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    Home > Events > Veristat to talk on use of biomarkers in clinical development regulatory submission at massbio forum

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    Veristat to Talk on “Use of Biomarkers in Clinical Development & Regulatory Submission” at MassBio Forum.

    Veristat’s President and Chief Biostatistician, John P. Balser, PhD will moderate the second in a two-part series of panel discussions on Biomarkers at the upcoming MassBio Forum taking place on Tuesday, August 4, 2015 from 8:00-10:00 AM.   This second forum will focus on the use of biomarkers in clinical development, with specific discussion on clinical study design, patient selection, statistical analysis, and the regulatory challenges with using biomarkers.

    The panel will explore the following:

    • How biomarkers may inform a meaningful clinical decision for a specific patient
    • How does research help systematize the utility of biomarkers?
    • Clinical issues in the use of biomarkers
    • Statistical issues in the use of biomarkers - prediction versus prognosis
    • Regulatory issues in the use of biomarkers as adjuncts to drug approvals
    • Case studies in the use of biomarkers in clinical research, successful or otherwise

    Additionally, the discussion will begin with a brief review of the main points covered during the Biomarker Part 1 Forum, titled “Basic Concepts of Biomarkers, Discovery and Identification”.

    To learn more about this Biomarker panel discussion or to register, visit the Biomarker Part II Forum.

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