Inactive

1. Scope: The current COVID-19 pandemic demands immediate action in developing life-saving Medical Countermeasures (MCM), which encompass technical efforts from early development through their Food an... 1. Scope: The current COVID-19 pandemic demands immediate action in developing life-saving Medical Countermeasures (MCM), which encompass technical efforts from early development through their Food and Drug Administration (FDA) approval. This document provides a summary of the Department of Defense (DOD) and Operation Warp Speed (OWS) major integrated efforts that include but are not limited to leveraging the use of Senior Subject Matter Experts (SMEs) consultants with recognized expertise in MCM development in a variety of disciplines, such as: diagnostics, vaccines, polyclonal antibodies (pAbs), and large and small molecule drug development efforts from early development through FDA approval and Post Licensure related efforts. The Government will draw upon consultant expertise of SMEs to support the Joint Program Executive Office, Chemical, Biological, Radiological & Nuclear Defense (JPEO-CBRND) mission through the development of MCM in the three major MCM domains: Diagnostics, Prevention, and Treatment for COVID-19. SMEs will include senior pharmaceutical technical experts to ensure the JPEO can accomplish the mission to deliver MCMs to DoD personnel and to the nation. Nested within these major integrated MCM development efforts are numerous technical challenges to clinical, non-clinical, and manufacturing processes, up to full scale production to obtain FDA approval. The consultant pharmaceutical SMEs will augment DOD MCM developers and contribute to analysis, assessment, design, and evaluation of alternative approaches to achieve the rapid development of MCMs against COVID-19. They will increase efficiency and effectiveness, reduce the risks, and shorten the schedule of delivering MCMs to protect the U.S. military, coalition forces, and the nation from the current COVID-19 pandemic. 2. The Government has determined that the need to accelerate COVID-19 development is of such an unusual and compelling urgency (FAR.6.302-2) that the Government has pursued a sole source procurement for the consultant services described above. The contract will have a Base Period of six (6) months duration, with the option to extend services in accordance with FAR 52.217-9 for a further six months.