FDA’s Predictive Toxicology Roadmap: Implications and Opportunities for Stakeholders – May 10th FDA Grand Rounds

FDA’s Predictive Toxicology Roadmap: Implications and Opportunities for Stakeholders – May 10th FDA Grand Rounds

The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute presentation is followed by questions from the audience.

Thursday, May 10, 2018

12:00 p.m. - 1:00 p.m. EST

Register here for webcast

Please pre-register at least one day before the event to ensure that the access link e-mails and outlook invitations are received for each day.

Toxicology is critical to FDA’s mission because it is applied across the breadth of FDA-regulated product areas.  Today’s advances in systems biology, stem cells, engineered tissues, and mathematical modeling are offering exciting opportunities to improve toxicology’s predictive ability--potentially enhancing FDA’s ability to quickly and more accurately predict potential toxicities--and reduce associated risks to the public.  And these breakthroughs also hold the potential for replacing, reducing, and/or refining animal testing.

FDA senior toxicologist Dr. Suzanne Fitzpatrick will discuss FDA’s Predictive Toxicology Roadmap, a six-part framework for integrating new predictive toxicology methods into safety and risk assessments of FDA products.  She’ll detail FDA’s collaborative efforts to advance toxicology toward a more predictive science with NIH, EPA and other federal agencies through programs like Tox21 and ICCVAM.  FDA’s unprecedented role in the development and evaluation of the organs-on-a-chip technology with sister federal agencies and industry will be described and offered as an example of how FDA is enabling innovation in this exciting field. Importantly, Dr. Fitzpatrick will discuss how diverse stakeholders can work with FDA to share ideas, discuss new technologies, and highlight collaborations that are developing and testing new methods.