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European Biopharmaceutical Review

A Challenge of Pandemic Proportions

In what ways was the Pfizer/BioNTech trial different from other vaccine trials ICON has run in the past?

From the beginning, we were aware of the significance of what we were engaged in. All clinical trials are important, but on this particular trial, we knew the world was watching and waiting for the results. The pandemic affects everyone, ICON staff included, on a personal and professional level, and we had those extra factors to contend with too. Operating in more than 40 countries meant we were all too aware of the pandemic sweeping the globe. We knew that the COVID-19 trials had to happen at the greatest speed and with the highest levels of safety, quality, and rigour.

Taking a look at the specific differences, the main one is obviously the scale and speed of this trial. The Pfizer/ BioNTech clinical trial was one of the largest and fastest clinical trials ever conducted. We recruited more than 44,000 patients across six countries and four continents, and the submission for emergency authorisation was made in 248 days for anyone familiar with clinical trial timelines, even considering vaccine trials generally have to move fast, this is unprecedented.

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Dr Steve Cutler was appointed Chief Executive Officer of ICON plc in March 2017, having previously served as Chief Operating Officer from January 2014. Steve served as Group President Clinical Research Services since November 2011 until his appointment as Chief Operating Officer. He was appointed to the board of ICON plc in November 2015.

Prior to joining the company, Steve held the position of Chief Executive Officer of Kendle, having previously served as Chief Operating Officer. Prior to Kendle, he 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.

Steve holds a BSc and a PhD from the University of Sydney, Australia, and a Masters of Business Administration from the University of Birmingham, UK.
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