1

2

3

Clinical research underpins the pharmaceutical and biotechnology industries and is the driver behind many areas of discussion and debate.Our source book specialists include some of the leading experts in clinical development and are available to answer your questions and provide comment on the key issues in clinical research, whether global or local.

If you would like to speak to any of the experts highlighted in this book, please contact:

EU USSusan Dempsey Erica Hill T: +353 1 291 2057 T: +1 215 616 3286 E: dempseys@iconirl.com E: hille@iconus.com

4

5

6

We specialise in the strategic development, management and analysis of programs that support Clinical Development; from compound selection to Phase I-IV clinical studies. Our services can be implemented separately or as part of a comprehensive full service clinical programme that can help expedite the time it takes to bring your drug to market and monitor its performance and safety post approval.

ICON is a global company with over 67 locations in more than 37 countries; we have managed trials in over 60 countries.

For a full list of our locations,visit www.iconplc.com

Our global services are offered through the expertise of our five international divisions.

7

8

Mr. Peter Gray CEO, ICON Expertise: Corporate spokesperson and industry expert

Mr. Bob Scott-Edwards President, ICON Central Laboratories Expertise: Central laboratories and their support services to the industry

Dr. John Hubbard Global President, ICON Clinical Research Expertise: The global clinical research market and general industry commentator

Mr. Alan Morgan President, ICON Clinical Research Europe Expertise: The European clinical research market

Dr. Malcolm Burgess Chief Operating Officer, ICON US Expertise: US clinical research market

Dr. Peter Sowood Chief Scientific OfficerExpertise: Scientific advances and their impact on the clinical research industry

Dr. Thomas Frey President, ICON Development Solutions Expertise: Regulatory and safety standards in early phase trials

Mr. Sean Leech President, ICON Contracting Solutions Expertise: The staffing market and contract staffing within clinical research

Mr. Ted Gastineau CEO, ICON Medical Imaging Expertise: The role and implementation of medical imaging in clinical trials

Dr. Suzanne Gagnon Sr. VP, and Global Head of Medical Affairs and Drug Safety Expertise: Surveillance and management of safety in clinical trials

Mr. Kris Gustafson Sr. VP, and Global Head of Interactive Technologies and Lifecycle Sciences Expertise: Interactive technologies and observational research services

Index Page

5

6

7

8

9

10

11

12

13

14

15

9

10

Mr. Peter GrayChief Executive Officer

The senior ICON spokes-person and commentator on the state of the clinical research landscape.

ICON is a global provider of outsourced development services to the bio-pharmaceutical industry. As CEO, Peter regularly meets and advises industry leaders.

Topics of expertise: • ICON corporate spokesperson - ICON strategic direction and vision - Overview of company services - Key company milestones, including major projects and acquisitions• General industry expert - CRO industry landscape - Future outsourcing trends - Competitive marketplace - Globalisation of clinical research

Background: Peter was appointed to his current position of Chief Executive Officer in 2002. The previous year, Peter held the position of Chief Operating Officer. Having joined ICON plc as CFO in 1997, he orchestrated its entry to the NASDAQ public market in 1998. The company has grown from revenues of $42m and staff of 400 when it went public in 1998 to over $600m and over 5,500 staff in 2007.

Prior to joining ICON, Peter worked at Unidare plc, an Irish Engineering and Distribution conglomerate, between 1992 -1997. Peter moved to Unidare from Food Industries plc, a publicly quoted Irish food conglomerate, where he held the position of Finance Director from 1990-1992. Between 1983-1990, Peter was employed by Elan Corporation plc, an Irish-headquartered pharmaceutical development company. He was involved in Elan’s entry to the NASDAQ public market in 1984 and subsequently acted as CFO and Vice President of operations at Elan’s Athlone headquarters.

Before joining Elan, Peter was the finance director at a small construction-related company where he started his career. Peter qualified as an accountant in 1980.

Publications / Commentary: Peter is a regular industry commentator.

11

Mr. Bob Scott-EdwardsPresident,ICON Central Laboratories

Commentator on central laboratories and their support services to the pharmaceutical and biotechnology industries.

ICON Central Laboratories provides excellent central laboratory and related support services to pharmaceutical and biotechnology companies by offering the most advanced laboratory and information technology.

Topics of expertise: • Future trends in laboratory services

Background: Bob was appointed President of ICON Central Laboratories in August 2004, having previously held the position of Vice President, Sales & Marketing for ICON Central Laboratories since June 2000.

Bob began his career in the pharmaceutical industry in 1971 at Wyeth and has also worked for Schering AG, Howmedica (Pfizer) and held various senior positions at Bristol-Myers Squibb from 1979 through to 1997.

