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

11:15 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

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