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Title: Executive%20Chairman


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Executive Chairman Dr. John Climax
CEO Peter Gray
President Corporate Development Bill Taaffe
ICON Central Laboratories President Bob
Scott-Edwards
Chief Financial Officer Ciaran Murray
ICON Development Solutions President Dr Thomas
Frey
ICON Clinical Research Global President Dr John
Hubbard
ICON Contracting Solutions President Sean Leech
VP Corporate QA Jo Coyle
ICON Medical Imaging Chief Executive Dr Ted
Gastineau
Commercial VP Brian ODwyer
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
Global Clinical
EU 38
Q4 Revenue by Region
ROW 9
US 53
6
ICONs Global Clinical Footprint
North America 2 Countries 17 Offices gt1,900 Staff
Eastern Europe / Russia 8 Countries 9 Offices gt
350 Staff
Japan 1 Country 2 Offices gt80 Staff
Western Europe / Africa 10 Countries 13
Offices gt1,600 Staff
Asia Pacific 8 Countries 10 Offices gt450 Staff
Latin America 5 Countries 5 Offices gt170 Staff
Projects in 60 Countries
7
Market Environment
8
Strong Market Environment with...
  • Continued RD 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
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 gt 20 Million
  • 168 gt 5 Million
  • 959 lt 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
Book to Bill Ratio
19
leading to record Total Backlog levels. (
millions)
20
From this backlog, coverage of next 4
quartersrevenues is robust..
coverage of next 4 quarters forecast revenues
Value of backlog forecast to be earned in next 4
quarters
21
This has led to a diversified customer base
Client Diversity 2005, 2006, 2007
2007 - New Business by Customer Segment
22
.and broad therapeutic expertise.
Revenue by Therapeutic Area 2007
23
Strategy
24
ICONs 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
  • gt Organic growth gt80
  • 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
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 ICONs Data Management activity in 2007
    was EDC

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Executive Chairman Dr. John Climax
CEO Peter Gray
President Corporate Development Bill Taaffe
ICON Central Laboratories President Bob
Scott-Edwards
Chief Financial Officer Ciaran Murray
ICON Development Solutions President Dr Thomas
Frey
ICON Clinical Research Global President Dr John
Hubbard
ICON Contracting Solutions President Sean Leech
VP Corporate QA Jo Coyle
ICON Medical Imaging Chief Executive Dr Ted
Gastineau
Commercial VP Brian ODwyer
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
CAGR 32
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 Q4 06 Increase
Net Revenue 181 181 129 40
Direct Costs 100 100 73 37
SG A 55 55 38 45
D A 5 5 4 37
_____ _____ _____ _____
Operating Income 20 20 14 43
Operating Margin 11 11 10.7
Net Income 16 16 11 40
_____ _____ _____ _____
EPS (Inc SFAS123R) 53c 53c 39c 36
Weighted Average no. of Shares (Inc SFAS123R) 29.9m 29.9m 29.1m 2.7
31
Recent Financial Performance ( millions)
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
32
Margin improvement is a key focus
  • Approx. 25 of ICONs 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

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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
Shareholders 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
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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
  • Treatment naïve patients

Cost perpatient
Cost perinvestigator
Cost per trial
  • Qualified investigators

Cost ofclinicaldevelopment
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
ICONs 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
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 TrialsBased 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
ICONs 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, gt80 250 - 300 50
45
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
46
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.
47
ICONs 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 Clinical Monitoring / Project Management / Regulatory Submissions 60 150 gt40
48
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
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 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
Key Red color An area of development or
current limitation.
51
ICONs 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 350 550-600 20
52
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

53
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

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 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
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
  • Opportunities
  • Large English speaking Caucasian population (gt
    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
  • 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 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
Key Red color An area of development or
current limitation.
59
  • Case Study
  • Study No 2 Phase II/III studyType 2 Diabetes-1
    protocol

60
Diabetes Estimates in Emerging Countries
Source World Health Organization Contract
Pharma, May 2007
61
Regional Performance
  US Israel Argentina India Total
Screened 245 215 239 477 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 clients
    needs

