Executive Chairman Dr. John Climax President Corporate Development Bill Taaffe CEO Peter Gray Chief Financial Officer Ciaran Murray ICON Development Solutions

Executive Chairman

Dr. John Climax

President

Corporate Development

Bill Taaffe

CEO

Peter Gray

Chief Financial Officer

Ciaran Murray

ICON Development

Solutions

President

Dr Thomas Frey

ICON Medical Imaging

Chief Executive

Dr Ted Gastineau

ICON Central Laboratories

President

Bob Scott-Edwards

VP Corporate QA

Jo Coyle

VP Global IT

Mike McGrath

VP Corporate Training &

Development

Anne Wesler

VP Strategic HR

Eimear Kenny

VP Market Development

Simon Holmes

ICON Clinical Research

Global President

Dr John Hubbard

Commercial VP

Brian O’Dwyer

COO US

Malcolm Burgess

Snr VP Global BD

Elizabeth Thiele

Snr VP Global Medical

Suzanne Gagnon

VP Global Data Management

Tom O’Leary

ICON Contracting Solutions

President

Sean Leech

Executive Chairman

Dr. John Climax

President


Bill Taaffe

CEO

Peter Gray


Ciaran Murray

ICON Development

Solutions

President

Dr Thomas Frey


Chief Executive

Dr Ted Gastineau


President

Bob Scott-Edwards

VP Corporate QA

Jo Coyle

VP Global IT

Mike McGrath


Development

Anne Wesler

VP Strategic HR

Eimear Kenny


Simon Holmes


Global President

Dr John Hubbard

Commercial VP

Brian O’Dwyer

COO US

Malcolm Burgess

Snr VP Global BD

Elizabeth Thiele


Suzanne Gagnon


Tom O’Leary


President

Sean Leech

Certain statements contained herein including, without limitation,

statements containing the words “believes,” “anticipates,” “intends,”

“expects” and words of similar import, constitute forward-looking

statements concerning the Company's operations, performance,

financial condition and prospects. Because such statements involve

known and unknown risks and uncertainties, actual results may differ

materially from those expressed or implied by such forward-looking

statements. Given these uncertainties, prospective investors are

cautioned not to place undue reliance on such forward-looking

statements. The Company undertakes no obligation to publicly update

or revise any forward-looking statements, whether as a result of new

information, future events or otherwise.

Forward Looking Statements

Global Full Service Clinical Development

US 53%

EU 38% ROW

9%

Q4 Revenue by Region

GlobalClinical

ICON Latin America5 countries5 Offices153 Clinical Staff

ICON North America2 Countries23 Offices2605 Clinical Staff

ICON Europe/Africa17 Countries20 Offices1980 Clinical Staff

ICON Asia Pacific9 Countries12 Offices478 Clinical Staff

ICON Global - Projects in 50+ Countries

North America2 Countries17 Offices>1,900 Staff

Western Europe / Africa

10 Countries13 Offices>1,600 Staff

Asia Pacific8 Countries10 Offices>450 StaffLatin America

5 Countries5 Offices>170 Staff

Projects in 60+ Countries

Eastern Europe / Russia8 Countries9 Offices> 350 Staff

Japan1 Country2 Offices>80 Staff

ICON’s Global Clinical Footprint

Market Environment

• Continued R&D Spending Growth.

– Phase II / III pipelines strengthening

• Increased Outsourcing

– Being accelerated by activity & funding in Biotech / Speciality

– Globalisation of clinical research

– New strategic thinking / cost containment

• Increasing Regulation

– More patients/ more studies

– Post marketing surveillance 5

Strong Market Environment with...

4000

4100

4200

4300

4400

4500

4600

4700

4800

4900

5000

5100

5200

Source: Pharmaprojects

Up ≈ 23%

The Pipeline continued to fill in 2007Preclinical Compounds in Development

880

930

980

1030

1080

1130

1180

1230

1280

1330

1380

Sep-06

Oct-06

Nov-06

Dec-06

Jan-07

Feb-07

Mar-07

Apr-07

May-07

Jun-07

Jul-07

Aug

-07

Sep-07

Oct-07

Nov-07


Up ≈ 22%

Phase I Compounds in Development

The Pipeline continued to fill in 2007

1800

1850

1900

1950

2000

2050

2100

2150

2200

2250

2300

2350

2400

Sep-06

Oct-06

Nov-06

Dec-06

Jan-07

Feb-07

Mar-07

Apr-07

May-07

Jun-07

Jul-07

Aug

-07

Sep-07

Oct-07

Nov-07


The Pipeline continued to fill in 2007

Up ≈ 14%

Phase II/III Compounds in Development

$18.1

$22.4

$29.2

$33.1

$38.6

$0.0

$5.0

$10.0

$15.0

$20.0

$25.0

$30.0

$35.0

$40.0

$45.0

2003 2004 2005 2006 2007

$Bil

lio

n

Biotech fundraising (excluding debt financing)

Source: Burrill and Company

US Biotech Funding Environment continued to grow

ICON in this Market Environment

14

RFP Value by Market Segment

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

10,000

2003 2004 2005 2006 2007 2008 2009 2010

(in

mill

ion

s)

Total Large Pharma MidSize Pharma Biotech

2007 Value

54% Increase / PY

Size of Projects

41 > 20 Million

168 > 5 Million

959 < 5 Million

Gross RFP Value by Market Segment(Including RFPs that never progress to award)

Number of Proposals

571

8871014

1118

400

600

800

1000

1200

2004 2005 2006 2007

Average Proposal Size ($ millions)

2.8 3.1 3.6

5.4

0

2

4

6

2004 2005 2006 2007

Strong RFP volume growth, with increasing average proposal value…

Number of New Awards Greater then $5 million

8 14

32

46

0

10

20

30

40

50

2004 2005 2006 2007

…which has led to increasing numbers of awards greater then $5 million.

$127

$165$186 $189 $193

$207

$245$264

$246

$366

Q3 05 Q4 05 Q1 06 Q2 06 Q3 06 Q4 06 Q1 07 Q2 07 Q3 07 Q4 07

ICON Gross Business Wins - Last 10 Quarters ($ millions)

Overall, Strong Gross Business wins has led to…

$140

$171$166

$157$171

$223 $230

$344

$230

Q4 05 Q1 06 Q2 06 Q3 06 Q4 06 Q1 07 Q2 07 Q3 07 Q4 07

1.6

1.3

1.6 1.6

1.9

1.3 1.41.6

1.7

Net Business Wins Book to Bill Ratio

.. excellent Net New Business wins and very strong book to bill ratios…

$633

$707

$772$815

$872

$963

$1,049

$1,125

$1,300

Q4 05 Q1 06 Q2 06 Q3 06 Q406 Q1 07 Q2 07 Q3 07 Q4 07

Up 38% YoY

Up 49% YoY

…leading to record Total Backlog levels. ($ millions)

$296 $307

$360

$395$415

$470

$542

$589

$493

Q4 '05 Q1 '06 Q2 '06 Q3 '06 Q4 '06 Q1 '07 Q2 07 Q3 '07 Q4 '07

76%

76% 76% 76%

77%77%76% 76%

77%

Value of backlog forecast to be earned in next 4 quarters

% coverage of next 4 quarters forecast revenues

From this backlog, coverage of next 4 quartersrevenues is robust……..

42.6%

34.6%

30.0%

62.7%

51.1%47.0%

81.4%

72.0%

66.0%

7.8%9.6%12.3%

FY To May 2005 2006 2007

Largest Client

Top 5

Top 10

Top 25

Client Diversity 2005, 2006, 2007

2007 - New Business by

Customer Segment

This has led to a diversified customer base……

….and broad therapeutic expertise.

