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CRO Leadership Awards 2014

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LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2014 7 Intel cofounder Gordon Moore predicted in 1965 that the number of transistors on an integrated circuit would double approximately every two years. What came to be known as Moore's Law has basically held true ever since. he reciprocal effect of this increased microchip perfor- mance is decreased computer costs. Similar economic gains have been made in other information- intensive industries (e.g. telecommunica- tions). Unfortunately, the same relation- ship does not exist for clinical trials, which have witnessed steady cost increases of 7.4 percent annually over inflation for the past 20 years — despite the advent of vari- ous technologies (e.g. electronic health records and electronic data collection) that significantly reduce the amount of time and effort required to gather clinical data. In a discussion paper (April 13, 2012) presented to the Institute of Medicine's Forum on Drug Discovery, Development, and Translation, Duke University Medical Center researchers Judith Kramer, M.D., and Kevin Schulman, M.D., note that the problem with escalating clinical trial costs is the result of sponsors, CROs, regulatory agencies, and providers failing to evolve the clinical research business model to keep pace with advances in technology. As a result, rising clinical trial costs have played a pivotal role in skyrocketing drug development costs. Performing clinical trials as they have been done for decades is no longer accept- able. Technological and methodological advances have afforded sponsors the opportunity to increase the quality of data collected while decreasing clinical time lines and costs. In order for the industry to continue to the extent it has, sponsors must evolve. It was with this mindset that Life Science Leader magazine and NextDocs, a clinical content document management solutions provider, convened an intimate thought-leadership roundtable event in New Jersey with a goal of providing you with some best business practice infor- mation on how to improve clinical trials. In addition to myself, the participants included Mark Anderson, executive direc- tor, global head of clinical data manage- ment, Alexion; Greg Fiore, M.D., founder of SSI Strategy consultancy; Reinilde Heyrman, M.D., VP, chief clinical develop- ment officer, IKARIA; Mitch Katz, Ph.D., executive director medical research operations, Purdue Pharma; and Eva Krusinska, Ph.D., principal at PharmaLand Executive Consulting Services. Together they have a combined 125+ years of indus- try experience. And though you may not recognize some of their current employers, their past career experiences include more recognizable company names such as Abbott, Acorda, Amgen, Covance, Daiichi Sankyo, Eisai, Forest Laboratories, GSK, Merck, Pharmacia & Upjohn, Schering- Plough, and The Medicines Company. What follows is some good old-fashioned wisdom on how you can improve clinical trials — and it doesn't require you to spend a fortune on the latest whiz-bang gizmo or gadget. ARE YOU ASKING THE RIGHT QUESTIONS? One of the first questions I posed during the group discussion was fairly straight- forward: How can we improve clinical trials? According to Katz, a good place to start is by reducing the complexity of clinical trials. "We have used clinical trials T 0 3 1 4 _ R o u n d t a b l e _ I m p r o v e . i n d d 2 0314_Roundtable_Improve.indd 2 2 / 1 9 / 2 0 1 4 1 : 4 0 : 5 1 P M 2/19/2014 1:40:51 PM

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