Infections by Ebola (EBOV), Sudan (SUDV), and Marburg (MARV) viruses result in a highly lethal Viral Hemorrhagic Fever (VHF) with mortality ranging from 25-90 percent depending on the outbreak and the virus species by which it was caused. The 2014-2016 EBOV epidemic in West Africa highlighted the threat filoviruses pose to public health, with greater than 28,000 confirmed cases and more than 11,300 deaths. The United States Government (USG) has supported numerous responses to naturally occurring outbreaks of EBOV and MARV and additionally these agents pose a threat to national security if purposely released as a biological weapon. Procurement of filovirus therapeutics is urgently needed to enable the USG’s preparedness and response to public health emergencies and to mitigate the threat of biological attacks.

In  order  to  address this unmet need,  the  Office  of  the  Biomedical  Advanced  Research  and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use Project BioShield (PBS) to support the late-stage development and procurement of therapeutics against EBOV, SUDV, or MARV. The  procured   therapeutics will either be delivered to the ASPR/Strategic National Stockpile or maintained as  vendor  managed  inventory.  The  USG  seeks therapeutics  that     meet  the     following     mandatory      criteria:

1)      The      Offeror must   have submitted    an   investigational    new    drug    (IND)   application    related    to   the  intended operational  use  of  a  product  as  a   filovirus   therapeutic;   and  

2)   The Offeror  must have   documented   FDA concurrence on the proposed regulatory path leading   to approval of the product as a filovirus therapeutic.