Education / Degree: Bob has a science background.

Publications / Commentary: Bob is a regular commentator on developments within laboratory services and provides counsel to the heads of R&D at pharmaceutical and biotechnology companies.

12

Dr. John HubbardGlobal President, ICON Clinical Research

Primary spokesperson for ICON Clinical Research and an expert commentator on the industry.

Clinical Research is the largest division within ICON and delivers excellence in managing, executing and analysing Phase IIb-IV clinical trials.

Topics of expertise: • ICON Clinical Research services• The clinical research competitive market • Globalisation of clinical research• US clinical research market• Novel approaches to outsourcing and

models to accelerate development• Outsourcing partnerships• Drug development and regulatory science

Background: John has been with ICON since 1999. He has more than 22 years of experience in pharmaceutical research and development and has held senior management positions at Clinical Studies, Ltd., PAREXEL International Corporation, Hoechst Marion Roussel Pharmaceuticals, and Revlon Health Care.

Education / Degree: John received a B.S. in Biopsychology from the University of Santa Clara, a Ph.D. in Cardiovascular Physiology from the University of Tennessee, and was a National Institute of Health (NIH) Postdoctoral Fellow in Cardiovascular Pharmacology at the University of Texas Health Sciences Center. He is a Fellow of the American College of Clinical Pharmacology and a Board Certified Diplomat in Applied Pharmacology by the American Board of Clinical Pharmacology.

Publications / Commentary: John has authored or co-authored three book chapters and 76 published articles and abstracts in the areas of cardiovascular / autonomic pharmacology, clinical pharmacology, and drug development.

13

Mr. Alan MorganPresident, ICON Clinical Research Europe

Spokesperson for ICON Clinical Research and an expert commentator on the European clinical research market and patient recruitment.

Clinical Research is the largest division within ICON and delivers excellence in managing, executing and analysing Phase IIb-IV clinical trials.

Topics of expertise: • ICON Clinical Research services• European clinical research market• Country specific issues within Europe• Patient recruitment• The clinical research competitive market • Globalisation of clinical research

Background: Alan joined ICON in August 2006 where he initially held the position of Vice President of Process Development for ICON plc, before appointment to President, ICON Clinical Research Europe. Prior to ICON, Alan was Global General Manager of the Phase II/IV business of MDS Pharma Services from August 2005, having joined the company in September 2002 as General Manager of their European, Latin American and Asian Clinical Development operations. In both roles he was responsible for Clinical Operations, Data Management and Biostatistics, Regulatory Affairs, and all of the commercial operations of the business.

He joined MDS from Covance Inc, where he held a number of senior positions including General Manager of their Phase II/IV business in Europe, Asia, and Latin America. Prior to moving into the clinical research market, Alan worked in the pharmaceutical industry - seven years with Glaxo Wellcome and two years with ICI Pharmaceuticals in various business financial roles.

Education / Degree: Alan is a graduate of the City University Business School in London and a Fellow of the Chartered Association of Certified Accountants.

Publications / Commentary: Alan is a frequent speaker at industry conferences, such as Partnerships in Clinical Trials, and has written articles on subjects including patient recruitment and the European clinical research landscape.

14

Dr. Malcolm BurgessChief Operating Officer, ICON US

Spokesperson for ICON US and a senior commentator on clinical research services to the pharmaceutical and biotechnology industries.

Clinical Research is the largest division within ICON and delivers excellence in managing, executing and analysing Phase IIb-IV clinical trials.

Topics of expertise: • Global and US clinical research market• Clinical Process Re-engineering • Standards for global operating procedures• Establishment and Management of ‘off-shore’

facilities• Biometrics & Data Management• New Data Management Technologies,

including Electronic Data Capture• CDISC (the Clinical Data Interchange

Standards Consortium)

Background: Malcolm has held the position of Chief Operating Officer, US Operations since April 2006. In addition to this role, he still maintains global leadership of the Biometrics and IVRS groups and was instrumental in the establishment of a Statistics and Programming unit in Mumbai and a Biometrics and Data Management unit in Chennai. Malcolm joined ICON in 2002 as Senior Vice President, Biometrics, and Data Management.

Malcolm has over 30 years experience within the Pharmaceutical sector having held various Research and Development positions within Novartis, Hoechst Marion Roussel and SmithKline Beecham.

Education / Degree: Malcolm holds a BSc in Chemistry from University College London and a Doctorate in Biochemistry and Physiology from Bath University, UK.

Publications / Commentary: Malcolm has published more than 20 scientific articles in the area of intestinal physiology during his years of basic research. He also filed three patents for NCEs during this time.

Malcolm is a regular contributor to clinical development forums such as DIA and SCDM. He serves frequently on the program committee for the US annual DIA CDM meeting.

