A schedule of events for Pediatric Master Protocols is provided below for the convenience of workshop attendees.
This one-day workshop scheduled for Friday, September 23, 2016, will be held in the Great Room at the FDA's White Oak Campus, located at 10903 New Hampshire Avenue in Silver Spring, Md.
The purpose of this workshop is to provide an opportunity for relevant stakeholders, including clinicians and scientists from the FDA and other government agencies, academia, non-profit organizations, and industry to discuss the use of pediatric master protocols for the development of medical products for children.
For a printable version of the workshop agenda, please download this document.
Video recordings from the conference are available at the following links:
- https://collaboration.fda.gov/p28gv8txmt9/
- https://collaboration.fda.gov/p4awnwvy2z2/
- https://collaboration.fda.gov/p11817w054a/
| Time | Activity |
|---|---|
| Introduction/Regulatory and Scientific Concerns Related to Pediatric Master Protocols Moderator: Gilbert J. Burckart, PharmD, Associate Director for Pediatrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), Food and Drug Administration |
|
| 8:30-8:35 a.m. | Welcome Gilbert J. Burckart, PharmD Associate Director for Pediatrics Office of Clinical Pharmacology, CDER Office of Translational Sciences, CDER Food and Drug Administration |
| 8:35-8:50 a.m. | Increasing Trial Efficiency through the Use of Master Protocols (Video Presentation) Robert Califf, MD Commissioner Food and Drug Administration Link referred to in presentation: http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials |
| 8:50-9:20 a.m. | Lynne Yao, MD Presentation Lynne Yao, MD Director, Division of Pediatric and Maternal Health Office of New Drugs, CDER Food and Drug Administration |
| 9:20-9:50 a.m. | Hubert Caron, MD, PhD Presentation Slides Hubert Caron, MD, PhD Professor and Senior Medical Director, Global Development Team Leader, Pediatric Oncology Genentech/Roche |
| 9:50-10:15 a.m. | Jean Temeck, MD Presentation Slides Jean Temeck, MD Office of Pediatric Therapeutics Commissioner’s Office Food and Drug Administration |
| 10:15-10:30 a.m. | Dionna Gree, MD Presentation Slides Dionna Green, MD Pediatric Clinical Pharmacology, Guidance Policy Team Office of Clinical Pharmacology, Office of Translational Sciences, CDER Food and Drug Administration |
| 10:30-10:45 a.m. | Break |
| 10:45-11:05 a.m. | Lisa M. LaVange, PhD Presentation Slides Lisa LaVange, PhD Director, Office of Biostatistics Office of Translational Sciences, CDER Food and Drug Administration |
| 11:05-11:25 a.m. | Kevin Watt, MD, Presentation Slides Kevin Watt, MD, PhD (Substituting for Danny Benjamin MD, PhD, MPH) Assistant Professor of Pediatrics Duke University School of Medicine |
| 11:25-11:45 a.m. | Steven Hirschfeld MD, PhD Presentation Slides Steven Hirschfeld, MD, PhD Associate Director for Clinical Research National Institute for Child Health and Human Development National Institutes of Health |
| 11:45-12:30 p.m. | Moderated Panel Discussion Panelists: Maura O'Leary, MD (FDA); Edress Darsey, PharmD (Pfizer); and Drs. Yao (FDA), Caron (Genentech/Roche), Temeck (FDA), Green (FDA), LaVange (FDA), Watt (Duke), and Hirschfeld (NIH) |
| 12:30-1:30 p.m. | Lunch |
| Applications of Pediatric Master Protocols in Specific Pediatric Therapeutic Areas Moderator: Jill Morgan, PharmD, Associate Professor and Chair, Department of Pharmacy Practice and Science, University of Maryland School of Pharmacy |
|
| 1:30-1:55 p.m. | Gregory Reaman, MD Presentation Slides Gregory Reaman, MD Associate Director for Oncology Sciences Division of Oncology Products Office of New Drugs, CDER Food and Drug Administration |
| 1:55-2:20 p.m. | Kevin Watt, MD, PhD Presentation Slides Kevin Watt, MD, PhD Assistant Professor of Pediatrics Duke University Medical Center Duke Clinical Research Institute |
| 2:20-2:45 p.m. | P. Brian Smith, MD, MHS, MPH Presentation Slides P. Brian Smith, MD, MHS, MPH Chief, Division of Quantitative Sciences, Pediatrics Duke University |
| 2:45-3:10 p.m. | Anand Pathak, MD, PhD, MPH Presentation Slides Anand Pathak, MD, PhD, MPH Medical Officer Center for Devices and Radiologic Health Food and Drug Administration |
| 3:10-4:00 p.m. | Moderated Panel Discussion Panelists: Gary Noel, MD (Chair, Pediatric Advisory Committee, J&J); Maura O'Leary, MD (FDA); Drs. Reaman (FDA), Watt (Duke), Smith (Duke), and Pathak (FDA) |
| 4:00-4:30 p.m. | Pediatric Master Protocols Slides Brian Smith, MD, MHS, MPH Neonatologist Department of Pediatrics Duke Health |