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 and immune-mediated diseases. The NIAID, Division of Microbiology and Infectious Diseases, has a requirement for advancing the development of new medical countermeasures against the biological agents that are most likely to be used in a terror attack on civilian populations.



The Pandemic and All-Hazards Preparedness Act (PAHPA) established the Biomedical Advanced Research and Development Authority (BARDA) in the Department of Health and Human Services (HHS) to facilitate the research, development, and acquisition of medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) agents and emerging infectious disease, including pandemic influenza, that threaten the U.S. civilian population. One of the central responsibilities of BARDA is to lead the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), which provides an integrated approach to the development, purchase and utilization of medical countermeasures for public health medical emergencies. The HHS PHEMCE consists of NIH, Assistant Secretary for Preparedness Response (ASPR), Food and Drug Administration (FDA), and Centers for Disease Control and Proevention (CDC), along with ex officio participation from other federal agencies. To guide progress toward the goal of public health preparedness, the HHS PHEMCE Implementation Plan for CBRN Threats (http://www.hhs.gov/aspr/barda/phemce/enterprise/strategy/index.html) provides insight into the current priorities for medical countermeasure development against advanced, enhanced, and emerging threats.





Description:



Through this solicitation NIAID and BARDA are partnering to support the development and evaluation of innovative technologies and platforms for the development of therapeutics with either single-pathogen or broad spectrum activity against select NIAID Category A, B and C (http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm) biothreat pathogens and toxins.



Homeland Security Presidential Directive (HSPD)-18 (www.whitehouse.gov/news/releases/2007/02/print/20070207-2.html) expands on the traditional classification of Category A, B, and C biological threats to include:

* Enhanced agents - traditional agents that have been modified or selected to enhance their ability to harm human populations or circumvent available countermeasures. (e.g. extensively drug-resistant Mycobacterium tuberculosis).

* Emerging agents - previously unrecognized pathogens that might be naturally occurring and represent a serious risk to human populations (e.g. Severe Acute Respiratory Syndrome Virus).

* Advanced agents - novel pathogens or other biological materials that have been artificially engineered in the laboratory to bypass traditional countermeasures or produce a more severe or otherwise enhanced spectrum of disease (e.g. multi-drug resistant Bacillus anthracis).



These designations highlight the fact that advanced, enhanced, and emerging threats are likely to be unanticipated and ill-defined in comparison to traditional threat agents. To more effectively address these lesser known and ill-defined threat agents and to encourage overall innovation in the product development process, NIAID and BARDA are supporting product development strategies that include:

* Development and Evaluation of treatments with broad spectrum activity.

* Development and evaluation of broad spectrum technologies.

* Development and evaluation of broad spectrum platforms.



Through this solicitation, NIAID and BARDA seek to support development of specific products in which one or more innovative broad spectrum technologies and/or platforms are proposed to be used and evaluated in the development of one of the following broad spectrum (e.g. inhibiting conserved, universal bacterial and/or viral targets) or narrow spectrum (single-agent) biodefense countermeasures:



Broad spectrum therapeutic:

* Broad spectrum anti-bacterial - therapeutic with activity against more than one genera of bacterial pathogen, including at least one of the following: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B. mallei, and Rickettsia prowazeki. Broad spectrum anti-bacterials that target other Category A, B and C bacterial threat agents will be considered on the basis of the overall innovation of the strategies proposed for their development.

* Broad spectrum anti-viral - therapeutic with activity against more than one genera of viral pathogen, including at least one of the following: Ebola virus, Marburg virus, Junin virus, Varioloa major, and influenza. Proposals for broad spectrum anti-virals that target other Category A, B and C viral threat agents will be considered on the basis of the overall innovation of the strategies proposed for their development.

* Broad spectrum anti-toxins - NIAID and BARDA are particularly interested in therapeutics with activity against multiple serotypes of botulinum neurotoxin. Proposals for broad spectrum anti-toxins that target other Category A, B and C toxins will be considered on the basis of the overall innovation of the strategies proposed for their development.

* Broad spectrum anti-disease - therapeutic directed at a host response that reduces morbidity and mortality from exposure/infection and is effective against more than one Category A, B or C priority threat agent.



Narrow spectrum or single-pathogen therapeutic:

* Treatment for Bacillus anthracis and multi-drug resistant Bacillus anthracis

* Post-exposure prophylactic for multi-drug resistant Bacillus anthracis

* Treatment and post-exposure prophylactic for Variola major

* Treatment and post-exposure prophylactic for Marburg virus

* Treatment and post-exposure prophylactic for Ebola virus

* Treatment and post-exposure prophylactic for Influenza

* Treatment for dengue virus



Proposals will be evaluated based on the following technical evaluation criteria:

* The potential of the proposed broad spectrum technology or platform to advance the product development process for the proposed therapeutic candidate/product or lead series, and contribute overall to ''state-of-the-art'' drug development technologies.

* The suitability of the proposed therapeutic candidate/product or lead series for further development.

* The soundness and feasibility of the Strategic Staged Product Development Plan for advancing the therapeutic candidate/product toward a licensed product for the proposed indication within the requested period of funding.

* The adequacy of the Statement of Work to describe the necessary activities, services, personnel, materials, equipment and facilities to be provided by the Offeror and any proposed subcontractors to perform the proposed Work Plan.

* Qualifications and availability of proposed personnel.

* Availability and adequacy/suitability of facilities, equipment, and other resources to effectively and safely perform all phases of the proposed project.

* Adequacy of the Project Management Plan in terms of staffing, organization, responsibilities, leadership and lines of authority.



It is anticipated that multiple cost reimbursement, completion type contracts will be awarded for a five-year period of performance beginning on or about May 15, 2009. It is estimated that the provision of FTEs will be approximately 5-8 FTEs.



Any responsible offeror may submit a proposal which will be considered by the Agency. This BAA will be available electronically on/about February 15, 2008, and may be accessed through 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.