Event
FDA Convening
Advancing Drug Development for the Prevention of Spontaneous Preterm Birth
RegisterMaterials
Agenda_Prevention of Preterm Birth_1.18.23.pdf (161.48 KB)Discussion Guide_Prevention of Spontaneous Preterm Birth_1.18.24.pdf (235.79 KB)
Speaker Biographies_Prevention of Spontaneous Preterm Birth.pdf (694.27 KB)
Preterm Birth Workshop Slide Deck.pdf (14.67 MB)
Advancing Drug Development for the
Prevention of Spontaneous Preterm Birth
January 23, 2024
1:00 - 4:30 PM ET
January 24, 2024
1:00 - 4:30 PM ET
In the United States, spontaneous preterm birth (sPTB) is the leading cause of infant mortality, with 1 in 10 babies being born preterm. Despite the significant impact and medical need, there are currently no US Food and Drug Administration (FDA) approved treatments for the prevention of sPTB. Duke-Margolis, under a cooperative agreement with the FDA, is a hosting a public virtual workshop on Advancing Drug Development for the Prevention of Spontaneous Preterm Birth. The workshop will bring together a multidisciplinary group of experts and individuals with lived experience to generate ideas and discussion around the challenges in developing and studying products to prevent preterm birth. Within the workshop speakers will cover the current landscape, challenges, and perspectives on preterm birth and expert panels will discuss the ethical, regulatory, and efficacy measurement considerations for clinical development programs for products intended to prevent preterm birth.
Workshop Recordings
Day 1
Day 2
Duke-Margolis Planning Team
Beth Boyer, MPH
Policy Research Associate
Cameron Joyce, MPA
Senior Policy Analyst
Mia Williams, MPH, CHES
Policy Analyst