U.S. Food and Drug Administration recently issued the following announcement.
Date: July 11, 2019Time:July 11, 2019
12:00 PM EDT – 01:00 PM EDT
Organized By: Office of the Chief Scientist
For technical assistance: Please contact Jeffery Rexrode at: Jeffery.Rexrode@fda.hhs.gov
or Devin Thomas at: Devin.Thomas@fda.hhs.gov
Amy Inselman, PhD
Division of Systems Biology
Biomarkers and Alternative Models Branch
FDA’s National Center for Toxicological Research (NCTR)
Overview of FDA’s Perinatal Health Center of Excellence: Development and Validation of Predictive Systems
About the Presentation:
FDA has recognized the need for coordinated research to address public health needs during the perinatal period. These include 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.
To tackle these regulatory science issues facing FDA, 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. This presentation will highlight a PHCE-funded project to investigate opioid-induced neural tube defects in a mouse model. 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 healthcare practitioners make more informed decisions about the risk of opioid exposure during early development.
About the Presenter
Dr. Amy Inselman is a staff fellow in NCTR’s Division of Systems Biology, Biomarkers and Alternative Models Branch. Dr. Inselman earned her PhD from the University of Tennessee, where she focused on elucidation of the key proteins involved in regulating the meiotic G2/MI division of mouse spermatocytes. Following completion of her PhD, Dr. Inselman was awarded an Intramural Research Training Award to complete her postdoctoral training at the National Institute for Environmental Health Sciences in the Laboratory of Developmental and Reproductive Toxicology, Gamete Biology section. In 2009, Dr. Inselman joined FDA as an ORISE fellow at NCTR. In 2012, she became a member of the Division of Systems Biology, Biomarkers and Alternative Models Branch. Dr. Inselman has worked with various FDA product centers investigating the developmental and reproductive toxicity of regulated products, using both in vivo and in vitro test systems.
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- July 11 FDA Grand Rounds CE Credit Activity Outline (161.39 KB)