Program

BASS XXXII > Program

BASS XXXII Program

  • NOV 3
  • NOV 4
  • NOV 5
  • 9:00 AM

    Keynote Address: RCTS, Real-World Data and the Patent Wars: Lies, Damn Lies, and Biostatistics Case Study presented by Dr. Stephen Ogenstad, Statogen Consulting

  • 10:00 AM

    Break

  • 10:15 AM

    Leveraging Baseline Covariate Adjustment Methods in Oncology Time-to-Event Studies presented by Dr. Daniel Backenroth, Johnson & Johnson

  • 11:00 AM

    Driving Operational Excellence: The Power of Statistical Innovation in Clinical Development presented by Dr. Fei Chen, Johnson & Johnson

  • 11:45 AM

    Lunch Break

  • 12:45 PM

    Bile Acids Are the Strong Indicators for the Progression of Metabolic Dysfunction Associated Steatotic Liver Disease in Ethnically Diverse Populations presented by Dr. Ekaterina Smirnova, Virginia Commonwealth University

  • 1:45 PM

    Integrated Analysis of Pre-Marketing Safety Data, Statistical Considerations and Estimands (part I) presented by Dr. Katarina Hedman, AstraZeneca

  • 2:45 PM

    Break

  • 3:00 PM

    Integrated Analysis of Pre-Marketing Safety Data, Statistical Considerations and Estimands (part II) presented by Dr. George Kordzakhia, AstraZeneca

  • 7:00 PM

    Banquet Dinner

  • 9:00 AM

    Evaluating Frequentist and Bayesian Confidence Intervals for Study Size Adjusted Risk Difference presented by Mr. Ben Duncan, Abbvie

  • 10:00 AM

    Enhancing the DMC Data Package Using Open Source Software, Artificial Intelligence, and LLMs presented by Dr. Melvin Munsaka, Abbvie

  • 10:45 AM

    Break

  • 11:00 AM

    A Structured Approach to Designing Pivotal Diagnostic Accuracy Studies for Noninvasive Tests Using Meta-Analytic Techniques presented by Dr. Ryan Butterfield and Dr. Ed De Vol, Siemens

  • 12:00 PM

    Lunch Break

  • 1:00 PM

    Multiple Testing in the Context of Group Sequential Designs presented by Dr. Yevgen Tymofyeyev and Dr. Michael Grayling, Johnson & Johnson

  • 2:00 PM

     SMART-MC: Characterizing the Dynamics of Multiple Sclerosis Therapy Transitions Using a Covariate-Based Markov Model presented by Dr. Priyam Das, Virginia Commonwealth University

  • 2:45 PM

    Harnessing Simulation to Inform Endpoint Selection in Cardiovascular Trials presented Dr. Stephan Ogenstad, Statogen Consulting – Co-Authored by Greg Ginn, ReAltaSciences

  • 4:00 PM

    Poster Session

  • 8:30 AM

    Rare Disease Clinical Trials: Challenges and Opportunities presented by Dr. Emily Morris, FDA Office of Biostatistics CDER

  • 9:30 AM

    Collecting and Applying Evidence to Interpret Clinical Outcome Assessments (COA)-based Endpoints in
    Clinical Trials     presented by Dr. Weimeng Wang, FDA Office of Biostatistics CDER

  • 10:30 AM

    Break

  • 11:00 AM

    Panel Discussion