Workshop | In Person
Event Title
Advancing the Development of Pediatric Therapeutics (ADEPT) 8 Workshop on Drug Dosing in Pediatric Patients with Renal Impairment
November 30, 2023 - December 1, 2023
- Date:
- November 30, 2023 - December 1, 2023
- Day1:
- - ET
- Day2:
- - ET
- Organized By:
-
Organizer
Location
FDA White Oak Campus
Building 31, Conference Center, The Great Room
10903 New Hampshire Ave.
Silver Spring, MD 20993
Organized by: CDER’s Office of New Drugs
Host Office Division: University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA)
Summary
The purpose of this public workshop is to discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge and consider innovative approaches to improve the current paradigm for dosing in pediatric patients with renal impairment.
Goals and Objectives
Advancing the Development of Pediatric Therapeutics Workshop on Drug Dosing in Pediatric Patients with Renal Impairment.
Meeting Agenda
- Agenda (PDF - 218 KB)
Contact
For additional details, contact the FDAs CDER/OND/Public Meeting Team at ONDPublicMTGSupport@fda.hhs.gov.
Workshop Presentations
Unfortunately, we are unable to provide alternate text for the presentations in the workshop. Persons with disabilities having problems accessing this page may call (301) 796-3634 for assistance.
Day 1: Thursday, November 30, 2023
Setting the Scene
- Shamir Tuchman | FDA (PDF - 1 MB)
Opening Presentation
- Martina Sahre | FDA (PDF - 433 KB)
Drug clearance in pediatric patients with renal impairment
- Saskia de Wildt | Radboud University Medical Center (PDF - 3 MB)
Case example: Avycaz (Abbvie)
- Henrietta Abodakpi | FDA (PDF - 1 MB)
Session 1: What constitutes as renal impairment in pediatric patients for the purposes of PK characterization and drug dosing?
Academic Perspective: Considerations around assessment of renal function
- Strengths and limitations of existing estimation methods and applications to specific population
George Schwartz | University of Rochester Medical Center (PDF - 1 MB)
Clinical Perspective: Considerations around assessment of renal function and drug dosing
- What clinicians and other stakeholders need to know about special populations
Guido Filler | Western University – London, Ontario, Canada; Children's Hospital, London Health Sciences Centre (PDF - 4 MB)
Industry Perspective: Considerations around assessment of renal function in the context of clinical trial
- Ashish Sharma | Boehringer-Ingelheim (PDF - 355 KB)
- Nicholas Webb and Deepa Chand | Novartis (PDF - 830 KB)
Session 2: Translating adult renal impairment data in pediatric patients with renal impairment
Recap of Case Example: Avycaz (Abbie)
- Henrietta Abodakpi | FDA (PDF - 1 MB)
Translating adult renal impairment PK data—Academic/clinical perspective
- Saskia de Wildt | Radboud University Medical Center (PDF - 20 MB)
Reliance on BSA indexed GFR values versus individualized eGFR values to guide drug dosing in adults and implications to pediatrics
Day 2: Friday, December 1, 2023
Session 3: Future Directions: Dosing in pediatric patients with renal impairment
Role of modeling and simulation
Considerations for modeling and simulation for pediatric renal impairment
- Justin Earp | FDA (PDF - 1 MB)
Role of systems biology modeling in extrapolating efficacy and safety from adult renal impairment data
- Karim Azer | Rutgers University (PDF - 2 MB)
Approaches for generating clinical trial data to assess impact of RI on PK in pediatric patients
Industry perspective
- Jan Marquard | Boehringer-Ingelheim (PDF - 1 MB)
Labeling considerations
- Su-Young Choi | FDA (PDF - 1 MB)