ICON by Industry Thought Leaders is Released

ICON plc (ICLR), a global provider of drug and development solutions and services to the pharmaceutical, biotechnology and medical device industries, today announced the release of the book "Re-Engineering Clinical Trials" (ISBN: 9780124202467), edited and co-authored by Brendan Buckley, ICON's Chief Medical Officer, and Peter Schüler, ICON's SVP of Global Medical and Safety Services.

Joined by co-authors at AstraZeneca, Bayer, Boehringer Ingelheim, IBM, McGill University, the Tufts Center for the Study of Drug Design, and 22 other institutes and companies, Buckley and Schüler set forth a comprehensive collection of reforms for a progressive model of drug development. The editors hope to propel faster change in some businesses restrained increasingly by companies, not regulators.

In this book, ICON and industry leaders have asked and answered some critical questions about the fundamentals of clinical development.

"For example, what causes good drugs to fail? Why do so many expenditures in clinical trials not benefit patients? Have other industries already invented what we need? The answers can spur reforms of fundamental processes that, when implemented together, represent a new business model for drug development," says Buckley.

The editors argue that most of the reforms do not require invention of new technologies or methodologies. The necessary innovations are either available in other industries or have already received regulatory approval and are in use in clinical trials.

"Knowledge of beneficial reforms remains siloed and not widely disseminated, making it difficult to build momentum for change. This book is part of the process for stimulating evolution of businesses by presenting these as a package for a suggested way forward," says Schüler.

The book, published by Elsevier B.V., compiles leading experts' factual reviews of critical reforms with express regulatory support, including:

• Failure Mode and Effects Analysis (FMEA) and other techniques from outside industries
• Centralised trial monitoring constructed through FMEA
• Site staff hiring, training, and performance analysis
• Innovative trial designs, including use of surrogate endpoints and adaptive designs
• Patient-centred recruitment and engagement
• Protocol design and data mining
• Unstructured data management
• Connected health, the clinical trial "app," and patients as investigators

On May 12th, 2015, ICON and the Tufts Center for the Study of Drug Development will present a 1-day Biopharma Summit that will discuss themes from selected chapters of the book. The event takes place at the Hyatt Regency Washington on Capitol Hill and the programme will include:

• FDA's Key Areas of Improving Clinical Trial Quality and Efficiency - a keynote delivered by FDA Deputy Commissioner, Dr. Robert Califf
• Engaging Sites and Patients To Optimise Drug Development
• Protocol Design: The Heart of Clinical Trial Re-engineering
• The Age of More Data and Analytics

Click here to register or email Ms. Rachel Stanton (Rachel.Stanton@tufts.edu).

About ICON plc

ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 83 locations in 38 countries and has approximately 10,600 employees.

Further information is available at www.iconplc.com

About the Editors

Professor Brendan Buckley

Professor Brendan Buckley is Chief Medical Officer at ICON plc. In this role, Professor Buckley is ICON's lead medical expert, representing the company's position on key scientific, ethical, and medical governance matters and he also provides guidance and oversight to the medical and scientific groups across ICON. Brendan joined ICON through the acquisition of Firecrest Clinical in 2011, where he was one of the founders of the company.

Professor Buckley is an Honorary Clinical Professor in the School of Medicine at University College Cork (UCC), Ireland. A medical graduate of the National University of Ireland and a doctoral graduate in Biochemistry from Oxford University, Professor Buckley has over 30 years' experience in clinical pharmacology research. Prior to joining ICON, he was Director of the European Collaborative Centre for Clinical Trials in Rare Diseases at UCC. He was also a member of the EMA Committee for Orphan Medicinal Products (COMP) from 2000-2003 and a member of the EMA Scientific Advisory Committee on Diabetes and Metabolism until 2011. He was a member of the Board of Directors of the Irish Medicines Board, the national regulatory authority for Ireland, 2004-2011 and chaired its statutory Advisory Committee for Human Medicines. Professor Buckley is chairman of the independent data and safety monitoring boards for a number of large clinical trials programmes with several sponsors. He is a member of the scientific advisory boards of a number of research charities and honorary Director of the Cork Cancer Research Centre. Professor Buckley is a Fellow of the Royal College of Physicians of Ireland, of the College's Faculty of Pathology, and a Fellow of the Faculty of Sports and Exercise Medicine.

Dr. Peter Schüler

Dr. Peter Schüler is Senior Vice President, Global Medical & Safety Services at ICON plc. In this role, Dr. Schüler oversees over 360 medical and safety professionals located in 11 ICON offices in Argentina, Brazil, Germany, India, Japan, Latvia, Mexico, Poland, Singapore, UK and US. He joined ICON in 2007.

Dr. Schüler is board certified in neurology (1996; German Medical Board) and in Pharmaceutical Medicine (2001; Swiss Medical Association). In 1999 he obtained a Certificate in Business Administration by Henley Management College, UK. Following his medical education Dr. Schüler began his professional career in 1987 at the Medical Imaging Application Center of Siemens AG Medical Solutions. In the same year he also started at the Department of Experimental Neuropsychiatry of the Neurological University Hospital Erlangen, Germany. In the ensuing 8 years he was involved in basic and clinical CNS research. He held the position of Secretary General of the German section of the International League Against Epilepsy (ILAE; 1991-1995) and was awarded two scientific awards (Alfred-Hauptman epilepsy prize and ILAE Young Investigator Award). In 1995 Dr. Schüler joined Pharmacia and while there, he participated in the launch of two NCEs in Parkinson's Disease and major depression. In October 2000 Dr. Schüler moved into the CRO industry and has since become an authority in medical affairs and drug safety. He has issued several publications on drug safety and authored an eBook about clinical trial design and conduct (Zenosis Ltd publisher) and continues to lecture Pharmaceutical Medicine at the Universities of Duisburg-Essen, Germany and Aveiro, Portugal.

This press release contains forward-looking statements. These statements are based on management's current expectations and information currently available, including current economic and industry conditions. These statements are not guarantees of future performance or actual results, and actual results, developments and business decisions may differ from those stated in this press release. The forward-looking statements are subject to future events, risks, uncertainties and other factors that could cause actual results to differ materially from those projected in the statements, including, but not limited to, the ability to enter into new contracts, maintain client relationships, manage the opening of new offices and offering of new services, the integration of new business mergers and acquisitions, as well as economic and global market conditions and other risks and uncertainties detailed from time to time in SEC reports filed by ICON, all of which are difficult to predict and some of which are beyond our control. For these reasons, you should not place undue reliance on these forward-looking statements when making investment decisions. The word "expected" and variations of such words and similar expressions are intended to identify forward-looking statements. Forward-looking statements are only as of the date they are made and we do not undertake any obligation to update publicly any forward-looking statement, either as a result of new information, future events or otherwise. More information about the risks and uncertainties relating to these forward-looking statements may be found in SEC reports filed by ICON, including its Form 20-F, F-1, S-8 and F-3, which are available on the SEC's website at http://www.sec.gov.

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