Biomarker Qualification in Clinical Trials
*Sue-Jane Wang, FDA Keywords: The recent advances in genomics, such as, gene expression and single neucleotide polymorphisms, and proteomics, such as, protein expression, opened the door for drug trials to investigate adaptively a potential single biomarker or composite biomarkers measured using noninvasive procedures for pharmacologic response and/or toxicity classifications. The interest is mounting because many believe that there should be a signal for pharmacologic effect or therapeutic effect, and there seem to be some promising findings. In this roundtable luncheon, we shall discuss the utility of genomic biomarkers versus that of surrogate biomarker, and the qualification of biomarkers when they are used as a scientific finding versus used for future drug trial design and evaluation of safety concern.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC