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Corporate Development

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Presentation on theme: "Corporate Development"— Presentation transcript:

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2 Corporate Development
Executive Chairman Dr. John Climax President Corporate Development Bill Taaffe CEO Peter Gray Chief Financial Officer Ciaran Murray ICON Development Solutions Dr Thomas Frey ICON Medical Imaging Chief Executive Dr Ted Gastineau ICON Central Laboratories 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 Sean Leech

3 CEO Peter Gray Chief Financial Officer Executive Chairman
Dr. John Climax CEO Peter Gray ICON Central Laboratories President Bob Scott-Edwards ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray President Corporate Development Bill Taaffe COO US Malcolm Burgess Snr VP Global BD Elizabeth Thiele Snr VP Global Medical Suzanne Gagnon VP Global Data Management Tom O’Leary VP Corporate QA Jo Coyle Commercial VP Brian O’Dwyer ICON Medical Imaging Chief Executive Dr Ted Gastineau VP Global IT Mike McGrath VP Strategic HR Eimear Kenny VP Corporate Training & Development Anne Wesler VP Market Development Simon Holmes

4 Forward Looking Statements
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.

5 Global Full Service Clinical Development
EU 38% Q4 Revenue by Region ROW 9% US 53%

6 ICON’s Global Clinical Footprint
North America 2 Countries 17 Offices >1,900 Staff Eastern Europe / Russia 8 Countries 9 Offices > 350 Staff Japan 1 Country 2 Offices >80 Staff Western Europe / Africa 10 Countries 13 Offices >1,600 Staff Asia Pacific 8 Countries 10 Offices >450 Staff Breakdown North America Latin America 5 Countries 5 Offices >170 Staff Projects in 60+ Countries

7 Market Environment

8 Continued R&D Spending Growth. Increased Outsourcing
Strong Market Environment with... 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 Increasing Regulation due to: The Number of Studies required to be performed Stricter monitoring of compliance Increasing safety studies 5

9 Preclinical Compounds in Development
The Pipeline continued to fill in 2007 Up ≈ 23% Source: Pharmaprojects

10 Phase I Compounds in Development
The Pipeline continued to fill in 2007 Up ≈ 22% Source: Pharmaprojects

11 Phase II/III Compounds in Development
The Pipeline continued to fill in 2007 Up ≈ 14% Source: Pharmaprojects

12 US Biotech Funding Environment continued to grow
Biotech fundraising (excluding debt financing) $Billion Source: Burrill and Company

13 ICON in this Market Environment

14 Gross RFP Value by Market Segment
(Including RFPs that never progress to award) RFP Value by Market Segment 2007 Value 54% Increase / PY Size of Projects 41 > 20 Million 168 > 5 Million 959 < 5 Million 14

15 Strong RFP volume growth, with increasing average proposal value…

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

17 Overall, Strong Gross Business wins has led to…
ICON Gross Business Wins - Last 10 Quarters ($ millions)

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

19 …leading to record Total Backlog levels. ($ millions)
Up 38% YoY Up 49% YoY

20 From this backlog, coverage of next 4 quarters revenues is robust……..
% coverage of next 4 quarters forecast revenues Value of backlog forecast to be earned in next 4 quarters

21 2007 - New Business by Customer Segment
This has led to a diversified customer base…… Client Diversity 2005, 2006, 2007 Amgen is 9.9% Client New Business by Customer Segment

22 Revenue by Therapeutic Area 2007
….and broad therapeutic expertise. Revenue by Therapeutic Area 2007

23 Strategy

24 ICON’s Core Strategy is Organic Growth, with acquisitions made to add new services or scale.
Acquisitions to date - 11 Revenues acquired $114m Staff acquired – 1,100 => Organic growth >80% 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

