BARDA DRIVe EZ-BAA (EZBAA - 22-100-SOL-00003)
Award Notice Posted
- Solicitation number
- 75A50126C00005
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Awarded
- to Isola Therapeutics Inc.
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 75A50126C00005 Federal contract award
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- Place of performance
- Minneapolis, Minnesota 55410, United States
- Points of contact
-
- BARDA DCMA DRIVe Team drivacquisitions@hhs.gov
- Richard Hall richard.hall@hhs.gov
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response awarded contract 75A50126C00005 to ISOLA THERAPEUTICS INC on April 27, 2026, in the amount of $7,485,416.99 under the BARDA DRIVe EZ-BAA program. The contract focuses on research and development for a nebulization therapy designed to prevent and treat pulmonary foam caused by inhaled chemical agents. The scope of work encompasses early-stage formulation and analytical development, nebulizer characterization, bioanalytical development including pharmacokinetic studies and chlorine exposure proof-of-concept testing, and regulatory strategy development to support an initial FDA meeting. The deliverables are intended to advance the technical readiness level through TRL 5 and generate the data necessary to support future contract vehicles and continued development phases.
Notice text
The purpose of the proposed Contract is for Nebulization Therapy to Prevent and Treat Pulmonary Foam Caused by Inhaled Chemical Agents.
The primary goal of the R&D effort described in this statement of work (SOW) is to generate the necessary data and information to support an initial FDA meeting to align on the regulatory strategy. The contract scope includes early-stage formulation and analytical development of the drug product; nebulizer characterization including flow rates and particle size distribution; bioanalytical development to support non-GLP studies using the proposed test article including PK, dose range finding, and chlorine exposure proof-of-concept (POC); and development of an overall regulatory strategy. This scope of work is expected to support a productive FDA engagement and advance the technical readiness level (TRL) through TRL 5 to meet minimum requirements to support various future contract vehicles. The generated data and completed non-GLP studies, along with FDA feedback, will inform work required in later development phases.
Awarded contract 75A50126C00005 to ISOLA THERAPEUTICS INC for 7485416.99 on 2026-04-27.
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Award Notice | |
| BARDA DRIVe EZ-BAA (EZBAA - 22-100-SOL-00003) | Solicitation |
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