Program
BASS XXXI Program
- NOV 4
- NOV 5
- NOV 6
- NOV 7
- 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