RFI – Advance Development of Broad Spectrum Countermeasures

The Department of Defense seeks to identify candidate medical countermeasures and supporting technologies for the Emerging Infectious Diseases Therapeutics (EID Tx) program.

The EID Tx program is seeking to develop Food and Drug Administration (FDA)-approved broad spectrum medical countermeasure (MCM) for protection against naturally occurring or biologically engineered viruses.

If an MCM candidate meets only some or portion of the criteria, or otherwise has capabilities not specifically called out by the criteria as stated in Purposes and Objectives (A through L) below, EID Tx still strongly encourages a response to this RFI so that a more complete understanding of the state-of-the-art may be obtained.

Respondents are asked to provide information on:

  • Efficacy data against any virus (non-human primates, other species, in vitro)
  • Route of administration (oral, intramuscular, inhalation, other)
  • Clinical trials completed for any indication or Investigational New Drug (IND)
  • Shelf life of drug product in years supported by cGMP stability studies
  • Number and type of pharmacologically relevant animal models in agents targeted
  • Storage requirements as demonstrated by cGMP studies (room temperature, refrigerated, frozen)
  • Number of treatment courses produced in a single manufacturing run
  • Estimated cost per treatment course
  • Therapeutic index in species in which efficacy testing for virus was carried out
  • Estimated number of months before New Drug Application (NDA) for any indication
  • Estimated number of months until IND can be submitted for any virus indication
  • Any associated intellectual property rights or patent coverage

The effort is managed by the Joint Product Manager Biological Defense-Therapeutics (JPdM BD-Tx), part of the Joint Project Manager Medical Countermeasures Systems (JPM-MCS), which is part of the Joint Program Executive Office for Chemical and Biological Defense.

Further details are available under Solicitaion Number: HDTRA1-14-JPM-0001. The response deadline is May 5, 2014.

Biodetection Technology Guide 2014 Available

Biodefense Headlines – April 13, 2014