National Academies Press: OpenBook

Rational Therapeutics for Infants and Children: Workshop Summary (2000)

Chapter: Appendix A: Workshop Agenda

« Previous: References
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2000. Rational Therapeutics for Infants and Children: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/9816.
×

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.

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2000. Rational Therapeutics for Infants and Children: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/9816.
×

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.

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2000. Rational Therapeutics for Infants and Children: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/9816.
×

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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2000. Rational Therapeutics for Infants and Children: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/9816.
×

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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2000. Rational Therapeutics for Infants and Children: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/9816.
×

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.

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2000. Rational Therapeutics for Infants and Children: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/9816.
×

 

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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2000. Rational Therapeutics for Infants and Children: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/9816.
×
Page 105
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2000. Rational Therapeutics for Infants and Children: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/9816.
×
Page 106
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2000. Rational Therapeutics for Infants and Children: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/9816.
×
Page 107
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2000. Rational Therapeutics for Infants and Children: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/9816.
×
Page 108
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2000. Rational Therapeutics for Infants and Children: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/9816.
×
Page 109
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2000. Rational Therapeutics for Infants and Children: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/9816.
×
Page 110
Next: Appendix B: Biographies »
Rational Therapeutics for Infants and Children: Workshop Summary Get This Book
×
Buy Paperback | $46.00 Buy Ebook | $36.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues.

From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM.

This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!