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Date and Time
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Mar 11 2010 11:00 AM -- Mar 11 2010 1:00 PM
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Location
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Enterprise Center of Johnson County
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Description
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Proof-of-Concept Clinical Trials Workshop: How to Maximize the Chances of Your Drug Demonstrating Benefit - Are you involved in maximizing the value of your company’s development compounds while minimizing the risks? Do you understand the safety, pharmacokinetic, and pharmacodynamic issues that need to be addressed and integrated before conducting a proof-of-concept clinical trial that will maximize your drugs’ chances of success? At this workshop, you will learn from Beckloff Associates’ Dr. Scott Oglesby, Ph.D., a top industry expert, about:
• Questions to address prior to conducting a proof-of-concept trial
• Factors that influence dose selection and dosing regimen
• How to minimize the time to get to the proof-of-concept clinical trial
• How much time and money is necessary to get to the proof-of-concept stage
• Major risks for a proof-of-concept trial and their mitigation
This presentation will examine the framework necessary to maximize the chance of a successful proof-of-concept trial for a new chemical entity (the hardest case). This will include discussion and case histories of the supporting nonclinical safety program, pharmacokinetic and pharmacodynamic evaluations, maximum tolerated dose issues, and study design and endpoints in the context of a regulated industry. Enterprise Center of Johnson County, 8527 Bluejacket, March 11th, 11am-1pm, $50(includes boxed lunch). To register - online at www.ecjc.com, call 913-438-2282 or email jvehlewald@ecjc.com.
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