State of the Science on Assessing Developmental Neurotoxicity (DNT) Using New Approach Methods (NAMs)

Food and Drug Administration
Wiley Building
5100 Campus Drive
College Park, Maryland 20740 USA

Dates: November 14-15, 2023
Time: 8:30 AM - 5:00 PM
Fee: None

Event Background

Human neurodevelopment involves highly complex biological processes that are essential for normal function. These processes may be susceptible to the effects of exposure to chemicals, including environmental contaminants, dietary components, and consumer products, that may adversely impact key neurodevelopmental processes which has the potential to result in permanent neurological dysfunction. Compared to the adult brain, the developing human brain is inherently more vulnerable to the effects of a variety of potentially toxic compounds. The rise in reported neurodevelopmental impairments in infants and children is suspected to be caused, in part, by exposure to certain compounds during the pre- and postnatal periods. To address the challenges associated with traditional in vivo DNT testing guidelines, there has been increased focus on developing new approach methods (NAMs) and other concepts [e.g., adverse outcome pathways (AOPs)] based on non-animal testing to assess the potential DNT effects of compounds on humans more efficiently. CFSAN seeks to bring together experts in DNT to discuss the current state of the science on the development and use of alternative approaches to animal testing (e.g., in silico, in chemico, in vitro, and non-mammalian whole organisms) and considerations to optimize their application in regulatory decision-making. This two-day in-person workshop will include speakers from governmental agencies, industry, and academia and moderated panel discussions to foster the exchange of ideas and perspectives on the most current advances, knowledge gaps, challenges, and anticipated future work in the development of alternative approaches for DNT, including increasing confidence in and acceptance of their incorporation into regulatory frameworks.