Collaboration is the cornerstone of FDA efforts to modernize the tools and processes the Agency uses to advance regulatory science, the science underpinning all FDA regulatory decisions.  One of the ways in which FDA’s Medical Countermeasures initiative (MCMi) is supporting collaborative research is through Broad Agency Announcements (BAA). The BAA mechanism enables FDA to leverage the knowledge and assets of its partners in industry, government laboratories, and academic institutions, among others to transform new discoveries in science into 21st-century treatments and cures.
 
Stanford University has been awarded funding from FDA's first BAA, the Advanced Research and Development of Regulatory Science and Innovation, in the area of Facilitating the Development of Medical Countermeasures to Protect against Threats to U.S. and Global Health and Security.
 

 

 

Translating results from animal models to human trials and therapies requires careful consideration of the similarities and differences any given animal species has when compared to humans.  Inasmuch as other mammals have organs similar to our own (heart, liver, kidneys, etc.), the immune system is composed of functional components that are similar, but not identical, when comparing humans to other animals.  Understanding where immune functions are similar in humans and animal models, and critically knowing where they are different, will help FDA and the biomedical research community to evaluate medical countermeasures and, eventually, aid in evaluating and delivering better countermeasures and therapies.

 

 

Stanford researchers will use mass cytometry to enable the first single-cell comprehensive cross-species analyses of immune system function by mapping the immune responses to certain biothreat agents and possible medical countermeasures in humans and animal models.  Mass cytometry is a new technology that enables scientists to take simultaneous measurements of dozens of features located on and in cells and to analyze immune cells in far more detail than was previously possible. Given that the immune system is the key “first responder” to disease threats, it follows that how the immune system responds in the first minutes and hours can determine the health outcome for the host—be it human or animal.

 

With this project focus in mind, human and animal immune responses will be used to create species-specific immune function maps. Employing advanced computational techniques, the maps will be overlaid to highlight differences and similarities. The resulting data – and analysis tools to evaluate results—will be made available to the community through an open-access resource.

 

 

This project will:

 

 

The data from these studies may help both to identify new biomarkers of disease and interpret studies performed in vitro and in animals to support the identification and development of countermeasures against CBRNE agents. Moreover, the tool box of reagents (substances or compounds that are added to a system to bring about a chemical reaction, or to see if a reaction occurs) being developed under this proposal and the data generated will inform studies far beyond those focused on CBRNE agents. The end result will translate into improved public health and better states of preparedness against emerging diseases and CBRNE threats.