Cellular Therapies and related products to treat Acute Radiation Syndrome

The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads the nation in preventing, preparing for, responding to, and recovering from the adverse health effects of emergencies and disasters by supporting our communities' ability to withstand adversity, strengthening our health and response systems, and enhancing national health security. The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and procurement of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA supports the advanced research, development, and procurement of medical countermeasures (MCMs) against a variety of Chemical, Biological, Radiological and Nuclear (CBRN) threats and in recent years has significantly expanded its investment in therapeutics for radiation exposure. Current BARDA initiatives include the development of MCMs to mitigate systemic injuries caused by exposure to ionizing radiation. Ionizing radiation exerts the greatest effect on rapidly dividing cells, such as those of the bone marrow and the gastrointestinal epithelium. Recent advances have led to the licensure of cytokines to mitigate the resultant neutropenic component of radiation-induced hematopoietic injury. However, it is anticipated that a portion of the patients who become neutropenic will be unresponsive to cytokine therapy leaving these patients susceptible to infection and possible death. Cellular therapies provide a possible treatment option to support the patient's immune system until it has fully recovered from radiation exposure (~21 days). Additionally, ionizing radiation damages endothelial cells and damage to the vascular endothelium likely contributes to the development of systemic and organ specific injury in response to radiation. Cellular therapies may provide the structural, anti-inflammatory and/or signaling components necessary to allow for healing and recovery of the vascular endothelium. Potential cellular therapies for radiation injury include, but are not limited to, embryonic stem cells (ESCs), mesenchymal stem cells (MSCs), progenitor cells, and induced pluripotent stem cells isolated from various tissues such as: bone marrow, adipose tissue, placenta, amniotic fluid, cord blood and vascular endothelium. Products that improve homing, engraftment, safety, and/or efficacy of cellular therapies are also of interest. This RFI is for planning purposes only and is issued in accordance with FAR Clause 52.215-3. No solicitation document exists at this time. The information provided in the RFI is subject to change and is not binding on the Government. Issuance of this notice does not constitute any obligation on the part of the Government to procure the supplies or to issue a solicitation. In addition, the Government is under no obligation to pay direct or indirect costs or charges that arise as a result of Responder submission of responses to this RFI or the Government's use of such information. Responses to this notice cannot be accepted as offers. The Government reserves the right to reject, in whole or in part, any Contractor's input resulting from this RFI. No contract will be awarded from this announcement. ASPR/BARDA has not made a commitment to contract any products or services, and release of this RFI should not be construed as a commitment or as authorization to incur cost for which reimbursement would be required or sought. All submissions become Government property and will not be returned. Any information that the vendor considers proprietary should be clearly marked as such. Information is being requested in order to make potential future requirements better for industry and the Government. PLEASE SEE ATTACHMENT FOR ADDITIONAL DETAILS.