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Steve Cutler

Chief Executive Officer, ICON plc

Expertise: The Global Clinical Research Market

Dr. Steve Cutler was appointed Chief Executive Officer of ICON in March, 2017. Steve has over 23 years’ experience within the pharmaceutical and CRO industry and joined ICON from Kendle where he held the position of Chief Executive Officer, having previously served as Kendle’s Chief Operating Officer. Prior to Kendle, Steve spent 14 years with Quintiles where he served as Senior Vice President, Global Project Management; Senior Vice President, Clinical, Medical and Regulatory; Senior Vice President, Project Management - Europe; and Vice President, Oncology - Europe as well as regional leadership positions in South Africa and Australia. Prior to joining Quintiles, Steve held positions with Sandoz (now Novartis) in Australia and Europe.

Recent media contributions:

  • Steve Cutler participated in the Business & Finance CEO Q&A in which he outlined his ambitions and priorities for ICON.
  • This article in Business & Finance features an interview with Steve Cutler after ICON won Company of the Year.
  • In the Irish Business Post, Steve Cutler discusses how Irish companies, including ICON, intend to approach the US market, which brings a wealth of new opportunities and challenges.
  • In Investor's Business Daily, Dr Steve Cutler dicusses applied innovation, and the importance of culture and communication, in driving business performance.
  • Participating in PWC's CEO Survey 2022, Dr Steve Cutler discusses the role of M&A in growth strategy.
  • In this Prisma Report (page 14), Dr Steve Cutler describes ICON’s efforts to combat the COVID-19 pandemic and how the crisis has pushed new digital technologies forward.
  • In Endpoint News, Dr. Steve Cutler, offers his perspective of the ever-changing CRO landscape based on recent mergers and acquisitions in the industry. (Subscription required to read)
  • Dr. Steve Cutler discusses clinical research as one of Ireland’s most promising industries in this special supplement on Ireland’s economy that appeared in the weekend edition of the New York Times.
  • In New Scientist, Dr. Steve Cutler discusses how the research industry has changed in the past year, concluding that decentralised models are helping to improve patient outcomes and bring treatments to market faster (page 12).
  • Steve Cutler chats with Newsweek on ICON’s role in the development of much needed medicines. The interview (page 12 of PDF) is part of a special report on Ireland.
  • An interview in which CEO Dr. Steve Cutler provides an overview of ICON’s evolution and drivers over the past few years from the pandemic to the recent PRA Health acquisition.
  • PharmaTimes talks to Dr Steve Cutler about the impact of the COVID pandemic and challenges of running large-scale vaccine trials.
  • A Medicircle article explaining how ICON was involved from the very first steps of the COVID-19 clinical trial supporting Pfizer‘s and BioNTech’s implementation of a strategic plan and framework for the monitoring of the trial.
  • In Pink Sheet, ICON CEO Steve Cutler discusses how the Pfizer COVID vaccine trial proves that starting clinical trials in weeks, as opposed to months, should be possible post- pandemic.
  • Irish Times article: ICON carried out trial of Pfizer-BioNTech vaccine.

Tom O'Leary

Chief Information Officer

Expertise: Innovation

Prior to this he held the position of Global Head of Data Management at ICON Clinical Research. He joined the company in Feb-2001 as Manager of Data management in Dublin. He subsequently went on to set-up ICON's process improvement initiative "IMPROVE" and returned to Data Management to become EU VP of Data Management before becoming Global Head of Data Management in 2006.

Recent media contributions:

  • Tom O'Leary provides expert commentary on integrating AI and machine learning into Pharma R&D in this Bio IT World article.
  • A thought leadership article authored by Tom O’Leary on how collected data from digital health technologies, coupled with novel clinical trial models, have the ability to increase the value proposition of drugs and medical devices.
  • ICON’s CIO, Tom Leary discusses in this GBR article the challenges to patient recruitment during the COVID pandemic and how big data, combined with advanced AI algorithms processing has the potential to reduce trial costs. 
  • Financial Times Global Pharma and Biotech Summit 2020. Panel discussion: How Technology is Transforming R&D?
Barry Balfe

Mr. Barry Balfe

President Global Operations (Large Pharma)

Expertise: Resourcing for Clinical Trials

Mr. Barry Balfe is President of Global Operations (Large Pharma). Mr. Balfe previously served as President of ICON Functional Services (IFS). Mr. Balfe has been with ICON for over fifteen years and has held a number of senior roles, predominantly within the FSP organisation, where he has successfully grown this business and has developed and led a number of new strategic partnerships. Mr. Balfe was previously EVP, Global Business Development. As part of the FSP team, Mr. Balfe served as Senior Vice-President, Global Program Management where he oversaw operational design, planning & delivery within FSP' resourcing & FSP businesses. He initially joined ICON’s Business Development team in 2003, before taking on the leadership of FSP' US Business in early 2007 and subsequently overseeing FSP' European Operations. Mr. Balfe holds a Bachelor of Science degree in chemistry, having studied at Dublin City University and Ecole Nationale Supérieure de Chimie de Toulouse. He subsequently studied pharmacoepidemiology and pharmacovigilance at London School of Hygiene and Tropical Medicine, the University of London.

Recent media contributions:

  • This spotlight feature in International Clnical Trials examines how pharmaceutical companies are increasing their functional service partnership expenditure at a rapid rate, and the key considerations in selecting and executing the FSP model which are being overlooked.
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