|
FORUM HOME
Click on a speaker's name to see their slides. Please note that some speakers did not give permission for their slides to be posted, and some speakers did not have slides.
7:30 am - Breakfast
8:00 am - Opening Remarks by discussion moderator
- Michael Katz, MD
Senior Vice President for Research and Global Programs
March of Dimes Birth Defects Foundation
8:10 am - Current Development Procedures and Impact on Clinical Practice
- Richard Gorman, MD
- Wayne Snodgrass, MD, PhD
American Academy of Pediatrics Committee on Drugs
8:40 am - Regulatory Perspective
- Lisa Mathis, MD
Acting Director, Division of Pediatric Drug Development
FDA
Historical and regulatory background
- William Rodriguez, PhD, MD
Science Director for Pediatrics OND
FDA
Re-labeling of existing drugs
- Dianne Murphy, MD
Director, Office of Pediatric Therapeutics
FDA
Lessons learned and future directions
9:40 am - Discussion
10:30 am - Break
10:40 am - Incentives and Disincentives for Pediatric Drug Development
- Robert Nelson, MD, PhD
Associate Professor of Anesthesiology and Critical Care
Children’s Hospital of Philadelphia
Ethical issues concerning testing of new drugs in children
- Natasha Jarrett
Director of Regulatory Affairs
Hoffman-LaRoche
- Tom Hassall, RPH, MS
Senior Director of Global Scientific, Medical, and Regulatory Affairs
Abbott Laboratories
11:40 am - Discussion
12:15 pm - Lunch Served
1:00 pm - Dose-finding and Bioavailability guessing
- Robert Ward, MD
Director, Pediatric Pharmacology Program
University of Utah
- George Giacoia, MD
National Institutes of Health, HHS
National Institute of Child and Human Development
Best pharmaceuticals for children act - pediatric formulation issues
1:30 pm - Discussion
2:00 pm - Could Vaccines be a Possible Model for Pediatric Drug Development
2:15 pm - Discussion
2:45 pm - Break
3:00 pm - European Development Models
- Annic Weyersberg, MD
Head of Sector Scientific Advice and Orphan Drugs
Paediatric Medicinal Products
European Agency for the Evaluation of Medicinal Products
European Union legislation
3:15 pm - Discussion
3:45 pm - Identification of Actions and Next Steps for the IOM Drug Forum
- William Evans, PharmD
Director and CEO
St. Jude Children’s Research Hospital
What can be done to address the IOM report "Making Better Drugs for Children with Cancer:" the St. Jude approach.
Conclusions and Next Steps for the IOM Drug Forum
4:30 pm - Adjourn
Online presentations from this meeting are subject to copyright protection. Permission from the speaker is required prior to any copying, reproducing, or rebroadcasting any portion of the speaker's presentations. Additional copyright and legal policies of The National Academies can be read in the National Academies Legal Statement.
FORUM HOME
|