Notice Number: NOT-AI-15-048
Key Dates
Release Date: July 17, 2015
None
Issued by
National Institute of Allergy and Infectious Diseases (NIAID)
Purpose
Background
Research supported and conducted by the National Institute of Allergy & Infectious Diseases, NIAID, National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat and ultimately prevent the myriad of 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. 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 as well as emerging and re-emerging infectious diseases such as MERS, Ebola Virus Disease, antibiotic resistant bacterial infections and pandemic influenza.
NIAID has been conducting and supporting much of the research and development for biodefense, targeting multiple pathogens, including NIAID Category A, B, and C priority pathogens (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Pages/CatA.aspx). This solicitation aims to further advance the translation of promising therapeutic products against priority pathogens and emerging infectious diseases.
These efforts are guided by the current NIAID Strategic Plan for Biodefense Research (http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/pages/strategicplan.aspx), which established a strategy for developing new and improved medical countermeasures against a broad array of emerging and re-emerging infectious diseases including NIAID Category A, B and C Priority Pathogens. NIAID’s plan 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 efforts 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 and Response (ASPR), HHS, PHEMCE consists of the NIH, Food and Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC), and senior leadership from other federal agencies. The PHEMCE Implementation Plan (http://www.phe.gov/Preparedness/mcm/phemce/Pages/strategy.aspx) describes the current priorities for medical countermeasure development against advanced, enhanced, or emerging threats.
Furthermore, an Executive Order released by the President of the United States in 2014 (http://www.whitehouse.gov/the-press-office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria) and the related National Strategy to Combat Antibiotic-Resistant Bacteria (http://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf) highlight one of the most urgent public health threats facing us today antibiotic resistance and encourage the development of new and next-generation antibiotics, among other goals. The goals of this solicitation also reflect the intent of this new guidance.
Technical Objectives
The objective of this solicitation is the development of therapeutic products for use in post-event settings following the intentional release of a NIAID Category A, B, or C Priority Pathogen or in response to naturally occurring outbreaks of infectious diseases caused by the NIAID Category A, B, and C Priority Pathogens. Only agents identified as NIAID Category A, B and C Priority Pathogens are eligible as proposed candidates/products for this solicitation.
Organizations responding to this BAA must have documented expertise in drug discovery and development, including demonstrated knowledge of regulatory guidelines and submission processes for candidate products directed against biological threats identified as NIAID Category A, B and C Priority Pathogens or 2012 HHS PHEMCE Strategy and Implementation Plan (http://www.phe.gov/Preparedness/mcm/phemce/Pages/strategy.aspx) and shall complete and submit the Summary of Related Activities form from the following website: http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf.
This BAA solicitation focuses on the development of promising lead therapeutic candidates/products. For the purposes of this BAA, a lead candidate has demonstrated feasibility of manufacturing, in vitro and in vivo evidence of efficacy, and sufficient characterization to allow the development of a draft target product profile.
One category of products being solicited are those with broad spectrum therapeutic activity against viruses or bacterial pathogens. This solicitation also focuses on supporting development of promising anti-toxins as 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 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, or directed at host functions that are required by 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 have the potential to be effective against one or more diseases. For these reasons, proposals on the non-traditional therapeutics are encouraged provided they have demonstrated therapeutic activity when used alone or in combination with an existing licensed product. Therapeutic activity is defined as the cure or mitigation of disease once signs and symptoms of infection are evident.
For the purposes of this BAA, the ideal broad spectrum therapeutic candidate is defined as a single agent that meets all three of the following criteria:
- A drug (synthetic or natural product) or a biological product (e.g. monoclonal antibodies, recombinant proteins) intended for use in the cure, mitigation, or treatment of two or more bacterial or viral pathogens; AND
- An agent with demonstrated in vivo activity in an appropriate therapeutic model of disease; AND
- An agent that will complete evaluation in a Phase 1 clinical trial within the 5-year proposed 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 (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf).
Toxins are poisonous substances 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 anti-toxin therapeutic candidate is a single agent, preferably a small molecule, meeting the following criteria/definitions:
- An agent intended for use in the cure, mitigation or treatment of intoxication; AND
- An agent that has demonstrated activity against a specific toxin in an in vivo model of disease; AND
- An agent that will complete evaluation in a Phase 1 clinical trial within the 5-year proposed 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 (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf).
Therapeutics targeted under this BAA are specified as the following:
- 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 in addition, activity against one other NIAID Category A, B or C bacterial threat agent.
- Antibacterial therapeutic with activity against two or more of the urgent, serious, and concerning drug-resistant bacterial threats listed in the 2013 CDC Antibiotic Resistance Threats in the United States report (http://www.cdc.gov/drugresistance/biggest_threats.html).
- Broad spectrum anti-viral:
- Therapeutic with activity against one of the following viral pathogens: Ebola virus, Marburg virus, Orthopox viruses representative of Variola major, Dengue virus, MERS-CoV, Chikungunya virus AND, in addition, activity against one other NIAID Category A, B or C viral threat agent including activity against discrete strains, species or serotypes within a virus genus.
- Therapeutic active against multiple influenza subtypes directed at either viral or host targets.
- Anti-toxins:
- A therapeutic agent, preferably 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.
Contracts awarded under this BAA will not target:
- Basic research and discovery of new candidates/products
- Refinement of a lead series to identify a candidate
- Development of devices, topical products, prophylactic products, or diagnostics
- Development of candidates/products that have not demonstrated therapeutic activity in a relevant animal model of disease
- Development of serum-derived products
- Development of licensed products as new formulations or for additional clinical indications
Offers submitted in response to this BAA must present detailed technical and business proposals designed to meet the Research and Technical Objectives described herein. The Statement of Work (SOW), including the specific technical requirements and performance specifications, shall be developed and proposed by the Offeror, not the Government. Since they are not submitted in accordance with a common SOW issued by the Government, proposals are NOT evaluated against each other. Instead, Research and Technical Objectives are provided in the BAA that describes the research areas in which the Government is interested. Proposals received in response to the BAA will be evaluated in accordance with Evaluation Factors for Award specified in Section VIII of this document.
Multiple awards are anticipated. The amount of resources made available under this BAA will depend on the quality of the proposals received and the availability of funds. The Government reserves the right to select for negotiation all, some, one, or none of the proposals received in response to this BAA, and to make awards without discussions with Offerors. The Government also reserves the right to conduct discussions, if it is later determined to be necessary. Additionally, the Government reserves the right to accept proposals in their entirety or to select only portions of proposals for award.
In the event NIAID desires to award only portions of a proposal, negotiations may be opened with that Offeror. The Government reserves the right to fund proposals in phases with options for continued work at the end of one or more of the phases.
NIAID estimates that two or more awards may be issued for a total cost (direct and indirect costs combined) of up to $15.3 million in Fiscal Year 2016 for all awards during the first non-severable phase.
Awards are expected to be made on or about June 1, 2016. It is anticipated that the total costs for each award may vary depending upon the scope and capacity of the technical objectives of the award. The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. The total period of performance comprised of a base period and options proposed by an Offeror should not exceed five (5) years.
Inquiries
Please direct all inquiries to:
Primary Point of Contact
Ms. Alexandra J. Buck
Contract Specialist
National Institute of Allergy and Infectious Diseases (NIAID)
Email: alexandra.buck@nih.gov
Secondary/Alternate Point of Contact
Mr. George W. Kennedy
Contracting Officer
National Institute of Allergy & Infectious Diseases (NIAID)
Email: kennedyg@mail.nih.gov
and Human Services (HHS)
