Abstract
BackgroundPediatric regulations enacted in both Europe and the USA have disrupted the pharmaceutical industry, challenging business and drug development processes, and organizational structures. Over the last decade, with science and innovation evolving, industry has moved from a reactive to a proactive mode, investing in building appropriate structures and capabilities as part of their business strategy to better tackle the challenges and opportunities of pediatric drug development.MethodsThe EFGCP Children’s Medicines Working Party and the IQ Pediatric working group have joined their efforts to survey their member company representatives to understand how pharmaceutical companies are organized to fulfill their regulatory obligations and optimize their pediatric drug development programs.ResultsKey success factors and recommendations for a fit-for-purpose Pediatric Expert Group (PEG) were identified.ConclusionPediatric structures and expert groups were shown to be important to support optimization of the development of pediatric medicines.
Highlights
Significant progress has been made since pediatric legislation was first enacted in the USA two decades ago and with the implementation of the Pediatric Regulation in the European Union (EU) in 2007
To better tackle the challenges and opportunities of pediatric drug development, the pharmaceutical industry has invested in building appropriate structures and capabilities as part of their business strategy, i.e., namely to create a Pediatric Expert Group (PEG)
Based on companies’ feedback received by both the EFGCP CMWP and the IQ consortium, five different models of PEG structures were identified (Table 1) which can be regrouped into three distinct general types of models: (1) Informal advisory pediatric networks: this type of network requires a person who is dedicated to pediatric drug development and can identify other subject matter experts with various expertise, e.g., CMC, Nonclinical, or Technical Development
Summary
Significant progress has been made since pediatric legislation was first enacted in the USA two decades ago and with the implementation of the Pediatric Regulation in the European Union (EU) in 2007. (2) Formal advisory pediatric networks: this type of network requires subject matter experts working part or full time across all functions, which increases the quality of the scientific support provided In this model, the individual project teams retain responsibility for the product’s strategic plan, whereas the PEG serves to provide consultation on pediatric-specific components to the product plan. (1) Informal advisory pediatric networks: this type of network requires a person who is dedicated to pediatric drug development and can identify other subject matter experts with various expertise, e.g., CMC, Nonclinical, or Technical Development In these PEGs, member involvement depends on the time allocated to provide support and advice on pediatric programs. When building a PEG, defining a work plan with annual objectives and achievements, resource demands, as well as means for regular communication through Town Hall meetings or via a dedicated share point site is important to demonstrate the PEG’s utility
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