A Human Multi-Organ Tissue Equivalent Platform to Model High Consequence Threat Agents

The United States Army Medical Research Acquisition Activity (USAMRAA) intends to issue a Firm Fixed Price sole source contract under the authority of FAR 6.302-1 (a) (2) - Only One Responsible Source and No Other Services will Satisfy Agency Requirements to Wake Forest Institute for Regenerative Medicine (WFIRM), Winston-Salem, NC, on behalf of the United States Army Medical Research of Infectious Diseases (USAMRIID). The Government has a requirement for the development of a micro engineered human organ/tissue equivalent platform for modeling the pathogenic outcomes of emerging infectious diseases and test the efficacy of medical countermeasures (MCMs). The scope of effort will encompass the task of protecting the warfighter from a natural or manmade attack and have the ability to rapidly identify the best methods available to maintain mission critical status. The Contractor will conduct all activities in compliance with FDA CVM regulations, current Good Manufacturing Processes (cGMP), and other applicable regulations as necessary. The Government seeks an Organ Tissue Equivalent (OTE) platform, which utilizes cutting edge 3D organ-on-a-chip technologies and offers one such solution for the military by providing a tool for rapidly identifying medical countermeasures for the prevention and treatment of emerging viral diseases. The lung OTE shall be comprised entirely of human cells including the epithelial, endothelial, stromal, and inflammatory components of native lung tissue. Unlike typical 2D systems, these constructs shall be arranged in a pseudostratified architecture and produce mucus and surfactant providing a physiologically relevant model system. The overarching goal of the proposed studies is to validate the human lung construct as a flexible model for viral pulmonary infections and the resultant inflammatory response. The system will also be used to test the efficacy of potential medical countermeasures, and for identifying potential downstream disease target organs. Using 3 highly relevant respiratory viruses, SARS-CoV-2, MERS and pandemic H1N1 influenza. Interested contractors may identify their interest and bona fide capability to fulfill this requirement. This notice of intent is not a request for competitive proposals. Interested parties who believe they can meet this requirement shall submit information about their capabilities not later than 10:00 AM EST, 14 April 2025. All questions and responses concerning this notice shall be emailed to Kirstin Quinn via email at Kirstin.L.Quinn.civ@health.mil. All information shall be furnished at no cost or obligation to the Government. No solicitation will be made available. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed solicitation based upon responses to this notice is solely within the discretion of the Government. Telephone inquiries will not be accepted.