25 Strategic v Tactical Outsourcing
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

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27 Chief Financial Officer Ciaran Murray
Executive Chairman Dr. John Climax CEO Peter Gray ICON Central Laboratories President Bob Scott-Edwards ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray President Corporate Development Bill Taaffe COO US Malcolm Burgess Snr VP Global BD Elizabeth Thiele Snr VP Global Medical Suzanne Gagnon VP Global Data Management Tom O’Leary VP Corporate QA Jo Coyle Commercial VP Brian O’Dwyer ICON Medical Imaging Chief Executive Dr Ted Gastineau VP Global IT Mike McGrath VP Strategic HR Eimear Kenny VP Corporate Training & Development Anne Wesler VP Market Development Simon Holmes

28 Net Revenue CAGR of over 30% since 2002 22% Forecast for ‘08
* Mid Point of 2008 Guidance issued December, 2007

29 Earnings Per Share Growth
CAGR 26% (E) * Mid Point of 2008 Guidance issued December 2007

30 Recent Financial Performance ($ millions, except EPS; includes stock option expense)
Q4 ’07 Q4 ’06 % Increase Net Revenue 181 129 40% Direct Costs 100 73 37% SG & A 55 38 45% D & A 5 4 _____ Operating Income 20 14 43% Operating Margin 11% 10.7% Net Income 16 11 EPS (Inc SFAS123R) 53c 39c 36% Weighted Average no. of Shares (Inc SFAS123R) 29.9m 29.1m 2.7% Q3, ’06 is to September ’06 Q3, PY is to August ’05 Change of Financial Year as at December 2005.

31 Recent Financial Performance ($ millions)
FY2007 FY2006 % Increase Net Revenue 631 456 38% Direct Costs 355 256 SG & A 188 137 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% YTD PY excludes one time charge of US$11.5m due to: Lease termination in US Write-off of Lab Goodwill.

32 Approx. 25% of ICON’s business is generating single digit margins
Margin improvement is a key focus 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” Increasing Regulation due to: The Number of Studies required to be performed Stricter monitoring of compliance Increasing safety studies 5

33 Summary Balance Sheet and Cash Flow ($ millions)
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 $11.7 $51.5 $42.9 Capital expenditures $15.6 $12.1 $31.5 $75.4 CAPEX Excl. Dublin Extn. $20.4 $36.8 Shares outstanding 27.8 28.0 28.5 28.8

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35 ICON Clinical Research Global President Dr John Hubbard
Executive Chairman Dr. John Climax President Corporate Development Bill Taaffe CEO Peter Gray Chief Financial Officer Ciaran Murray ICON Development Solutions Dr Thomas Frey ICON Medical Imaging Chief Executive Dr Ted Gastineau ICON Central Laboratories 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 Sean Leech

36 The Globalisation of Clinical Research:
Challenges and Opportunities in Argentina, Brazil, Russia, China and India John W. Hubbard, Ph.D., FCP Global President, ICON Clinical Research

37 Products in Development by Therapeutic Area
Source – BioPharmInsight.com, 2007

38 Pharma & Device Industry Challenges
Trend Driver Cost per patient Treatment naïve patients Cost per trial Cost per investigator Qualified investigators Cost of clinical development Complexity of protocols Number of procedures, and type of inclusion/ exclusion criteria Infrastructure cost Number and size of trials Regulatory requirements Global trend for higher costs, more patients and experienced clinical investigators! Source McKinsey 2004

39 Why Conduct Global Clinical Trials?
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 PharmafocusAsia, 2005

40 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

41 ICON’s Global Clinical Footprint
Eastern Europe / Russia 8 Countries 9 Offices 339 Staff North America 2 Countries 17 Offices 1896 Staff Japan 1 Country 2 Offices 72 Staff Western Europe / Africa 10 Countries 13 Offices 1554 Staff Breakdown North America Asia Pacific 8 Countries 10 Offices 448 Staff Latin America 5 Countries 5 Offices 166 Staff Projects in 60+ Countries

42 Key Countries for Clinical Trials Based on the Overall Country Attractiveness Index1
6.88 4.90 5.26 5.55 5.58 6.10 1A.T. Kearney Attractiveness Index , Pharmaceutical Executive Supplement, 2006

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

44 ICON’s Clinical Trial Experience in Russia
Country Office Locations Services Current Staff Staff by 2010 Number of Ongoing Studies Russia Moscow / Novosibirsk Clinical Operations, Regulatory/EC/submissions, >80 ~50

45 Russia: Opportunities and Challenges
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

46 Key Features of a Clinical Trial
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 Speed of recruiting patients for trial Low-Medium Very High Speed of conducting a trial Follow-up rate of patients Number of qualified doctors and clinicians Heterogeneous populations Medium-High Awareness of ICH GCP guidelines Availability of technology to streamline trials Regulatory & ethical issues and barriers Key: Red color = An area of development or current limitation.

