254092 Application of IVD Testing in Therapeutic Trials

Tuesday, November 1, 2011: 5:10 PM

Elizabeth Mansfield, PhD , Oivd/Cdrh, Food and Drug Administration, Silver Spring, MD
Development of therapeutics that require a companion diagnostic is a key step in the evolution of personalized medicine. The integration of the diagnostic device into the therapeutic clinical trial is critical, and appropriate design requires an understanding of what information FDA will be looking for regarding both the therapeutic and the device. This presentation will provide some pointers on how to plan an appropriate approach.

Learning Areas:
Biostatistics, economics

Learning Objectives:
Describe opportunities and challenges for personalized medicine.

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I oversee the personalized medicine program in OIVD at FDA.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.