DIA 48th Annual Meeting
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Can Human Carcinogenic Risk Be Communicated Without a Rodent Bioassay?
Track
:
Track 04: Nonclinical and Translational Development/Early Phase Clinical Development
Program Code:
331
Date:
Wednesday, June 27, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Joy Cavagnaro, Access BIO, United States
PRESENTER
(S):
Samuel Cohen, University of Nebraska Medical Center, United States David Jacobson-Kram, FDA, United States Ronald Steigerwalt, Amgen Inc., United States
Description
Has our understanding of carcinogenicity advanced sufficiently that data from alternative assays could be used to support decisions that are as protective of the public health as are current approaches?
Learning Objectives:
Discuss approaches to standard preclinical assessment of carcinogenic risk and limitations to understanding human risk
Describe potential alternative approaches to current "gold standard"
Describe challenges of biotechnology-derived pharmaceuticals use of alternative approaches.
Learning Objectives:
Discuss approaches to standard preclinical assessment of carcinogenic risk and limitations to understanding human risk
Describe potential alternative approaches to current "gold standard"
Describe challenges of biotechnology-derived pharmaceuticals use of alternative approaches.
This session is a part of:
Handout Online
