Details
- Type Event
- Date -
- Time -
- Location 1608 Rhode Island Ave NW, Washington, DC 1608 Rhode Island Ave NW, Washington, DC
About
This is Session 4 of 6. Must register for the entire 2025 Course and not per session.
Session Co-chairpersons:
Telba Irony, PhD, Senior Scientific Director, Quantitative Sciences, J&J Innovative Medicine
John Scott, PhD MA, Director, Division of Biostatistics, Center for Biologics and Evaluation Research, US Food and Drug Administration (FDA)
Lecturers
| Joshua Galanter, MD MAS |
Sr Medical Director, gRED OMNI Early Clinical Development, Genentech |
| Thomas E. Gwise, PhD | Consultant |
| Telba Irony, PhD | Senior Scientific Director, J&J Innovative Medicine |
| Mark Levenson, PhD | Director, Biometrics VII, Office of Biostatistics, Office of Translational Science, Center for Drug Evaluation and Research, US FDA |
| David Ohlssen, PhD |
Head of Advanced Exploratory Analytics, Novartis |
| Richard D. Payne, PhD MS | Senior Advisor - Statistics, Eli Lilly and Company |
| John Scott, PhD MA | Director, Division of Biostatistics, Center for Biologics and Evaluation Research, US FDA |
| Kert Viele, PhD | Director and Senior Statistical Scientist, Berry Consultants |
| Janet Wittes, PhD |
Consultant |
| others to be confirmed |
Additional faculty - case study proctors
| Cynthia DeKlotz, MD PhD FAAD | Director, Clinical Development – Immunology, J&J Innovative Medicine |
| Charlie Gombar, PhD | ACDRS Director |
| Kristin Fiorino, MD | Global Development Medical Director, CVRM, AstraZeneca |
| Leila Lackey, DEnv MHS | former Program Lead, Decision Support Service, OPSA/OSP/CDER/US FDA |
| Adam Levy, MD |
Executive Director | Head, Pediatric Center of Excellence, Global Drug Development, BMS |
| Julie Schneider, PhD | former Associate Director for Research Strategy and. Partnerships, Oncology Center of Excellence, US FDA |
| Presley L. Warner, JD | Partner, Gibson, Dunn & Crutcher UK LLP |
Topics (subject to change)
- Role of confirmatory phase in drug development
- Statistical principles for clinical trials
- Choice of control groups in clinical trials
- Study objectives, hypothesis testing, sample size, and probability of study success
- Multiplicity in clinical trials
- Missing data and estimands
- Data and Safety Monitoring Committees
- Interim analysis
- Bayesian statistics
- The design, analysis, and interpretation of a clinical endpoint trial
- Modeling and simulation
- Adaptive design in clinical trials and optimization
- Design and analysis of adaptive clinical trials
- Enrichment designs
- Co-development of a diagnostic and tailored therapeutic
- Biomarkers and surrogate endpoints
- Statistical issues related to design, analysis, and reporting of gene therapy clinical trials
- Rare disease and pediatrics
- Safety assessment and surveillance
- Real-World Evidence
- Data science and machine learning