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:

TimeActivity
  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