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Development of Therapeutics Medical Countermeasures for Biodefense and Emerging Infectious Diseases

Solicitation Number: BAA-NIAID-DMID-NIHAI2012149
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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BAA-NIAID-DMID-NIHAI2012149
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Combined Synopsis/Solicitation
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Added: Jul 17, 2012 5:38 pm
Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strive to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents, with the exception of the human immunodeficiency virus (HIV). This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which are funded through a variety of research grants and contracts. The NIAID also has a mission to advance the development of new medical countermeasures (MCM) against the biological agents that are most likely to be used in a terror attack on civilian populations.

The NIAID has been conducting and supporting much of the research and development for biodefense with defined research priority and agenda against select Category A, B, and C biothreat agents.

The current NIAID's Strategic Plan for Biodefense Research establishes a strategy for developing new and improved medical countermeasures against a broad array of biological threats, emerging and re-merging infectious diseases, including pathogens and toxins. The NIAID's plan supports the national biodefense strategy and reflects the Institute's partnerships with the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and Department of Homeland Security.

The HHS PHEMCE coordinates interagency effort aiming to optimize our preparedness for public health emergencies with respect to the creation, stockpiling, and use of medical countermeasures. Led by the Assistant Secretary for Preparedness Response (ASPR), HHS, PHEMCE consists of NIH, Food and Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC), along with ex officio participation from other federal agencies. PHEMCE Implementation Plan for Threats Chemical, Biological, Radiological, and Nuclear (CBRN) sets the current priorities for medical countermeasure development against advanced, enhanced, and emerging threats and advanced agents.

The NIAID is interested in supporting the development of promising biodefense therapeutic and prophylactic (vaccine) candidates/products with the eventual goal of stockpiling these medical countermeasures and associated technologies to protect the American public.

The objective of this solicitation is to support the development of candidate therapeutic products for use in post-event settings following the intentional release of the NIAID Category A, B, and C biothreat agents or in response to naturally occurring outbreaks of infectious diseases caused by the NIAID Category A, B, and C pathogens. Only agents identified as the NIAID Category A, B and C Priority Pathogens are eligible as proposed candidates/products for this solicitation.

This Broad Agency Announcement (BAA) specifically focuses on supporting the development of promising biodefense therapeutic candidates/products with broad spectrum therapeutic activity against viruses or bacterial pathogens. This solicitation also focuses on supporting development of promising anti-toxins as biodefense therapeutic candidates/products, particularly small molecule therapeutics with anti-toxin activity. The research and development activities supported through this BAA will allow candidate therapeutic countermeasures to progress through the product development pipeline toward licensure by the FDA.

Broad spectrum activity is a characteristic that enables a particular product to mitigate biological threats across a wide range or class of agents. There are a number of traditional threats for which effective treatments are either non-existent, of limited usefulness, or vulnerable to both naturally emerging and intentionally engineered antibacterial and antiviral resistance. A limited number of anti-infectives with broad spectrum activity directed at common, invariable, and essential components of different classes of microbes could potentially be effective against both traditional and non-traditional threats. This approach would allow a small number of drugs to replace dozens of pathogen-specific drugs for emergency use. Additionally, strategies to overcome bacterial and viral drug resistance could extend the clinical utility of existing broad spectrum anti-infectives and have immediate benefits. Moreover, broad spectrum treatments directed towards host targets or human immunological responses to infection have the potential to be effective against one or more diseases. For instance, targeting host receptors and cellular processes to treat infections can directly prevent or treat diseases. As well, targeting immune response mechanisms may be an effective way to reduce morbidity and mortality by controlling the host responses that contribute to disease or by non-specifically activating the host's natural immune defenses to induce a faster, more potent protective response. These approaches could provide clinical utility when used alone or in combination with conventional anti-infectives.