63
Executive Chairman Dr. John Climax
CEO Peter Gray
President Corporate Development Bill Taaffe
ICON Central Laboratories President Bob
Scott-Edwards
Chief Financial Officer Ciaran Murray
ICON Development Solutions President Dr Thomas
Frey
ICON Clinical Research Global President Dr John
Hubbard
ICON Contracting Solutions President Sean Leech
VP Corporate QA Jo Coyle
COO US Malcolm Burgess
ICON Medical Imaging Chief Executive Dr Ted
Gastineau
Commercial VP Brian ODwyer
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 OLeary
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 RD 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
  • 2007 Value
  • 54 Increase / PY
  • Size of Projects
  • 41 gt 20 Million
  • 168 gt 5 Million
  • 959 lt 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 RD 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
Executive Chairman Dr. John Climax
CEO Peter Gray
President Corporate Development Bill Taaffe
ICON Central Laboratories President Bob
Scott-Edwards
Chief Financial Officer Ciaran Murray
ICON Development Solutions President Dr Thomas
Frey
ICON Clinical Research Global President Dr John
Hubbard
ICON Contracting Solutions President Sean Leech
VP Corporate QA Jo Coyle
COO US Malcolm Burgess
ICON Medical Imaging Chief Executive Dr Ted
Gastineau
Commercial VP Brian ODwyer
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 OLeary
VP Market Development Simon Holmes
73
Global Data Management and EDC Thomas
OLeary 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 (2008-2011)
  • 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
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
    (lt1 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)

77
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78
Data Management Locations
Edinburgh
Dublin
San Francisco
Marlow
Hong Kong
Philadelphia
North Carolina
Chennai
79
Data Management Headcount
Position East Coast West Coast Europe India Support Offices Global Total
DM Project Managers 31 5 24 3 1 64
Data Coordinators /EDC Analysts 123 14 80 48 0 265
Data Entry Specialists / EDC Testers 24 0 6 53 0 83
Medical Coders 3 1 3 2 0 9
DBAs / EDC Study Builders 16 4 15 15 2 52
Total Staff 197 24 128 121 3 473
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)

82
Technology Capabilities
Integration with other ICON systems
83
Executive Chairman Dr. John Climax
CEO Peter Gray
President Corporate Development Bill Taaffe
ICON Central Laboratories President Bob
Scott-Edwards
Chief Financial Officer Ciaran Murray
ICON Development Solutions President Dr Thomas
Frey
ICON Clinical Research Global President Dr John
Hubbard
ICON Contracting Solutions President Sean Leech
VP Corporate QA Jo Coyle
COO US Malcolm Burgess
ICON Medical Imaging Chief Executive Dr Ted
Gastineau
Commercial VP Brian ODwyer
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 OLeary
84
IVR in Clinical Trials the impact of technology
on CR Malcolm Burgess Chief Operating Officer,
U.S. Operations ICON Clinical Research
85
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
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
Electronic Patient Report Outcomes
  • 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
ICON IVR Metrics
  • Current IVR project portfolio
  • 325 active IVR projects
  • gt650 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
Dublin
Marlow
Chicago
Philadelphia
Houston
Raleigh
Chennai
200 ICOPhone dedicated staff worldwide"
91
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
Executive Chairman Dr. John Climax
CEO Peter Gray
President Corporate Development Bill Taaffe
ICON Central Laboratories President Bob
Scott-Edwards
Chief Financial Officer Ciaran Murray
ICON Development Solutions President Dr Thomas
Frey
ICON Clinical Research Global President Dr John
Hubbard
ICON Contracting Solutions President Sean Leech
VP Corporate QA Jo Coyle
COO US Malcolm Burgess
ICON Medical Imaging Chief Executive Dr Ted
Gastineau
Commercial VP Brian ODwyer
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 OLeary
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
  • FDAs
  • Office of Drug Safety
  • Office of Surveillance and Epidemiology
  • Task Forces
  • IOMs 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
ICONs 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 gt30M

99
ICON Global Safety Portfolio 2004
100
ICON Global Safety Portfolio 2007
101
ICONs 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 gt 100 by end of 2008 as
    workload increases

