Developing safe and effective oncology medications for children presents unique challenges due to ethical considerations and physiological differences across age groups. Traditional clinical trials often face limitations in sample size and recruitment of specific pediatric populations, hindering the efficient development of these critical drugs.
This presentation explores strategies to overcome these challenges and optimize pediatric oncology drug development. We will discuss:
- Innovative approaches: Utilizing advanced methodologies such as model informed drug development MIDD and technologies to improve drug development efficiency.
- Regulatory considerations: Navigating the complex regulatory landscape for pediatric oncology drugs.
- Data-driven decision-making: Leveraging data at various phases from both clinical studies and from real world →analytics to inform drug development decisions.
By understanding and implementing strategic solutions to address challenges in these key areas, we can accelerate the development of essential oncology medications for children, improving patient outcomes and addressing unmet medical needs.
Learning Objectives:
- Understand the unique challenges associated with dose optimization of pediatric oncology drugs.
- Explore the impact of the RACE Act and dose optimization guidance (Project Optimus) on pediatric oncology drug development.
- Discuss clinical pharmacology, pharmacometrics (MIDD), PIP, and iPSP considerations specific to pediatric oncology drug development.
- Learn how MIDD can support dose finding, justification, and extrapolation.
- Understand the role of real-world data in accelerating pediatric oncology drug development.
Who Should Attend:
Regulatory professionals, clinical pharmacists, researchers, and healthcare providers involved in pediatric oncology drug development. Individuals with a basic understanding of drug development and clinical pharmacology will benefit most from this webinar.