TL06: Biomarker Development, Validation Standards, and Reproducible Biomedical Research
*Maha C Karnoub, Pfizer 


In recent years, a large number of discussions and publications have been made to define rigorous criteria for developing and validating various biomarkers. In parallel, the biomedical science community has paid great attention to reproducible biomedical research. At this current FDA/Industry meeting, several sessions are devoted to these two topics, with a significant overlap between them. We thus plan to gather the interested individuals to further discuss the issues presented at the meeting and to share our views on various efforts for deriving better statistical guidelines, including the white paper being written by many statistical expert scientists on Minimum Statistical Biomarker Development Standards (StatBDS). In particular, StatBDS discusses key issues in biomarker development including the intended use of the biomarker data, the most appropriate design for the work, and whether or not the biomarker is already in the clinic, with the goal of Reproducible Research in every step of the way.