FDA Announces Monthly Forum on Framework to Enable Pediatric Drug Development

Forum on Framework to Enable Pediatric Drug Development

FDA Announces Monthly Forum on Framework to Enable Pediatric Drug Development In a collaborative effort with pediatric drug development stakeholders, and the Best Pharmaceuticals for Children (BPCA) program under the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the U.S. Food and Drug Administration (FDA) Office of Clinical Pharmacology (OCP) announces a new forum to discuss a generic framework to enable pediatric drug development studies. On December 14-15, 2020, speakers at the BPCA Stakeholders Meeting shared updates on current work within the BPCA program and identified challenges in pediatric drug development and therapeutics. Breakout sessions were held on pediatric drug development issues relating to: Advancing Clinical Trials Biomarkers Research PK Modeling that Informs Dosing Pediatric-Friendly Formulations Pharmacoepidemiology Systems Pharmacology The BPCA meeting created momentum to host a forum to discuss the development of an annotated, selective, curated collection of resources to assist drug developers, researchers, and clinicians with a range of topics prior to conducting pediatric drug development research. This collaborative effort will engage subject matter experts in pediatric care and research, and work on the framework will continue throughout 2021. This forum is open to the public and will be held beginning on the dates/times below (once per month per topic for 4 months). Please feel free to join discussions for more than one group if interested. To obtain the Zoom meeting information, please email bpca@infinityconferences.com and request the Zoom information for the groups of interest. Topic Recurring Virtual Forum First Call Pharmacokinetic Modeling to Inform Dosing 3rd Thursday of the month at 11 AM EDT 3/18/2021 Pediatric-Friendly Formulations 3rd Friday of the month at 1 PM EDT 3/19/2021 Pharmacoepidemiology 4th Tuesday of the month at 1 PM EDT (NOTE: a different call time will be selected for the April call) 3/23/2021 Biomarkers/ Developmental Pharmacodynamics 4th Wednesday of the month at 4 PM EDT 3/24/2021 Systems Pharmacology 4th Friday of the month at 1:00 PM EDT 3/26/2021 Advancing Clinical Trial Design Initial Call: March 30 at 12:00 PM EST Subsequent Calls: 4th Monday at 2:00 PM EST 3/30/2021 The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and select Clinical Pharmacology Corner under Drugs. We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov. This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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