47 ICON’s Clinical Trial Experience in Latin America
Country Office Locations Services Current Staff Staff by 2010 Number of Ongoing Studies Argentina Buenos Aires Clinical Monitoring / Project Management / Regulatory Submissions / Pharmacovigilance 73 145 43 Brazil Sao Paulo Clinical Monitoring / Project Management / Regulatory Submissions 33 90 30 Mexico / Chile / Peru Capital Cities 60 150 >40

48 Latin America: Opportunities and Challenges
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

49 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 region Sources: Espicom / PWC

50 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 No. of patients with tropical diseases Low High Speed of recruiting patients for trial Low-Medium Speed of conducting a trial Follow-up rate of patients Number of qualified doctors and clinicians Very High Heterogeneous populations Awareness of ICH GCP guidelines Availability of technology to streamline trials Regulatory & ethical issues and barriers Key: Red color = An area of development or current limitation.

51 ICON’s Experience in India and China
Country Office Locations Services Current Staff Projected Staff by 2010 Number of Ongoing Studies China Beijing / Hong Kong Clinical Operations, Regulatory, Consulting 22 130 16 India Chennai Bangalore Clinical Operations, Data Management, Biostatistics, IVRS, Pharmacovigilance, Medical Imaging 350 20

52 China: Opportunities and Challenges
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

53 China: Opportunities and 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

54 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 Speed of recruiting patients for trial Low - Medium Very. High Speed of conducting a trial Follow-up rate of patients Medium - High Number of qualified doctors and clinicians Heterogeneous populations High Awareness of ICH GCP guidelines Availability of technology to streamline trials Regulatory & ethical issues and barriers Key: Red color = An area of development or current limitation.

55 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

56 India: Opportunities and Challenges
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

57 India: Opportunities and 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

58 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 Speed of recruiting patients for trial Low-Medium Speed of conducting a trial Follow-up rate of patients Number of qualified doctors and clinicians Medium – High Heterogeneous populations High Awareness of ICH GCP guidelines Low – Medium Availability of technology to streamline trials Low - Medium Regulatory & ethical issues and barriers Medium - High Key: Red color = An area of development or current limitation.

59 Case Study: Study No 2: Phase II/III study Type 2 Diabetes-1 protocol
Merck – Project Manager - Melissa Atrip Time lines were extended but ICON finished the project within that timeline (or earlier) and met all other clients expectations. The reason for extended timeline was because Merck team had never outsourced a study before so they were reluctant to ‘let go’ until we won their trust. Merck subsequently outsourced 2 other studies to us utilizing the same ICON team.

60 Diabetes Estimates in Emerging Countries
Source: World Health Organization & Contract Pharma, May 2007

61 Regional Performance US Israel Argentina India Total Screened 245 215
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

62 In Conclusion…. 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

63 Snr VP Global BD Elizabeth Thiele
Executive Chairman Dr. John Climax CEO Peter Gray ICON Central Laboratories President Bob Scott-Edwards ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray President Corporate Development Bill Taaffe VP Corporate QA Jo Coyle COO US Malcolm Burgess Commercial VP Brian O’Dwyer ICON Medical Imaging Chief Executive Dr Ted Gastineau VP Global IT Mike McGrath Snr VP Global BD Elizabeth Thiele VP Strategic HR Eimear Kenny VP Corporate Training & Development Anne Wesler Snr VP Global Medical Suzanne Gagnon VP Market Development Simon Holmes VP Global Data Management Tom O’Leary

64 CRO Marketplace Dynamics
Elizabeth Thiele Sr. Vice President Global Business Development ICON Clinical Research

65 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” 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