15

Dr. Peter SowoodChief Scientific Officer

Senior ICON commentator on scientific advances and their impact on the clinical research industry.

ICON Clinical Research delivers excellence in managing, executing and analysing Phase IIb-IV clinical trials.

Topics of expertise: • The structure of clinical trials• Globalisation of clinical trials • Patient enrolment and retention • Managing trial volunteer safety• Feasibility and site selection services

Background: Peter was appointed to his current role, as Chief Scientific Officer, for ICON Clinical Research in March 2007. Prior to this role, he had been President of ICON Clinical Research Europe since November 2003.

Before joining ICON, Peter held various positions at Covance Clinical and Periapproval Services, Ltd., including the position of Vice-president Clinical Research.

Prior to moving into the clinical trials industry, Peter worked at the RAF as a Medical Officer conducting and managing research in human physiology.

Education / Degree: Peter was educated at the University of Cambridge in Medical Sciences and followed on to Oxford University where he took medical degrees. Dr. Sowood obtained his Ph.D. in 1988 and MBA in 1993.

Publications / Commentary: Peter has spoken and written frequently on the management of clinical trials. Peter has also published scientific work in the field of thermal physiology and survival.

16

Dr. Thomas FreyPresident, ICON Development Solutions

Commentator on the strategy, management and execution of product development and early phase clinical development.

ICON Development Solutions specialises in product development and early phase clinical development, with expertise in delivering clinical pharmacology, regulatory affairs, pharmacokinetics, pharmacometrics, biopharmaceutics, and bioanalytical services.

Topics of expertise: • Changing regulatory framework (FDA, EMEA, etc)• Safety in Phase I clinical trials• Safety standards governing early phase

clinical trials• Pharmacodynamics in early phase clinical trials

Background: Prior to his current role as President, ICON Development Solutions, Thomas served as Chief Operating Officer for ICON Europe since June 2001 and has also served as Vice President of ICON Clinical Operations Europe from January 2000 to May 2001.

Thomas has over 20 years of experience in pharmaceutical research and development. Prior to joining ICON, Thomas was Senior Director of Clinical Development Europe at Hoechst Marion Roussel, where he worked from 1995 to the end of 1999.

He started his career in 1987 with Hoechst Pharmaceuticals.

Education / Degree: Thomas received his medical degree in 1980 from the University of Heidelberg. Before joining the pharmaceutical industry he gained medical experience as a resident in surgery and intensive care for 4 years and practiced as a family doctor for 3 years.

Publications / Commentary: Thomas regularly attends and speaks at industry events on clinical research.He is a member of the Faculty of Pharmaceutical Medicine, UK and Drug Information Association.

17

Mr. Sean LeechPresident, ICON Contracting Solutions

Commentator on the state of the staffing market with specific focus on contract staffing within clinical research.

ICON Contracting Solutions provides temporary and permanent personnel to meet the research needs of pharmaceutical and biotechnology companies, including staff shortages, unforeseen monitoring issues and study ramp-up initiatives.

Topics of expertise: • The role of contract workers in clinical

research• The evolution of different resourcing models• General staffing trends across geographic

markets• Benefits of in-sourcing • The challenges of attracting and recruiting

skilled personnel • The integration of staffing company

acquisitions

Background: In 2007 Sean was appointed to President of ICON Contracting Solutions, a division that focuses on providing experienced contract and permanent clinical research individuals and teams. Sean led the recent acquisition of DOCS International, a leading European based clinical research staffing organisation that establishes ICON as a global provider of contract staffing solutions.

Sean has also held the role of Executive Vice President of Commercial and Organisational Development where he worked on key management and strategic initiatives and before this spent over 4 years as the Chief Financial Officer of ICON.

Prior to joining ICON in 1999, Sean was Group Financial Controller of Jones Group plc, a shipping, manufacturing and fuel distribution company based in Ireland.

Education / Degree: Sean qualified as Accountant in 1993 and is an Associate member of the Chartered Institute of Management Accountants.

18

Mr. Ted GastineauChief Executive Officer, ICON Medical Imaging

Commentator on the role and implementation of medical imaging in clinical trials.

ICON Medical Imaging offers complete imaging solutions for pharmaceutical and biotechnology product development – utilising 20+ years of experience in 250 trials across all key therapy areas.

Topics of expertise: • Expanding role of medical imaging in clinical trials • Use of medical imaging in oncology,

cardiology, CNS, devices, diagnostics, and musculoskeletal • Design and implementation of imaging

charters• Transition from surrogate endpoints to primary endpoints• FDA and EMEA regulatory consulting

Background: Ted is the CEO and co-founder of ICON Medical Imaging (formerly Beacon Bioscience). Prior to Beacon, Ted co-founded Intelligent Imaging, a research company specialising in imaging, which was acquired by Quintiles in 1997. From 1997-2000 he served as Senior Vice-President and Business Unit Head within Quintiles.

