Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)

Subsidy: no limit

Deadline: 30 April 2020, 31 July 2020, 31 October 2020 (Stage 1). Full proposal on invitation only.

Consortium: All researchers from anywhere in the world. Both for-profit and non-profit organizations are eligible.

Scope:

Area of interest #7: Emerging diseases diagnostics: diagnostic assay for detection of COVID-19 disease (SARS-CoV-2 infection) including the following topics:  

• Diagnostic Assay for human coronaviruses using existing FDA-cleared platforms:  development, and FDA clearance of an in vitro diagnostic pan-coronavirus assay that can also differentiate known human coronaviruses (SARS-CoV-2 (2019-nCoV), MERS CoV, CoV 229E, CoV OC43, CoV NL63, and CoV HKU1) in clinical specimens. The pan-coronavirus assay should be designed to ensure high probability of detecting any future novel or emerging coronavirus that infects humans. The assay should be designed to test clinical specimens including upper and lower respiratory tract specimens and blood.  BARDA prefers assays that will be used with an existing FDA-cleared molecular platform that is currently widely placed in U.S. healthcare settings. Minimum TRL for this assay is TRL-4, in silico evaluation for all proposed targets is required. BARDA will also prioritize manufacturing in the United States.
• Point-of-Care Diagnostic Assay for detection of SARS-CoV-2 virus: the aims is to develop, Emergency Use Authorization (EUA), and 510k clearance of an in vitro diagnostic assay for the detection of SARS-CoV-2 in respiratory specimens that has a small foot-print, and is easy to use at the point of care and produces results in less than 30 minutes (less than 15 minutes preferred). Minimum Technology Readiness level (TRL) for the platform is TRL-5, and for the assay is TRL-4. BARDA will also prioritize manufacturing in the United States.
• Diagnostic Assay for detection of COVID-19 disease (SARS-CoV-2 infection): the aim is to develop, Emergency Use Authorization (EUA) and 510k clearance of an in vitro diagnostic assay for COVID-19 that has a small foot-print, and is easy to use at the point of care. Assays should detect host or pathogen biomarkers specific for acute COVID-19 disease in non-invasive specimens that can be easily collected in CLIA-waived settings, and provide results in less than 30 minutes (less than15 minutes preferred). BARDA will prioritize platforms and assays for detection of COVID-19 disease that have reached TRL-4 level. At a minimum, the application is required to show proof of concept data on the proposed platform to demonstrate ability to discriminate etiology of other respiratory infections. BARDA will also prioritize manufacturing in the United States. 

Area of interest #8: Influenza and emerging infectious diseases vaccines: technologies and approaches that will improve preparedness and response against pandemic influenza and emerging infectious diseases with pandemic potential. Divided in the following subtopics:  

• Advanced development of more effective vaccines.Candidates and approaches that have achieved TRL 6 or greater and that will improve preparedness and response against pandemic influenza are requested. Vaccine candidates and approaches that provide one or more of the following are of particular interest:  

1. licensure of domestically manufactured vaccines amenable to both rapid production from time of strain identification to release of bulk product, and rapid scale up and manufacturing technology transfer to new facilities;  

1. clinical trials to expand the age range on the label of currently licensed vaccines;  

1. decrease response time, such as adjuvants or other technologies that allow a priming and protective response with a single vaccine dose; or
2. improve the stability, sustainability and/or utility of stockpiled vaccines.  

• Innovative vaccine production enhancements. Support for improvements in vaccine production and administration that accelerate the availability of pandemic influenza vaccines and for which feasibility data is available. Enhancements include but are not  restricted to: 
  1. Virus: development or implementation of new technology platforms that promote high-yield or improved cross-reactivity or methods and technologies that will allow the assessment of improved vaccine performance
  2. Manufacturing: up-stream and downstream methods to improve production yields.
  3. Assay: methods to decrease the time required to produce essential potency reagents for vaccine release testing or development or implementation of new potency determination methods that relieve virus strain-specific standard reagent dependencies.
  4. Administration: Improved approaches to route of vaccine delivery that are more amenable to large scale vaccination campaigns in a short period of time. 
  
