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Company Overview - ICON plc

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<strong>ICON</strong><br />

<strong>Company</strong> <strong>Overview</strong><br />

March 2011


What we do<br />

• <strong>ICON</strong> is a global provider of outsourced development<br />

services to the pharmaceutical, biotechnology and<br />

medical device industries.<br />

• We specialise in the strategic development,<br />

management and analysis of programs that support<br />

Clinical Development - from compound selection to<br />

Phase I-IV clinical studies.


Our Mission Statement<br />

“To provide flexible, superior<br />

quality, global pharmaceutical<br />

development services, that enable<br />

clients to expedite development,<br />

reduce costs, and establish the<br />

benefits of treatments that<br />

enhance people’s lives"


The Clinical Development Process<br />

Phase I:<br />

• Initial phase of testing in humans.<br />

• Small number of healthy volunteers<br />

(20 to 100).<br />

• Determine what happens to the<br />

drug in the human body.<br />

Phase II:<br />

• May last several months to two<br />

years.<br />

• Involve up to several hundred<br />

patients.<br />

• Randomized-"control" group<br />

receive placebo.<br />

• "blinded“ - neither patients nor<br />

researchers know who is getting the<br />

drug.<br />

Phase III:<br />

• Drug is tested in several hundred<br />

to several thousand patients.<br />

• Aim to give more thorough<br />

understanding of the drug's<br />

effectiveness, benefits, and<br />

possible adverse reactions.<br />

• Drugs approved at this stage can<br />

be marketed.<br />

Marketing - Late Phase III Phase IV<br />

• Compare a drug with other drugs<br />

already in the market.<br />

• Monitor a drug's long-term<br />

effectiveness/impact on a patient's<br />

quality of life.<br />

• Determine cost-effectiveness of drug<br />

therapy relative to other therapies.


<strong>ICON</strong>: Global full service clinical development


<strong>ICON</strong>: Broad Therapeutic Experience


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far


The Journey So Far<br />

$0.5 million<br />

•Staff 5<br />

1990•Revenues<br />

• Revenues $900m<br />

•EPS $1.44<br />

2010•Staff 7,800


A Global<br />

Organisation


Global Headquarters: Dublin, Ireland


<strong>ICON</strong>’s Global Footprint<br />

<strong>ICON</strong> operates from 77 offices in 39 Countries


<strong>ICON</strong> Plc Staff Growth 1990 - Today


<strong>ICON</strong> Plc – Staff Educational Qualifications


<strong>ICON</strong> Divisional Structure


Senior Management<br />

Peter Gray<br />

CEO<br />

<strong>ICON</strong> Plc<br />

Mike McGrath<br />

Global IT<br />

Ciaran Murray<br />

CFO – Global<br />

Finance and<br />

Contracts<br />

Eimear Kenny<br />

Global HR<br />

Simon Holmes<br />

Global Mkt. & Market<br />

Development<br />

Mark Quigley<br />

Global QA &<br />

Compliance<br />

Elizabeth Thiele<br />

Late Phase Services<br />

Alan Morgan<br />

Clinical Research<br />

Services<br />

TBD<br />

Early Clinical Research<br />

& Lab Services<br />

Bill Taaffe<br />

DOCS<br />

Thomas Frey<br />

<strong>ICON</strong> Development<br />

Solutions<br />

Ted Gastineau<br />

<strong>ICON</strong> Medical Imaging<br />

Diarmaid Cunningham<br />

General Counsel<br />

Linda Meyerson<br />

<strong>ICON</strong> Clinical Research<br />

Tom O’Leary<br />

<strong>ICON</strong> Central Laboratories


Our Divisions


<strong>ICON</strong> Clinical Research<br />

• Global provider of outsourced Phase IIb – IV development<br />

services<br />

• Following service groups:


<strong>ICON</strong> Central Laboratories<br />

• Global network of Central Laboratories dedicated<br />

exclusively to clinical trials<br />

• <strong>ICON</strong>-owned facilities in New York, Dublin, India,<br />

Singapore and China<br />

– All laboratories are accredited by the College of American<br />

Pathologists (CAP)<br />

• Main Services:<br />

– Extensive testing capabilities, including biomarkers, flow<br />

cytometry, custom-developed assays and safety testing<br />

– Sample management services, including frozen sample<br />

storage and pharmacogenomic extraction services<br />

– Global Logistics Management<br />

– Multi-lingual Investigator site support<br />

– iRIS local laboratory result management services


<strong>ICON</strong> Development Solutions<br />

• Clinical Pharmacology Units<br />

– San Antonio Texas<br />

– Omaha Nebraska<br />

– Manchester, England (hospital<br />

based)<br />

– Total capacity 290 + beds<br />

• Bioanalytical Facilities<br />

– Manchester, England<br />

– Syracuse, New York<br />

– Extensive Small/Large Molecule<br />

experience


<strong>ICON</strong> Medical Imaging<br />

• Based in Warrington PA, USA<br />

• Recently Acquired TIMAQ - Zurich based Imaging CRO<br />

• Complete Service Offering includes:<br />

– Medical Imaging Core Laboratory Services for Efficacy and / or Safety Endpoints<br />

– Full-Service Solution for Diagnostic Contrast Agents and Imaging Device Trials<br />

– Electronic Solutions for Safety, Endpoint and Adjudication Committees<br />

• Manages all digital images centrally<br />

• Provides centralised analysis of images<br />

• Comprehensive digital databases for trial Sponsor and Regulatory<br />

Agencies


<strong>ICON</strong> Late Phase & Outcomes Research<br />

• New division formed in October 2010 – services formerly<br />

delivered through <strong>ICON</strong> Clinical Research division<br />

• Acquired Oxford Outcomes in January 2011<br />

• Services include:<br />

– Non-interventional, Observational Research<br />

– Disease and Product Registries<br />

– Post-Approval Safety-Surveillance Studies<br />

– Phase IV Clinical Trials<br />

– Epidemiologic Studies<br />

– Patient-Reported Outcomes/Quality-of-Life Research<br />

– Health Economic Evaluations<br />

– Scientific and Medical Communications


DOCS<br />

• <strong>ICON</strong>’s contract resourcing division<br />

• Provider of full-spectrum resourcing solutions<br />

– Contingent staffing,<br />

– Functional resourcing,<br />

– Large-scale FSP<br />

– Executive search<br />

– Training & Development Programs


<strong>ICON</strong> & The Market


Industry Aligned Expertise<br />

Drugs in Development by<br />

Indication (#compounds)<br />

<strong>ICON</strong> Backlog by Indication<br />

(US$)<br />

Source – R&D Directions 9 th Annual Report


Analysis of Backlog by client type Q4 10


What we value


What we Value: Common themes<br />

We care about our people as they are key to our<br />

success. We provide an open and friendly work<br />

environment. We empower people and provide them<br />

with opportunites to develop their long-term careers.<br />

We value: Leadership, Teamwork, Energising &<br />

Developing others.<br />

We care about our clients and their projects, and<br />

are proactive, flexible and responsive in<br />

understanding and meeting their unique needs.<br />

We value: Delivery to our customers, Building on<br />

relationships.<br />

We care about delivering Excellence in everything<br />

we do. The quality, speed and efficiency of our<br />

services are essential to our success. We stand by<br />

our commitments, and strive to be the best we can<br />

today and in the future.<br />

We value: Personal Effectiveness, Commercial<br />

Awareness, Robust Thinking.

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