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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

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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   

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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