A
Workshop Agenda

ROUNDTABLE ON RESEARCH AND DEVELOPMENT OF DRUGS, BIOLOGICS, AND MEDICAL DEVICES

Rational Therapeutics for Infants and Children

24–25 May 1999

MONDAY, MAY 24, 1999

 

Opening Plenary

8:30 a.m.

Welcome and Opening Remarks

Kenneth I. Shine, M.D., President,

Institute of Medicine

8:45

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. This session will provide the scientific underpinning for the subsequent sessions.



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Rational Therapeutics for Infants and Children: Workshop Summary A Workshop Agenda ROUNDTABLE ON RESEARCH AND DEVELOPMENT OF DRUGS, BIOLOGICS, AND MEDICAL DEVICES Rational Therapeutics for Infants and Children 24–25 May 1999 MONDAY, MAY 24, 1999   Opening Plenary 8:30 a.m. Welcome and Opening Remarks Kenneth I. Shine, M.D., President, Institute of Medicine 8:45 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. This session will provide the scientific underpinning for the subsequent sessions.

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Rational Therapeutics for Infants and Children: Workshop Summary Moderator: Sumner Yaffe, M.D., Roundtable Member, Director, Center for Research for Mothers and Children, National Institute for Child Health and Human Development, National Institutes of Health 9:00 Characteristics of Infants and Children Versus Adults Ralph Kauffman, M.D., Director of Medical Research Children's Mercy Hospital 9:30 Differential Drug Response of Children John T. Wilson, M.D., Professor and Chief of Clinical Pharmacology, Department of Pediatrics, Louisiana State University Medical Center 10:00 Break 10:30 Molecular Basis of Drug Metabolism Thierry Cresteil, Ph.D., Director of Research, Centre National de la Recherche Scientifique, Institut Gustave Roussy, Villejuif, France 11:00 Gene Expression-Ontogeny of Drug Metabolism Steve Leeder, Pharm. D., Ph.D., Associate Professor of Pediatrics and Pharmacology, Children's Mercy Hospital   Special Address 11:30 Science, Challenges, and Children Jane Henney, M.D., Commissioner, U.S. Food and Drug Administration 12:15 p.m. Lunch Break SESSION H: 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. Moderator: Whaijen Soo, M.D., Ph.D., Roundtable Member, Vice President, Clinical Services Roche Pharmaceuticals, Hoffmann-La Roche, Inc.

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Rational Therapeutics for Infants and Children: Workshop Summary 1:30 p.m. Drug Metabolism in Children and Adolescents: Insights from Therapeutic Adventures Greg Keams, Pharm. D., Professor of Pediatrics, Pharmacology and Therapeutics, and Chief, Division of Pediatric Clinical Pharmacology, Children's Mercy Hospital 2:00 Ontogeny of P-Glycoprotein as a Transporter John Watchko, M.D., Associate Professor of Pediatrics, Obstetrics, Gynecology, and Reproductive Science, University of Pittsburgh School of Medicine, and Department of Pediatrics, Magee Women's Hospital 2:30 Glucose Transporters-Developmental Aspects Sherin U. Devaskar, M.D., Professor of Pediatrics, Obstetrics, Gynecology, and Reproductive Science, University of Pittsburgh School of Medicine, and Chief of Pediatrics, Magee Women's Hospital 3:00 Formulations Emmett Clemente, Ph.D., Chairman and Founder, Ascent Pediatrics, Inc. 3:30 Break 3:45 Anti-Infectives Charles H. Ballow, Pharm. D., Director, Anti-Infective Research, Kaleida Health Millard Fillmore Hospital 4:15 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 4:45 Oncology David Poplack, M.D., Elise C. Young Professor of Pediatric Oncology, and Head, Hematology Oncology Section, Department of Pediatrics Baylor College of Medicine and Texas Children's Cancer Center 5:15 Adjournment and Reception in the Great HaH for Roundtable Members, Participants, and Guests

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Rational Therapeutics for Infants and Children: Workshop Summary TUESDAY, MAY 25, 1999 8:00 a.m. Opening Remarks Ronald Estabrook, Ph.D., Roundtable Chair SESSION III: Extrapolation of Safety and Efficacy Data for Children This session will examine the special requirements in evaluating drugs and biologics in pediatric populations. Questions to be explored include when and how safety and efficacy data can be used for children. Moderator: Michael R. McGarvey, M.D., Roundtable Member, Chief Medical Officer, Blue Cross and Blue Shield of New Jersey, Inc. 8:15 Special Considerations for Evaluating Medical Devices in Infants and Children David Feigal, Jr, M.D., Director [Designate], Center for Devices and Radiological Health, U.S. Food and Drug Administration 8:45 Defining Surrogate Endpoints and Biomarkers for Drug Action in Pediatric Trials Robert Temple, M.D., Associate Director for Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration 9:15 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 9:45 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 10:15 Break

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Rational Therapeutics for Infants and Children: Workshop Summary SESSION IV: Raising Awareness of Regulatory, Legal, and Ethical Issues This session will examine the many interrelated legal and regulatory issues in evaluating new drugs and biologics for pediatric populations. The session will also examine the interrelated social and ethical concerns when evaluating drugs and biologics with children. Moderator: The Honorable Paul G. Rogers, J.D., Roundtable Member, Partner, Hogan & Hartson, Former Member, U.S. House of Representatives 10:30 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 11:00 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. Food and Drug Administration 11:30 Ethics of Drug and Biologic Research in Infants and Children Robert M. (''Skip") Nelson, M.D., Ph.D., Associate Professor of Pediatrics and Bioethics, Medical College of Wisconsin 12:00 noon Legal and Regulatory Considerations for the Conduct of Pediatric Clinical Trials Michael Labson, J.D., Covington & Burling 12:30 p.m. International Pediatric Drug Development: An Industry Perspective Steven Spielberg, M.D., Global Head, Pediatric Drug Development, R.W. Johnson Pharmaceutical Research Institute 1:00 Lunch Break 2:00 Panel Discussion Panelists: Susan Ellenberg, Ph.D, Michael Labson, J.D.

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Rational Therapeutics for Infants and Children: Workshop Summary   Michael R. McGarvey, M.D. Dianne Murphy, M.D. Robert M. Nelson, M.D., Ph.D., The Honorable Paul G. Rogers, J.D. Steven Spielberg, M.D. Sumner Yaffe, M.D. 3:00 Conclusions Murray Lumpkin, M.D., Deputy Director for Review Management, Center for Drug Evaluation and Research, U.S. Food and Drug Administration 3:30 Closing Remarks Ronald Estabrook, Ph.D., Roundtable Chair 4:45 Adjournment