Unique challenges posed by Enrichment Strategies in Oncology combination drug development
*Ram Suresh, GlaxoSmithKline Keywords: Predictive enrichment, combination products Predictive Enrichment Designs have dominated the molecularly targeted agent (MTA)-era in Oncology, giving rise to many life-saving drugs. However, recent examples in oncology suggest that enrichment strategies need further adaptation, especially in combination drug development. The unique challenges presented by combination products with enrichment strategies will be demonstrated via two major drug development examples. In addition, a novel enrichment approach that enables studying multiple cancers simultaneously will be presented. The clinical appeal and the statistical/regulatory challenges associated with this design will be discussed.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC