Use of a Structured Framework for Evaluating Benefits and Risks of a Drug-Companion Diagnostic Combination
*Rebecca Noel, Eli Lilly and Company *Margaret Warner, Eli Lilly and Company Keywords: The use of a structured framework for benefit-risk assessment (B-RA) across the lifecycle of a drug is becoming standard practice for both the pharmaceutical industry and regulatory agencies. Frameworks facilitate decision making and improve transparency by including key decision factors such as context (condition to be treated, alternative therapies), key benefits and key risks, and the strengths and limitations of the evidence. To date, structured B-RA frameworks have been applied mainly to therapeutic products. This presentation will include examples of how a structured framework for the B-RA of a drug may be applied to a drug-companion diagnostic combination.
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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