In the second episode of this Podcast series, the IDDI experts will be discussing Project Optimus with a deeper dive into dose finding designs: establishing safety and tolerability of a dose.
Key takeaways:
- The focus of the current research
- Implications for dose escalation trials
- How are the currently investigated/developed designs different from those considered in the early 2000’s
- Highlights & drawbacks of so-called “model-assisted” and “model-based” study designs
Speakers:
- Tomasz Burzykowski, Ph.D – VP Research
- Vincent Staggs, Ph.D – Senior Scientist
- Moderator: Erik Falvey – Sr. Director Business Development Europe
LISTEN TO THE PODCAST HERE:
About the Podcast Series:
In January 2023, the Food and Drug Administration (FDA) released a draft guidance detailing the core principles of Project Optimus. This initiative aims to educate, innovate, and collaborate with relevant stakeholders to advance a dose-finding and dose-optimization framework in oncology, ensuring an optimal balance between efficacy, safety, and tolerability of new therapies. In August 2024, the final guidance was published, incorporating feedback from various stakeholders.
The IDDI experts will dive into this initiative and its implications on oncology drug development through 5 episodes:
- Episode 1: From idea to final FDA guidance on dose optimization in oncology
- Episode 2: Dose-finding designs: establishing safety and tolerability of a dose
- Episode 3: Role of PK/PD in dose-finding and dose-optimization
- Episode 4: Designing randomized trials for dose optimization
- Episode 5: Generalized Pairwise Comparison (GPC) for dose finding
Stay tuned for this insightful podcast series and contact our experts for a complete guidance from dosing and study design to regulatory strategy and submission!
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