BASS XXXI Program

  • 9:00 AM

    A Case Study: The Adventure of the Missing Data, presented by Dr. Ryan Butterfield and Dr. Viral Panchal, Siemens Healthineers

  • 10:00 AM

    Up-Front Matching: A Recruitment Method for Prospective Observational Studies That Mimics Randomization, presented by Ibrahim Turkoz, Janssen

  • 11:00 AM

    Break

  • 11:15 AM

    Optimizing Drug Development Designs for Precision Medicine Considerations, presented by Dr. Gary Cline, Cline Consulting LLC

  • 12:00 PM

    Lunch Break

  • 12:45 PM

    Real-World Data for Enhanced Drug Development in the Pharmaceutical Industry, presented by Mr. Greg Ginn, Realta Life Sciences

  • 1:45 PM

    Using Skeptical and Informative Priors in Bayesian Adaptive Clinical Trial Designs, presented by Dr. Roy Sabo, VCU

  • 2:45 PM

    Break

  • 3:00 PM

    Biostatistics: Reflections of the Past and Projections for the Future, Panel Discussion

  • 7:00 PM

    Banquet Dinner

  • 9:00 AM

    Keynote Address: Building Your Career in Statistics: A Guide to Accomplishment, Happiness, and Longevity, presented by Dr. Craig Mallinckrodt, Pentara

  • 10:00 AM

    Follow-Up Planning for Time to Event Endpoints in Randomized Cancer Trials: Learnings for RWE Studies, presented by Shankar Srinivasan, Bayer U.S. LLC

  • 11:00 AM

    Break

  • 11:15 AM

    Session I: Gene and Cell Therapy

    Drug Target Discovery for Genetic Disorders Leveraging Multi-Omics Data and Comparability Assessment for Manufacturing Changes in CGT, presented by Dr. Lira Pi, Pharmalex;  

    Challenges of Underdosing Control in Dose-Escalation Studies for DNA-Based Gene Therapies, presented by Quang Nguyen, Regenereon

  • 12:00 PM

    Lunch Break

  • 1:00 PM

    Session 2: Gene Therapy in Rare Disease, presented by Chenkun Wang, Vertex;  

    Assessing the Impact of Crossover on the Power for Overall Survival in Randomized Clinical Trials: A Simulation-Based Method, presented by Zhi Yang, BMS

  • 2:00 PM

    Statistical Techniques and Learnings from GVHD Treatment Trials, presented by Dr. Laura Morrison, Emmes

  • 3:00 PM

    Poster Session

  • 8:30 AM

    Applications of Unsupervised Learning for Plasma Concentration-Time Curves, presented by Junghi Kim,Senior Mathematical Statistician, Division of Biometrics VIII, Office of Biostatistics, FDA

  • 9:30 AM

    Emerging Digital Technology Data from Continuous Glucose Monitoring in Anti-Diabetic Product Clinical Trials, Yoonhee Kim, Lead Mathematical Statistician, Diabetes Statistical Review Team, Division of Biometrics II, Office of Biostatistics, FDA

  • 10:30 AM

    Break

  • 11:00 AM

    Interpretable Machine Learning – Applications in Clinical Research, Presented by Dr. Kao-Tao Tsai

  • 1:00 – 4:00 PM

    Online Short Course: Building Your Career as a Statistician, presented by Dr. Craig Mallinckrodt, Pentara