Advancing Drug Development for the Prevention of Spontaneous Preterm Birth Workshop - Day 2

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 brought 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 covered the current landscape, challenges, and perspectives on preterm birth and expert panels discussed the ethical, regulatory, and efficacy measurement considerations for clinical development programs for products intended to prevent preterm birth.