Virtual Public Webinar Series:

Improving the Investigation of New Antibacterial Agents for Use in Children:

Ensuring That Our Youngest Patients Benefit from Innovative Treatments of Infections Caused by Multi-Drug Resistant Bacteria

Infections caused by multi-drug resistant (MDR) bacteria have emerged as an important cause of morbidity and mortality. It is clear that children, especially newborns, need access to the innovative therapies being developed to address the challenge of treating patients with MDR bacterial infections. As this access is driven by regulatory approval and labeling for use in children, it is critical for the work supporting this process be completed as efficiently as possible. An analysis of approval and labeling of new antibiotics since 2000 indicates that it has taken up to 7.4 years for sponsors to satisfy the requirements for FDA approval and labeling of new antibiotics for use in children after approval and labeling occurred in adults (Mc Neeley, 2022). In this analysis no trend was evident indicating that the period between adult and pediatric approvals is shortening.

The Institute for Advancing Clinical Trials for Children has convened a group of experts to develop a webinar series aimed at identifying the challenges in completing the work required for regulatory approval and recommend action items that will address these challenges.

Look for the final announcement and agendas for two, half-day webinars I-ACT for Children will be hosting in the coming months.

Mc Neeley DF et al. ASM Microbe 2022, abstract #HMB03

Webinar #1: “The Challenges” will:

  • Review the impact of multi-drug resistant bacterial infections on the morbidity and mortality in children
  • Share the status of approval and labeling of innovative antibacterial therapies for use in children and understand the consequences of this labeling and approval on safe and effective treatment of children with MDR infections
  • Identify the challenges being faced in investigating innovative antibacterial agents in children

Webinar #2: “Addressing the Challenges” will:

  • Explore the impact of inclusion of older children in initial phase 3 clinical trials
  • Discuss improving pediatric clinical trial conduct with innovative trial designs and improved resourcing of existing trial infrastructures
  • Share the role of real-world data in informing antibacterial use and regulatory labeling and approval for children

This webinar series has been supported by grants/sponsorships from the Pharmaceutical Research and Manufacturers of America (PhRMA), Shionogi, and Pfizer.

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