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SELECTBIO Conferences Multi-Cellular Engineered Living Systems Summit

Donna Mendrick's Biography



Donna Mendrick, Associate Director of Regulatory Activities, US Food and Drug Administration (FDA)

Dr. Donna L. Mendrick is the Associate Director of Regulatory Activities at the National Center for Toxicological Research (NCTR) and serves as the liaison between NCTR and the regulatory centers at the FDA. Dr. Mendrick’s FDA wide committee assignments include the Senior Science Council and Chair of the Emerging Sciences, the Artificial Intelligence Working Groups and the Stem Cell and MPS Discussion Group.

Prior to becoming the Associate Director and locating to FDA’s White Oak campus, she was the Director of the Division of Systems Biology at NCTR. Dr. Mendrick was an Assistant Professor of Pathology at Harvard Medical School and Brigham and Women’s Hospital until 1995 when she joined joining Human Genome Sciences. Just prior to joining the FDA in 2008, she was a Scientific Fellow and Vice President of Pharmacogenomics at Gene Logic.

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Alternative Models Use: Regulatory Context

Wednesday, 25 March 2020 at 09:30

Add to Calendar ▼2020-03-25 09:30:002020-03-25 10:30:00Europe/LondonAlternative Models Use: Regulatory ContextMulti-Cellular Engineered Living Systems Summit in Boston, USABoston, USASELECTBIOenquiries@selectbiosciences.com

In 2017 FDA published the Predictive Toxicology Roadmap (https://www.fda.gov/science-research/about-science-research-fda/fdas-predictive-toxicology-roadmap)-a framework for integrating predictive toxicology methods into safety and risk assessments.  FDA welcomes data from alternative methods and is working internally and externally to learn more about technologies such as MPS.  This presentation will provide an overview of MPS work being done within FDA and the actions being taken to help move alternative assays into a regulatory context.


Add to Calendar ▼2020-03-25 00:00:002020-03-25 00:00:00Europe/LondonMulti-Cellular Engineered Living Systems SummitMulti-Cellular Engineered Living Systems Summit in Boston, USABoston, USASELECTBIOenquiries@selectbiosciences.com