In the third episode of our Podcast series, the IDDI experts will be discussing the role of PK/PD in dose finding and dose optimization.
Key takeaways:
- Current context of PK/PD modelling in oncology
- Integrating PK modelling analyses in dose finding and dose optimization
- Role of PD in the early dose finding trials
Speakers:
- Vaiva Deltuvaite-Thomas – Senior Scientist, Statistical Consulting
- Jennifer Menda – Statistical Programmer
- Moderator: Erik Falvey – Senior 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In January 2023, the Food and Drug Administration (FDA) released a draft guidance detailing the core principles of Project Optimus.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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