TL4: Considerations for clinical development plans of oncology drugs with a companion diagnostics
*Qi Xia, Roche/Genentech Keywords: companion diagnostic, clinical development plan, oncology, adaptive design, co-development with CDx The Co-development of novel therapeutics and a companion diagnostic is playing an increasingly important role in drug development. Several clinical development plan options can be discussed. These options range from the lengthiest, e.g. traditional "Ph2 followed by Ph3" plan to the shortest, e.g. a "direct to Ph3" plan, with other options such as adaptive enrichement design (aka adaptive accrual design)that vary in terms of development timelines and risk level. A specific option needs to chosen based on the strategic context, the strength of the available data, and the performance of the diagnostic.
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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