66 RFP Flow by Market Segment
2007 Volume 500+ RFIs 1100+ RFPs - 38% Increase / PY - Program vs. Project - 32% Multi-Region 66

67 RFP Value by Market Segment
54% Increase / PY Size of Projects 41 > 20 Million 168 > 5 Million 959 < 5 Million 67

68 RFP Flow by Participating Region
68

69 RFP Value by Participating Region
69

70 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” 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

71 Observations in the Post Approval Arena…
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

72 VP Global Data Management Tom O’Leary
Executive Chairman Dr. John Climax CEO Peter Gray ICON Central Laboratories President Bob Scott-Edwards ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray President Corporate Development Bill Taaffe VP Corporate QA Jo Coyle COO US Malcolm Burgess Commercial VP Brian O’Dwyer ICON Medical Imaging Chief Executive Dr Ted Gastineau VP Global IT Mike McGrath Snr VP Global BD Elizabeth Thiele VP Strategic HR Eimear Kenny Snr VP Global Medical Suzanne Gagnon VP Corporate Training & Development Anne Wesler VP Global Data Management Tom O’Leary VP Market Development Simon Holmes

73 Global Data Management and EDC
Thomas O’Leary Vice President Global Head of Data Management ICON Clinical Research

74 EDC Adoption in the Market Place
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 ( ) Spending expected to exceed $3.1 billion Average time to deploy study will be halved

75 EDC Capabilities at ICON 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

76 Current EDC project portfolio
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)

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78 Data Management Locations
Edinburgh Dublin San Francisco Marlow Philadelphia Hong Kong North Carolina Chennai

79 Data Management Headcount
Position East Coast West Europe India Support Offices Global Total DM Project Managers 31 5 24 3 1 64 Data Coordinators /EDC Analysts 123 14 80 48 265 Data Entry Specialists / EDC Testers 6 53 83 Medical Coders 2 9 DBAs / EDC Study Builders 16 4 15 52 Total Staff 197 128 121 473

80 Data Management Metrics 2007
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

81 Technology & Capabilities
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) January ICON signed an agreement with Phase Forward and will provide our clients the option of using the InForm solution in trials.

82 Technology & Capabilities
Integration with other ICON systems

83 COO US Malcolm Burgess Executive Chairman Dr. John Climax CEO
Peter Gray ICON Central Laboratories President Bob Scott-Edwards ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray President Corporate Development Bill Taaffe VP Corporate QA Jo Coyle COO US Malcolm Burgess Commercial VP Brian O’Dwyer ICON Medical Imaging Chief Executive Dr Ted Gastineau VP Global IT Mike McGrath VP Strategic HR Eimear Kenny Snr VP Global BD Elizabeth Thiele VP Corporate Training & Development Anne Wesler Snr VP Global Medical Suzanne Gagnon VP Market Development Simon Holmes VP Global Data Management Tom O’Leary

84 IVR in Clinical Trials & the impact of technology on CR
Malcolm Burgess Chief Operating Officer, U.S. Operations ICON Clinical Research

85 Interactive Voice Response (IVR) Utilizes telephone to collect data
IVR/IWR Defined 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

86 IVR/IWR in Clinical Trials 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

87 Patient Report Outcomes
IVR/IWR Cost Saving Advantages 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

88 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

89 Current IVR project portfolio
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

90 ICON Global Reach “200+ ICOPhone dedicated staff worldwide" Dublin
Marlow Chicago Philadelphia Houston Raleigh Chennai “200+ ICOPhone dedicated staff worldwide"

91 ICON solution (ICOPhone) has been in place for 8 years
ICON Advantage 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%

92 So where is the technology taking us ……
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

93 Snr VP Global Medical Suzanne Gagnon
Executive Chairman Dr. John Climax CEO Peter Gray ICON Central Laboratories President Bob Scott-Edwards ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray President Corporate Development Bill Taaffe VP Corporate QA Jo Coyle COO US Malcolm Burgess Commercial VP Brian O’Dwyer ICON Medical Imaging Chief Executive Dr Ted Gastineau VP Global IT Mike McGrath Snr VP Global BD Elizabeth Thiele VP Strategic HR Eimear Kenny Snr VP Global Medical Suzanne Gagnon VP Corporate Training & Development Anne Wesler VP Market Development Simon Holmes VP Global Data Management Tom O’Leary

94 Developments in Pharmacovigilance
Suzanne Gagnon Snr VP Global Medical Affairs & Drug Safety ICON Clinical Research

95 Developments in Pharmacovigilance (PV)
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

96 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

97 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

98 ICON’s Response 2004… 2008… Global Headcount: 68 Safety Management: 10
Safety Centers WW: Stand Alone Projects Value Largest Project $350K 2008… Global Headcount: Safety Management: Safety Centers WW: Stand Alone Projects: Value Largest Project: $ >30M

99 ICON Global Safety Portfolio 2004

100 ICON Global Safety Portfolio 2007

101 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

102 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

103 VP Corporate QA Jo Coyle
Executive Chairman Dr. John Climax CEO Peter Gray ICON Central Laboratories President Bob Scott-Edwards ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray President Corporate Development Bill Taaffe VP Corporate QA Jo Coyle COO US Malcolm Burgess Commercial VP Brian O’Dwyer ICON Medical Imaging Chief Executive Dr Ted Gastineau Snr VP Global BD Elizabeth Thiele VP Global IT Mike McGrath Snr VP Global Medical Suzanne Gagnon VP Strategic HR Eimear Kenny VP Corp Training & Development Anne Wesler VP Global Data Management Tom O’Leary VP Market Development Simon Holmes

104 Jo Coyle VP Quality Assurance ICON plc

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

106 Quality is our Focus

107 External assessment of ICON’s Global Quality System
ISO 9001:2000 Registered 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)

108 ICON Internal QA Audits – 2007
Quality is our focus… ICON Internal QA Audits – 2007 Division US EU ROW Total ICR 221 154 50 425 ICL 54 22 76 IDS 30 220 250 IMI 23 Corporate system audits 18 43 28 89 346 439 78 863

109 …Clients check it… Client, Regulatory and ISO Audits – 2007 Division
Sponsor ICR 148 ICL 41 IDS 31 IMI 18 238

110 …Regulatory Agents inspect 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 North Wales, PA May 2005 Nashville, TN Oct/Nov 2005 Dec 2005 Jan 2006 Eastleigh, UK Oct 2004 EU MHRA No critical findings Dublin, Ireland Apr 2005 IMB Eastleign/Marlow, UK Sept 2007 Frankfurt. Germany Local regulatory authority: RP Darmstadt Singapore Oct 2005 ROW HSA - Health Services Authority of Singapore

111 …and Third Parties validate it…
Survey Year Comments William Blair / PharmaMediation 2004 Top CRO for quality and execution. CenterWatch Survey of Investigative Sites 2005 Top 3 CRO for Investigator relationships and site management. Frost Sullivan 2006 Top 3 CRO for timely database lock and key attributes of overall quality, personnel expertise, therapeutic expertise, and project turnaround. 2007 North American Service Provider of the Year Thomson CenterWatch and William Blair Vendor you most prefer working with based on quality. Lehman Brothers Top CRO for quality of global execution. SGS – ISO Audit Annual Passed without significant comments since 1992 Welcome and retention kits include diabetes educational materials such as cook books, water bottle, running socks, pedometer with BMS on it (because diet and exercise will be part of lifestyle modification), Blockbuster video cards (because away from their families due to intensive visit schedule), etc. Site Staff Acknowledgments include nursing book, conference attendance, etc.

