Extramural Research
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BAA funding | Areas of interest | Current projects | Completed projects | Alignment with U.S. MCM priorities
To help develop solutions to complex regulatory science challenges, FDA funds medical countermeasure (MCM)-related regulatory science through intramural and extramural research grants.
Our goal is to help develop the tools, standards, and approaches to assess MCM safety, efficacy, quality, and performance and to help translate cutting-edge science and technology into innovative, safe, and effective MCMs.
BAA funding
FDA has established a robust extramural research portfolio under the Medical Countermeasures Initiative (MCMi) regulatory science program. Extramural MCM regulatory science is primarily funded through a Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation, under area 7: Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security.
Proposers are encouraged to submit BAA white papers by 5:00 p.m. ET, January 21, 2022 for FY 2022 award consideration.
Areas of interest
MCM-related research areas of interest include:
Area 3: Support New Approaches to Improve Product Manufacturing and Quality
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3.1.7. Refine or enhance existing technologies to improve the sensitivity, specificity, and robustness of testing methods used to measure MCM potency, in-process characteristics, and final drug substance characteristics (for example, in-line sensors and process analytical technologies)
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3.1.8. Advance broadly-applicable, commercially-ready (manufacturing readiness level [MRL] 4-6) tools, technologies, and platforms that improve manufacturing efficiency, consistency, quality, and speed of MCMs to bolster the MCM supply chain; for example, “plug-and-play” modular unit operations applicable for downstream processing, or continuous manufacturing
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3.1.9. Investigate the effects in supply chain of implementing advanced manufacturing for specific types of medical products, especially such as biologics, vaccines and medical devices. Topics may include:
- 3.1.9.1. Supply chain resilience to disruption
- 3.1.9.2. Increased access
- 3.1.9.3. Personalization
- 3.1.9.4. Decreased reliance on foreign supply chains
Submitters interested in Research Area 3.1 may want to review the FDA web page Advanced Manufacturing.
Area 7: Facilitate Development and Availability of Medical Countermeasures (MCMs) to Protect Against Threats to U.S. and Global Health and Security
Offerors to Area 7 are encouraged to coordinate with FDA's Office of Counterterrorism and Emerging Threats, via the OAGS point of contact, for any questions or concept discussion prior to submission.
MCMs include qualified countermeasures as defined in section 319F–1(a)(2)(A) of the Public Health Service Act (PHS Act) (42 USC. § 247d–6a(a))(2)(A); qualified pandemic or epidemic products as defined in section 319F–3(i)(7) of the PHS Act (42 USC. § 247d–6d(i)(7)); and security countermeasures as defined in section 319F-2(c)(1)(B) of the PHS Act (42 USC § 247d–6b(c)(1)(B)).
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The Animal Rule is defined under 21 CFR 314.600/21 CFR 601.90. Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses is defined under 21 CFR Part 601, Subpart E. Accelerated Approval of New Drugs
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7.1.1. Advance the capability to conduct natural history studies necessary to support MCM development under the Animal Rule (e.g., further the understanding of the pathophysiological mechanisms of toxicity, species specificity, or virulence of challenge agents)
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7.1.2. Develop improved in-silico models to extrapolate pharmacokinetic/pharmacodynamic (PK/PD) data from animals to humans (e.g., PK modeling, PK/PD modeling, physiologically-based pharmacokinetic (PBPK) modeling, or population modeling)
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7.1.3. Develop, qualify, and/or facilitate innovative analytical technology or quantitative imaging modality assessments of tissues/cells infected with emergent diseases and biological threats in order to advance characterization and further scientific understanding of pathophysiological mechanisms of infection, disease progression, susceptibility, or virulence;
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7.1.4. Identify and qualify biomarkers and immune correlates of protection that enhance the understanding of the mechanism of action of MCMs, support appropriate clinical dosing of MCMs, and enable comparisons to be made between animal models and humans;
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7.1.5. Develop and qualify in vitro systems (e.g., microphysiological systems) that can accurately predict in vivo responses in humans and/or animals to support the assessment of the safety and efficacy of MCMs
- 7.1.6. Identify and evaluate biomarkers and predictors of harm, susceptibility, latency, or virulence of biological threat agents of concern using innovative analytical technologies, imaging modalities, and other advanced approaches (e.g., omics).
- 7.1.7. Develop and/or advance the capability to conduct in vitro or in vivo assessments with threat agents, at greater than or equal to Biosafety level 3 containment, in order to:
- 7.1.7.1. Further scientific understanding of the pathogenesis of disease or exposure and the pathophysiological mechanisms of disease, toxicology, progression, susceptibility, or virulence;
- 7.1.7.2. Investigate pathogenesis and pathophysiological mechanisms in alternative models of special populations, such as juveniles and patients with underlying medical conditions or rare diseases;
- 7.1.7.3. Identify potential biomarkers of harm, toxicological effects, susceptibility/resistance, latency, or virulence
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7.2.1. Enhance capabilities to rapidly assess the safety, efficacy and/or effectiveness of MCMs used during public health emergencies including:
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7.2.1.1. Develop and refine tools and methodologies to collect, monitor, track, and analyze real-world data and real-world evidence to support regulatory decision making
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7.2.1.2. Develop capabilities to inform or support multisite/multi-center clinical studies during public health emergencies including pre-positioned protocols, rapid and flexible clinical trial designs, novel statistical methods for analysis of clinical data, and clinical trial networks Also see: Medical Countermeasure Monitoring and Assessment
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7.2.2. Develop and validate reference materials to facilitate the development and availability of vaccines, therapeutics, and diagnostics related to threat agents of concern
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7.2.3. Develop new tools and methodologies to leverage large, unstructured data sets for analysis of MCM-relevant safety and efficacy endpoints
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7.2.4. Develop technologies that can rapidly detect counterfeit, substandard, or adulterated MCMs
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7.2.5. Develop technologies that can support the rapid assessment of MCMs for shelf-life extension
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7.2.6. Develop technologies and methods to monitor and predict disruptions in medical device/medical product supply chain security due to technological or CBRN threats (see BAA Area 3.1.2)
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7.3.1. Develop and validate rapid testing methods to speed characterization, in-process testing, and/or lot release for MCMs (e.g. sterility, immunogenicity, neurovirulence, mycoplasma, etc.)
