Early Development and The Dose Selection in the Immune-oncology
- Author
- Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry
- Published
- Mon 16 Dec 2024
- Episode Link
- https://podcastae8fac.podigee.io/408-new-episode
Interview with Teppo Huttunen
Key points:
- Dose Selection Challenge
- Limitations of 3+3 Design
- BOIN Design
- Backfilling
- Efficacy vs. Safety
- Statisticians’ Role
- Practical Challenges
- FDA Guidance
- Cross-Functional Approach
- Industry Trends
- Cost & Timeline Estimation
Understanding dose selection in immune-oncology is crucial for developing safer and more effective treatments, and statisticians play a central role in driving these decisions.
In this episode, Teppo shares practical insights into overcoming the limitations of traditional methods and adopting more flexible approaches like the BOIN design.
If you want to stay ahead in oncology research and learn how to balance safety, efficacy, and practical challenges in dose optimization, this episode is a must-listen!
