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

ISBN-10: 0309107423

ISBN-13: 9780309107426

ISBN-10: 0309107431

ISBN-13: 9780309107433

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It monitors rates of adverse events from eight managed care organizations that cover roughly 2 percent of the population. VAERS works by identifying signals that indicate there may be a problem, while VSDL is better for assessing causality. Dr. Orenstein suggested that two components of vaccine development might transfer well to pediatric drug development: the fact sheets used for vaccines would likely be helpful for pediatric drugs as well, and a no-fault compensation system could remove a barrier to the industry’s testing and distribution of products among pediatric populations.

Some have been purchased outright; others involve the right to first refusal if a lead compound or potential therapeutic is found. Dr. Evans warned that, with molecular characterization of tumors, more and more drugs will be found to be useful in smaller subsets of patients. A new business model needs to be devised for the development of these drugs with small potential markets, a need that is growing for adult diseases as well. 5 Challenges and Opportunities for the Future D espite progress made in the development and study of drugs for use in pediatric populations, many such drugs have not been tested substantially in children.

Dr. Mathis and others suggested that relying solely on FNIH for funding for these studies is unrealistic. Dr. Nelson also argued that the process used by NIH to get contracts for studies of these drugs, as well as for on-patent drugs that a sponsor chooses not to study, is cumbersome and unnecessarily lacking in transparency. A number of participants, including Dr. Gorman and Ms. Jarrett, agreed that the infrastructure needed to conduct multisite pediatric studies is lacking. Enhancing this infrastructure would require not only the additional training in therapeutics discussed above, but also increased funding for practice-based research networks.

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Addressing the Barriers to Pediatric Drug Development: Workshop Summary by Development, and Translation Forum on Drug Discovery, Institute of Medicine


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