Revenue by Therapeutic Area 2007

Strategy

ICON’s Core Strategy is Organic Growth,with acquisitions made to add new services or scale.

Capitalise on market fundamentals to drive organic growth in all business units.

Pursue acquisitions to enhance depth and scale of current operations and to add additional complementary services e.g.

Phase I - US

Bioanalytical / Biomarkers

Therapeutic specialists

Safety / Phase IV

Patient Recruitment

Staffing

Cross-sell services to grow sales and margin

Acquisitions to date - 11

• Revenues acquired $114m

• Staff acquired – 1,100

• => Organic growth >80%

Key Strategic Trends

• Strategic v Tactical Outsourcing– More large companies are seeking to use outsourcing strategically rather

than tactically. – ICON fully engaged.

• Globalisation– Growth in Eastern Europe, Latin America and Asia as a venue.– ICON growing rapidly in these regions

• Greater Scientific Involvement– Customers seeking greater scientific input from CROs – ICON has added TAGS, IDS, Imaging, new Lab technologies etc. to

respond.

• EDC– Estimated that over 40% of clinical trials now use EDC– 49% of ICON’s Data Management activity in 2007 was EDC

Executive Chairman

Dr. John Climax

President


Bill Taaffe

CEO

Peter Gray


Ciaran Murray

ICON Development

Solutions

President

Dr Thomas Frey


Chief Executive

Dr Ted Gastineau


President

Bob Scott-Edwards

VP Corporate QA

Jo Coyle

VP Global IT

Mike McGrath


Development

Anne Wesler

VP Strategic HR

Eimear Kenny


Simon Holmes


Global President

Dr John Hubbard

Commercial VP

Brian O’Dwyer

COO US

Malcolm Burgess

Snr VP Global BD

Elizabeth Thiele


Suzanne Gagnon


Tom O’Leary


President

Sean Leech

$327$297

$226$157

$456

$631

$760(E)

$0

$100

$200

$300

$400

$500

$600

$700

FY2002 FY2003 FY2004 FY2005 FY2006 FY2007 FY2008*

Mil

lio

ns CAGR 32%

* Mid Point of 2008 Guidance issued December, 2007

Net Revenue CAGR of over 30% since 2002 22% Forecast for ‘08

$0.58

$0.94$0.85

$1.35

$2.32(E)*

$1.88

$0.75

$0.00

$0.50

$1.00

$1.50

$2.00

$2.50

FY2002 FY2003 FY2004 FY2005 FY2006 FY2007 FY2008

CAGR 26%

(E)

* Mid Point of 2008 Guidance issued December 2007

Earnings Per Share Growth

Q4 ’07 Q4 ’06 % Increase

Net Revenue 181 129 40%

Direct Costs 100 73 37%

SG & A 55 38 45%

D & A 5 4 37%_____ _____ _____

Operating Income 20 14 43%

Operating Margin 11% 10.7%

Net Income 16 11 40%_____ _____ _____

EPS (Inc SFAS123R) 53c 39c 36%

Weighted Average no. of

Shares (Inc SFAS123R)

29.9m 29.1m 2.7%

Recent Financial Performance ($ millions, except EPS; includes stock option expense)

FY2007 FY2006 % Increase

Net Revenue 631 456 38%

Direct Costs 355 256 38%

SG & A 188 137 38%

D & A 19 15 27%_____ _____ _____

Operating Income 69 48 45%

Operating Margin 11% 10.5%

Net Income 56 38 46%_____ _____ _____

EPS (Inc SFAS 123R) 188c 133c 41%

Weighted Average no. of

Shares (Inc SFAS123R)

29.7m 28.7m 3.5%

Recent Financial Performance ($ millions)

• Approx. 25% of ICON’s business is generating single digit

margins– Further margin growth in Lab – Improve performance from Phase I and Consultancy businesses – Bring Japan to higher profitability

• Expand margins in Phase II – IV through leverage as

growth moderates.

• Currency Movements creating some “Headwinds”5

Margin improvement is a key focus

May 31, 05

(Year)

Dec 31, 05

(7 mths)

Dec 31, 06

(Year)

Dec 31, 07

(Year)

Net Cash $78.4 $82.3 $98 $23.8

Total assets $347.6 $349.1 $476.3 $693.1

Shareholder’s equity $233.1 $241.6 $302.7 $388.4

Cashflow from operations $23.8 $11.7 $51.5 $42.9

Capital expenditures $15.6 $12.1 $31.5 $75.4

CAPEX Excl. Dublin Extn. $15.6 $12.1 $20.4 $36.8

Shares outstanding 27.8 28.0 28.5 28.8

Summary Balance Sheet and Cash Flow ($ millions)

Executive Chairman

Dr. John Climax

President


Bill Taaffe

CEO

Peter Gray


Ciaran Murray

ICON Development

Solutions

President

Dr Thomas Frey


Chief Executive

Dr Ted Gastineau


President

Bob Scott-Edwards

VP Corporate QA

Jo Coyle

VP Global IT

Mike McGrath


Development

Anne Wesler

VP Strategic HR

Eimear Kenny


Simon Holmes


Global President

Dr John Hubbard

Commercial VP

Brian O’DwyerCOO US

Malcolm Burgess

Snr VP Global BD

Elizabeth Thiele


Suzanne Gagnon


Tom O’Leary


President

Sean Leech

The Globalisation of Clinical Research: Challenges and Opportunities in Argentina, Brazil, Russia, China and India

John W. Hubbard, Ph.D., FCPGlobal President, ICON Clinical Research

Products in Development by Therapeutic Area

Source – BioPharmInsight.com, 2007

Cancer 7,015 104 527 1,537 1,463 2,865 438 81Infectious Diseases 2,963 89 198 350 425 1,325 544 32CNS 2,900 155 211 394 397 1,217 507 19Cardiovascular 2,136 75 219 299 290 739 480 34Hormonal Systems 1,517 71 124 221 266 514 311 10Miscellaneous 1,492 9 8 18 169 1,232 44 12Immune System 1,436 48 93 127 215 731 215 7Gastrointestinal 1,097 49 98 208 176 347 211 8Musculoskeletal 1,088 39 84 177 160 387 222 19Pain 959 60 99 172 147 236 232 13HIV Infections 880 17 45 102 171 453 72 20Respiratory 867 27 56 165 162 309 136 12

Diagnostic / Imaging Agents / Delivery 833 17 23 47 126 508 106 6Genitourinary 670 32 57 134 90 165 186 6Dermatology 661 27 43 141 109 173 151 17Hematological 581 24 39 78 125 198 112 5Eye and Ear 429 20 42 62 84 154 60 7

Total 27,524 863 1,966 4,232 4,575 11,553 4,027 308

Status Unclear

#Products Launched

Pre-Clinical /

DiscoveryPhase I / IND FiledTherapeutic Area Phase III Phase II

NDA / BLA Filed

Total Investigational

Drugs

Global trend for higher costs, more patients and experienced clinical investigators!

Cost perpatient

Cost perinvestigator

Complexity of protocols

• Treatment naïve patients

• Qualified investigators

• Number of procedures, and type of inclusion/

exclusion criteria

Trend Driver

Cost per trial

Cost ofclinical

development

Infrastructure cost

• Number and size of trials• Regulatory requirements

Pharma & Device Industry Challenges

Source McKinsey 2004

• Access to treatment naïve patients, or patients who have only been

treated with older medications

• Emergent disease populations, e.g., Type II diabetes, treatment

resistant infections such as HIV, tuberculosis, hepatitis B & C, and

various forms of cancer, and cardiovascular disease

• Cost and time benefits: Faster patient recruitment and lower cost base

• Since 1990, global clinical research has grown from 28 to 79 countries

and the amount of FDA regulated research has increased 16-fold

• ICH E5 regulations allow the use of foreign data in new drug

submissions

Why Conduct Global Clinical Trials?

