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Mon. Mar 17, 2025

Tue. Mar 18, 2025

Wed. Mar 19, 2025

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Non-clinical safety assessments using human cells for pediatric drug development

The delay and loss of drugs and devices are serious problems in pediatric medicine. The Japanese government states that there is an urgent need to promote the development of therapeutic drugs and medical devices for children. In order to provide appropriate therapies for children, it is important to extrapolate drugs and devices approved for adults to children, and to advance basic research to understand the pathophysiological characteristics of children. However, variations in the etiologies and backgrounds of pediatric diseases, along with the cost-benefit issues and limited enrollment in pediatric clinical trials faced by the industry, hinder the development of appropriate pediatric drugs and devices. To overcome these problems, it is necessary to advance research in pediatric medicine through industry-academia-government collaboration. This symposium aims to present recent insights from anatomical, physiological, and pharmacological research on drug development and medical engineering, as well as key considerations for pediatric medical research suggested from industry and regulatory perspectives. Our goal is to facilitate discussion on how to expand pediatric medical research, fostering the launch of innovative pediatric drugs and devices.

Collaborative efforts of industry, academia, and government to provide appropriate therapies for children

APPW2025

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[[OD]2S14a-3]Non-clinical safety assessments using human cells for pediatric drug development

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