112 Integration of new US Phase I facility into Quality System
Quality plans for the year ahead… 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

113 ICON Development Solutions President Dr Thomas Frey
Executive Chairman Dr. John Climax CEO Peter Gray ICON Central Laboratories President Bob Scott-Edwards ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray President Corporate Development Bill Taaffe VP Corporate QA Jo Coyle COO US Malcolm Burgess ICON Medical Imaging Chief Executive Dr Ted Gastineau VP Global IT Mike McGrath Commercial VP Brian O’Dwyer Snr VP Global BD Elizabeth Thiele VP Strategic HR Eimear Kenny Snr VP Global Medical Suzanne Gagnon VP Corporate Training & Development Anne Wesler VP Global Data Management Tom O’Leary Group Director Market Development Simon Holmes

114 Thomas Frey President ICON Development Solutions

115 Clinical Pharmacology
Expeditious Drug Development – Enhanced Decision Making Regulatory Strategy Development Plan IND/CTA Clinical Pharmacology Proof Of Concept

116 Scientific Consulting Pre-clinical CMC Formulation Development
Expeditious Drug Development – Enhanced Decision Making Regulatory Strategy Scientific Consulting Pre-clinical CMC Formulation Development Target Product Profile

117 Scientific Consulting Phase I Development Plan & Protocol Design
Expeditious Drug Development – Enhanced Decision Making 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

118 Pre-IND Meeting/Regulatory Advice IND Compilation
Expeditious Drug Development – Enhanced Decision Making IND/CTA Regulatory Affairs Pre-IND Meeting/Regulatory Advice IND Compilation Paper & Electronic Submissions Annual Updates

119 Clinical Pharmacology
Expeditious Drug Development – Enhanced Decision Making 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

120 Planning, Management & Execution Of Targeted Proof of Concept Studies
Expeditious Drug Development – Enhanced Decision Making 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

121

122 NONMEM - NONlinear Mixed Effects Model-base analyses
Expeditious Drug Development – Enhanced Decision Making 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.

123 Anticipated Added Value For Users: Anticipated Added Value For ICON:
Expeditious Drug Development – Enhanced Decision Making 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

124 Global Publishing System
Expeditious Drug Development – Enhanced Decision Making 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

125 Expeditious Drug Development – Enhanced Decision Making
Submission Source Documents Document Management System (Documentum) Publishing Systems (CoreDossier, Insight Publisher) Submission Sent To Regulatory Authorities (e-Gateway)

126 Commercial VP Phase I Brian O’Dwyer
Executive Chairman Dr. John Climax CEO Peter Gray ICON Central Laboratories President Bob Scott-Edwards ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray President Corporate Development Bill Taaffe VP Corporate QA Jo Coyle COO US Malcolm Burgess Commercial VP Phase I Brian O’Dwyer ICON Medical Imaging Chief Executive Dr Ted Gastineau VP Global IT Mike McGrath Snr VP Global BD Elizabeth Thiele VP Strategic HR Eimear Kenny Snr VP Global Medical Suzanne Gagnon VP Corporate Training & Development Anne Wesler VP Global Data Management Tom O’Leary Group Director Market Development Simon Holmes

127 Phase I Developments Brian O’Dwyer, General Manager & Vice President

128 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

129 Strengthened business development significantly
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

130 Access to hospital based beds for FIM & complex studies
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

131 Phase I Acquisition In The US
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

132 Development Solutions - Key Differentiators
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

133 ICON Central Laboratories President Bob Scott- Edwards
Executive Chairman Dr. John Climax CEO Peter Gray ICON Central Laboratories President Bob Scott- Edwards ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray President Corporate Development Bill Taaffe VP Corporate QA Jo Coyle VP Global IT Mike McGrath VP Corporate Training & Development Anne Wesler VP Strategic HR Eimear Kenny Group Director Market Development Simon Holmes COO US Malcolm Burgess Commercial VP Brian O’Dwyer ICON Medical Imaging Chief Executive Dr Ted Gastineau Snr VP Global BD Elizabeth Thiele Snr VP Global Medical Suzanne Gagnon VP Global Data Management Tom O’Leary

134 Robert Scott - Edwards President ICON Central Laboratory

135 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!)

