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.
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.
The current BAA announcement will remain open until further notice, but proposers are encouraged to submit white papers by March 29, 2019 for current fiscal year (FY19) awards.
MCM-related research areas of interest include:
- 7.1 Develop, characterize, and qualify tools to support MCM development under the Animal Rule or accelerated approval provisions
- 7.2 Modernize tools to evaluate MCM product safety, efficacy, and quality; and improve/ensure MCM supply chain
For more detail on these areas, please view the full BAA PDF (648 KB). MCM research areas of interest descriptions begin on page 24.
|Project||Awarded To||Dates||Funding Mechanism|
|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||September 2013 - April 2019||BAA (2013) and FDA Contract: HHSF223201820398A/0001 (2018)|
|Optimizing Respirator Decontamination to Ensure Supplies for Emergency Preparedness||Applied Research Associates, Inc. (ARA)||September 2014 - April 2019||BAA|
|Streamlining Countermeasure Data Collection During Public Health Emergencies (Discovery, the Critical Care Research Network)||University of Southern California||September 2014 - September 2019||BAA|
|Melioidosis Modeling: Research to Support Countermeasures for a Tricky Pathogen||Defence Science and Technology Laboratory (Dstl)||September 2015 - March 2019||BAA|
|Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics||Public Health England (PHE)||September 2015 - September 2020||BAA|
|Supporting Field Laboratory Testing of Ebola Antibodies in Sierra Leone||National Institute for Infectious Diseases “Lazzaro Spallanzani” (INMI)||September 2015 - September 2018||BAA|
|Survivor Studies: Better Understanding Ebola's After-Effects to Help Find New Treatments - Study expanded to include investigation of Zika virus disease in September 2017||Stanford University School of Medicine||May 2016 - November 2019||BAA|
|Comparison of Host Responses to Ebola Virus Disease (EVD)||Public Health England (PHE)||October 2017 - October 2020||BAA|
|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||Broad Institute of MIT and Harvard||November 2018 - October 2020||BAA|
|Project||Awarded To||Dates||Funding Mechanism|
|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|
|Hybrid Genome Sequencing and Assembly of Bacterial Pathogens Using Emerging Innovative Technologies [ARCHIVED]||University of Maryland School of Medicine||September 2013 - September 2017||BAA|
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)