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BARDA DRIVe EZ-BAA (EZBAA - 22-100-SOL-00003)

Awarded
75A50126C00005Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The contract, titled BARDA DRIVe EZ-BAA (EZBAA - 22-100-SOL-00003), is aimed at advancing research and development for a nebulization therapy designed to prevent and treat pulmonary foam induced by inhaled chemical agents. The effort focuses on early-stage formulation and analytical development of the drug product, characterization of the nebulizer system including flow rates and particle size distribution, and bioanalytical method development to support non-GLP studies such as pharmacokinetics, dose range finding, and proof-of-concept exposure to chlorine. A critical objective is to generate the data and regulatory strategy required to secure alignment from the FDA during an initial regulatory meeting, with the goal of advancing the technical readiness level to TRL 5 to meet baseline requirements for future contracting opportunities. Outcomes from this phase will directly inform the design and scope of subsequent development stages. This award is managed by the Biomedical Advanced Research and Development Authority within the Department of Health and Human Services, with the primary point of contact located in Washington, D.C., and the performance of work taking place in Minneapolis, Minnesota. The contract was posted on April 27, 2026, under NAICS code 541714 for research and development in the physical, engineering, and life sciences. Funding and oversight are coordinated through BARDA’s DRIVe initiative, and all inquiries should be directed to the designated team at DRIVeAcquisitions@hhs.gov or Richard Hall at Richard.Hall@hhs.gov. The successful execution of this contract is intended to lay the groundwork for future development of a medical countermeasure against chemical agent-induced pulmonary injury.

General Info

Develop nebulization therapy for chemical-induced pulmonary foam, reach TRL 5, secure FDA alignment, perform work in Minneapolis.

Agency

Department Of Health And Human Services → Barda - Aspr / Daappo / Barda DcmaView Agency

Contract Value

$7,485,416.99

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)View NAICS

Place of Performance

Minneapolis, MN, 55410, USA

Set-Aside

NONE

Awardee

ISOLA THERAPEUTICS INCView Profile

Award Issued Date

Documents

(0)

No documents available

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Timeline

PhaseAwarded
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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma
Contacts2 people available
OfficeWASHINGTON, DC, 20515, USA
Organization / Agency
Department Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma
View Agency Profile
Office AddressWASHINGTON, DC, 20515, USA
Contacts
BARDA DCMA DRIVe Team
contact@example.gov
Richard Hall
contact@example.gov

Full Description

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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.

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NAICS: 541380
Federal
In Vivo Imaging and Data Acquisition (Preclinical)This contract involves conducting in vivo preclinical imaging using modalities such as MRI, CT, and PET to study live animal models during nonclinical investigations. The goal is to evaluate physiological responses to various chemical agents and medical countermeasures, supporting the assessment and development of these substances. The contract is issued as a subcontract under the NAICS code 541380 and is managed by the Department of Health and Human Services through its bureaus including BARDA and ASPR. The contract emphasizes data acquisition and analysis in preclinical settings, playing a critical role in advancing medical research and product development aimed at improving public health preparedness and response. The location details and point of contact information were not specified, but the contract was posted on April 22, 2026, reflecting ongoing efforts to support nonclinical study capabilities in biomedical research.
Testing Laboratories and Services

POSTED

3 months ago

DEADLINE

N/A
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NAICS: 541611
Federal
Tissue Collection, Processing, and HistopathologyThis contract involves the collection, preservation, sectioning, and histological analysis of animal tissues following exposure to chemical agents and medical countermeasures (MCMs). The purpose is to support toxicology and efficacy assessments, ensuring thorough examination of tissue responses to these substances. The scope includes detailed processing and microscopic evaluation to provide critical data for understanding the biological effects and safety profiles of the tested agents. Issued by the Department of Health and Human Services under the BARDA-ASPR/DAAPO/BARDA DCMA umbrella, this subcontract falls under the NAICS code 541611, indicating professional, scientific, and technical services. The contract was posted on April 22, 2026, and although specific location details and points of contact are not provided, it is structured to facilitate specialized laboratory analysis essential for public health preparedness and response initiatives.
Administrative Management and General Management Consulting Services

POSTED

3 months ago

DEADLINE

N/A
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NAICS: 541714
Federal
Nonclinical Animal Dose Escalation Studies (Schedule 1 Chemicals)This contract involves the execution of nonclinical dose escalation studies using highly hazardous chemical agents, such as phosphine and cyanide, in animal models. The primary goal is to evaluate the efficacy of medical countermeasures under the FDA’s Animal Rule, which allows for drug approval based on animal testing when human trials are not ethical or feasible. The work focuses on Schedule 1 chemicals, requiring strict adherence to safety and regulatory standards due to the high-risk nature of the substances involved. The contract is a subcontract under the Department of Health and Human Services, specifically managed by the Biomedical Advanced Research and Development Authority (BARDA) along with associated offices. It falls under the NAICS code 541714, which covers research and development in biotechnology. While specific details about the location of performance and points of contact are not provided, the contract supports the development of critical medical countermeasures aimed at protecting public health from chemical threats.
Research and Development in Biotechnology (except Nanobiotechnology)

POSTED

3 months ago

DEADLINE

N/A
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