103
Executive Chairman Dr. John Climax
CEO Peter Gray
President Corporate Development Bill Taaffe
ICON Central Laboratories President Bob
Scott-Edwards
Chief Financial Officer Ciaran Murray
ICON Development Solutions President Dr Thomas
Frey
ICON Clinical Research Global President Dr John
Hubbard
ICON Contracting Solutions President Sean Leech
VP Corporate QA Jo Coyle
COO US Malcolm Burgess
ICON Medical Imaging Chief Executive Dr Ted
Gastineau
Commercial VP Brian ODwyer
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 OLeary
VP Market Development Simon Holmes
104
Jo Coyle VP Quality Assurance ICON plc
105
  • Agenda
  • ICONs quality framework and philosophy
  • Internal QA Program
  • Client and Regulatory focus
  • The year ahead

106
Quality is our Focus
107
ISO 90012000 Registered
  • External assessment of ICONs 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
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
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 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 EU Local regulatory authority RP Darmstadt No critical findings
Singapore Oct 2005 ROW HSA - Health Services Authority of Singapore No critical findings
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.
Frost Sullivan 2007 North American Service Provider of the Year
Thomson CenterWatch and William Blair 2007 Vendor 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
112
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
Executive Chairman Dr. John Climax
CEO Peter Gray
President Corporate Development Bill Taaffe
ICON Central Laboratories President Bob
Scott-Edwards
Chief Financial Officer Ciaran Murray
ICON Development Solutions President Dr Thomas
Frey
ICON Clinical Research Global President Dr John
Hubbard
ICON Contracting Solutions President Sean Leech
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 ODwyer
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 OLeary
Group Director Market Development Simon Holmes
114
Thomas Frey President ICON Development Solutions
115
Expeditious Drug Development Enhanced Decision
Making
116
Expeditious Drug Development Enhanced Decision
Making
Regulatory Strategy
Scientific Consulting Pre-clinical CMC Formulation
Development Target Product Profile
117
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
Expeditious Drug Development Enhanced Decision
Making
IND/CTA
Regulatory Affairs Pre-IND Meeting/Regulatory
Advice IND Compilation Paper Electronic
Submissions Annual Updates
119
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
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
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122
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
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
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
126
Executive Chairman Dr. John Climax
CEO Peter Gray
President Corporate Development Bill Taaffe
ICON Central Laboratories President Bob
Scott-Edwards
Chief Financial Officer Ciaran Murray
ICON Development Solutions President Dr Thomas
Frey
ICON Clinical Research Global President Dr John
Hubbard
ICON Contracting Solutions President Sean Leech
VP Corporate QA Jo Coyle
COO US Malcolm Burgess
ICON Medical Imaging Chief Executive Dr Ted
Gastineau
Commercial VP Phase I Brian ODwyer
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 OLeary
Group Director Market Development Simon Holmes
127
Phase I Developments Brian ODwyer, 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
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
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
Executive Chairman Dr. John Climax
CEO Peter Gray
President Corporate Development Bill Taaffe
Chief Financial Officer Ciaran Murray
ICON Development Solutions President Dr Thomas
Frey
ICON Central Laboratories President Bob
Scott-Edwards
ICON Clinical Research Global President Dr John
Hubbard
ICON Contracting Solutions President Sean Leech
COO US Malcolm Burgess
ICON Medical Imaging Chief Executive Dr Ted
Gastineau
Commercial VP Brian ODwyer
Snr VP Global BD Elizabeth Thiele
Snr VP Global Medical Suzanne Gagnon
VP Global Data Management Tom OLeary
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 gt126m
  • Won 284 studies in 2007 (Strike rate 48)
  • Built gt600,000 kits in 2007
  • Resulted gt8,000,000 tests in 2007
  • 87 of New Business is repeat
  • 70 Clients say we are the best CL! (26same!)

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
  • 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
  • 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
  • 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

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
Executive Chairman Dr. John Climax
CEO Peter Gray
President Corporate Development Bill Taaffe
ICON Central Laboratories President Bob
Scott-Edwards
Chief Financial Officer Ciaran Murray
ICON Development Solutions President Dr Thomas
Frey
ICON Clinical Research Global President Dr John
Hubbard
ICON Contracting Solutions President Sean Leech
VP Corporate QA Jo Coyle
COO US Malcolm Burgess
ICON Medical Imaging Chief Executive Dr Ted
Gastineau
Commercial VP Brian ODwyer
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 OLeary
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
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
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

147
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
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