PharmafocusAsia, 2005

Drivers of Country Selection

• Medical practice

• Regulatory process

• Commercial and post-marketing value

• Cost of the trial

• Disease demographics

• Speed of enrollment

• Quality, quality, quality

Quality is the key driver: If a country cannot deliver quality, all other benefits are irrelevant

ICON Latin America5 countries5 Offices153 Clinical Staff

ICON North America2 Countries23 Offices2605 Clinical Staff

ICON Europe/Africa17 Countries20 Offices1980 Clinical Staff

ICON Asia Pacific9 Countries12 Offices478 Clinical Staff

ICON Global - Projects in 50+ Countries

North America2 Countries17 Offices1896 Staff

Western Europe / Africa

10 Countries13 Offices1554 Staff

Asia Pacific8 Countries10 Offices448 Staff

Latin America5 Countries5 Offices166 Staff

Projects in 60+ Countries

ICON’s Global Clinical Footprint Eastern Europe / Russia8 Countries9 Offices339 Staff

Japan1 Country2 Offices72 Staff

Key Countries for Clinical TrialsBased on the Overall Country Attractiveness Index1

0 1 2 3 4 5 6 7

China

India

Russia

Brazil

Argentina

United States

Patient Pool Cost Efficiency

Regulatory Conditions Relevant Clinical Expertise

Infrastructure and Environment

1A.T. Kearney Attractiveness Index , Pharmaceutical Executive Supplement, 2006

6.88

5.58

5.55

5.26

6.10

4.90

Clinical Research in Russia, Argentina, Brazil, China and India:Opportunities and Challenges

ICON’s Clinical Trial Experience in Russia

CountryOffice

LocationsServices

Current Staff

Staff by 2010

Number of Ongoing Studies

Russia Moscow /

Novosibirsk

Clinical Operations,

Regulatory/EC/submissions,

>80 250 -

300

~50

Russia: Opportunities and Challenges• Opportunities

– Population of more than 142 million, with only 274 ongoing multi-national clinical trials (only 5% of the clinical research potential)

– Large urban hospitals and medical centers

– 768 Clinical sites registered by the Federal Service for Healthcare and Social Development in the Russian Federation

– High average patient enrollment rates of 4.7 patients/site/month

– FDA has conducted 36 audits since 1995 and ranks #1 in quality amongst other E7 countries

– Low cost relative to Western EU and the US

– Relatively straight forward regulatory and clinical site contracting process

• Challenges– New regulatory requirements regarding the shipment of blood, DNA, and tissue

samples

– Rapidly maturing marketplace Sources: UBC International Clinical Trials, 2007

Russia versus U.S. in Clinical Research

Key Features of a Clinical Trial U.S. Russia

No. of patients across urban life style diseases Medium High

No. of patients with tropical diseases Low Low

Speed of recruiting patients for trial Low-Medium Very High

Speed of conducting a trial Medium High

Follow-up rate of patients Medium High

Number of qualified doctors and clinicians Very High High

Heterogeneous populations High Medium-High

Awareness of ICH GCP guidelines Very High High

Availability of technology to streamline trials Very High Medium-High

Regulatory & ethical issues and barriers Low Low-Medium

Key: Red color = An area of development or current limitation.

ICON’s Clinical Trial Experience in Latin America

CountryOffice

LocationsServices

Current Staff

Staff by 2010


Argentina Buenos

Aires

Clinical Monitoring / Project

Management / Regulatory

Submissions /

Pharmacovigilance

73 145 43

Brazil Sao Paulo Clinical Monitoring / Project


Submissions

33 90 30

Mexico /

Chile /

Peru

Capital

Cities

Clinical Monitoring / Project


Submissions

60 150 >40

Latin America: Opportunities and Challenges

• Opportunities– The seven main Latin American markets add up to 448 million

people with a GDP of US $2.5 trillion in 2006.• Highly concentrated: 70% urban / mega-cities

• Only two main languages

• Counter-season enrollment in Southern Hemisphere

– Led by Mexico, Brazil and Argentina, they are expected to represent a market value of US $52 billion at retail prices by 2011.

Sources: Espicom / PWC

Latin America: Opportunities and Challenges– Between 1995 & 2000, the number of clinical trials executed in the region

rose by a factor of ten.• High quality of medical practice and experienced clinical investigators

• Growing clinical trails sector

– Development of dedicated CT sites, ERBs, SMOs

– Expansion of CROs and Pharma clinical operations

– Availability of GCP/CRA/SC training Courses

– Support services: central labs, CTM logistics, QA consultants

• Challenges

– Regulatory agencies are “stretched” due to lack of resources to meet the clinical trial demand

– Longer regulatory start-up in some countries (e.g., Brazil)

– Evolving regulatory environment– Some agencies are recognizing the need to adapt their regulations harmonization

initiatives, which could enhance the attractiveness of the regionSources: Espicom / PWC

Latin America versus U.S. in Clinical Research

Key Features of a Clinical Trial U.S. Latam

No. of patients across urban life style diseases Medium Medium

No. of patients with tropical diseases Low High

Speed of recruiting patients for trial Low-Medium High

Speed of conducting a trial Medium Medium

Follow-up rate of patients Medium High

Number of qualified doctors and clinicians Very High Medium

Heterogeneous populations High Medium

Awareness of ICH GCP guidelines Very High High

Availability of technology to streamline trials Very High Medium

Regulatory & ethical issues and barriers Low Medium


ICON’s Experience in India and China

CountryOffice

LocationsServices

Current Staff

Projected Staff by

2010


ChinaBeijing /

Hong Kong

Clinical Operations, Regulatory,

Consulting22 130 16

IndiaChennai

Bangalore

Clinical Operations, Data

Management, Biostatistics, IVRS,

Pharmacovigilance, Medical

Imaging

350 550-600 20

China: Opportunities and Challenges

• Opportunities

– Homogenous population of 1.3 billion

– Increasing incidence and prevalence of infectious diseases, cancer, and metabolic disorders

– History of pharmaceutical usage

– Clinical Trial Site Management Regulation enacted in 2004

• Only GCP-certified sites were approved to conduct clinical trials

– Centralized medicine: 80% of medical resources are in large cities

– Strong commercial pharmaceutical market approaching $75 billion by 2010

China: Opportunities and Challenges

• Challenges

– Slow to accept ICH/GCP requirements

– High demand for limited resources

– Inexperienced clinical investigators may under report AEs/SAEs

– Long regulatory approval to initiate clinical trials (6-12 months)

– All regulatory documents must be translated into Chinese and local dialects may be a challenge

– Restricted export of whole blood – Lab analysis and clinical chemistries need to be conducted in the country

– Logistical challenges: Time and costs may be higher than other locations

China versus U.S. in Clinical Research

Key Features of a Clinical Trial U.S. China

No. of patients across urban life style diseases Medium Very High

No. of patients with tropical diseases Low Very High

Speed of recruiting patients for trial Low - Medium Very. High

Speed of conducting a trial Medium Medium

Follow-up rate of patients Medium Medium - High

Number of qualified doctors and clinicians Very High Low - Medium

Heterogeneous populations High Low

Awareness of ICH GCP guidelines Very High Low

Availability of technology to streamline trials Very High Medium

Regulatory & ethical issues and barriers Low High


India: Opportunities and Challenges

• Intellectual Property Changes

– India Patent Act (1970) did not recognize pharmaceutical patents

– India agreed to uphold the Trade-Related Intellectual Property Rights (TRIPS) agreement in 1995 and committed to enforcement by 2005

