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Cross-Species Immune System Reference

Solicitation Number: FDABAA-12-00118
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Location: Office of Acquisitions and Grants Services - Rockville
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Award Notice
September 14, 2011
Leland Stanford Junior University
340 Panama St

Stanford, California 94305
United States
Added: Mar 23, 2013 11:36 am
The objective of this project is to utilize mass cytometry to map immune responses in humans and animals that result from various stimuli (including biothreat agents and candidate medical countermeasures or MCMs). The human and animal responses will be compared and the resulting data will be made available to the community through an open-access resource. It is
anticipated that this work may enhance the understanding of the diversity of immune responses elicited by these stimuli both within and across species. Specifically, the project provides a potential means to better understand the potential mechanism(s) of toxicity of biothreat agents, identify off target effects of candidate countermeasures, the mechanism(s) of action for candidate MCMs, and the comparability of these responses in animals and man. This data will be critical for not only facilitating interpretability of animal data but will provide novel and unprecedented potential to assess toxicity and off target effects. In addition the incorporation of studies with biothreat agents may provide new insight into pathogenesis and identify biomarkers as well as
providing data that may assist in interpreting studies in animals to support countermeasures being advanced under the Animal Rule. Importantly, many MCMs will or are pursuing licensure through the Animal Rule. The Animal Rule requires "a reasonably well understood pathophysiological mechanism for the toxicity of the chemical, biological, radiological, or nuclear substance and its amelioration or prevention by the product as well as a demonstration of
effectiveness in one or more species expected to react with a response predictive for humans". This project could provide an additional pathway to generating the necessary data to meet this regulatory standard.
5630 Fishers Lane, Room 2129
Rockville, Maryland 20857-0001
Sean Wybenga
Phone: 301-827-6761
For General Questions