A--Performance of Good Clinical Practices (GCP) Compliant Clinical Trials of a Freeze Dried Plasma (FDP) Product of Support Efforts to Obtain Food and Drug Administration (FDA) Licensure

The contract involves the US Army's effort to develop and license a Freeze Dried Plasma (FDP) product in compliance with Department of Defense acquisition procedures, FDA regulations, and industry standards. It focuses on conducting Good Clinical Practice (GCP) compliant clinical trials covering pre-clinical through Phase III stages to support the product's regulatory approval. The acquisition strategy is twofold: a Cooperative Research and Development Agreement (CRADA) partner will finance and handle the manufacturing development and supply clinical trial material, while the government contract in this solicitation covers clinical trial management and regulatory or technical support. The U.S. Army Office of The Surgeon General (OTSG) serves as the regulatory sponsor for the Investigational New Drug (IND) application, whereas the CRADA partner will assume responsibility for submitting and managing the Biologics License Application (BLA). This arrangement underscores a collaborative approach between government and industry to ensure successful clinical evaluation and regulatory approval of the Freeze Dried Plasma product. The solicitation, identified by number W81XWH14R0059, aims to secure expertise and services to fulfill these clinical and regulatory requirements.