Invited Sessions
Enhancing Regulatory Decision Making to Support Drug Development: US FDA Pilot Programs on Complex Innovative Designs and Model-Informed Drug Development
| Organizer(s): | Olga Marchenko, Bayer; José Pinheiro, Johnson & Johnson |
Statistical Designs and Considerations in Early Clinical Development
| Organizer(s): | Chin-Fu Hsiao, National Health Research Institutes |
Recent Development and Challenges in Bioequivalent or Biosimilar assessment
| Organizer(s): | Seung-Ho Kang, Yonsei University; Hsiao-Hui Tsou, National Health Research Institutes |
Rethinking Estimators within the Estimand Framework
| Organizer(s): | Dong Xi, Novartis Pharma |
Demystifying Estimands for Life History Processes
| Organizer(s): | Jiawei Wei, Novartis Institutes for BioMedical Research |
Use of Machine Learning and AI for Precision Medicine in Drug Development
| Organizer(s): | Ivan SF Chan, AbbVie |
Adaptive Designs for Small Population Clinical Trials
| Organizer(s): | Frank Bretz, Novartis AG |
Statistical Issues and Methods for Vaccine Development
| Organizer(s): | Frank Liu, Merck & Co., Inc.; Jie Chen, Merck & Co., Inc. |
Recent Development on Missing Data Issues under ICH E9 (R1) Estimand Framework
| Organizer(s): | Frank Liu, Merck & Co., Inc.; Jie Chen, Merck & Co., Inc. |
Methodology Research for Biopharmaceutical Industry
| Organizer(s): | Frank Liu, Merck & Co., Inc.; Jie Chen, Merck & Co., Inc. |
Some Innovative Clinical Trial Designs in CNS and Renal Diseases
| Organizer(s): | Toshimitsu Hamasaki, National Cerebral and Cardiovascular Center; H.M. James Hung, Food and Drug Administration |
Statistical Methods in Drug Development
| Organizer(s): | Hongyuan Cao, Florida State University |
Innovative Approaches for Trial Design and Analysis
| Organizer(s): | Jie Chen, Merck & Co., Inc. |
Issues in Adaptive and Complex Clinical Trial Design
| Organizer(s): | Franz König, Medical University of Vienna |
Oncology Trials with Non-Proportional Hazards
| Organizer(s): | Franz König, Medical University of Vienna; Martin Posch, Medical University of Vienna |
Statistical methodology for the comparative assessment of quality attributes
| Organizer(s): | Florian Klinglmueller, Austrian Medicines & Medical Devices Agency |
Bayesian Methods in Medical Product Development
| Organizer(s): | Satoshi Morita, Kyoto University |
Efficient Clinical Trial Design Strategies for Accelerating Biopharmaceutical Product Development
| Organizer(s): | Toshimitsu Hamasaki, National Cerebral and Cardiovascular Center; Jie Chen, Merck & Co., Inc. |