FDA-M CERSI: Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design Public Workshop

Dear Colleagues, FDA's Division of Pediatrics and Maternal Health and Complex Innovative Trial Design Pilot Meeting Program in CDER and The University of Maryland CERSI, are announcing a 2-day public workshop, "Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design". The purpose of this workshop is to discuss opportunities for leveraging complex and innovative trial designs, understand the challenges with their applications, and develop solutions on how challenges in the designs can be overcome. The workshop will specifically focus on two topics of interest: bridging biomarkers in pediatric extrapolation and Bayesian techniques in pediatric studies. In addition, the workshop will allow for an open dialogue around the use of these approaches among regulators, industry, academia, and patient organizations. The public workshop will be held on: Date: September 1 and 2, 2021 Time: 10:00 am to 3:00 pm The public workshop will be held in virtual format only. Webcast: https://cersi.umd.edu/event/16424/advancing-the-development-of-pediatric-therapeutics-adept-7 Agenda and Registration: To access the agenda and registration for the public workshop, visit the following website: https://cersi.umd.edu/event/16424/advancing-the-development-of-pediatric-therapeutics-adept-7 . Registrants will receive confirmation when they have been accepted. There is no registration fee to attend this public workshop. Best regards, Lily Mulugeta, PharmD Associate Director, Policy and Research (Acting) Division of Pediatrics and Maternal Health, ORPURM Office of New Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration