2021 VIRTUAL CMC PANEL DISCUSSION
Pediatric Development: CMC Challenges and Opportunities
AAPS CMC Community
DATE: April 30, 2021
TIME: 1 PM – 2:30 PM ET (10:00-11:30 AM PT)
PARTICIPANT NUMBER LIMITED TO 250
Please join us for an engaging panel discussion on Pediatric Development: CMC Challenges and Opportunities.
Developing age appropriate formulations is a key to pediatric development. What is an age appropriate formulation? There is limited regulatory guidance on the CMC development of pediatric formulations. The formulation approach is guided by information based on the drug substance characteristics, anticipated age of pediatric patients, anticipated dosing, results of clinical studies, and public knowledge. Flexible dosing is likely required for pediatric patients. Development of ready to use dosage forms are not always feasible, thus many require manipulation (compounding or administration with liquids or soft foods). Developing age appropriate formulations has challenges, including excipient selection, palatability, and stability, as well as complexities with respect to dosing and administration.
This session seeks to explore industry challenges and strategies to overcome these Pediatric development challenges.
The following experts will share their experiences and views on this topic:
- Jeremy Bartlett (Pfizer)
- Hanlin Li (Vertex)
- Julia Pinto (FDA/OPQ/ONDP)
- Erika Englund (FDA/OPQ/ONDP)