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Appendix A: Workshop Agenda
Pages 105-110

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From page 105...
... Shine, M.D., President, Institute of Medicine Statement of Objectives, Charge to Participants, Introductions Ronald W Estabrook, Ph.D., Roundtable Chair, Virginia Lazenby O'Hara Professor of Biochemistry, University of Texas Southwestern Medical Center SESSION I: Similarities and Dissimilarities in Physiology, Metabolism, and Disease States and Responses to Therapy Among Children and Adults Presentations in this session will address the uniqueness of children and how they are similar or dissimilar to adults with regard to physiology, drug metabolism, immunology, cognitive effects, and response to disease states and therapy.
From page 106...
... Food and Drug Administration 12:15 p.m. Lunch Break SESSION II: Pharmacokinetics and Pharmacodynamics in Children Versus Adults Presentations in Session II will identify new advances in biomedical science that are uniquely applicable to children and that could be applied to the development and testing of drugs and biologics for children.
From page 107...
... Ballow, Pharm.D., Director, Anti-Infective Research, Kaleida Health Millard Fillmore Hospital Rational Therapeutics for Childhood Asthma Stanley J Szefler, M.D., Helen Wohlberg and Henry Lambert Chair in Pharmacokinetics, Director of Clinical Pharmacology, National Jewish Medical and Research Center, and Professor of Pediatrics, and Pharmacology, University of Colorado Health Sciences Center Oncology David Poplack, M.D., Elise C
From page 108...
... Food and Drug Administration Prediction of Long-Term Effects on Postnatal Brain Development Mark Batshaw, M.D., Chair of Pediatrics, George Washington University Medical Center, and Director, Children's Research Institute, Children's National Medical Center Evaluating Biological Therapeutics in Pediatric Clinical Trials Karen Weiss, M.D., Director, Division of Clinical Trial Design and Analysis, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration Break
From page 109...
... House of Representatives 10:30 11:00 1 1:30 FDA Perspective on New Regulations Dianne Murphy, M.D., Associate Director for Pediatrics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration The Role of IRB and Data Safety Boards Susan Ellenberg, Ph.D., Division of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S.
From page 110...
... 3:00 3:30 Conclusions Murray Lumpkin, M.D., Deputy Director for Review Management, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Closing Remarks Ronald Estabrook, Ph.D., Roundtable Chair Adjournment


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