– Significant expansion of local pharmaceutical and bulk chemical manufacturing

Source: Pharmaceutical Manufacturing and Packing Sourcer, 2006


• Opportunities– Large English speaking Caucasian population (> 1.1 billion)

– Educated and cost-effective workforce

– Nearly 700,000 hospital beds

– 221 Medical colleges

– Robust IT infrastructure

– FDA has accepted data from India in large pivotal trials

– Improving regulatory approval times for study start-up (12-18 weeks)

– $100 million market in 2007 for clinical trials outsourced to India growing to $1.1 - $1.5 billion by 2010

Source: Pharmaceutical Manufacturing and Packing Sourcer, 2006


• Challenges

– Concerns over quality of patient data

– High demand for limited resources and experienced clinical investigators

– Large patient populations are dispersed throughout the country

– Infrastructure across the country is under developed

– Less desirable market place for pharmaceutical companies to commercialize products

• Low health insurance coverage

• Limited consumer purchasing power

• Controlled drug-pricing

• Entrenched generic market

India versus U.S. in Clinical Research

Key Features of a Clinical Trial U.S. India

No. of patients across urban life style diseases Medium Very High

No. of patients with tropical diseases Low Very High

Speed of recruiting patients for trial Low-Medium Very High

Speed of conducting a trial Medium Very High

Follow-up rate of patients Medium Very High

Number of qualified doctors and clinicians Very High Medium – High

Heterogeneous populations High High

Awareness of ICH GCP guidelines Very High Low – Medium

Availability of technology to streamline trials Very High Low - Medium

Regulatory & ethical issues and barriers Low Medium - High


• Case Study:

Study No 2: Phase II/III studyType 2 Diabetes-1 protocol

Diabetes Estimates in Emerging Countries

0 10 20 30 40 50 60 70 80 90 100

Total Number of People with Diabetes (Millions)

Mexico

Egypt

Brazil

Pakistan

China

India

2030

2000

Source: World Health Organization & Contract Pharma, May 2007

Regional Performance

Summary Report- Recruitment

0

100

200

300

400

500

600

Screened: Run-In: Randomized Completed:

No

. Of

Su

bje

cts

United StatesIsrael

ArgentinaIndia

Summary Report- Recruitment

0

100

200

300

400

500

600

Screened: Run-In: Randomized Completed:

No

. Of

Su

bje

cts

United StatesIsrael

ArgentinaIndia

US Israel Argentina India Total

Screened 245 215 239 477 1176

Run-In 106 142 140 305 693

Randomized 46 85 84 181 396

Completed 42 78 74 169 363

• Globalization of clinical trials is accelerating and will continue to develop in regions such as Eastern Europe, Latin America, and Asia-Pacific (India, and China)

• There are many challenges and opportunities that must be addressed as the market matures in these regions

• This represents a huge opportunity for CROs who have a global structure and capability to conduct trials in these regions

• ICON is well positioned in these locations and will continue to expand its global clinical development capabilities to meet our client’s needs

In Conclusion….

Executive Chairman

Dr. John Climax

President


Bill Taaffe

CEO

Peter Gray


Ciaran Murray

ICON Development

Solutions

President

Dr Thomas Frey


Chief Executive

Dr Ted Gastineau


President

Bob Scott-Edwards

VP Corporate QA

Jo Coyle

VP Global IT

Mike McGrath


Development

Anne Wesler

VP Strategic HR

Eimear Kenny


Simon Holmes


Global President

Dr John Hubbard

Commercial VP

Brian O’Dwyer

COO US

Malcolm Burgess

Snr VP Global BD

Elizabeth Thiele


Suzanne Gagnon


Tom O’Leary


President

Sean Leech

CRO Marketplace Dynamics

Elizabeth ThieleSr. Vice PresidentGlobal Business DevelopmentICON Clinical Research

• Increased Number of Strategic Outsourcing Initiatives– Reduced Oversight Models

– Use of Low Cost Regions for Process Rich Services

– Implementation of Alternative Study Execution Methodologies

– Integration of Technology Based Information Management Systems

• Growing Number of Global Projects Across All Market Segments

Why is Growth so High for CROs…

“Large Pharma & Biotech are Searching for Ways to Stretch R&D Funds & Small Biotech/Emerging Pharma are Holding onto the their Assets Longer”

0

200

400

600

800

1,000

1,200

1,400

1,600

1,800

2,000

2003 2004 2005 2006 2007 2008 2009 2010


66

RFP Flow by Market Segment

2007 Volume

500+ RFIs

1100+ RFPs

- 38% Increase / PY

- Program vs. Project

- 32% Multi-Region

67

RFP Value by Market Segment

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

10,000

2003 2004 2005 2006 2007 2008 2009 2010

(in m

illio

ns)


2007 Value

54% Increase / PY

Size of Projects

41 > 20 Million

168 > 5 Million

959 < 5 Million

0

200

400

600

800

1,000

1,200

1,400

1,600

1,800

2,000

2003 2004 2005 2006 2007 2008 2009 2010

Gross US (Gross) EU (Gross) ROW (Gross)

68

RFP Flow by Participating Region

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

10,000

2003 2004 2005 2006 2007 2008 2009 2010

(in m

illio

ns)

Gross US (Gross) EU (Gross) ROW (Gross)

69

RFP Value by Participating Region

• Increased Number of Strategic Outsourcing Initiatives– Reduced Oversight Models

– Use of Low Cost Regions for Process Rich Services

– Implementation of Alternative Study Execution Methodologies

– Integration of Technology Based Information Management Systems

• Growing Number of Global Projects Across All Market Segments

• Incremental Number of Requests for Feasibility Related to Study Design and/or Available Patients

• Greater Demand for Regulatory Support Services

• Overall Demand for “Scientific” Input

Why is Growth so High for CROs…

“With Large Pharma & Biotech Searching for Ways to Stretch R&D Funds & Small Biotech/Emerging Pharma Holding on the their Assests Longer”

• Three-fold Increase in the Number of RFIs Overall & a Specific

Interest in the Universe of Post-approval Services at ICON

• Emerging RFIs Related to “Risk Minimization Action Plan”

Development (starting approximately 1Q07)

• Increased Number of RFIs & 75% Increase in RFPs for 2007

Related to Stand-alone Safety & Pharmacovigilance Work

• Increase in the Number of RFIs & RFPs for Assistance with

Epidemiological Design & Analysis

• Increase in the Number of RFPs for Registries, Particularly

Originating in Europe

Observations in the Post Approval Arena…

Executive Chairman

Dr. John Climax

President


Bill Taaffe

CEO

Peter Gray


Ciaran Murray

ICON Development

Solutions

President

Dr Thomas Frey


Chief Executive

Dr Ted Gastineau


President

Bob Scott-Edwards

VP Corporate QA

Jo Coyle

VP Global IT

Mike McGrath


Development

Anne Wesler

VP Strategic HR

Eimear Kenny


Simon Holmes


Global President

Dr John Hubbard

Commercial VP

Brian O’Dwyer

COO US

Malcolm Burgess

Snr VP Global BD

Elizabeth Thiele


Suzanne Gagnon

VP Global Data

Management

Tom O’Leary


President

Sean Leech

Global Data Management and EDC

Thomas O’LearyVice PresidentGlobal Head of Data ManagementICON Clinical Research

• What is driving Electronic Data Capture (EDC) Adoption– Number of clinical procedures quadrupled in last 20 years– Data more complex, speed of availability is critical– Paper based processes not scalable– 2005: Watershed year for EDC Market

• Two Enterprise-level leaders emerge in the market place

– 2006: Crossing the Chasm• Industry switched their concerns about not being first to not being last

