1:00 – 4:00 PM

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

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

11:00 AM

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

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