Sessions
Patient-Centricity
Scope: Patient-centric product development in the context of pediatric formulation means using a user-focused approach that understands the physiological, developmental and psychological needs of the pediatric population that spans from neonates to adolescence. This translates into tailoring dosage forms to address factors such as dosing flexibility, taste-masking and swallowing abilities across this age group and ascertain that caregivers can deliver these medications where needed to ensure adherence to dosing regimen to impact health outcomes. This concept also applies to easing the burden of clinical studies and arriving at appropriate dosing regimens with minimal hardships on this vulnerable population. This session will present perspectives on some of these aspects to promote understanding and generate discussion on some of these key topics.
Formulation and Analytical Aspects of a Pediatric Dosage Form: Mini tablets
Scope: This session will focus on key aspects of developing mini tablets as a dosage form for pediatrics. This session will provide a forum to discuss acceptability of mini tablets across pediatric age groups, inconsistencies in nomenclature, manufacturing and packaging challenges and limitations, and strategies for identifying appropriate food vehicles.
Formulation and Analytical Aspects of a Pediatric Dosage Form: Excipients for Pediatric Formulations
Scope: This session features presentations on the assessment of excipients for pediatric formulations, including tools such as the IID and ELSA, delivered by FDA experts. Industry perspectives are provided through talks on challenges and considerations in selecting excipients for pediatric products, including the use of the PERA tool. Additional insights focus on excipient needs for special populations—such as neonates. The program concludes with a breakout session on the PARA tool and a forward-looking panel discussion on future needs, research priorities, and regulatory challenges in pediatric excipient development.
Imagining the Future of Pediatric Formulation Development
Scope: Since our last pediatric workshop in 2019, we have seen transformational innovations in drug delivery systems, the evolution of complex biologics, as well as new techniques for gene editing and gene therapy. Furthermore, recent advances in AI/ML methodologies, including agentic AI, are having a broad impact on drug discovery and development. In this session, we will discuss these recent trends and how they will shape the future of developing better drugs and delivery systems for children.
Collaboration for Kids (across Academia, Health Authorities, Industry, and Non-profit Organizations)
Scope: This session will look towards establishing potential collaboration opportunities through shared understanding of the work done by various organizations such as industry, academia, philanthropic organizations or governments. The distinguished panel members from each of these organizations will share their perspectives through panel discussion. Workshop participants are encouraged to share their questions even ahead of time to enable productive, focused discussion on key topics as they relate to pediatric formulation development.
Funding Statement
This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award to the Center of Excellence in Regulatory Science and Innovation, U01FD005946 totaling $10,000 funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. government.