SOT FDA Colloquium Series Continues May 15 with Focus on In Silico Methods

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SOT and the US Food and Drug Administration (US FDA) Center for Food Safety and Applied Nutrition (CFSAN) cordially invite you to join us for our May 15 colloquium,In Silico Methods for Food Ingredient, Dietary Supplement, and Cosmetic Safety.” This session is open to the public to attend in person or via webcast at no charge. These colloquia are an update on toxicological science and not a public forum for discussion of toxicology regulatory issues. The colloquium will take place from 8:30 am to 12:45 pm (ET) in the Wiley Auditorium at US FDA in College Park, Maryland. The Chair of the colloquium is Kirk Arvidson of US FDA in College Park, Maryland. The Co-Chair is Chihae Yang of MN AM in Nurnberg, Germany.

Speakers will explore 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 being further 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. Presenters will review the common concerns related to the relevance of in silico chemical safety assessment that may hinder its adoption if not properly addressed.

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Register for On-Site Participation Register for Webcast Participation
               Register Button                        Register Button
   Deadline for participants who are
 not federal employees: May 6, 2019

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Presentations include:

8:30 AM–8:40 AM   Welcome and Introductions
TBD
Speaker Introductions
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
Mark Cronin, Liverpool John Moores University, Liverpool, UK
 
9:20 AM–10:00 AM Identifying, Estimating, and Communicating Uncertainty within In Silico Approaches to Chemical Safety Assessment
James F. Rathman, The Ohio State University, Columbus, OH
 
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
Annie Lumen, NCTR, Jefferson, AR
 
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
Corie Ellison, Procter and Gamble, West Chester, OH
 
11:45 AM–12:45 PM Roundtable Discussion
Moderator: Kirk Arvidson, US FDA, College Park, MD
All Speakers

Questions concerning the regulatory science are encouraged from the audience on-site and from webcast participants for the roundtable discussion. Regulatory policy will not be discussed.

The SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety present scientific training that is high-quality, cutting-edge, future-oriented toxicological science for US FDA employees and are open to the public at no cost.

Recordings and slides from the previous colloquia are available free via the SOT FDA Colloquia website. Materials for the April 9, 2019, session, “Alternative Methods for Predictive Safety Testing: 3D Bioprinted Tissue Models,” will be posted later this month.

Plans are underway for four colloquia in 2019–2020:

  • October: Integrated Approaches to Testing and Assessment
  • December: Dermal Absorption Concepts
  • February: Route-Route Extrapolation
  • April: Use of Artificial Intelligence/Big Data in Food Additive, Ingredient, and Cosmetics Evaluation
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