Session 3: Innovative Strategies for Neonatal and Rare Disease Clinical Trials (Part 2)

Back to: FDA ADEPT 10: Addressing Challenges in Neonatal Product Development

Panel Discussion: Leveraging Networks/Consortia/Centers of Excellence to Optimize Harmonization and Operational Feasibility of Neonatal/Rare Disease Clinical Trials

Moderator:
Shannon Hamrick, MD
OPT/OCMO/OC, FDA

Panelists:

Rachel G. Greenberg, MD, MB, MHS
PTN, DCRI

Augusto Santos Schmidt MD, PhD
Neonatal Research Network (NRN), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)

Klaus Romero, MD, MS, FCP
C-Path

Debra Regier, MD, PhD
RareCap
Levine Children’s Hospital, Advocate Health

Ralph Bax, MD, MA
Paediatric Medicines Office, Scientific Evidence Generation Department,
Human Division, European Medicines Agency (EMA)

Sarah Zaidi, MD
OPT/OCMO/OC, FDA