Development of Therapeutic Agents for Select Biodefense Pathogens

Added: Aug 29, 2008 2:04 pm "Novel Agents for Gram-Negative Biodefense Pathogens"

Added: Aug 29, 2008 1:48 pm "ST-246 Smallpox Antiviral: Expanded Utility and Additional Indications"

Added: Aug 29, 2008 12:54 pm "AVP-21D9 Anthrax Monoclonal Antibody"

Added: June 26, 2007 Introduction:The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious diseases. The NIAID Division of Microbiology and Infectious Diseases (DMID) has a requirement for the development of therapeutic agents for select biodefense pathogens.

Description:

Through this solicitation, the NIAID, is seeking to support projects to advance the development of promising candidate therapeutics with demonstrated in vivo activity against one or more of the following NIAID biodefense priority pathogens: Bacillus anthracis, Variola major, Filoviruses: Marburg and Ebola, Influenza, Gram negative biodefense bacteria. Note: NIAID seeks to support the development of broad spectrum antimicrobials with activity against more than one NIAID Category A, B, or C priority biodefense Gram negative pathogen, (e.g. Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B. mallei, Rickettsia prowazeki, Coxiella burnetti, Escherichia coli, Campylobacter jejuni). Antimicrobial resistant pathogens were recently added to the NIAID Category C priority biodefense pathogens list and are defined as pathogens, excluding sexually-transmitted organisms (see http://www3.niaid.nih.gov/biodefense/anti_stis.htm for list of excluded organisms), resistant to antimicrobial agents. Broad spectrum Gram negative candidate therapeutic agents proposed for advancement under this program should have demonstrated in vivo activity against at least one Gram negative Category A, B, or C pathogen; AND in vitro activity against at least three different genera of Gram negative Category A, B, or C pathogens.



The candidate therapeutic should be at a stage of development that is, at a minimum, within five (5) years of completion of a Phase 1 clinical trial. Support will be provided for non-clinical studies, medicinal chemistry, manufacturing, Phase 1 and Phase 2 clinical trials, and other Investigational New Drug (IND)-, New Drug Application (NDA)-, or Biologic License Application (BLA)-enabling studies. The NIAID is particularly interested in candidate therapeutics with broad spectrum activity and that are within the regulatory purview of the Center for Drug Evaluation and Review (CDER) of the U.S. Food and Drug Administration (FDA). Contracts awarded under this solicitation will not support: The design and conduct of Phase 3 clinical trials, the development of vaccines (vaccine is defined as an intervention that directly elicits a pathogen specific immune response), and the development of polyclonal antibody blood-derived products.



It is anticipated that one or more cost reimbursement, completion type contracts will be awarded for a five-year period of performance beginning on or about July 31, 2008. It is estimated that the provision of FTEs will be approximately 5 ? 8. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about July 11, 2007, and may be accessed through the NIAID Office of Acquisitions (OA) Home Page at http://www.niaid.nih.gov/contract and on FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26.