INDIA AS AN EMERGING DESTINATION FOR CLINICAL TRIALS

Dr. S K GuptaDr. S K GuptaDean & Director General

Institute Of Clinical Research, IndiaNew Delhi-110037

REQUIREMENTS FOR GLOBAL RESEARCH

Infrastructure Regulatory Environment Patient Pool-Genetic Diversity I.P Protection Investigator Availability Bioethics Regulation Cost Advantage

CDSCO

INFRASTRUCTURE AVAILABLE • Over 200 Medical Colleges• Over 22,000 graduates per year• 15,622 hosp., 903,952 hosp.beds >75% in urban area• 14000 diagnostic labs • 700,000 scientists and engineering graduates / year • World class medical / lab facilities at secondary / tertiary care centers • Skilled computer savvy biomedical work force

• Highly developed IT / ITES

• Motivated & committed personnel

Clin. Res. Infrastructur

e

IT Support

Connectivity• High quality digital connectivity• Excellent air/surface transport facilities across country

CDSCO

• Large No. of specialists in different therapy segments• Medical Training In English• 600,000 Eng. Speaking physicians• PG training from Europe/US• Treatment Protocols in line with West• Large no. of ICH/GCP compliant Investigators / sites• Large, Diverse, therapy-naïve• Advantage of having 6 out of 7 genetic varieties • Large pt. pool in acute/chronic disease segment• Increasing no. of pts in life style disorders segment, HIV, Oncology

INDIA : ADVANTAGES

Patient population

Investigators

200

1000

300

400

1000

6000

2000

4000

0 1000 2000 3000 4000 5000 6000 7000

Sponsor Staff

CRO Staff

Invigilator

Other Site Staff

Demand

Supply

Demand-Supply Gap of CR Professionals, 2010 in IndiaDemand-Supply Gap of CR Professionals, 2010 in India

HUMAN RESOURCE DEVELOPMENT

Established in 2004 Established in 2004 To meet the challenges 50,000 Professionals To meet the challenges 50,000 Professionals

DELHI, MUMBAI, BANGALORE AHEMEDABAD AND HYDERABAD

DRUG DISCOVERY & DEVELOPMENTDRUG DISCOVERY & DEVELOPMENTR&D investment by Indian Pharma Companies

Before patent protection implementation

Process researchProcess research NDDSNDDS NCENCE

After patent protection implementation -ExpectedProcess Process researchresearch

NDDSNDDS NCENCE

Process Research NDDS NCE

Amended Schedule Y

Phase I clinical trial NCE from

abroad in Pipeline

Phase I trial for NCE developed in India: Yes

Pharmacovigilance launch

ICMR/Bioethics

Product patent regime

Clinical Trial Registry launched

ICH-GCP

LANDMARK YEAR: 2005 LANDMARK YEAR: 2005 CLINICAL RESEARCH CLINICAL RESEARCH

WHY INDIA IS BECOMING A HOT DESTINATION FOR CLINICAL RESEARCH?

Clinical trials in India is growing at a 60% AAGRClinical trials in India is growing at a 60% AAGR• • Crossed USD 100 million in 2004.Crossed USD 100 million in 2004.• • By 2010, the industry will spend USD 300M+ on clinical trials in By 2010, the industry will spend USD 300M+ on clinical trials in India.India.

More than 150 CRO’s are conducting clinical trials complying

Estimated market size of clinical trials in India (USD in mn)

TREATMENT NAIVE PATIENTS (DISEASE WISE)TREATMENT NAIVE PATIENTS (DISEASE WISE)

45 million asthmatics 45 million asthmatics 30 million diabetics 30 million diabetics 18 million hypertensive18 million hypertensive 13 million hepatitis C13 million hepatitis C 10 million or more HIV 10 million or more HIV

patients patients

8 million epileptics 3 million cancer 1.5 million Alzheimer's one million

schizophrenics

CLINICAL DATA MANAGEMENT CLINICAL DATA MANAGEMENT ADVANTAGE INDIAADVANTAGE INDIA

Capabilities of Vendors HR capabilities to support

large work force

well capitalized & willing to invest

committed to innovation

long term high level relationship

Opportunity From Deals Strategic outsourcing of a global

function

Seek more than cost saving

Long term contracts

Board level oversight

Scale & Scope to effect a “Tipping Point”

Study Average US cost (in millions)

Indian cost

Phase I 20 50% less than the average cost in US

Phase II 50 60%less than the average cost in US

Phase III 100 60%less than the average cost in US

Cost of Clinical trials in USA vis-à-vis in IndiaCost of Clinical trials in USA vis-à-vis in IndiaCLINICAL TRIALS

CROS CONTRIBUTING FOR OUTSOURCING CROS CONTRIBUTING FOR OUTSOURCING CLINICAL RESEARCH CLINICAL RESEARCH

CROs Can Deliver Quicker and More Efficient Trials

• Specialized in clinical research and can generate economies of scale

• Utilize latest data management tools & technologies as well as other technologies (e.g., patient recruitment)

• Can conduct trials in lower cost regions

• Reduce time to complete trials*– CROs complete trials 30% faster than

pharma companies*– CROs complete trials in less time

across phases

14013989 978166

Phase I Phase II Phase IIISponsor CRO

ADVANTAGE INDIA OVER OTHER COUNTRIES

DISEASE WISE CLINICAL TRIALS DONE IN INDIA

THE PERCENTAGE OF CRO REVENUES FROM BIOTECH THE PERCENTAGE OF CRO REVENUES FROM BIOTECH FIRMS IS RAPIDLY INCREASINGFIRMS IS RAPIDLY INCREASING

70% 68% 66% 64% 62% 60%

30% 32% 34% 36% 38%

77% 73%

40%23% 26%

0%

25%

50%

75%

100%

2000 2001 2002 2003 2004 2005 2006 2007

Biotech

Pharma

% ofExpenditure

CRO R&D Expenditure Forecast(2000–2007)

Source: Frost & Sullivan, 2003.

