In this last episode of our Podcast Series, the IDDI and One2Treat experts will be discussing the use of Generalized Pairwise Comparisons (GPC) in the dose escalation process.
Key takeaways:
- How will GPC methodology apply to “Project Optimus”
- How can GPC/ Net Treatment Benefit be used in the context of dose finding & dose optimization in Oncology trials.
- How this approach can be helpful to prepare for Market Access.
Speakers:
- Pascal Piedbois – Chief Medical Officer, One2Treat
- Rudradev Sengupta – Senior Trial Design Lead, One2Treat
- Moderator: Erik Falvey – Senior Director Business Development Europe, IDDI
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In January 2023, the Food and Drug Administration (FDA) released a draft guidance detailing the core principles of Project Optimus.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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