Biomarkers in Early Phase Drug Devlopment – Some Industry Experience
View Presentation *Tommy Fu, Celgene Corp Xiaolong Luo, Celgene Corp Alan Wu, Celgene Corporation Keywords: Biomarker; Early Phase; Adaptive Design Biomarker development is considered as the most important area for improving drug development. Successful use of biomarker requires a close collaboration of early researchers and clinicians where early researchers need to look forward to understand how their research would impact clinical development, and clinicians need to look backward to conisder all the preclinical experiments performed into clinical trials. We will present a few recent oncology cases of utilizing biomarker in early phase adaptive clinical trials aiming for identifying patients who can benefit the greatest from the experimental drug which lead to better phase III study design and increased chance of success. Statistically, we will use appropriate procedure for the inference of treatment effect that would adjust for potential random high. We will share our excitement, challenges and issues with recommended solutions.
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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