Session Information
2009 BIO International Convention
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Moving Preclinical Safety Evaluation from Toxicity Determination to Risk Assessment
Track : Drug Discovery and Development
Program Code: 2859
Date: Tuesday, May 19, 2009
Time: 8:00 AM to 9:30 AM  EST
Location: B309
SPEAKER (S):
Christopher Austin, MD, NIH Chemical Genomics Center
Ernest Bush, PhD, Cambridge Healthtech Associates
Donna Mendrick, PhD, FDA/NCTR
Nina Sawczuk, MBA, Zygogen, LLC
Greg Stevens, PhD, Pfizer Global Research and Development
Description
In-life toxicology studies are expensive in terms of man-power, amount of materials and time required to perform a complete evaluation. Lower cost, faster and higher throughput screens that can predict those compounds that are not worth the cost and expense of conducting pilot toxicity studies will increase the success rate of compounds entering pilot studies, provide significant savings to companies performing pharmaceutical R&D, and reduce unproductive laboratory animal usage. This session will focus on the promise and implementation of new approaches to preclinical safety liability assessment and the challenges of translating preclinical results to human risk assessment in this context.

• Discuss and define goals and expectations for early preclinical safety liability testing
• Report on progress and challenges with new preclinical safety asessment technologies
• Discuss and define critical parameters for adoption of new preclinical safety assessment technologies


Audio Synchronized to PowerPoint
(Code: 2859)
  
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