For the purposes of this BAA, the ideal "promising" broad spectrum therapeutic candidate is defined as a single agent that meets the following three criteria/definitions:

a) A drug (synthetic or natural product) or a biological product (e.g. monoclonal antibody or a recombinant protein) intended for use in the cure, mitigation, or treatment; AND

b) A single agent with demonstrated activity in appropriate in vitro assays and in vivo models against more than one selected bacterial or viral pathogen ; AND


c) An agent that either has completed or will have completed evaluation in a Phase 1 clinical trial within the 5-year contract period of performance. Phase 1 clinical trial completion is defined as completion of a Final Clinical Study Report following International Conference on Harmonization (ICH) Guidelines on Structure and Content of Clinical Study Reports E3.

Toxins are poisonous substances, especially protein, produced by living cells or organisms that are capable of causing or exacerbating disease when introduced into the body tissues. While bacteria that produce toxins may often be eliminated by the use of antibiotics during an infection, disease may still occur or may progress because of the presence of toxins produced by the pathogen. In addition, toxins may be isolated and themselves be introduced into body tissues and thereby cause disease and death, as in the case of ricin. Treatments are needed to target specific toxins in order to cure or mitigate disease caused by those toxins.

For the purposes of this BAA, the ideal "promising" anti-toxin therapeutic candidate is a single agent, preferably a small molecule, meeting the following criteria/definitions:
a) An agent intended for use in the cure, mitigation or treatment; AND
b) An agent that has demonstrated activity against a specific toxin in an in vivo model of disease; AND
c) An agent that either has completed or will have completed evaluation in a Phase 1 clinical trial within the 5-year contract period of performance. Phase 1 clinical trial completion is defined as completion of a Final Clinical Study Report following International Conference on Harmonization (ICH) Guidelines on Structure and Content of Clinical Study Reports E3.


Broad spectrum therapeutics supported under this BAA are specified as the following classes:

• Broad spectrum anti-bacterial: Therapeutic with activity against one of the following bacterial pathogens: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B. mallei, and Rickettsia prowazekii AND in addition, activity against one other NIAID Category A, B and C bacterial threat agent.


• Broad spectrum anti-viral: Therapeutic with activity against one of the following viral pathogens: Ebola virus, Marburg virus, Variola major, Dengue virus, Venezuelan encephalitis virus, Western Equine encephalitis virus, Eastern Equine encephalitis virus and human influenza virus AND, in addition, activity against one other NIAID Category A, B and C viral threat agent.


• Host-directed broad spectrum therapeutic: Therapeutic directed at a host response thereby reduces morbidity and mortality from exposure/infection and is effective against one of the following bacterial and viral pathogens: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B. mallei, Rickettsia prowazeki, Ebola virus, Marburg virus, Variola major, Dengue virus, Venezuelan Encephalitis virus, Western Equine Encephalitis virus, Eastern Equine Encephalitis virus and human influenza virus AND, in addition, is effective against one other NIAID Category A, B and C bacterial or viral threat.


Anti-toxins supported under this BAA are specified as the following:
• A therapeutic agent, particularly a small molecule, with activity against one of the following toxins: Botulinum neurotoxin, Staphylococcus enterotoxin B, Bacillus anthracis Protective Antigen, Lethal Factor or Edema Factor, and ricin toxin.


Offerors are encouraged to apply state-of-art and innovative technological approaches and platforms in the development of the proposed candidates. State-of-art and innovative technological approaches refer to capabilities, such as temperature stabilization or delivery method, that can be engineered into a wide array of existing and candidate products to enhance the product performance. Technological platforms, on the other hand, are standardized methods that can be used to significantly reduce the time and cost required to bring medical countermeasures to licensure.
Contracts awarded under this BAA will not support:
• Basic research and discovery of new candidates/products.
• Refinement of a lead series to identify a lead candidate.
• Development of devices or diagnostics.
• Development of candidates/products that have not demonstrated activity in a relevant animal model of disease.

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Broad Agency Announcement

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
Broad Agency Announcement
Posted Date:
July 17, 2012
Description: Broad Agency Announcement
:
Office of Acquisitions
6700 B Rockledge Room 3214 MSC7612
Bethesda, Maryland 20892-7612
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Kathy Fetterman,
Contract Specialist
Phone: 301-496-0612
Fax: 301-480-4675
:
Charles Jackson,
Contracting Officer
Phone: 301-451-3686
Fax: 301-480-4675