Program
- OCT 23
- OCT 24
- OCT 25
- OCT 26
- 9:00 AM
Dr. Frank Rockhold, Duke University—Clinical Trials Using Patient Health Data: A Primer on Pragmatic Trials
- 10:00 AM
Break
- 10:15 AM
Dr. Joe Cappelleri, Pfizer Inc.—Advances in Interpretation of Patient-Reported Outcomes
- 11:45 AM
Lunch Break
- 12:45 PM
Dr. Sarah Stanley, Eli Lilly and Company—Pediatric Trial Design: Opportunities, Challenges, Bioethics and Innovation
- 1:45 PM
Dr. Robert Perera, Virginia Commonwealth University—An Integrated Multiple Adaptive Design (IMAD) for Randomized Control Trials
- 2:45 PM
Break
- 3:00 PM
Dr. Ryan Butterfield, Siemens Healthineers—The Future of Statistical Analysis – to AI or not AI?
- 7:00 PM
Banquet Dinner
- 9:00 AM
Dr. Tianle Chen and Dr. Luan Lin, Biogen Inc.—Statistical Leadership in Establishing Surrogacy: Applications and Reflections
- 10:30 AM
Break
- 11:00 AM
Dr. Yannis Jemiai, Cytel—Simulation-guided Designs: A New Approach to Trial Design and Probabilistic Risk Assessment
- 12:00 PM
Lunch Break
- 1:00 PM
Dr. Juhua Luo, School of Public Health-Bloomington—SGLT2 Inhibitors and Cancer Prognosis –Using SEER-Medicare Linked Data Cohorts
- 2:00 PM
Dr. Isik Karahanoglu, Pfizer Inc.—Perspectives and Use Cases of AI/ML in Clinical Development
- 3:00 PM
Poster Session
- 8:30 AM
Dr. Yan Wang, CDER, FDA—Global Tests for Multiple Endpoints in Rare Disease Clinical Trials
- 9:30 AM
Dr. James Travis, CDER, FDA—Informative Bayesian Methods and Pediatric Extrapolation
- 10:30 AM
Break
- 11:00 AM
Panel Discussion: Reflections from the Past and Projections for the Future of Biopharmaceutical Statistics
- 9:00 AM
Online Short Course: Dr. Nolan Wages, Virginia Commonwealth University—Novel Designs for Contemporary Early-Phase Clinical Trials