Issues for the Industry Statistician When a Potential Predictive Biomarker is Identified
View Presentation *Nancy Gustafson, Bristol-Myers Squibb Co. Keywords: biomarker, predictive, registrational, oncology Many issues arise for an Industry statistician when a potential predictive biomarker is identified for a drug under development. This talk will focus on two scenarios: 1) introducing the marker prior to start of the registrational Phase 3 trial(s), and 2) dealing with markers discovered after approval. A practical study design for internal decision making around the usefulness of the biomarker and need for refinement will be described, with oncology examples. Design and analysis considerations for supporting parallel regulatory submissions for both the NDA/BLA and the companion diagnostic kit PMA will be discussed. With respect to markers discovered after approval, challenges related to label change and modification of ongoing trials will be illustrated with examples from experiences with EGFR antagonists and K-ras.
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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