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SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety—April 9, 2019

Chair: Edward L. LeCluyse, LifeNet Health, Research Triangle Park, NC

Co-chair: Margaret Kraeling, US FDA, Laurel, MD

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Overview

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.

Bioprinting of 3D human tissues is a newly developing field that is currently being pursued by private industry, academia, and government. Human 3D bioprinted tissues represent a valuable in vitro approach for chemical, personal care product, cosmetic, and preclinical toxicity/safety testing. Bioprinting applications are appealing alternative methods for cosmetics testing especially given the current regulatory situation in the European Union that bans animal testing on new cosmetic products. Bioprinting of skin, liver, and kidney is already appearing in toxicity testing applications for chemical exposures and disease modeling. The use of 3D bioprinted tissues and organs may provide future alternative approaches for testing that may more closely resemble and simulate intact human tissues to more accurately predict human responses to chemical and drug exposures.

Schedule
8:00 AM–8:30 AM Badge Pick Up
8:30 AM–8:40 AM Welcome and Overview
Speaker Introductions
8:40 AM–9:20 AM

Overview and Challenges of Bioprinting
Sharon Presnell, Amnion Foundation, Winston-Salem, NC

9:20 AM–10:00 AM

Putting 3D Bioprinting to the Use of Tissue Model Fabrication
Y. Shrike Zhang, Brigham and Women’s Hospital, Harvard Medical School and Harvard-MIT Division of Health Sciences and Technology, Boston, MA

10:00 AM–10:20 AM Break
10:20 AM–11:00 AM

Uses of Bioprinted Liver Tissue in Drug Development
Jean-Louis Klein, GlaxoSmithKline, Collegeville, PA

11:00 AM–11:40 AM

Biofabrication of 3D Tissue Models for Disease Modeling and Chemical Screening
Marc Ferrer, National Center for Advancing Translational Sciences, NIH, Rockville, MD

11:45 AM–12:45 PM Roundtable Discussion
Moderator: Edward L. LeCluyse, LifeNet Health, Research Triangle Park, NC
All Speakers
On-Site Participation

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 April 1.

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

Webcast Registration
Webcast Registration

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.

Location, Transportation, and Parking

Location

Wiley Auditorium

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

Transportation

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.

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

  • Take the Capital Beltway in Maryland and exit at Exit 23
  • Drive on MD-201 S/Hwy 201S/Kenilworth Ave in Greenbelt
  • Proceed to Campus Drive in College Park; turn left onto River Road
  • The CFSAN campus is on the left
  • CFSAN is across from the College Park/U of MD Metro Station

Parking

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.

Security

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 April 1, 2019.

Organizing Committee
  • Bryan Delaney, PhD, DABT, ATS, Colloquium Series Chair, DuPont Pioneer, Johnston, IA
  • Allen Rudman, PhD, Colloquium Series Co-chair, US FDA, College Park, MD
  • Jason L. Aungst, PhD, US FDA, College Park, MD
  • Suzanne Compton Fitzpatrick, PhD, DABT, US FDA, College Park, MD
  • Jieun Lee, PhD, DABT, Kellogg, Battle Creek, MI
  • Stephen M. Roberts, PhD, University of Florida, Gainesville, FL
  • Jia-Sheng Wang, MD, PhD, University of Georgia, Athens, GA
  • Jeffrey J. Yourick, PhD, DABT, ATS, US FDA, Laurel, MD
  • Patricia Ganey, PhD, Council Contact, Michigan State University, East Lansing, MI
  • Edward L. LeCluyse, PhD, Colloquium Chair, LifeNet Health, Research Triangle Park, NC
  • Margaret Kraeling, MS, Colloquium Co-chair, US FDA, Laurel, MD
  • Betty Eidemiller, PhD, SOT Staff, Reston, VA