• Where is EDC headed (2008-2011)– Spending expected to exceed $3.1 billion– Average time to deploy study will be halved

EDC Adoption in the Market Place

• Medidata Rave™ (February 2005)– Non-exclusive agreement

• Phase Forward Inform™ (January 2007)– Rave™ and Inform™ dominated 2007 (about 40% of market each)– Allows us to cover the majority of our EDC committed client base

• Oracle Clinical OC RDC™ (Dec 2007)– Oracle have invested heavily in order to establish market share– Specific clients committed due to heritage

• Niche products emerging (eg Phase I, Late Phase/registry trials)– Medidata and Phase Forward specific products for early and late

phase requirements.– ICON has agreed partnerships with two niche providers– ICON extends clinical reach with such providers

• Recognised as CRO who understands optimal use of technology

EDC Capabilities at ICON

EDC Adoption Metrics

• In the last 4 years– ICON has won 6 times as many EDC projects than pre 2003– EDC Wins have more than doubled year on year

• 8 wins in 2004, 17 wins in 2005, 38 wins in 2006, 79 wins 2007

– Requests for proposals featuring EDC comprised about 52% of our portfolio at the end of 2007 (<1% in 2003)

– Currently over 33% of our projects are using EDC, this is projected to reach 45-50% by the end of 2008, 85-90% by 2010

• Current EDC project portfolio– 116 ongoing EDC studies (plus 37 completed studies)

• 77 studies in Medidata Rave™ • 22 studies using Phase Forward Inform™• 17 studies using other EDC systems (client mandated)

Data Management Locations

Dublin

Edinburgh

Marlow

Chennai

Hong Kong

Philadelphia

North Carolina

San Francisco

Position East Coast

WestCoast

Europe India SupportOffices

GlobalTotal

DM Project Managers

31 5 24 3 1 64

Data Coordinators/EDC Analysts

123 14 80 48 0 265

Data EntrySpecialists / EDC

Testers

24 0 6 53 0 83

Medical Coders 3 1 3 2 0 9

DBAs / EDC StudyBuilders

16 4 15 15 2 52

Total Staff 197 24 128 121 3 473

Data Management Headcount

• Databases set up – 96 (EDC = 29%)

• Edit checks programmed – 89,504

• CRF pages processed – 3,189,323 (EDC = 49%)

• DM Queries processed – 352,169

• All Queries processed – 472,206

• Medical terms coded – 437,111

• Databases closed (final) – 67

• Audits Performed – 30

Data Management Metrics 2007

• Electronic Data Capture– Medidata Rave™ (v5.6.1)– Phase Forward InForm™ (v4.5)– Oracle Clinical RDC ® (v4.5.2)

• Oracle Clinical® (v4.0.3, 4.5.1)• DataFax™(v3.7)• Clintrial™ (v4.4)• OptICON (Integic) - CRF Scanning & Workflow Manager• ICONet – Web Portal Application

• ICOSaurus – coding application• SAS (8.2, 9.1.3)• FrameMaker (v8.0) - CRF design, structured (XML)• E-Diaries (CRF Inc & PHT & Invivodata)

Technology & Capabilities

Technology & Capabilities

Integration with other ICON systems

Executive Chairman

Dr. John Climax

President


Bill Taaffe

CEO

Peter Gray


Ciaran Murray

ICON Development

Solutions

President

Dr Thomas Frey


Chief Executive

Dr Ted Gastineau


President

Bob Scott-Edwards

VP Corporate QA

Jo Coyle

VP Global IT

Mike McGrath


Development

Anne Wesler

VP Strategic HR

Eimear Kenny


Simon Holmes


Global President

Dr John Hubbard

Commercial VP

Brian O’Dwyer

COO US

Malcolm Burgess

Snr VP Global BD

Elizabeth Thiele


Suzanne Gagnon


Tom O’Leary


President

Sean Leech

IVR in Clinical Trials & the impact of technology on CR

Malcolm BurgessChief Operating Officer, U.S. OperationsICON Clinical Research

• Interactive Voice Response (IVR)– Interactive Web Response (IWR)

• Utilizes telephone to collect data– Mobile or landline

• Technology used in many different industries– Banking, IT support, etc

• IVR usage in Clinical trials– Been around for 25 years– IWR more recently adopted

• Modern IVR systems integrated with IWR– Allows users to select interface that works best for them

IVR/IWR Defined

• Low cost solution for simple data entry• Enrollment and Randomization

– Prevents over recruitment– Can also be used to recruit patients

• Dispensing pharmaceuticals drugs – according to need or type of clinical trial

• Used to record complete clinical trial data about the recruitment of subjects

• Can be integrated with other tools to manage the clinical study data (CTMS, EDC, etc)

• Maintain a record of drug accountability– Dispensed, used, returned, etc

• Patient Reported Outcomes– Improves Quality and Integrity of data

IVR/IWR in Clinical Trials

• Enrollment– Reduced costs due to over-enrollment of patients

• Randomization– Supports complex randomization and Adaptive trials

• Drug Management– Reduce costs of drug due to less waste

• Patient Report Outcomes– Improve quality and integrity of the data collected

IVR/IWR Cost Saving Advantages

• IVR can be used for Electronic Patient Report

Outcomes (ePRO)– FDA mandates and guidance will drive the number trials

requiring ePRO up significantly

• None of the implementation costs associated with

handheld ePRO solution

• PRO can be submitted using the IVR or IWR

concurrently

• Low cost, Global, Multilingual solution

Electronic Patient Report Outcomes

ICON IVR Metrics

• Current IVR project portfolio– 325 active IVR projects– >650 projects launched since inception in March 2000

• Growth since 2006– 90% increase in per study revenue– 105% increase in total awards

• Staff– 235 global staff– 35 staff in Chennai providing back end support

“200+ ICOPhone dedicated staff worldwide"

ICON Global Reach

Dublin Marlow

Chennai

Philadelphia

Raleigh

Chicago

Houston

• ICON solution (ICOPhone) has been in place for 8 years

• Utilized in over 650 clinical trials

• Integrates with all major CTMS and EDC platforms

• Combines IVR and IWR in a seamless package

• All data is available real-time for decision making

• New technology release– EDGE– Reduce timelines for setup by 50%

ICON Advantage

• Changing the paradigm of Clinical Research– Site Monitors more focused on …

• Site Management• Representing the client rather than monitoring the data

– Data Flow accelerated• Direct data collection from site/patient (eg EDC, ePRO)• On-line (instead of on-site) data review• Majority of query & study management done remotely• Real time data access and decisions (adaptive designs)

– Reduced classical Data Management• No data entry, minimal manual queries – reduced workload• More focus on holistic ‘clinical management’ of the study• More focus on technology, less of a commodity

• But slowly – many still think in the paper paradigm

So where is the technology taking us ……

Executive Chairman

Dr. John Climax

President


Bill Taaffe

CEO

Peter Gray


Ciaran Murray

ICON Development

Solutions

President

Dr Thomas Frey


Chief Executive

Dr Ted Gastineau


President

Bob Scott-Edwards

VP Corporate QA

Jo Coyle

VP Global IT

Mike McGrath


Development

Anne Wesler

VP Strategic HR

Eimear Kenny


Simon Holmes


Global President

Dr John Hubbard

Commercial VP

Brian O’Dwyer

COO US

Malcolm Burgess

Snr VP Global BD

Elizabeth Thiele

Snr VP Global

Medical

Suzanne Gagnon


Tom O’Leary


President

Sean Leech

Developments in Pharmacovigilance

Suzanne GagnonSnr VP Global Medical Affairs & Drug SafetyICON Clinical Research

Since 2004:

