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DTRA Issues Ebola Broad Agency Announcement

The Defense Threat Reduction Agency (DTRA) Chemical and Biological Defense Program (CBDP) has issued a new funding mechanism for advancing Ebola countermeasures during FY2015-2016.

The primary objective of the Broad Agency Announcement (BAA) is to support development of near-term solutions such as Ebola therapeutic and vaccine candidates; diagnostic capabilities; modeling capabilities; and data gaps.

Although some diagnostics are available and are being utilized in West Africa, capability improvements are sought. Similarly, improved modeling data, methods, and/or tools are required to better understand and predict the course of the current outbreak.

“Recognizing that industry may have solutions applicable to the current outbreak, this BAA has been released to ensure that all potential near-term solutions are considered,” states the DTRA announcement.

Highlighted topics of interest include:

  • Rapid, low burden, potentially CLIA-waivable, triage level diagnostics
  • Inexpensive (<$10 per sample) multiplexed diagnostics or detection
  • Exposure monitoring tools
  • Improved determination and understanding of quantitative infectious dose
  • Biohazard PPE improvements such as reducing thermal and cognitive burden or reducing hazards during doffing process
  • Rapid disinfection processes
  • In vitro and non-Good Laboratory Practices (GLP) in vivo testing for toxicity, activity, ADME
  • Preclinical non-GLP efficacy testing for EBOV
  • Manufacturing, characterization and release of Current Good Manufacturing Practices (cGMP) material
  • Completion of IND-enabling non-clinical studies
  • Development, submission, and sponsorship of an IND application
  • Development of EBOV vaccine formulations that display thermal stability
  • Clinical studies in humans
  • Social network modeling which mitigates lack of local and temporal data
  • Assessing efficacy of public health interventions
  • Road mobility modeling data, methods and tools relative to weather impact
  • Estuary mobility modeling to assess viability or impassability during rainy season
  • Human mobility modeling to refine estimates of disease spread
  • Micro scale economic, marketing and general activity social network modeling
  • Hospital disease transmission modeling given level/quality of healthcare available for area
  • Assessment of virus survival rates under a range of controlled environmental conditions (e.g. dark, simulated solar radiation, and ranges of temperature and humidity)
  • Assessing persistence of Ebola virus in media such as water or sewage biofilm
  • Use of phylogenetics to identify potential genes involved in environmental persistence
  • Metagenomic analysis of potential reservoir environments
  • Elucidation of mechanisms and environmental conditions that promote mutations in animal reservoirs

For medical countermeasures, DTRA stated it will only consider late stage development products that can be completed and implemented in time to assist with the current outbreak.

Collaborations with Federal Biocontainment, Testing Facilities

DTRA is encouraging organizations to collaborate with others in Government, academia, and the private sector to broaden and strengthen their capabilities. Where possible, offerors are also encouraged to take advantage of specialized resources in the DoD and other Government agencies such as facilities/capabilities for biocontainment, collections of biothreat pathogens, Core testing, or advanced manufacturing.

Background: DTRA’s Ebola Efforts

DTRA, with industry and government partners, has been working aggressively for the past decade to understand and counter Zaire ebolavirus (EBOV). DTRA’s program is currently supporting the accelerated development of a therapeutic through preclinical Investigational New Drug (IND) enabling activities as well as the clinical evaluation for one EBOV vaccine.

The program co-developed the rapid field deployable diagnostic systems currently in use in West Africa. The program has also been adapting and improving upon North Atlantic Treaty Organization (NATO) approved and high performance computing methods of modeling EBOV to perform analysis of the current EBOV outbreak.

Further details are available under Solicitation Number: HDTRA1-15-EBOLA-BAA.

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