• COVID-19 Vaccine.The aim is to develop vaccine countermeasures to COVID-19, this may consist of the vaccine itself, viral or genetic (DNA or RNA) vectors, or other technologies that can quickly generate a safe and protective immune response. The manufacturing technology for the proposed vaccine should be suitable for commercial scale production and for product delivery. Manufacturing must occur in the United States. While there is no TRL minimum requirement, more advanced submissions are preferred. Preference will be given to technologies that leverage late stage or licensed platforms and those that have non-clinical data from SARS or MERS-CoV and human exposure data to include safety and potential immunogenicity. 

Area of interest #9: influenza and emerging infectious diseases therapeutics: COVID-19 therapeutics:  

Development of novel therapeutics for the treatment of influenza A and B infections, as well as for the treatment of disease caused by emerging infectious diseases of pandemic potential to be determined by BARDA. 

• COVID-19 Therapeutics: Direct acting antivirals or host-directed therapeutics (indirectly inhibiting the virus lifecycle), with proven efficacy against coronaviruses. In vitro efficacy versus human coronaviruses is required. The best proposals will demonstrate efficacy in vitro and in vivo versus MERS-CoV, SARS-CoV, or SARS-CoV-2 (2019-nCoV). In addition to the in vitro and in vivo efficacy prioritization, repurposed products that are already FDA approved or in late stages of development with clinical exposure data will be prioritized.  

BARDA will prioritize candidates against SARS-CoV-2 (2019-nCoV) that have reached the TRL6 level, however, earlier stage candidates may be considered. Manufacturing of products in the United States will be a requirement.  

• Immunomodulators or therapeutics targeting lung repair: Immunomodulators that improve the clinical response to and/or resolution of symptoms associated with influenza or other viral respiratory infections will be considered. Product candidates must demonstrate efficacy as measured by a significant reduction in morbidity, mortality, viral titers, or a significant change in immunological markers (for example) in relevant influenza or viral respiratory disease animal models. Proposed candidates must have an active Investigational New Drug application filed with the FDA and have demonstrated safety in a Phase 1 study as evidenced by a final clinical study report.  

BARDA will prioritize candidates against SARS-CoV-2 (2019-nCoV), related coronaviruses, or respiratory infections that have reached the TRL6 level, however, earlier stage candidates may be considered. Manufacturing of products in the United States will be a requirement.  

Area of interest #17: (NEW) Advanced Manufacturing technologies: The development and demonstration of innovations and enhancements to manufacturing platforms to support the development of necessary medical countermeasures including vaccines and therapeutics in prevention, preparation, and response to COVID-19. The purpose of the innovations and enhancement to advanced manufacturing technologies may include but is not limited to improving pharmaceutical quality, rapidly scale manufacturing capabilities, shorten supply chains, increase manufacturing resilience to disruption, accelerate availability of emerging therapies/vaccines, and reduce the risk of pharmaceutical shortages. Advanced manufacturing technologies may include but is not limited to continuous manufacturing and additive manufacturing (including 3D printing). Priority will be given to products manufactured in the United States. 

We appreciate your interest in partnering with BARDA. Due to the COVID-19 response, any white papers or full proposals submissions, other than those that are in support of COVID-19, will be put into a queue.

Link to subsidy: https://beta.sam.gov/opp/1b46a4169fcb4902b9c4fcbb5bf981f7/view

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The subsidy landscape is responding quickly to the COVID-19 virus and the problems this crisis causes world-wide. A lot of new funding opportunities are being released to assist researchers and companies with their Research and Development activities against COVID-19. We have made an overview of all COVID-19 grants & funding opportunities. Check our COVID-19 Call Overview and stay up-to-date.

A more detailed and tailor-made overviews are available in 3 different products:

1. Funding Scan. A summarized overview of funding opportunities for one specific R&D project with a short profile of the researcher or company. This includes a strategy with upcoming funding opportunities for the next year.
2. Funding Advice. A detailed description of your company, research group, R&D projects and an overview of the timelines involved in future development. This includes a funding strategy for each project for the next 2 years.
3. Funding Plan. A long-term funding strategy taking into consideration multiple R&D pillars. This detailed strategy focuses on multiple sources of funding and addresses financial weaknesses in continuing strategic planning.

Read more about it on our Strategic Funding Advice page.

For more information: https://www.catalyze-group.com/covid-19/barda-covid-19-response-proposal/