The Certara Blog

Author: Barry Mangum

As Paidion’s Founder and CEO, Dr. Mangum is responsible for their vision of profound and meaningful change in global pediatric clinical research. Paidion is catalyzing change in an old paradigm and laying the groundwork for developing safe and effective medicines for children. Responsible for partnering with clients to implement clinical trials for all phases of pediatric drug development, Dr. Mangum brings decades of pediatric clinical research expertise to Paidion. His extensive academic experience includes serving as faculty and researcher in pediatrics and clinical pharmacology/pharmacotherapy at Duke's and UNC's medical schools. His corporate experience includes serving as Senior Director of Pediatric Clinical Development Services at Quintiles. He has numerous publications, presentations, and memberships, including co-authorship of NeoFax: A Manual of Drugs Used in Neonatal Care, the leading guide for dosing neonatal medications in the US, as well as the NeoFax software package and mobile device app.

Recent Posts

A Practical Approach to the Challenges of Pediatric Drug Development

Drug developers can’t take an adult clinical trial protocol and simply retool it for pediatrics. Yet, in my work at a pediatric clinical research organization (CRO), I frequently see sponsors attempt to do just that. Successfully implementing a pediatric drug development plan poses challenges regarding trial planning, design, and conduct. In this blog post, I’ll […]

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The European Regulatory Landscape for Pediatric Drug Development

In my 35 years of working to develop safer, more effective medications for children, I’ve often been asked about how to navigate the regulatory landscape in the US and Europe. In a previous blog post, I discussed the latest FDA trends regarding pediatric drug development. In this blog, I’ll focus on the path for achieving […]

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What the FDA Expects from Your Pediatric Drug Program

Historically, 80 percent of medicines used in children had little to no data guiding prescribers on proper use. To address this market failure, regulatory legislation for drug development in pediatric patients was passed worldwide over the past decade. The number of drugs tested in and labeled for children has increased dramatically as a result. In […]

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