SOT FDA Colloquium Will Explore 3D Bioprinted Tissue Models for Predictive Safety

SOT FDA April 9 Colloquium.png

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 April 9 colloquium, “Alternative Methods for Predictive Safety Testing: 3D Bioprinted Tissue Models.” This session is open to the public to attend in person or via webcast. 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 (EDT) in the Wiley Auditorium at US FDA in College Park, Maryland. The Chair of the colloquium is Edward L. LeCluyse of LifeNet Health in Research Triangle Park, North Carolina. The Co-Chair is Margaret Kraeling of US FDA in Laurel, Maryland.

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 EU that bans animal testing on new cosmetic products. Bioprinting 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. 

Presentations include:

8:30 AM–8:40 AM   Welcome and Introductions
TBD
 
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
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.

The final colloquium for this academic year is scheduled for May 15, 2019, and will be “In Silico Modeling and Methods for Food Ingredient, Dietary Supplement, and Cosmetic Safety.” In addition, planning is already underway for the four topics selected for 2019–2020.

Recordings and slides from the previous colloquia are available free via the SOT FDA Colloquia website, including those from the February 20, 2019, session, “Redesigning the Rodent Bioassay for the 21st Century.”

Register for On-Site Participation

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Deadline for participants who are not federal employees: April 1, 2019

Register for Webcast Participation

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