Regardless of the pharmaceutical development company, therapeutic area or regulatory pathway taken to get a drug onto the market, at some point there is a need to validate the business and scientific/regulatory case in a “proof-of-concept” clinical trial. If the development program supporting a proof-of-concept trial is done well, then it is up to the drug to demonstrate an acceptable risk-benefit profile.
In this audio conference, our speaker examines the framework necessary to maximize the chance of a successful proof-of-concept trial for a new chemical entity (the hardest case). The session also includes a discussion and case histories of the supporting nonclinical safety program, pharmacokinetic and pharmacodynamic evaluations, maximum tolerated dose issues, study design and endpoints in the context of a regulated industry.
Proof-of-Concept Clinical Trials: How to Maximize the Chances of Your Drug Demonstrating Benefit is being presented by Dr. Scott Oglesby, Director, Scientific Consulting, with Beckloff Associates, a Cardinal Health Company and airs on Tuesday, January 19, 2010. For more details or to register, please visit our site at www.fxconferences.com
