Addressing the Barriers to Pediatric Drug Development: by Development, and Translation Forum on Drug Discovery,

By Development, and Translation Forum on Drug Discovery, Institute of Medicine

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Snodgrass described some shortcomings in the existing framework for pediatric drug use. Although the current system offers a good mechanism for testing onpatent drugs (see the discussion of this issue in Chapter 2), it falls short for older, off-patent drugs. With a common drug such as morphine, little information is available on optimal use and basic pharmacokinetics in different age groups. Dr. Snodgrass also expressed concern that pediatricians lack a good evidence-based reference for making prescription decisions.

Dr. Spielberg called for better training in therapeutics in medical school because many of today’s physicians do not fully understand how to use drugs wisely. Physicians must not only be able to understand drug labels, but also be thoughtful in challenging the labels on the basis of good pharmacological principles. Dr. Ward added that the majority of medical schools fail to recognize therapeutics as a discipline to be taught to students. As a result, the importance of clinical drug studies is not fully recognized.

The major disease focus of his pharmacogenomics research has been on acute lymphoblastic leukemia in children. Dr. Evans has authored more than 300 articles and book chapters, has been the editor of several textbooks and scientific journals, and has received several national awards for his research. He was elected to the Institute of Medicine (IOM) in 2002. George P. Giacoia, MD, is the Program Director of the National Institute of Child Health and Development (NICHD) Pediatric Pharmacology Research Network and the coordinator and planner of the NICHD Pediatric Formulation Initiative.

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