Increased emphasis on monitoring safety throughout the product life cycle

– Recent withdrawals of several marketed products

– Increased scrutiny of Regulatory Agencies

– Lack of enforcement of Phase IV commitments

– Impression that FDA was not adequately protecting the public health

– Need to respond

Developments in Pharmacovigilance (PV)

Regulatory Agencies’ Response

• FDA’s– Office of Drug Safety

– Office of Surveillance and Epidemiology

• Task Forces– IOM’s 2006 Report on the Future of Drug Safety – Promoting and

Protecting the Health of the Public

• Guidance Documents

• Risk Management

• European Directive on Pharmacovigilance

• Increased Safety Audits

Pharmaceutical Companies’ Response

• Phase IV clinical trials, observational studies, safety registries

• Data basing of legacy cases

• Risk Minimization Plans (RiskMAPs)– Increased outsourcing

– FSP model for safety

– Total product safety support

• Case processing

• Signal detection and analysis

• Drug Information and product complaints

• Regulatory report writing

ICON’s Response

2004…

Global Headcount: 68

Safety Management: 10

Safety Centers WW:

3

Stand Alone Projects

3

Value Largest Project $350K

2008…

Global Headcount: 392

Safety Management: 28

Safety Centers WW: 5

Stand Alone Projects: 16

Value Largest Project: $ >30M

ICON Global Safety Portfolio 2004

ICON Global Safety Portfolio 2007

ICON’s 2008 Plan for Drug Safety

• Safety Alliance within ICON

– Medical Affairs and Drug Safety (Case Processing)

– Lifecycle Sciences Group (Registries)

– Development Solutions (Consulting)

– Medical Imaging (Endpoints)

– Biostatistics (Signal Detection and Analysis, DSMBs)

– Call Center (Safety Reporting, Drug Information, Product Complaints)

– Regulatory Affairs

• Global Safety Marketing Campaign

• Total Product Safety Solution

Off-shoring to Low Cost Markets 2008

• Only certain clients want low cost options off-shore for PV

• Services to be off-shored vary

– Case processing

– Safety Narratives

– Call Center activities

• Not all PV services off-shored easily

• Technology enables seamless interaction between ICON Safety Centers

• Training within the cultural framework is key

• Currently 48 Medical Affairs and Drug Safety staff in Chennai, India

• Plan to increase to > 100 by end of 2008 as workload increases

Executive Chairman

Dr. John Climax

President


Bill Taaffe

CEO

Peter Gray


Ciaran Murray

ICON Development

Solutions

President

Dr Thomas Frey


Chief Executive

Dr Ted Gastineau


President

Bob Scott-Edwards

VP Corporate

QA

Jo Coyle

VP Global IT

Mike McGrath

VP Corp Training & Development

Anne Wesler

VP Strategic HR

Eimear Kenny


Simon Holmes


Global President

Dr John Hubbard

Commercial VP

Brian O’Dwyer

COO US

Malcolm Burgess

Snr VP Global BD

Elizabeth Thiele


Suzanne Gagnon


Tom O’Leary


President

Sean Leech

Jo CoyleVP Quality AssuranceICON plc

Agenda

ICON’s quality framework and philosophy Internal QA Program Client and Regulatory focus The year ahead

Quality is our Focus

External assessment of ICON’s Global Quality System

• Group registration for the whole company

Annual random surveillance audits across regional offices to monitor

compliance - audit frequency is based on office size and number of services

All new offices independently audited to attain registration

• 2007 audit program

USA: PA, FL, NC, CA-Irvine, CA-Redwood City

Europe: IRL, GER, SWE, RUS, HUN, ROW: South Africa, CAN, MEX*, ARG (*new offices registration audit)

The following accreditations are maintained by ICON Laboratories ISO 17025 CAP accreditation CLIA (New York facility only)

ISO 9001:2000 Registered

Quality is our focus…

ICON Internal QA Audits – 2007

Division US EU ROW Total

ICR 221 154 50 425

ICL 54 22 0 76

IDS 30 220 0 250

IMI 23 0 0 23

Corporate system audits 18 43 28 89

346 439 78 863

Division Sponsor

ICR 148

ICL 41

IDS 31

IMI 18

238

Client, Regulatory and ISO Audits – 2007

…Clients check it…

Office Date Region Auditing Authority Outcome

Redwood City, CA Oct 2003 US FDA No findings (no FDA 483)

New York City, NY Mar/Apr 2005 US FDA No findings (no FDA 483)

North Wales, PA May 2005 US FDA No findings (no FDA 483)

Nashville, TN Oct/Nov 2005 US FDA No findings (no FDA 483)

North Wales, PA Dec 2005 US FDA No findings (no FDA 483)

Nashville, TN Jan 2006 US FDA No findings (no FDA 483)

Eastleigh, UK Oct 2004 EU MHRA No critical findings

Dublin, Ireland Apr 2005 EU IMB No critical findings

Eastleign/Marlow, UK Sept 2007 EU MHRA No critical findings

Frankfurt. Germany Sept 2007 EULocal regulatory authority:

RP DarmstadtNo critical findings

Singapore Oct 2005 ROWHSA - Health Services

Authority of SingaporeNo critical findings

…Regulatory Agents inspect it…

Survey Year Comments

William Blair / PharmaMediation

2004 Top CRO for quality and execution.

CenterWatch Survey of Investigative Sites

2005Top 3 CRO for Investigator relationships and site management.

Frost Sullivan 2006Top 3 CRO for timely database lock and key attributes of overall quality, personnel expertise, therapeutic expertise, and project turnaround.

Frost Sullivan 2007 North American Service Provider of the Year

Thomson CenterWatch and William Blair

2007Vendor you most prefer working with based on quality.

Lehman Brothers 2007 Top CRO for quality of global execution.

SGS – ISO Audit Annual Passed without significant comments since 1992

…and Third Parties validate it…

• Integration of new US Phase I facility into Quality System

• Development of the Quality System in new ICON offices

• New ISO registrations in IMI, Brazil, Bangalore and Italy

• Acquire new MHRA Supplementary accreditation for Phase 1 units

(UK)

• Implementation of electronic QA system - improve efficiency in

internal audit process

• Expansion of audit program in ROW region

Quality plans for the year ahead…

Executive Chairman

Dr. John Climax

President


Bill Taaffe

CEO

Peter Gray


Ciaran Murray

ICON Development

Solutions

President

Dr Thomas Frey


Chief Executive

Dr Ted Gastineau


President

Bob Scott-Edwards

VP Corporate QA

Jo Coyle

VP Global IT

Mike McGrath


Development

Anne Wesler

VP Strategic HR

Eimear Kenny

Group Director Market

Development

Simon Holmes


Global President

Dr John Hubbard

Commercial VP

Brian O’Dwyer

COO US

Malcolm Burgess

Snr VP Global BD

Elizabeth Thiele


Suzanne Gagnon


Tom O’Leary


President

Sean Leech

Thomas FreyPresidentICON Development Solutions

Regulatory Strategy

Development Plan

IND/CTA

Clinical Pharmacology

Proof Of Concept

Expeditious Drug Development – Enhanced Decision Making

Regulatory Strategy

Scientific Consulting

Pre-clinical

CMC

Formulation Development

Target Product Profile


Development Plan

Scientific Consulting

Phase I Development Plan & Protocol Design

Proof Of Concept Study Design

Outline Of Phase II & III

Non-Clinical Development Plan

Cost Of Development


IND/CTA

Regulatory Affairs

Pre-IND Meeting/Regulatory Advice

IND Compilation

Paper & Electronic Submissions

Annual Updates


Clinical Pharmacology

Phase I

Full Range of Regulatory Pharmacokinetic

Special Populations Studies

PK/PD Studies – Pharmacodynamic Models

Bioanalytical & Immunoassay Analysis

PK/PD Analysis, Modeling & Simulations

Data Management, Statistics, Medical Writing


Proof Of Concept

Phase IIa

Planning, Management & Execution Of Targeted Proof of Concept Studies

Bioanalytical & Immunoassay Analysis

PK/PD Analysis, Modeling & Simulations

Data Management, Statistics, Medical Writing


NONMEM - NONlinear Mixed Effects Model-base analyses

– Developed at the University of California, San Francisco

– Licensed to end-users by ICON Development Solutions

– Used worldwide in drug development to quantify exposure (PK) - response (PD) relations in support of internal decision-making and to provide evidence of safety and efficacy for regulatory evaluation.

• ICON Development Solutions provides a proprietary interface

program, PDx-POP, that runs the NONMEM Software Package

in a Windows-like environment.


Anticipated Added Value For Users:

• To improve numerical stability & computational efficiency

• To ease code maintenance

• To add more modern, robust estimation methods

Anticipated Added Value For ICON:

• Intellectual property

• Enhanced pricing

• Visibility and scientific reputation throughout the industry


Global Publishing System• GPS is a validated, 21 CFR Part 11 compliant,

centralized system for the organization, assembly, and dispatch of navigable electronic & paper documents to regulatory agencies

• Changing Regulatory Environment – eCTD “requirement” with FDA (January 2008) and EMEA

(2009)– The UK, NL & Belgian authorities are already

requesting electronic submissions


Submission Source Documents

Document Management System (Documentum)

Publishing Systems (CoreDossier, Insight Publisher)

Submission Sent To Regulatory Authorities (e-Gateway)


Executive Chairman

Dr. John Climax

President


Bill Taaffe

CEO

Peter Gray


Ciaran Murray

ICON Development Solutions

President

Dr Thomas Frey


Chief Executive

Dr Ted Gastineau


President

Bob Scott-Edwards

VP Corporate QA

Jo Coyle

VP Global IT

Mike McGrath


Development

Anne Wesler

VP Strategic HR

Eimear Kenny


Development

Simon Holmes


Global President

Dr John Hubbard

Commercial VP Phase I

Brian O’Dwyer

COO US

Malcolm Burgess

Snr VP Global BD

Elizabeth Thiele


Suzanne Gagnon


Tom O’Leary


President

Sean Leech

Phase I Developments

Brian O’Dwyer, General Manager & Vice President

Manchester Phase I Clinical Research Unit

• Clinical Trial Directive Implementation in 2004

negatively impacted most of UK based CPUs

• Inadequate business development contributed to the

sluggish business

• High value and high risk studies combined with

significant cancellations aggravated the situation

• Imbalance between high science and low business

acumen

Manchester Phase I Clinical Research Unit

Way to Success

• Maintained scientific strengths complemented by

commercial and operational management– Focus on biomarker models incl. imaging techniques, e.g. CNS,

diabetes, CV– Improved volunteer recruitment & study delivery

• Strengthened business development significantly

• Re-branded to ICON Development Solutions and creating

the “quality” brand image with sponsors

• Increased substantially bed utilization and backlog

MEU Collaboration

• Access to hospital based beds for FIM & complex

studies

• Enhanced flexibility through additional bed capacity

• For MEU access to support services e.g. bioanalysis,

DM, PK etc.

• Access to respiratory patients

• Proof of Concept capability

• MEU is quality unit, close proximity to existing facility &

strong reputation in respiratory internationally

• 85 bed clinical research unit in San Antonio, TX

• Experienced team with excellent market reputation

• Clinical pharmacology platform in the US to complement the UK CPU

• Highly synergistic to our existing Development Solutions business and

service offering

• Healthy client base, RFP flow and new business wins

Phase I Acquisition In The US

• Full spectrum of services to support early drug development from

compound selection to proof of concept (and beyond – RA, PK/PD

• Clients may wish to choose individual functional services or the

integrated IDS package: regulatory strategy, development planning,

operational execution, evaluation and reporting

• The IDS business model is unique in our industry. The competition

offers a similar “shopping list”, but lacks the early phase drug

development integration

Development Solutions - Key Differentiators

Executive Chairman

Dr. John Climax

President


Bill Taaffe

CEO

Peter Gray


Ciaran Murray


President

Dr Thomas Frey


Chief Executive

Dr Ted Gastineau


President

Bob Scott-Edwards


Global President

Dr John Hubbard

VP Corporate QA

Jo Coyle

VP Global IT

Mike McGrath


Development

Anne Wesler

VP Strategic HR

Eimear Kenny


Development

Simon Holmes

Commercial VP

Brian O’Dwyer

COO US

Malcolm Burgess

Snr VP Global BD

Elizabeth Thiele


Suzanne Gagnon


Tom O’Leary


President

Sean Leech

Robert Scott - EdwardsPresident ICON Central Laboratory

ICON Central Laboratories - Quick Facts:

• 425 staff in 4 Labs – NY, NJ, Dublin, Singapore

• 528 active studies Backlog >$126m

• Won 284 studies in 2007 (Strike rate = 48%)

• Built >600,000 kits in 2007

• Resulted >8,000,000 tests in 2007

• 87% of New Business is repeat

• 70% Clients say we are the best CL! (26%=same!)

Drivers of the Business:

• The search for subjects…– USA remains strong– Classic Europe remains steady– New Europe still growing very strongly– Asia/Pacific showing good growth/high interest

• More complex testing required…– More than just “safety testing”– Biomarkers and esoteric testing

Our Challenges:

• LOGISTICS– Getting a sample into a Laboratory; TIME/COST

• BROADENING MENU of TESTING– New technology, investment, having scale & mass

• FLEXIBLE IT system to support global activity– Data is what we deliver– From a global platform– Serviced & supported 24/7

STRATEGY:

• Expand Network to support market growth– Additional testing in Singapore: June 2008– New Laboratory in India: September

2008– Strengthen partnership in China: Ongoing

• Expand technology base to meet market demand– Ongoing: Example: Flow Cytometry network

• Upgrade IT systems to support business– Ongoing: Pilot phase successful

Global Flow Cytometry:

• Standardized analyzers (BD)

• Custom reagents from central source

• Link all cytometers to central hub for analysis/gating

• Build EDC system and give Client access

• FC is key for Oncology, Immunology, Cell Signaling

• NY, Dublin, Singapore, Japan, Argentina, India

• The challenge in meeting

Client demand for more

complex testing is simple:

VOLUME!

• Unlike Bioanalytical work in

the phase I arena, CL testing

is not batch-oriented.

• Margin comes from being

adept at managing volume.

• Volume, Informatics, Agility -2

0

2

4

6

8

Volume

Margin

Critical Success Factors:

• Global Coverage is essential…– USA, Europe, China, India, Asia/Pacific– Strong Logistics skills

• Broad Test Menu is essential…– 65% of testing is esoteric– Rapid deployment of technology on global scale

• Flexible IT system is essential…– Information to support proactive management– Global data & 24/7 Customer Support

Executive Chairman

Dr. John Climax

President


Bill Taaffe

CEO

Peter Gray


Ciaran Murray


President

Dr Thomas Frey


Chief Executive

Dr Ted Gastineau


President

Bob Scott-Edwards

VP Corporate QA

Jo Coyle

VP Global IT

Mike McGrath


Development

Anne Wesler

VP Strategic HR

Eimear Kenny


Development

Simon Holmes


Global President

Dr John Hubbard

Commercial VP

Brian O’Dwyer

COO US

Malcolm Burgess

Snr VP Global BD

Elizabeth Thiele


Suzanne Gagnon


Tom O’Leary


President

Sean Leech

Ted GastineauCEOICON Medical Imaging

Medical Imaging

• ICON Medical Imaging is focused on medical imaging endpoints for the development of pharmaceutical, biotech, and medical device products.