Ted has more than 18 years experience in imaging for drug development and has worked closely with industry, FDA, and academia to establish best practices in place today.

Education / Degree: Ted has held academic positions with the University of Maryland, The Johns Hopkins School of Medicine, Cambridge University, and The Smithsonian Institution. Ted received a bachelor’s degree in zoology from Marshall University and pursued a Ph.D. in neurophysiology prior to founding Intelligent Imaging.

Publications / Commentary: Ted has six lead author publications within the field of zoology and has co-authored a further eight publications during his academic career in the 1990’s.

19

Dr. Suzanne GagnonSr. Vice President, and Global Head of Medical Affairs and Drug Safety

Commentator on surveillance and management of safety issues within clinical trials from an academic and industry perspective.

ICON’s trial services are supported by comprehensive and consistent processes that conform to stringent quality standards. This includes a Medical Affairs and Drug Safety department that oversees and supports safety monitoring in clinical research.

Topics of expertise: • Pharmaceutical product safety using CROs• Safety surveillance in a changing regulatory

environment • Monitoring patient safety during product

development• Medical management of clinical trials• Strategic post-marketing surveillance

Background: Suzanne was appointed to the role of Global Head of Medical Affairs and Drug Safety in April 2006. Prior to her current role, Suzanne held the position of Sr. Vice President of US Medical Affairs, Regulatory Affairs and Scientific Writing. Suzanne joined ICON in 2001.

Suzanne has held various senior management positions in Medical Affairs and Clinical Research and Development at Rhone-Poulenc Rorer, Luitpold Pharmaceuticals and Omnicare Clinical Research. Her background includes eight years in academic medicine at Boston University, the University of Miami and as the Director of Clinical Research at the University of Kansas School of Medicine.

Education / Degree: Suzanne received her medical degree from Boston University School of Medicine, is Board Certified in Internal Medicine and is a Fellow of the American College of Physicians. She has held a number of academic faculty appointments and has published articles and abstracts on drug safety and in therapeutic areas including HIV disease, chronic renal failure and oncology. She currently lectures in Pharmaceutical Product Development and Drug Safety at West Chester University.

Publications / Commentary: Suzanne has written widely and commented within articles on managing drug safety in clinical trials and still lectures on this subject, in addition to her management role at ICON.

20

Mr. Kris GustafsonSr. Vice President, and Global Head of Interactive Technologies and Lifecycle Sciences

Commentator on interactive technologies and observational research services.

ICON’s Lifecycle Sciences Group offers a full range of observational research services, including patient registries, post-approval safety studies, health economic evaluations, patient-reported outcomes research, and statistical analysis.

Topics of expertise: • New technology adoption• Outcomes Research• Patient Registries• Application of technology in global clinic trials• Electronic Patient Reported Outcomes• Real time data collection and integration

Background: Kris was promoted to his current role as Global Head of the Interactive Technologies business unit and the Life Sciences business unit in January 2007. He has been with ICON since 2000 in multiple roles and positions.

Prior to ICON, Kris was President and co-founder of Electronic Trial Management Technologies, a technology company specialising in IVR and IWR solutions for clinical trials, which was acquired by ICON in 2000. From 1995-1999 he served as Senior Director of Information Management at Applied Logic Associates. From 1990-1995 he worked as a Mechanical Engineer in the Nuclear sector.

Education / Degree: Kris received his Bachelor of Science degree in Mechanical Engineering from Washington State University in 1990.

Publications / Commentary: Kris has authored a number of articles in recent years on the use of technology in clinical trials.

21

ICON plc Corporate HeadquartersSouth County Business ParkLeopardstown, Dublin 18IrelandT: +353 1 291 2000F: +353 1 291 2700info@iconirl.comwww.iconplc.com

Divisional Contact Details

T: +1 267 482 6300info@iconmedicalimaging.com www.iconmedicalimaging.com

ICON Medical Imaging

T: +1 215 616 3000T: +44 2380 688 500info@iconclinical.comwww.iconclinical.com

T: +1 410 696 3000T: +44 1628 496 300www.icondevsolutions.com

ICON Development Solutions

ICON ClinicalResearch

T: +1 886 627 4473T: +31 20 715 000info@docs-int.com

ICON Contracting Solutions

T: +1 631 777 8833 T: +353 1 291 2000info@iconlabinc.comwww.icolabs.com

ICON Central Laboratories

V1: 04/08