Chair: Kirk Arvidson, US FDA, College Park, MD
Co-chair: Chihae Yang, MN AM, Nurnberg, Germany
The Society of Toxicology in conjunction with the US FDA Center for Food Safety and Applied Nutrition CFSAN) have partnered to provide this colloquia series. 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. These sessions are open to the public to attend in person or via webcast. These events are not a public forum for discussion of toxicology regulatory issues.
This colloquium will feature the science behind new international trends in the in silico safety assessment of chemical exposure. Two common themes shared by international regulatory bodies are the critical issues involved in alternative methods to animal testing and the rigorous treatment of uncertainties to obtain reproducible and transparent weight-of-evidence approaches to decision making. For alternative methods to repeated-dose toxicity, toxicokinetics and metabolism are emphasized to understand chemical exposure and bioavailability. Biokinetics is further being applied to data-waiving methods such as the Threshold of Toxicological Concerns (TTC). Internal TTC is a TTC concept for situations of low internal exposure, where this value is more relevant than the external exposure. Development of internal TTCs requires a significant amount of data and computational tools (e.g., PBPK modeling) to convert the chemical specific external doses (i.e., NOAELs) in the TTC databases into an estimate of the internal exposure. The common concerns related to the relevance of in silico chemical safety assessment that may hinder its adoption if not properly addressed will be discussed.
|8:00 AM–8:30 AM||Badge Pick Up|
|8:30 AM–8:40 AM||Welcome and Overview
Suzanne Fitzpatrick, US FDA, CFSAN, College Park, MD
Kirk Arvidson, US FDA, College Park, MD
|8:40 AM–9:20 AM||
Drivers for the Application and Acceptance of In Silico Safety Assessment Based on Chemical Exposure
|9:20 AM–10:00 AM||
Current Issues of Uncertainty in In Silico Methods
|10:00 AM–10:20 AM||Break|
|10:20 AM–11:00 AM||
A Case Study on PBPK and Biologically Based Dose-Response Modeling for Safety Assessment Considerations: Utility and Challenges
|11:00 AM–11:40 AM||
Transformation of Threshold of Toxicological Concerns (TTC) to Internal TTC: Why Internal Exposure Matters and How We Will Get There
|11:45 AM–12:45 PM||Roundtable Discussion
Moderator: Kirk Arvidson, US FDA, College Park, MD
On-site seating has no cost. Preregistration is required for those who are not Federal employees. US Federal employees may register on-site, but registration for others closed on May 6. Webcast registration remains open.
A cafeteria is located outside the security entrance to the facility.
Webcast participants may submit questions online during the event. These will be answered as time allows.
Questions about the SOT FDA Colloquium registration?
Contact Jim Dailey or 703.438.3115 ext. 1428.
Harvey W. Wiley Federal Building
US FDA, Center for Food Safety and Applied Nutrition
5001 Campus Dr., College Park, Maryland 20740
We strongly encourage visitors to take the Metro via the Green Line to the College Park-University of Maryland station stop, which is across the street from the Wiley Building.
Directions from the Capital Beltway (I-495) to CFSAN
For those who must drive, there is limited public parking at CFSAN which must be reserved in advance by indicating the parking request on the registration form. Alternatively, paid parking is available at the College Park Metro Station across the street from the campus.
Wiley Auditorium is a secured space. All on-site participants will pass through security, which will require a photo ID for those who are not FDA employees. In addition, anyone who is not a US citizen or permanent resident will be required to complete a Foreign Visitor Form to submit to SOT by May 6, 2019.