PHASE IV TRIAL MARKET INCREASING DUE TO PHASE IV TRIAL MARKET INCREASING DUE TO SAFETY CONCERNSSAFETY CONCERNS

20.2% 20.6%

23.4% 22.2%

39.3% 37.2% 34.2% 31.1%

15.5% 18.8% 22.2% 26.1%

19.7%19.0%

24.3%26.2%

0%

25%

50%

75%

100%

2001 2003 2005 2007

Phase IV

Phase III

Phase II

Phase I

% of Revenue

CRO Revenues by Clinical Phase (2001–07)

Source: Frost & Sullivan, 2003.

INDIA BUILDING A TRACK RECORDINDIA BUILDING A TRACK RECORDClinical Trial Data From India to Achieve an FDA NDA

Drug Company Compound Researched Indication US Launch

Canagene Hepagam Hepatitis B Jan 06Eli Lilly Alimta Cancer Feb-04Eli Lilly Cialis Erectile dysfunction Nov-3Jannsen Risperidal Psychosis Oct-03Wyeth Flumist Influenza May-03Alcon Vigamox Ophthalmic Infections Jan-03Glaxo Lamictal Epilepsy Jan-03Novrtis Zelcorm Irritable Bowel Syndrome Jul-02Pfizer Vfend Fungal Infection May-02Eli Lilly Xigris Septicemia Nov-01Santen Quixin Ophthalmic Infections Oct-00

Sr. No. Company Clinical Trial in India CLINICAL Trial in China1 Astra Zeneca 10 102 BMS 17 63 Eli Lilly 17 124 GSK 22 145 J&J 20 136 Merck 8 57 Novartis 9 68 Pfizer 16 59 Roche 5 14

10 Sanofi Aventis 15 13Total 139 98

GLOBAL CLINICAL TRIALS GLOBAL CLINICAL TRIALS COMPARISON INDIA : CHINACOMPARISON INDIA : CHINA

1

10

100

1000

10000

100000

Phase of trial

No.

Tria

ls (L

og tr

ansf

orm

ed)

India 32 165 394 63USA 6324 11305 5683 2474All 8540 16878 11662 6142

Phase-1 Phase-2 Phase-3 Phase-4

Clinical Trials from India Clinical Trials from India ((www.clinicaltrials.govwww.clinicaltrials.gov.: 15Apr08).: 15Apr08)

CLINICAL TRIAL ACTIVITIES IN ASIA CLINICAL TRIAL ACTIVITIES IN ASIA ALL STUDIES ALL STUDIES

Country All Studies % Industry Sponosred

Australia 1572 62.72Chinese Taipei 903 45.29Japan 732 67.76Korea 674 72.26China 643 53.50India 582 72.16Singapore 335 68.36Thailand 327 69.42Chinese Hong Kong 250 82.00Philippines 206 93.20Malaysia 180 93.33

www.clinicaltrials.gov-snapshot: 7 Feb 2008

Countries with more than 100 studies listed

YEAR No. of Trials

2003 30

2004 50

2005 100

2006 143

2007 264

2008( upto August) 115

Total 702

CDSCO

Global Clinical Trials Permitted

No import duty on clinical trial supplies (2003)

Exemption from registration requirements for clinical

trial supplies (2003)

Export of clinical trial related biological specimens

allowed, based on protocol approval (2005)

Exemption from Service Tax on new Drug testing (2007)

GOVERNMENT’S INITIATIVESINCENTIVES

RECENT INITIATIVES BY CDSCO FORPROMOTING ETHICAL CLINICAL

RESEARCH

Review of proposal- Time linesPhase O, Phase-1 and Micro dosing trial-initiatives Registration CRO’s Registration of Clinical Trials

Establish Single Window clearance for approvals

Fix timelines for each application (2-6 Weeks) New Drug application status on the web –

Update fortnightly Subject Experts-reviewers – Internal / External Staff & Infrastructure at one site Training

PRIORITIES SET BY CDSCO PRIORITIES SET BY CDSCO

Short Term Goals Year – 2008

Guidelines for Registration of CROsMeeting timelines

Registration of CROs Mandatory registration of clinical trials in

centralized clinical trial registry Allow Phase 0 (micro dosing) studies and

phase 1 studies in the country in controlled manner

CDSCO

CDSCO GOALS FOR CLINICAL TRIALS REGULATION

CDSCO

** LAN / WAN connectivity of CDSCO LAN / WAN connectivity of CDSCO campuscampus** Online submission of all the formsOnline submission of all the forms** Digitalized interactive portalDigitalized interactive portal** Digitalization of recordsDigitalization of records** Online approvals with Digital signature Online approvals with Digital signature ** Inbuilt feature would administer Inbuilt feature would administer spontaneous and random spontaneous and random ** Checks to ensure quality ethical standards.Checks to ensure quality ethical standards. Vision : Paperless CDSCO office Vision : Paperless CDSCO office

CDSCO INITIATIVES E-GOVERNANCE-DRUG REGULATORY SYSTEM

“India’s business and regulatory climates have undergone dramatic change in the past 18 months through passage of a patent bill, regulations updated to harmonize with TRIPs and international standards, and plans for a more US FDA-like regulatory body.”

CenterWatch (July 2007)

CLINICAL TRIALS IN INDIA CLINICAL TRIALS IN INDIA

CHALLENGES AHEAD

Improvement in Regulatory FrameworkExpanding Investigators PoolMoving from Metro to Mini CitiesScale up Competence Building Making India a Vibrant Destination

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