Biomarker Qualification in Clinical Trials
*Sue-Jane Wang, FDA 


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.