October 12 SOT FDA Colloquium: Science Supporting Regulatory Decision-Making in Developmental Neurotoxicology


By Timothy Shafer posted 09-15-2016 09:52


 Scientists and regulators have long been aware that neurodevelopment is a critical window of susceptibility for childhood and adult-onset diseases, but only recently has the lack of data on potential neurodevelopmental effects of compounds been widely recognized. As such, the next SOT FDA Colloquium will focus on novel experimental approaches and the scientific concepts to address the need for more informative and comprehensive testing for the potential developmental neurotoxicity effects of chemicals.

This is the ninth colloquium of a series presented by the SOT in conjunction with the US FDA Center for Food Safety and Applied Nutrition. The series presents scientific information that is high-quality, cutting-edge, future-oriented toxicological science to provide a well-grounded foundation to inform the work of US FDA employees. The colloquia are open to the public at no charge to attend in person or via webcast. These events are not a public forum for discussion of toxicology regulatory issues.

Register in advance by October 4 to participate on-site.

Register to participate in the webcast.

Colloquium website

Recognizing that the development of the nervous system is a complex process that is critically important for normal function and it is vulnerable to both endogenous and exogenous factors, the colloquium will begin with an overview of neurodevelopment and discuss the current state-of-the-art in developmental neurotoxicity assessment. Second, advances in the use of whole-animal alternative models, such as zebrafish, in evaluating developmental neurotoxicity will be discussed. Third, an overview of in vitro alternative models and screening batteries to assess developmental neurotoxicity will be presented. Fourth, the framework of adverse outcome pathways will be used to demonstrate the utility of novel data streams from alternative species and in vitro assays to improve mechanistic understanding of how chemicals elicit developmental neurotoxicity. Finally, the colloquium will conclude with a panel discussion addressing the key issues brought up by the speakers and questions from participants.


(All times are Eastern US, GMT-5)

Onsite: US FDA Wiley Auditorium, College Park, Maryland

8:00 AM–8:30 AM      

Badge Pick Up

8:30 AM–8:50 AM      

US FDA Welcome and Overview, TBD US FDA, College Park, Maryland. Welcome from SOT and Introductions, TBD

8:50 AM–9:30 AM       

Developmental Neurotoxicity Testing: An Introduction to the State of the Science and Opportunities for Improvement, Charles V. Vorhees, Cincinnati Children's Hospital Research Foundation, Cincinnati, Ohio

9:30 AM–10:10 AM

Zebrafish as an Alternative Species for Developmental Neurotoxicity Testing that can Provide Hazard Identification and Mechanistic Information, Randall T. Peterson, Harvard University, Boston, Massachusetts

10:10 AM–10:30 AM  


10:30 AM–11:10 AM  

In Vitro Approaches to Screening Compounds for Developmental Neurotoxicity Hazard, Ellen Fritsche, University of Düsseldorf, Düsseldorf, Germany

11:10 AM–11:50 AM 

Adverse Outcome Pathways for Developmental Neurotoxicity, Anna K. Price, ECVAM, Ispra, Italy

11:50 AM–12:50 PM              

Roundtable Discussion, Timothy Shafer, US EPA, Research Triangle Park, North Carolina, Moderator;  Jason L. Aungst, US FDA, College Park, Maryland, Panelist; All Speakers

The recordings and slides from all of the previous colloquia are accessible at no charge on the SOT FDA Colloquium webpage.