Extramural MCM Regulatory Science Research
ORES funds MCM regulatory science research to develop the tools, standards, and approaches necessary to assess MCM safety, efficacy, quality, and performance.
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BAA funding | Areas of interest | Current projects | Completed projects | Alignment with U.S. MCM priorities
The Office of Regulatory and Emerging Science (ORES) provides funding to support high-priority regulatory science research for internal FDA scientists as well as for external scientists that align with U.S. Government medical countermeasure (MCM) priorities to develop the tools, standards, and approaches necessary to assess MCM safety, efficacy, quality, and performance. Our work helps translate cutting-edge science and technology into safe and effective MCMs needed to respond to chemical, biological, radiological, and nuclear threats (CBRN) threats and emerging infectious diseases.
Extramural funding
ORES funds extramural MCM regulatory science using various contract and grant mechanisms including the FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science (under research area of interest III).
Priority research areas
- Developing and cauterizing tools to support MCM development under the Animal Rule, or Emergency Use Authorization (EUA)
- Enhancing the agility, quality, and utility of diagnostics and diagnostic data
- Modernizing tools to evaluate MCM product safety, efficacy, and quality; and secure the MCM supply chain
- Advancing the development of tools to enable the rapid development and availability of investigational MCMs
Current projects
| Project | Awardee | Dates |
|---|---|---|
| Characterizing immunity to Ebola and Marburg to support medical countermeasure development | University of California, Los Angeles (UCLA) School of Public Health | September 2019 - March 2025 |
| FDA and global partners to analyze coronavirus samples Study expanded to add characterization of SARS-CoV-2 (including variants of concern) pathogenesis and disease severity in humans and animal models (August 2021) |
University of Liverpool | September 2020 - September 2025 |
| Cellular signaling and immune correlates for SARS-CoV-2 infection Study expanded to research diversity of immune responses across clinical populations (September 2021) |
Stanford University School of Medicine | October 2020 - September 2025 |
| Expanding next-generation sequencing tools to support pandemic preparedness and response | Embleema and George Washington University | September 2021 - September 2025 |
| Strengthening coronavirus models with systems biology and machine learning | Commonwealth Scientific and Industrial Research Organisation (CSIRO), Australia | September 2021 – September 2026 |
| Pediatric disease modeling for long COVID | Children’s Hospital Los Angeles | June 2022 - March 2025 |
|
Development of a Novel Challenge Model of Systemic Botulinum Neurotoxin Intoxication to Support the Advancement of Candidate Therapeutic Medical Countermeasures |
Battelle Memorial Institute | July 2023 - July 2025 |
Development of an Alternative Ferret Nerve Agent Exposure Model for Chemical Agent Countermeasure Evaluation |
Battelle Memorial Institute | May 2023 - November 2024 |
Completed projects
| Project | Awarded To | Dates |
|---|---|---|
| Adverse Events Monitoring and Analysis Pilot Program | MITRE Corporation | September 2013 - March 2015 |
| Cross-Species Immune System Reference | Stanford University | October 2012 - June 2016 |
| Ensuring Appropriate Public Use of Medical Countermeasures through Effective Emergency Communication |
University of Pittsburgh Medical Center - UPMC Center for Health Security | June 2014 - June 2016 |
| Investigating Decontamination and Reuse of Respirators in Public Health Emergencies |
Battelle Memorial Institute | August 2014 - July 2016 |
| Companion Studies to Define the Distribution and Duration of Zika Virus in Non-Human Primates |
University of California, Davis | October 2016 - April 2017 |
| Supporting Field Laboratory Testing of Ebola Antibodies in Sierra Leone |
National Institute for Infectious Diseases “Lazzaro Spallanzani” (INMI) | September 2015 - September 2018 |
| Organs-On-Chips for Radiation Countermeasures Study expanded to analyze differences in sex-specific responses to radiation in September 2018 |
Wyss Institute for Biologically Inspired Engineering at Harvard University | September 2013 - April 2019 |
| Streamlining Countermeasure Data Collection During Public Health Emergencies (Discovery, the Critical Care Research Network) |
University of Southern California | September 2014 - September 2019 |
| Optimizing Respirator Decontamination to Ensure Supplies for Emergency Preparedness |
Applied Research Associates, Inc. (ARA) | September 2014 - September 2019 |
| Melioidosis Modeling: Research to Support Countermeasures for a Tricky Pathogen | Defence Science and Technology Laboratory (Dstl) | September 2015 - September 2019 |
| Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics Study expanded to apply technology used for the Ebola project to gather important information about COVID-19 infection (March 2020) |
Public Health England (PHE) | September 2015 - March 2021 |
| Assessing the Role of Additive Manufacturing in Support of the U.S. COVID-19 Response | National Center for Defense Manufacturing and Machining (America Makes) | September 2020 - February 2021 |
| U.S. Department of Defense and FDA collaborate to help speed potential countermeasures for Ebola and other viruses |
U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) | September 2018 - September 2021 |
| A new approach for understanding Ebola virus pathogenesis Study expanded to apply technology used for the Ebola project to gather important information about COVID-19 infection (March 2021) |
Broad Institute of MIT and Harvard | November 2018 - September 2021 |
| Survivor Studies: Better Understanding Ebola's After-Effects to Help Find New Treatments Study expanded to include investigation of Zika virus disease (September 2017), apply new technologies (September 2019), and development and evaluation of potential medical countermeasures for COVID-19 (March 2020) |
Stanford University School of Medicine | May 2016 - June 2022 |
| Comparison of Host Responses to Ebola Virus Disease (EVD) Study expanded to apply technology used for the Ebola project to gather important information about COVID-19 infection (March 2020) |
UK Health Security Agency (formerly Public Health England) | October 2017 - October 2022 |
| Human organ chips for radiation countermeasure development Study expanded to add development of new organs-on-chips to aid development and evaluation of countermeasures for COVID-19 (September 2021) |
Wyss Institute for Biologically Inspired Engineering at Harvard University | September 2019 - March 2024 |
| Provision of Marburg Virus Control Serum |
University of Oxford | April 2023 - April 2024 |
|
Using real-world evidence to advance COVID-19 medical countermeasures |
Aetion | September 2021 - September 2023 |
View FDA BAA awards in other research areas