Statistical evidences observed and review experiences of clinical biomarkers that led to FDA CDER qualifications
*Sue-Jane Wang, US FDA 


Abstract: FDA CDER biomarker qualification (BQ) program has qualified three clinical biomarkers. In this presentation, I will share regulatory and scientific review experiences in two biomarkers, Galactomannan and total kidney volume. Specifically, I will discuss analytical methods used and statistical evidences observed in light of their proposed contexts of use for their qualification supports. I will also illustrate how FDA statisticians work together as a team in a multi-disciplinary setting and their contributions toward the qualification of biomarkers. Challenges identified will be shared as part of our review experiences that led to the qualification.