• Our industry leading technology enables clients through digital asset management, real time information access, and knowledge management.

Medical Imaging

• X-Ray, MRI, CT, Nuclear

Medicine, PET, Ultrasound,

Video, Photography

• Imaging shows how drugs

work inside the body

• Medical Imaging in clinical

trials is growing across

Phase I, II, III and IV

PET Movie

Medical Imaging

• Why?– See and measure structure and

function– Dose effects, target effects, side

effects– Better information faster

– Phase I: Internal decision making/ Compound screening

– Phase II: Dose, Safety, Efficacy, Accelerated Approval

– Phase III: Surrogate Endpoint, Disease Modifying Effect, Safety, Efficacy

Medical Imaging

• FDA Continues to Accept and Promote Imaging

• Critical Path: Janet Woodcock, MD Deputy Director, CMO FDA– “Imaging technologies are currently very important, and will become

even more crucial to therapeutic development”– “FDA, under its critical path initiative, is seeking to advance

development of these imaging biomarkers in an organized fashion”

• Oncology Guidance Document: updated May 2007– Supports the use of Objective Response Rate and Progression

Free Survival…all are imaging based endpoints– “When the study endpoint is based on tumor measurements (e.g.,

PFS or ORR), tumor endpoint assessments should be verified by central reviewers blinded to study treatments”

Medical Imaging

Genentech Clears Hurdle On Cancer Drug AvastinBy MARILYN CHASE and ANNA WILDE MATHEW Wall St Journal February 23, 2008; Page A3

– Accelerated approval based on Progression Free Survival– Independent Review of Imaging data was key

– "We are very confident of the effect of this drug on progression-free survival." said Richard Pazdur, director of the FDA's office of oncology-drug products.”

– “Dr. Pazdur said the Avastin decision didn't represent a shift for the agency, which has considered progression-free survival in a number of other approvals. "We're not boxed in to a survival-only mentality," he said. "We have to demonstrate regulatory flexibility."

Medical Imaging

• Therapeutic Initiatives– Oncology: 40% - 70%– Cardiovascular 40%– CNS: 10%-20%– Musculoskeletal: – Gastrointestinal: – Dermatology:

Medical Imaging

• Cardiac Safety– Cardiovascular function with

CT, MR, Nuclear Med, US, Angio

– Echo growing as measure of cardiac function

– Integrated offering differentiates ICON

– Adjudication of Cardiac Events powered by IMI technology (MIRA)

– Key academic relationships: Harvard, Duke, Cleveland Clinic, UCSF, Oxford (UK)

Medical Imaging

Medical Imaging

Medical Imaging

• Technology– MIRA ™

IMI’s leading image management/project tracking platform• Complete workflow• 24/7 access to images and information• Real time data

– SpeedTrial™IMI’s validated cancer review application

• Image display and analysis• Linked in electronic case report form• Ready to Read in as little as 2 weeks

– Image Knowledge Expert (IKE™)• Image based Educational/Information Portal• Built for Major Pharma• Available for clients and projects

Meta Data Image Storage

Computational Platform: HW-OS

Algorithms

Image Data

Standardization

Common Back-plane

QueryIdentify

RetrieveProcess

Project Management

Clinical DBLegacy Data

Sales and Marketing

User

PET User

MRI User

Remote User

Query

Retrieve Images or Information

Browser Interface

SERIES

STUDIES

PR

OT

OC

OL

S

SIT

ES

CA

SE

S CO

DE

S

Task Lists (Work Flows)

PR

OT

OC

OL

S

FILTERS

TASK LISTS

SERIES FOR PROCESSING

CODES FOR PROCESSING

Sean LeechPresident ICON Contracting Solutions

MARKET DEVELOPMENTS & DEFINITION

Staffing Industry Definition

The staffing industry can be broadly defined as a collection of

business that provides organisations and individuals with a range

of employment related services. The industry has evolved from

what was once very discreet types of businesses, for example

temporary hire, retained search, permanent placement, contract

project staffing and professional employer organizations (PEO) into

one industry with many sectors with the lines of demarcation

blurring as the industry develops further.

DEFINITION

• Shift in Business Models– Temporary to Permanent– Contract Teams– FSP– VMS– Unique Projects

• A Move to Full Service

• Global Positioning

• Fewer Vendors Consolidation(i3, KForce, Kelly, RPS, Inventiv)

• Candidate Acceptance

Move to scale & flexible solutions

MARKET DEVELOPMENTS

MARKET SCALE

WORLD STAFFING MARKETCountry US$B

USA 119.9

Europe

UK 47.8

France 25.3

Germany 10.6

Netherlands 10.2

Switzerland 5.1

Sweden 1.6

Denmark 1.0

Norway 0.9

Finland 0.9

ROW

Japan 26.2

China 2.7

South Africa 2.2

Clinical Staffing Market 2004-206E

0

0.5

1

1.5

2

2.5

3

3.5

2004 2005E 2006E

US

$ B

illi

on

s

Source: CenterwWatch October 2005

CLINICAL STAFFING MARKET

MARKET SPLIT

Regional Clinical Staffing Market Breakdown of Market

ROW 12%

EU 44%

US 44%

75%Temporary Help

15%Place and Search

9%Insourcing

1% Staff leasing

0%

1%

2%

3%

4%

5%

6%

UK

Nether

lands

Belgiu

mUSA

France

Finla

nd

South A

frica

Switz

erla

ndJa

pan

Irela

nd

Ger

man

y

Swed

en

Norway

Spain

Denm

ark

Italy

Poland

China

TEMPORARY STAFF PENATRATION RATES

ICS COVERAGE

INDUSTRY SECTOR GROWTH US 2005

11.50%

-5.00%

8.50%

25.40%

9.70%

-10.00% 0.00% 10.00% 20.00% 30.00%

Total Staffing Industry

Outplacement

PEO/Staff Leasing

Place & Search

Temporary Help

OUR GROWTH

2007 2008

Growth

EUROPE $30m €45m 50%

USA $16m €20m

25%

TOTAL ICS $46m €65m

41%

• Leverage centralised cost/management infrastructure.

• Project/Multiple assignment focus = reduced business/candidate acquisition cost.

• Layered in permanent placement revenue.

• Value added service – More $ same client.

• Candidate market therefore pricing is favourable.

Average Operating Margin

excess 15% within 2 years

OUR MARGIN OPPORTUNITY

STRATEGY

• Full Range of Staffing Services

• Global Infrastructure– Greater scale required in the US; acquisition a

possibility

• Flexible Solutions

STRATEGY

ICON CONTRACTING SOLUTIONS – INTERNATIONAL, NOT YET GLOBAL

SwedenDenmarkFinlandNetherlandsPolandGermany x2BelgiumFranceUK x3

New YorkNorth CarolinaTampa

PERMANENT PLACEMENT

CONTRACT PLACEMENT

FLEXIBILITYTRAINING

FROM ONE ASSIGNMENT TO INTEGRATED STRATEGIC INSOURCING

Permanent Placement

- Executive Search

- Search and Selection

- Basic Search

- Advertising

- Assessments

Contract Placement

- Project based

- Project or functional teams

- Vacancy Management

- Interim Management

- Administration

Training

- Traineeships

- Coaching

- Training and Education

STRATEGIC STAFFING SOLUTION

ICS is the staffing arm of ICON, providing

flexible staffing solution to the Pharma

Industry on an International basis

SUMMARY