JPEO-CBRND & BARDA Commercial Solutions Opening (CSO) Area of Interest (AoI) W911QY-20-S-C001-A003 SARS-CoV-2 Medical Counter Measures (MCM) Therapeutics
Closed Solicitation Posted
- Solicitation number
- W911QY-20-S-C001-A003
- Agency
-
ACC Aberdeen Proving Ground
Army Contracting Command, Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325412 Pharmaceutical Preparation Manufacturing
- PSC
- 6505 Drugs And Biologicals
- Place of performance
- Natick MA 01760 USA
Notice details come from SAM.gov. Updated .
About this opportunity
This solicitation from the Joint Program Executive Office - Chemical Biological Radiological Nuclear Defense (JPEO-CBRND) and Biomedical Advanced Research and Development Authority (BARDA) seeks proposals for the manufacturing and fill-finish of a minimum of 100,000 treatment courses of advanced SARS-CoV-2 medical countermeasure therapeutics by March 31, 2021 to treat the indicated US population. Candidate therapeutics must demonstrate the capability to obtain Emergency Use Authorization or FDA approval by the end of 2020, begin phase 3 clinical trials by fourth quarter 2020, and receive FDA approval in 2021. Solution briefs must be submitted by specified dates with proposals requested from selected offerors within seven days of solicitation.
There is no set-aside designation. The main NAICS code is 325412 and PSC code is 6515. Awards will be fixed price contracts with performance in Natick, MA. Offerors must demonstrate the ability to produce bulk drug substance and finished drug product meeting cGMP standards and have started or completed a phase 1 clinical study by August 31, 2020. Pricing should be provided as a rough order of magnitude estimate.
Notice text
Under the President’s Operation Warp Speed Mission, Health and Human Services is leading a whole of nation effort with the primary goal to execute on a well-defined portfolio of COVID-19 medical countermeasure candidates to maximize probability of having safe and effective diagnostics, therapeutics and vaccines as fast as possible for mass distribution. As such, BARDA has an Area of Interest (AoI) for therapeutics manufacturing and fill-finish of advanced SARS-CoV-2 MCMs. Therapeutics manufacturing is expected to meet the necessary US Food and Drug Administration (FDA) requirements for beginning a Phase 3 clinical trial, and the product be granted licensure by the FDA.
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