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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Addressing the Barriers to Pediatric Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11911.
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Page 43
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Addressing the Barriers to Pediatric Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11911.
×
Page 44
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Addressing the Barriers to Pediatric Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11911.
×
Page 45

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Appendix A Workshop Agenda Forum on Drug Discovery, Development, and Translation Addressing the Barriers to Pediatric Drug Development June 13, 2006 8:00 am–4:30 pm The National Academies 7:30 am Breakfast 8:00 am Opening Remarks by Discussion Moderator Michael Katz, MD March of Dimes Birth Defects Foundation Current Development Procedures and Impact on Clinical Practice 8:10 am Richard Gorman, MD American Academy of Pediatrics 8:25 am Wayne Snodgrass, MD, PhD American Academy of Pediatrics Committee on Drugs 8:40 am Discussion Regulatory Perspective 9:10 am Historical and Regulatory Background Lisa Mathis, MD U.S. Food and Drug Administration 43

44 ADDRESSING THE BARRIERS TO PEDIATRIC DRUG DEVELOPMENT 9:25 am Relabeling of Existing Drugs William Rodriguez, PhD, MD U.S. Food and Drug Administration 9:40 am Lessons Learned and Future Directions Dianne Murphy, MD U.S. Food and Drug Administration 9:55 am Discussion 10:25 am Break Incentives and Disincentives for Pediatric Drug Development 10:40 am Ethical Issues Concerning Testing of New Drugs in Children Robert Nelson, MD, PhD Children’s Hospital of Philadelphia 10:55 am Natasha Jarrett ���������������� Hoffmann-LaRoche 11:10 am Thomas Hassall, RPh, MS ������������������� Abbott Laboratories 11:25 am Discussion 12:00 pm Lunch Dose Finding and Bioavailability Guessing 1:00 pm Robert Ward, MD University of Utah 1:15 pm Best Pharmaceuticals for Children Act: Pediatric Formulation Issues George Giacoia, MD  National Institute of Child Health and Human Develop- ment, National Institutes of Health 1:30 pm Discussion   

APPENDIX A 45 Could Vaccines Be a Possible Model for Pediatric Drug Development? 2:00 pm Walter Orenstein, MD Vaccine Adverse Event Reporting System 2:15 pm Discussion 2:45 pm Break Current Models and Alternative Approaches 3:00 pm European Union Legislation Annic Weyersberg, MD European Agency for the Evaluation of Medicinal Products 3:15 pm  Jude’s Approach to Addressing the Institute of Medicine St. Report: Making Better Drugs for Children with Cancer William Evans, PharmD St. Jude Children’s Research Hospital 3:30 pm Discussion Identification of Actions 4:00 pm Conclusions and Next Steps for the Institute of Medicine Drug Forum 4:30 pm Adjourn

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Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children--50 to 75 percent--have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.

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