Back to: FDA ADEPT 10: Addressing Challenges in Neonatal Product Development
Presentations:
Welcome
An Massaro, MD
OPT/OCMO/OC, FDA
Innovative study designs to address small populations
Rebecca Chiu, PhD
Office of Biostatistics (OB), Center for Drug Evaluation and Research (CDER), FDA
Artificial Intelligence (AI)/ Digital Health Technologies (DHTs) in the NICU- Academic Perspective
Ryan Michael McAdams, MD
University of Wisconsin School of Medicine and Public Health
AI/DHTs in Neonatology/Rare Disease- Regulatory Perspective
Hussein Ezzeldin, PhD
Office of Medical Policy, CDER, FDA
Leveraging Real World Data (RWD) in Neonatology/Rare Diseases
Kanwaljit Singh, MD, MPH, MBA
International Neonatal Consortium (INC), Critical Path Institute (C-Path)
Platform Trials/Master Protocols in Pediatrics
Danny Benjamin, MD, PhD, MPH
Pediatric Trials Network (PTN), Duke Clinical Research Institute (DCRI)
Selecting Patient-focused Outcomes for Neonatal Conditions and Rare Diseases
Michelle Campbell, PhD
Office of Neuroscience, CDER, FDA