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 work to develop a generic framework to provide an overall structure to enable pediatric drug development studies.

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 includes participation in public assemblies to discuss framework document development. Stakeholders identified as those who could both benefit and contribute to these meetings include:

  • Clinical investigators
  • Preclinical investigators
  • Regulators
  • Patients and patient advocates
  • Industry and other institutions that:
    • Own assets for pediatric drug development (e.g., drugs, biomarkers, preclinical models, etc.)
    • Drive drug development (e.g., sponsors)
    • Support drug development (e.g., contract research organizations or academic research organizations)

Since the 2020 meeting, BPCA stakeholders have convened six public assemblies, each of which has focused in some way on the goal of developing an annotated, selective, curated collection of resources to assist drug developers, researchers, and clinicians with a "read this first" universal resource of relevant topics (existing resources and remaining gaps) before conducting pediatric drug development research. The assemblies have 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 Qualitative Systems Pharmacology in Pediatric Drug Development

BPCA will continue to spearhead this framework development effort through 2021 in collaboration with subject matter experts in pediatric care and research.

All are welcome to join the discussion and contribute to the framework. Assemblies will meet monthly through at least June 2021. Download the assembly flyer external link (PDF 397 KB) to view more information on call dates. For Zoom call information or questions about the initiative, contact bpca@infinityconferences.com.

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