The Biomedical Advanced Research and Development Authority (BARDA) is a part of HHS under the Assistant Secretary of Preparedness and Response (ASPR). BARDA has developed a simplified portal for submission of proposals to support U.S. government medical countermeasure (MCM) research and development for products targeted to COVID-19. The TechWatch program can be found as part of the BARDA website, www.medicalcountermeasures.gov. Proposals submitted through this platform will be shared across relevant U.S. government agencies such as the Department of Defense and the NIH.
- BARDA is interested in proposals for:
- repurposed or new antivirals or antimicrobials
- vaccines and novel platforms for vaccine development
- new diagnostics, and other technologies
- Ideal technologies and products will:
- Be relevant to the U.S. government COVID-19 medical countermeasure research and development efforts and/or the BARDA Emerging Infectious Disease mission;
- Utilize an already-approved platform, have non-clinical data suggesting efficacy, and/or have significant manufacturing capability; and
- Be fully owned or licensed by your organization (you have full IP rights).
Submissions must include a brief (500-word) description of your product or technology, accompanied by a quad chart slide and one other slide of your choosing.
Questions related to the program and submissions can be directed to TechWatchInbox@hhs.gov.
BARDA Broad Agency Announcement
In addition to the TechWatch program, BARDA solicits proposals for the advanced research and development of medical countermeasures under the BARDA Broad Agency Announcement (BAA-18-100-SOL-00003). BARDA amended the BAA in March 2020 and is currently prioritizing review of proposals for COVID-19 products, including:
- AOI 7.7.1 Diagnostic assay for human coronavirus using existing FDA-cleared platforms
- AOI 7.7.2 Point-of-care diagnostic assay for detection of SARS-CoV-2 virus
- AOI 7.7.3 Diagnostic assay for detection of COVID-19 disease (SARS-CoV-2 infection)
- AOI 8.3 COVID-19 Vaccine
- AOI 9.2 COVID-19 Therapeutics
- AOI 9.3 Immunomodulators or therapeutics targeting lung repair
- AOI 9.5 Pre-exposure and post-exposure prophylaxis
- AOI 10 Respiratory protective devices
- AOI 11 Ventilators
- AOI 17 Advanced Manufacturing Technologies
Any white papers or full proposals submissions, other than those that are in support of COVID-19, will be put into a queue. Once the response to COVID-19 has subsided, BARDA will resume normal review of submissions for other research areas of interests.
Submission of white papers for the BAA are requested by October 31, 2020.
HHS EZ-BAA for Diagnostics
On February 6th, HHS announced an Easy Broad Agency Announcement (EZ-BAA) for development of COVID-19 diagnostics. Solicitation BAA-20-100-SOL-0002
FDA Template for Diagnostics EUA
FDA has developed a COVID-19 Emergency Use Authorization (EUA) template for diagnostic developers, which is available upon request. Sponsors interested in potential Emergency Use Authorization (EUA) for tests to detect COVID-19 may contact CDRH-EUA-Templates@fda.hhs.gov for further information and templates.
COVID-19 molecular assays for mature, FDA-cleared, widely placed devices are of great interest to the Agency.
NIH Supplemental Applications
The NIH has initiated basic research building upon the SARS and MERS research base, including developing animal models and reagents for use by academic institutions and companies, to facilitate the acceleration of candidates into clinical trials.
Existing NIH grantees are encouraged to submit a supplemental application should their technology or product have a potential application to COVID-19. NOT-AI-20-034
NIH Notice of Special Interest
NIAID is issuing this Notice of Special Interest (NOSI) to highlight the need for research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). NIAID is particularly interested in projects focusing on viral natural history, pathogenicity, transmission, as well as projects developing medical countermeasures and suitable animal models for pre-clinical testing of vaccines and therapeutics against SARS-CoV-2/COVID-19. The notice expires on April 5, 2021. NOT-AI-20-031
Coalition for Epidemic Preparedness Innovations (CEPI) RFP
CEPI is a global non-profit organization funded by governments, the Wellcome Trust and the Bill and Melinda Gates Foundation. CEPI issued a call for proposals in January and has since made several awards supporting vaccine R&D. While the CfP has formally closed, companies that feel they have “Proven vaccine technologies, applicable for large scale manufacturing, for rapid response against novel coronavirus, 2019-nCoV” should contact CEPI leadership via their website at www.cepi.net.
Gates-Wellcome Trust-Mastercard COVID-19 Therapeutics Accelerator
In March 2020, The Bill & Melinda Gates Foundation, the Wellcome Trust, and Mastercard announced $125 million in seed funding to accelerate the development of therapeutics for COVID-19. The accelerator aims to identify, assess, develop, and scale up treatments. The press release announcing the accelerator states:
The COVID-19 Therapeutics Accelerator will work with the World Health Organization, government and private sector funders and organizations, as well as the global regulatory and policy-setting institutions. The Accelerator will have an end-to-end focus, from drug pipeline development through manufacturing and scale-up. By sharing research, coordinating investments, and pooling resources, these efforts can help to accelerate research…To identify candidate compounds, the Accelerator will take a three-pronged approach: testing approved drugs for activity against COVID-19, screening libraries of thousands of compounds with confirmed safety data, and considering new investigational compounds and monoclonal antibodies.
The press release also notes that “the expertise of pharmaceutical companies will be critical in identifying, researching, and commercializing successful drugs.”
Additional information is available at https://www.gatesfoundation.org/Media-Center/Press-Releases/2020/03/COVID-19-Therapeutics-Accelerator.