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