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International Clinical Trials

The Balanced Approach to Optimising Clinical Trial Design and Execution

According to internal Phase 2 termination analysis, as many as 17% of clinical trials fail to answer the questions their sponsors had aimed to address (1). These failed trials end up wasting significant time, money, and resources, effectively ending with a whimper instead of a bang. Moreover, such failures are especially upsetting to patient communities, who must wait longer for new treatments.

In many cases, sponsors conduct dozens of trials at once without comprehensive data-led design and planning. All too often, sponsors activate hundreds of sites for a single trial without thoroughly analysing investigator site performance data. Even when a trial results in regulatory approval, it may have been dogged by a lack of operational excellence.

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Gen Li PhD is founder and President of Phesi and is passionate about improving patientsí lives. Prior to founding Phesi in 2007, Gen was Head of Productivity at Pfizer in clinical development, following Pfizerís acquisition of Pharmacia where he delivered the first implementation of clinical development productivity measurement. At Pharmacia/Pfizer, Gen significantly contributed to the Centre for Medicines Research international database for pharmaceutical R&D performance. Previously, he led the creation of the first computer-automated resource management system at Bristol-Myers Squibb. He earned his PhD in biochemistry from Beijing University, China, and an MBA from the Johnson Graduate School of Management at Cornell University, US.

Paul Chew MD is a board-certified cardiologist and internist and Chief Medical Officer at Phesi. He recently served as CMO at Silicon Valley-based Omada Health. Previously, Paul held various positions at Sanofi and Bristol- Myers Squibb, including Senior Vice President, Global Chief Medical Officer, and US R&D Head. He is currently on the Board of Trustees for the US Pharmacopoeial Convention. Paul spent 22 years at Johns Hopkins University, US, where he received his undergraduate and medical education, served his Osler medical residency, was a member of the interventional cardiology faculty, and held joint faculty appointments in radiology and cardiology.

Jonathan Peachey is Chief Operations Officer at Phesi with a background in business and IT transformation across pharma R&D for the past 25 years. Jonathan came to Phesi after serving as a Board Director at Kinapse, where he transformed the advisory and outsourcing delivery model for life sciences companies. Previously, Jonathan delivered business transformation for IBMís EU pharma R&D consulting practice. He also led development projects at GlaxoSmithKline, Bristol-Myers Squibb, and Pfizer. Jonathanís demonstrated capabilities span strategy, business and IT management, performance improvement and solution design, through to implementation. He holds a first class honours degree and an Advanced Strategy diploma from Said Business School, Oxford University, UK.


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Gen Li PhD
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Paul Chew MD
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Jonathan Peachey
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