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.

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