BioServices: Clinical Trials & India's potential

Dr Krathish Bopanna Chief Technology Officer Manipal Acunova Bangalore

Manipal Acunova Proprietary

Biotechnology Market

The human health sector accounts for 52% of the total biotech firms and for 88% of the total $1,337M in R&D spending

Number of Firms by Sector, 2001

13% 3% 3% 9% 3% 52% 17%

R&D distribution by Sector, 2001

4% 2% 1% 0% 1% 4% Food Processing Bioinformatics Aquaculture Environment Natural Resources 88% Agriculture Biotech Human Health

Food Processing Bioinformatics Aquaculture Environment Natural Resources Agriculture Biotech Human Health

Source: Statistics Canada, Biotechnology Use and Development Survey, 2001

Human health predominate Biotechnology

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Drug Development

Years
Discovery
(2-10 Years)

Compound Success Rates by Stage 5,00010,000 Screened

Preclinical Testing
Laboratory and Animal Testing

0 2 4 6 8 10 12 14 FDA Review/Approval Phase II

250 Enter Preclinical Testing 5 Enter Clinical Testing

20-80 Healthy Volunteers Used to Determine Safety And Dosage

Phase I

1,000-5,000 Patient Volunteers Used to Monitor Adverse Reactions to Long-term Use

Phase III

100-300 Patient Volunteers Used to Look for Efficacy and Side Effects

Additional Post-marketing Testing

1 Approved by the FDA

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Net Cost: $802 million invested over 15 years

Source: Tufts Center for the Study of Drug Development

Drug development is a risky and expensive proposition

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Crisis in Research Productivity

60
New drugs approved by FDA (left scale)

$35

50
R&D spending in billions (right scale)

$30

$25 40 $20 30 $15 20 $10 10

$ Billions

$5

$0

1980

1985

1990

1995

2002

Source: Food & Drug Administration; PhPharma; Kaiser Family Foundation

Key reasons of outsourcing R&D activities

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Industry Overview
Clinical trials in India is growing at a 60% AAGR Crossed USD 100 million in 2004. By 2010, the industry will spend USD 300M+ on clinical trials in India.
300 250 200 150 100 50 0 2004 2005 2006 2007 2008 2009 2010

Estimated Market Size of Clinical Trials in India (USD mn)

Source CenterWatch
20 CROs including Quintiles, Manipal Acunova offer Phase I to IV trials complying with ICH-GCP guidelines. With 80 hospitals serving as sites for clinical trials, India is emerging as one of the fastest recruiter of subjects across the world.

Why is India becoming a Hot Destination for Clinical Research?

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Estimates of CR Activity in India

Conservative Potential (2008) $ 200 M Rs 1,100 Cr 4,000 6,000 50,000 Speculative Potential (2008) $ 1,000 M Rs 5,500 Cr 20,000 30,000 3,00,000

Estimate (2003) Value (US $) Value (INRs) Full-time staff Site staff Patients $ 50 M Rs 225 Cr 800 1,500 10,000

Estimates of over 1 Bio USD by 2008

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Pharma & Device Industry Challenge

Trend
Cost per patient Cost per trial Cost of clinical development Cost per investigator Complexity of protocols Infrastructure cost

Driver
War for patients

War for investigators

Number of procedures, and type of inclusion/ exclusion criteria Number and size of trials Regulatory requirements

Source: McKinsey 2004

Global trend is unavailability of Patients and PIs! & High cost

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Advantages in R&D Sourcing

Low Medium High

India

Israel P-pines Ireland

Canada

China

Russia

Government Support Labour Pool Infrastructure Educational System Cost Process Quality Cultural Compatibility (US) Legal System Globalisation Skills Overall Climate
Source: Gartner Report, Jan 2003

India has distinct advantages over all other countries

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Regulatory Interface

Government
Manufacturers

Experts

Products

Regulatory authority

Prescribers Medicines Patients/Consumers

Source: Bio 2004

Importers/Wholesalers/Retailer

Regulatory framework is complex in Clinical Research

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Patent Protection

Patent granted for 20 years from application 12 years to develop the drug Invest 800 Million US$ 8 years to sell it exclusively Recoup the investment

Only 1 out of every 12 marketed drugs recoups the investment mega brand status
Prolong patents by developing new formulations and/or new indications
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10

Good Clinical Practice Safeguards the interest of

Patient

Investigator

Sponsor

Society

Definition of Responsibilities of Investigators, Sponsors, Ethics Committees Protection of trial subjects (Informed consent, Safety reporting) Data Quality / Study documents / record keeping Quality Assurance /Audit
Source: www.ich.org

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Ensuring that only quality clinical trials are performed Provide reliable support for regulatory approval of new drugs
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Clinical Trial Process

12

Valuable process to ensure high quality data!

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Skill Sets

Mid-life & Maturity Early Stage: Start-up: Scientists Product Development Finance HR Mgmt Board General Mgmt Scientific Team Process Development Administration Business development Patents Regulatory Clinical Board Quality Assurance and Quality Control Tech Services

Strategic planners Legal

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Manipal Acunova Proprietary

Organization

President CFO VP Ops Finance AR/AP Purchasing Manuf. Engnr. Facilities VP R&D VP Clin VP Reg VP S&M Quality RA Pharmvig Tech Sales Mkt.

Discovery Develop.

Clin Ops Clin Res Biometrics

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Endless possibilities!
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Outsourcing Clinical Research

Source: GCRC

15

Newer Avenues in the field of clinical research!

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Value Proposition

Source: GCRC

16

Using our intellectual capital to support Global Studies!

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Hot Jobs

R&D QA/QC 7% Clinical Research Process Development/Mfg Sales and Marketing Admin/Operations Information systems Regulatory Affairs Finance 4% Business Development HR

18% 38% 10% 9% 7% 5% 5% 4% 0.5%

Source: Data on File

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Clinical research job offerings tops hot job lists!

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HR Challenges

Very rapid growth in number and size of companies Spectrum of skills required in scarcity Lack of specialization Limited pool of experienced people IT enabled services: Cross functional approach Lack of differentiation New emerging platform technologies and convergence of disciplines

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Adaptability and Flexibility are key factors that drives this business opportunity !
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