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

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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Jarrett and Mr. Hassall provided presentations on the barriers to pediatric drug development from the perspective of the industry, echoThis section is based on the presentations of Ms. Natasha Jarrett, Director of Regulatory Affairs, Hoffmann-LaRoche, and Mr. Thomas Hassall, Senior Director of Global Scientific, Medical, and Regulatory Affairs, Abbott Laboratories. CHALLENGES IN DEVELOPING AND PRESCRIBING DRUGS FOR CHILDREN 25 ing many of the points made by previous speakers. Ms. Jarrett noted a shift away from protecting pediatric patients against experimentation and toward protecting them through the generation of data from drug trials.

Similarly, sevoflurane, also used for induction and maintenance of general anesthesia, was found to cause rare cases of seizure in children without a previous seizure history. Seizures can occur immediately or up to 24 hours after the therapy is stopped. This information is now on the label for these drugs. • Etodolac (Lodine), used for symptom relief in juvenile rheumatoid arthritis, underwent labeling changes after studies showed that patients aged 6 to 16 years required a higher dose (on a per-kilogram basis) than expected—approximately twice the lower dose recommended for effective treatment in adults.

Evans’ presentation, Dr. Nelson raised concerns about relying on independent, well-funded pediatric institutions to compensate for the deficits in funding for traditional academic research. Dr. Evans replied that all involved need to do what they can, and that he is concerned about the flat funding for the National Institutes of Health. To address the funding issue, he plans to rely more on team science, looking to academic partners and others for what they do well. Dr. Susan Weiner, a member of the audience from the Children’s Cause for Cancer Advocacy, asked whether St.

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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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