136 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

137 BROADENING MENU of 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

138 Expand Network to support market growth
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

139 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

140 Margin comes from being adept at managing volume.
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 2 4 6 8 Volume Margin

141 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

142 ICON Medical Imaging Chief Executive Dr Ted Gastineau
Executive Chairman Dr. John Climax CEO Peter Gray ICON Central Laboratories President Bob Scott-Edwards ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray President Corporate Development Bill Taaffe VP Corporate QA Jo Coyle COO US Malcolm Burgess Commercial VP Brian O’Dwyer ICON Medical Imaging Chief Executive Dr Ted Gastineau VP Global IT Mike McGrath Snr VP Global BD Elizabeth Thiele VP Strategic HR Eimear Kenny Snr VP Global Medical Suzanne Gagnon VP Corporate Training & Development Anne Wesler VP Global Data Management Tom O’Leary Group Director Market Development Simon Holmes

143 Ted Gastineau CEO ICON Medical Imaging

144 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.

145 PET Movie 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

146 Why? Medical Imaging 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

147 FDA Continues to Accept and Promote Imaging
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”

148 Genentech Clears Hurdle On Cancer Drug Avastin
Medical Imaging Genentech Clears Hurdle On Cancer Drug Avastin By 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."

149 Therapeutic Initiatives
Medical Imaging Therapeutic Initiatives Oncology: 40% % Cardiovascular 40% CNS: 10%-20% Musculoskeletal: Gastrointestinal: Dermatology:

150 Cardiac Safety Medical Imaging
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)

151 Medical Imaging

152 Medical Imaging

153 Technology Medical Imaging
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

154 Computational Platform: HW-OS
Algorithms User PET User MRI User Remote User Computational Platform: HW-OS Identify Retrieve Process Common Back-plane Image Storage Query Meta Data Query Retrieve Images or Information Project Management Clinical DB Legacy Data Sales and Marketing Standardization Image Data

155 Browser Interface SERIES STUDIES PROTOCOLS SITES CASES CODES

156 Task Lists (Work Flows)
PROTOCOLS FILTERS TASK LISTS SERIES FOR PROCESSING CODES FOR PROCESSING

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166 Sean Leech President ICON Contracting Solutions

167 MARKET DEVELOPMENTS & DEFINITION

168 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.

169 Shift in Business Models
MARKET DEVELOPMENTS 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

170 MARKET SCALE

171 WORLD STAFFING MARKET Country US$B Europe USA 119.9 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 ROW Japan 26.2 China 2.7 South Africa 2.2

172 CLINICAL STAFFING MARKET
Source: CenterwWatch October 2005

173 MARKET SPLIT Regional Clinical Staffing Market Breakdown of Market
1% Staff leasing EU 44% 75% Temporary Help 9% Insourcing 15% Place and Search US 44% ROW 12%

174 TEMPORARY STAFF PENATRATION RATES
ICS COVERAGE

175 INDUSTRY SECTOR GROWTH US 2005

176 2007 2008 Growth EUROPE $30m €45m 50% USA $16m €20m 25%
OUR GROWTH Growth EUROPE $30m €45m % USA $16m €20m % TOTAL ICS $46m €65m %

177 Leverage centralised cost/management infrastructure.
OUR MARGIN OPPORTUNITY 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

178 STRATEGY

179 Full Range of Staffing Services Global Infrastructure
STRATEGY Full Range of Staffing Services Global Infrastructure Greater scale required in the US; acquisition a possibility Flexible Solutions

180 ICON CONTRACTING SOLUTIONS – INTERNATIONAL, NOT YET GLOBAL
New York North Carolina Tampa Sweden Denmark Finland Netherlands Poland Germany x2 Belgium France UK x3

181 FROM ONE ASSIGNMENT TO INTEGRATED STRATEGIC INSOURCING
STRATEGIC STAFFING SOLUTION Permanent Placement - Executive Search - Search and Selection - Basic Search - Advertising - Assessments PERMANENT PLACEMENT FLEXIBILITY TRAINING Training - Traineeships - Coaching - Training and Education CONTRACT PLACEMENT Contract Placement - Project based - Project or functional teams - Vacancy Management - Interim Management - Administration FROM ONE ASSIGNMENT TO INTEGRATED STRATEGIC INSOURCING

182 SUMMARY ICS is the staffing arm of ICON, providing flexible staffing solution to the Pharma Industry on an International basis


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