Nebulization Development in Biotechnology
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🏆 Award Details
- Awarded To
- ISOLA THERAPEUTICS INC
- Award Amount
- $7.5M
- Location
- Minneapolis, MN, USA
- UEI
- M3QDM72NME75
- Award Date
- April 27, 2026
The contract is for Nebulization Therapy to prevent and treat pulmonary foam caused by inhaled chemical agents, aimed at supporting an initial FDA meeting on regulatory strategy. The work includes early-stage formulation, nebulizer characterization, bioanalytical development, and overall regulatory strategy development.
Scope & Requirements
The work involves generating data and information to support FDA engagement, including formulation development, nebulizer characterization, and bioanalytical studies.
Attachments
This listing does not include downloadable attachments. The solicitation details may be in the description below.
Verify on SAM.govContract Details
- Awarded Amount
- $7.5MSimilar contracts award $30K – $917K (median $200K, 3,316 awards)Above typical range
- Incumbent Contractor
- ISOLA THERAPEUTICS INC
- NAICS Codes
- Place of Performance
- Minneapolis, MN, USA
Agency & Contact
Contracting Organization
- Agency
- HEALTH AND HUMAN SERVICES, DEPARTMENT OF
- Sub-Agency
- OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE
- Office
- BARDA - ASPR / DAAPPO / BARDA DCMA
Point of Contact
Key Dates
Description
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. BARDA DCMA DRIVe Team Alternative
Point of Contact Richard Hall Contracting ’NEILL HOUSE (No Street Address
2) WASHINGTON, DC 20515 USA to this opportunity.
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