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7.3.2. Develop technologies and methods to accelerate collection and assessment of MCM-relevant clinical safety and efficacy endpoints
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7.3.3. Develop methods using digital design and manufacturing data to increase efficiency of review
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7.3.4. Develop technologies to support the adoption of advanced manufacturing technologies for MCMs (see BAA Area 3.1.7 and 3.1.8);
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7.3.5. Evaluate methods for facilitating and incentivizing the production and development of MCMs or bolstering the MCM supply chain within the U.S (see BAA Area 3.1.9).
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7.3.6. Develop and/or advance the capability to conduct in vitro or in vivo assessments with biological threat agents, at greater than or equal to Biosafety level 3 containment, in order to:
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7.3.6.1. Identify measurable characteristics of toxicological effects, safety and efficacy when evaluating therapeutic regimens and/or interventions to enable translational comparisons between animal model species and humans and to support clinical dosing; or
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7.3.6.2. Identify interactions between therapeutics, characteristics of alternative models of special populations, and disease variables influencing efficacy and adverse event outcomes.
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For more information, please view the full BAA PDF (414 KB).
Current projects
Project | Awarded To | Dates | Funding Mechanism |
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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 | BAA |
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 | BAA |
Characterizing immunity to Ebola and Marburg to support medical countermeasure development | University of California, Los Angeles (UCLA) School of Public Health | September 2019 - September 2023 | BAA |
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 2023 | BAA |
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 | BAA |
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 - April 2023 | BAA |
Expanding next-generation sequencing tools to support pandemic preparedness and response |
Embleema and George Washington University | September 2021 - September 2022 | BAA |
Strengthening coronavirus models with systems biology and machine learning | Commonwealth Scientific and Industrial Research Organisation (CSIRO), Australia | September 2021 – September 2026 | BAA |
Using real-world evidence to advance COVID-19 medical countermeasures | Aetion | September 2021 - August 2022 | BAA |
Completed projects
Project | Awarded To | Dates | Funding Mechanism |
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Adverse Events Monitoring and Analysis Pilot Program | MITRE Corporation | September 2013 - March 2015 | FFRDC |
Cross-Species Immune System Reference | Stanford University | October 2012 - June 2016 | BAA |
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 | BAA |
Investigating Decontamination and Reuse of Respirators in Public Health Emergencies | Battelle Memorial Institute | August 2014 - July 2016 | BAA |
Companion Studies to Define the Distribution and Duration of Zika Virus in Non-Human Primates | University of California, Davis | October 2016 - April 2017 | FDA Contract: HHSF223201610542P |
Supporting Field Laboratory Testing of Ebola Antibodies in Sierra Leone | National Institute for Infectious Diseases “Lazzaro Spallanzani” (INMI) | September 2015 - September 2018 | BAA |
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 | BAA (2013) and FDA Contract: HHSF223201820398A/0001 (2018) |
Streamlining Countermeasure Data Collection During Public Health Emergencies (Discovery, the Critical Care Research Network) | University of Southern California | September 2014 - September 2019 | BAA |
Optimizing Respirator Decontamination to Ensure Supplies for Emergency Preparedness | Applied Research Associates, Inc. (ARA) | September 2014 - September 2019 | BAA |
Melioidosis Modeling: Research to Support Countermeasures for a Tricky Pathogen | Defence Science and Technology Laboratory (Dstl) | September 2015 - September 2019 | BAA |
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 | BAA |
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 | FDA Contract: 75F40120P00531 |
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 | Interagency Agreement (IAA) |
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 | BAA |
View FDA BAA awards in other research areas
Alignment with U.S. MCM priorities
To ensure that funded research aligns with Public Health Emergency Medical Countermeasures Enterprise priorities, FDA established a Steering Committee for Advancing MCMi Regulatory Science.
Representatives evaluate MCMi Regulatory Science Program research proposals for scientific/technical merit and feasibility and alignment with U.S. MCM priorities. In addition to FDA, members include:
- National Institutes of Health (NIH)
- Centers for Disease Control and Prevention (CDC)
- Biomedical Advanced Research and Development Authority (BARDA)
- U.S. Department of Defense (DoD)
FDA Focus Areas of Regulatory Science
The 2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report outlines topics FDA has identified as needing continued targeted investment in regulatory science research to facilitate development of innovative products, provide data and methods to inform regulatory decision-making, and improve guidance to sponsors. Public health preparedness and response is a focus area, including medical countermeasures and preparedness for emerging infectious diseases. Please contact FARS@fda.hhs.gov with questions about this initiative.