Presentations for the September 19, 2023 Meeting of the Pediatric Advisory Committee

• FDA Opening Remarks
  Dionna Green, MD, FCP, Director, Office of Pediatric Therapeutics
   
• Regulatory Considerations for Artificial Womb Technology Development Programs 
  Kalkidan Molla, MS, Lead Reviewer, Office of Cardiovascular Devices 
   
• FDA’s Regulatory Safeguards for Children Involved in Clinical Trials: Considerations for Artificial Womb Technologies  
  Elizabeth Durmowicz, MD, Medical Officer, Office of Pediatric Therapeutics
   
• Clinical Considerations for Evaluating Benefit versus Risk for Artificial Womb Technology Development Programs 
  An Massaro, MD, Supervisory Medical Officer, Office of Pediatric Therapeutics
   
• Animal Study Considerations for Artificial Womb Technology Devices 
  Annabelle Crusan, DVM, MS, Veterinary Medical Officer, Office of Cardiovascular Devices
   
• AWT in a Preterm Lamb Model 
  Alan Flake, MD, FACS, FAAP, Director, Center for Fetal Research, Children’s Hospital of Philadelphia 
   
• Artificial Placenta in a Preterm Lamb Model 
  George B. Mychaliska, MD, Robert Bartlett, MD Collegiate Professor of Pediatric Surgery, C.S. Mott Children’s Hospital, University of Michigan Health
   
• AWT in a Piglet Model 
  Mike Seed, MBBS, MRCPCH, FRCR, Head, Division of Cardiology, The Hospital for Sick Children (Toronto) 
   
• Contemporary Outcomes for Extremely Preterm Infants (EPI)
  Susan R. Hintz, MD, MS, Epi , Robert Hess Family Professor of Neonatal and Developmental Medicine, Stanford University
   
• Hemostasis in preterm infants undergoing extracorporeal membrane oxygenation
  Gail M. Annich, MD, MS, FRCP, Professor of Pediatrics; Director of Resuscitation Oversight, The Hospital for Sick Children (Toronto) 
   
• Cardiovascular considerations for AWT in the EPI 
  Peta-Maree Alexander, MBBS, Associate Professor of Pediatrics, Boston’s Children’s Hospital 
   
• Gastrointestinal considerations for AWT in the EPI 
  Josef Neu, MD, Professor of Pediatrics, University of Florida 
   
• Ethical Considerations for a First-in-Human Trial of AWT 
  Mark Mercurio, MD, MA, Professor of Pediatrics and Director of the Program for Biomedical Ethics, Yale School of Medicine