Perinatal Health Center of Excellence: Development and Validation of Predictive Systems

Activity: FDA Grand Rounds
Amy Inselman, PhD Faculty
Staff Fellow
National Center for Toxicological Research
 
Devin Thomas, LCDR, MPH, CHES Activity Coordinator
Health Promotions Specialist
FDA/OC/OCS/OSPD
 
Thu, 7/11 2019: 12:00 PM  - 1:00 PM 
Regularly Scheduled Series 
WO 32: 1325 
Credits:
FDA has recognized the need for coordinated research to address public health needs during the perinatal period, which includes the health of the mother, premature infants, and newborns as well as development throughout childhood. To that end, FDA's National Center for Toxicological Research (NCTR) established FDA's virtual Perinatal Health Center of Excellence (PHCE) to address the special public health needs of these important and understudied populations. For example, many FDA-regulated products given to newborns and infants - or provided to pregnant mothers - haven't been studied extensively in such populations. This has left knowledge gaps about their safety, efficacy, or potential toxicity. Environmental exposure through foods and pre-existing conditions are another area where vast knowledge gaps exist. Infants consume more food per kilogram of body weight than any other age group, resulting in the potential for higher dietary exposures to chemicals. And there may also be maternal transfer to the infant from environmental exposures through foods, including breast milk.
To tackle these regulatory science issues that FDA faces, studies will be planned and conducted across the agency's product centers. PHCE-funded research includes in silico models, stem cell systems and other in vitro models, laboratory animal studies, translational and clinical studies, mathematical modeling, bioanalytical chemistry, exposure science, and bioinformatics targeting the perinatal period. A PHCE funded project to investigate opioid-induced neural tube defects in a mouse model will be highlighted. This project seeks to clarify the link between maternal toxicity and embryo-fetal development following opioid exposure. The results may improve health communications (i.e. label change) that would help pregnant women and their health-care professionals make more informed decisions regarding the risk of opioid exposure during early development.

Objectives

Describe the goals and priority areas of the PHCE.|List of key physiology parameters for development of a preterm and neonate PBPK model.|List challenges in collecting plasma samples and predicting drug plasma concentrations in neonates using a PBPK model.|Explain (qualitatively) likely sources responsible for the observed variability in measured plasma drug concentrations.