• Serum Institute of India, Pune• Torrent,Ahmedabad

Synergy, 2005



Business Challenges

0 2 4

Stage 1

Stage 2

Stage 3

Improve Patient Recruitment

Quality & Delivery Time

Competition

Retention of Human capital

Regulatory Issues

IPR Issues


CRO (Clinical Research



(Organizations )

• CROs provide product development services to the pharmaceutical,biotechnology, and medical device industries allowing their clients tomanage product development efforts more efficiently & cost-effectively.

• CROs employ some 100,000 professionals around the world.

• CRO market size is estimated at $12 billion and growing. Revenueis increasing at an annual rate of 14-16 %.

Source: Center Watch Estimates, World Contract Research Organizations Markets, Frost & Sullivan,2003PARAXEL’s Pharmaceutical R&D Statistical Sourcebook 2003/2004

CRO I d t



CRO IndustryFacts & Figures

• According to an independent analyst, clinical trialsconducted by CROs are completed at an average of 30% more quickly than those conducted in-house. Thisresults in an average time-saving of some 4-5 monthstranslating to $120 million to $150 million in increasedrevenue potential.

• This is based on market expectation that an averageproduct generates $1 million in revenues every day.

Source: PARAXEL’s Pharmaceutical R&D Statistical Sourcebook 2004/2005

Jobs !



Jobs !

ICRI, 2005

Key Qualifications Sought



Key Qualifications Sought

Experience59%

Flexibility4%Attitude

11%

Degree16%

Communication Skills4% Work Ethic

2%

Computer Skills2%

OrganizationalSkills2%

Source: CenterWatch Survey



Changes in Roles & Responsibilities



Changes in Roles & ResponsibilitiesDuring Past 3 Years

66.7%

48.6%

46.6%

14.4%

0% 20% 40% 60% 80% 100%

Significantly changedroles & responsibilities

Changed employer

Received a promotion

Relocation

N = 1771

Source: ACRP Outlook

Salaries by Function



Sa a es by u ct o

12 1520

15

23

32

20

30

40

INR 0

INR 40

INR 80

2003 2004 2005

CRA I CRA II CRA III


S l i b F i



Salaries by Function

35

50

70

25

40

60

20

35

50

INR 0

INR 50

INR 100

2003 2004 2005

CDM Project Managers QA / Regulatory




Technologies & Clinical Trials

14% 16%5%

17%

45%

58%60%

52%

0%

20%

40%

60%

80%

100%

Electronic CRF RDE Internet-based ClinicalData Management

Electronic MedicalRecords

Currently Use Often Will Use Often in 2 yearsPercent of Total

Source: ACRP Outlook,

Business Process Flow



Business Process Flow

Source : Data on File

Employment Facts &



Trends

Wages are up; Productivity is rising; Inflation is in

checkLiving in a new economy

powered by technologyfueled by informationdriven by knowledgea new century with new opportunities

Source: Futurework- Bureau of Labor Statistics

Summary



Summary

Industry is in fluxMore trialsMore speedMore burnout

Jobs and roles are changing2/3 have had recent major role changes1/2 have recently changed jobs

Pace will only accelerateBlurring of roles, end of road warrior?

Documents

Clinical Research ICRI