BPCA Framework to Enable Pediatric Drug Development

During the BPCA Stakeholders Meeting in December 2020 (PDF 218 KB), speakers shared updates on current work within the BPCA program as well as identified challenges and gaps in pediatric drug development and therapeutics. They also discussed the development of a generic framework: an annotated, selective, curated collection of resources to assist drug developers, researchers, and clinicians with a universal resource of relevant topics (existing resources and remaining gaps) before conducting pediatric drug development research.

To continue this effort, stakeholders were invited to participate in and provide subject matter expertise on the next steps in developing this framework. Part of this commitment included participation in public assemblies to evaluate resources for the framework.

From March 2021 through August 2021, BPCA stakeholders convened six public assemblies, each of which focused on providing recommendations for existing resources that can be made available for those who conduct and/or sponsor pediatric drug development research. The assemblies focused on the following topics:

  • Advancing Clinical Trial Designs and Conduct in Pediatric Drug Development
  • The Role of Pharmacodynamic Biomarkers Research in Pediatric Drug Development
  • How Pharmacokinetic Modeling Can Be Used to Inform Drug Dosing
  • Enhancing Research in Pediatric-Friendly Formulations
  • The Role of Pharmacoepidemiology in Pediatric Drug Development
  • The Role of Quantitative Systems Pharmacology in Pediatric Drug Development

As a result of their work, a draft framework of resources has been prepared and is undergoing final review. Further discussions were held at the 2021 BPCA Stakeholders Meeting on December 2-3, 2021, where gaps in knowledge were also discussed along with proposed solutions.

The next steps are to incorporate final recommendations from NIH-wide committees, develop a curation plan for annual updates, and finalize a dissemination plan. The penultimate goal is for this framework of resources to be available on a web-based platform that can be easily accessed by all interested stakeholders. Input on the framework and any other actionable items is welcome from all. Send feedback to bpca@infinityconferences.com.

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