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In Vitro to In Vivo Concordance for Toxicity Prediction and Use in Safety Assessments—October 24, 2017

Chair: Bryan Delaney, PhD, DABT, ATS, DuPont Pioneer, Johnston, IA
Co-Chair: Paddy Wiesenfeld, PhD, CFSAN, US FDA, Laurel, MD

This is the thirteenth colloquium of a series presented by the Society of Toxicology 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 FDA employees. Open to the public to attend in person or via webcast, these events are not a public forum for discussion of toxicology regulatory issues.

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Concordance in safety assessment generally refers to the accuracy of in vitro test results to correctly predict an in vivo response in humans. For food additive ingredients in vivo, animal studies in various targeted areas (e.g., carcinogenicity, neurological disorders, developmental delays and deficits, and reproductive disorders) are typically used. Dietary supplements and cosmetic ingredients, which do not require pre-market approval, still must be safe for consumer use and require safety assessments. Toxicological reviews for safety assessments typically consider in vitro data as one facet of their evaluation but there is increasing emphasis to increase their use and to replace some aspects of in vivo testing. Many challenges remain to be addressed (e.g., metabolic activation of agents in in vitro systems) and there are limitations to the interpretation of the data (e.g., the mechanistic relationship between rapid in vitro responses and more chronic in vivo responses), however, there also are benefits to using in vitro studies to assess safety (e.g., cost, speed of the assay, ability to use high-throughput, and high-output methods to address a large range of potential toxic substances). New and innovative in vitro technologies (e.g., high-throughput sequencing methods for quantifying gene expression, microRNA expression and proteomics) are emerging that may also increase concordance to tissue, organ, and the whole organism effects. However, there is still a need to improve scientific confidence in the utilization of these in vitro tests to replace in vivo testing in safety assessment. The invited speakers to this colloquium will review the state-of-the-art in using in vitro technologies for safety assessment and how they are being utilized.


(all times are Eastern US, GMT-4)

8:00 AM–8:30 AM Badge Pick Up, Meeting Desk
8:30 AM–8:35 AM Welcome from FDA and Overview
Steven Musser, PhD, Deputy Director of Scientific Operations for CFSAN, CFSAN, US FDA, College Park, MD
8:35 AM–8:50 AM Welcome from SOT and Introductions
Speaker Introductions
Bryan Delaney, PhD, DABT, ATS, DuPont Pioneer, Johnston, IA
8:50 AM–9:30 AM ’Omic Biomarkers for Assessing Cellular Toxicity: Integration of In Vivo and In Vitro Data—Why It Is Important
Bruce Fowler, PhD, ATS, Toxicology and Risk Assessment Consulting Services, LLC, Rockville, MD
9:30 AM–10:10 AM Establishing an Integrated Ex Vivo Female Reproductive Tract in the Microfluidic Platform: Screening of Reproductive Toxic Chemicals
Shuo Xiao, PhD, University of South Carolina, Columbia, SC
10:10 AM–10:30 AM Break
10:30 AM–11:10 AM Investigation of an In Vitro Method for Protein Hazard Characterization
Bryan Delaney, PhD, DABT, ATS, DuPont Pioneer, Johnston, IA
11:10 AM–11:50 AM Analysis of In Vitro to In Vivo Concordance Studies for Food Safety Assessment in Humans
Miriam E Mossoba, PhD, U.S. FDA, Laurel, MD
11:50 AM–12:50 PM Roundtable Discussion
Paddy Wiesenfeld, PhD, US FDA, Laurel, MD
All speakers

On-Site Participation

Registration to participate on-site is closed, except for US federal employees. Note that only US federal employees can register on-site.

On-site seating has no cost.

A cafeteria is available outside the security entrance to the facility.

Webcast Registration

Register for webcast.
International Toll-Free Numbers

Webcast participants can submit questions online during the event. These will be answered as time allows.

Questions about the SOT FDA Colloquia registration?
Contact Jim Dailey or 703.438.3115 Ext. 1428.

Location, Transportation, and Parking


Wiley Auditorium
Harvey W. Wiley Federal Building
US FDA, Center for Food Safety and Applied Nutrition
5001 Campus Drive, College Park, Maryland 20740


Metro Rail

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. Please check the Metro schedule for possible service disruptions.


Directions from the Capital Beltway (I-495) to CFSAN

  • Take the Capital Beltway in Maryland and exit at the following interchange.
  • Exit 25B to merge onto US 1 S/Baltimore Avenue toward College Park South
  • Travel approximately 3 miles on US 1 South/Baltimore Avenue
  • Turn left onto Paint Branch Parkway
  • Travel approximately 1 mile on Paint Branch Parkway
  • The CFSAN Campus will be on the right


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 October 10, 2017.

Organizing Committee
  • Bryan Delaney, PhD, DABT, ATS, Colloquium Series Chair, DuPont Pioneer, Johnston, IA
  • Jason L. Aungst, PhD, US FDA, College Park, MD
  • Suzanne Compton Fitzpatrick, PhD, DABT, US FDA, College Park, MD
  • Norbert E. Kaminski, PhD, Michigan State University, East Lansing, MI
  • Jieun Lee, PhD, DABT, Kellogg, Battle Creek, MI
  • Stephen M. Roberts, PhD, University of Florida, Gainesville, FL
  • Allen Rudman, PhD, US FDA, College Park, MD
  • Jeffrey J. Yourick, PhD, DABT, ATS, US FDA, Laurel, MD
  • Peter L. Goering, PhD, DABT, ATS, US FDA, Silver Spring, MD
  • John B. Morris, Council Contact, University of Connecticut, Storrs, CT
  • Paddy Wiesenfeld, PhD, Colloquium Co-Chair, CFSAN, US FDA, Laurel, MD
  • Clarissa Russell, SOT Staff, Reston, VA