Notice Number: NOT-AI-14-043
Release Date: April 8, 2014
National Institute of Allergy and Infectious Diseases (NIAID)
This is a Request for Information (RFI) only and does not constitute a commitment, implied or otherwise, that the Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), will take procurement action in this matter. This is NOT a solicitation for proposals, applications, proposal abstracts or quotations. The purpose of this RFI is to obtain knowledge and information to assess the current state of the science. Further, neither DHHS/NIH/NIAID nor the government will be responsible for any cost incurred in furnishing this information.
NIAID is seeking information from pharmaceutical product developers regarding their efforts toward the translational development of therapeutic compounds or lead series of compounds into clinical drug candidates that demonstrate activity in appropriate in vitro assays or in vivo models for the treatment of diseases on the NIAID Category A, B and C Priority Pathogens list (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Pages/CatA.aspx). More specifically, this RFI solicits information on activities being undertaken toward the iterative optimization of lead compounds to improve their physiochemical properties and down-select through such means as medicinal chemistry, structure activity relationship, synthetic route scouting and other methods to eventually nominate a clinical lead candidate.
Of particular interest are discovery and development efforts for broad-spectrum antibacterials with emphasis on targeting antimicrobial resistant strains, as well as broad-spectrum antivirals and small molecule antitoxins. The therapeutic agent may be active against pathogen-specific targets, or target pathways necessary for pathogenesis, including host factors and responses that contribute to disease progression.
Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), strives to understand, diagnose, 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 medical diagnostics, therapeutics and vaccines 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 biological agents that are most likely to be used in a terror attack on civilian populations. In August 2012 the NIAID held a workshop entitled “Bridging the Gap: Overcoming Bottlenecks in the Development of Therapeutics for Infectious Diseases.” This workshop brought together product development experts from industry, government, academia and the non-profit sector to identify and clarify challenges in the development of therapeutics for infectious diseases. One of the areas highlighted at the workshop was the importance of medicinal chemistry in early drug development, and the need to integrate chemistry and biology as well as computational and structural biology in early drug development. This request for information is intended to assess the current programs of the pharmaceutical development community that is engaged in translational development efforts.
Organizations are invited to submit a white paper describing their research efforts to identify and optimize lead therapeutic compounds against the pathogens on NIAID’s Category A, B and C Priority Pathogens list (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Pages/CatA.aspx). The paper paper can include but is not limited to:
a) the spectrum of anti-microbial activity and planned indication(s) for use;
b) the relevant chemical or physical chemical characteristics;
c) the pathogenic pathway or molecular target for the product targets or mechanism of action, if known;
d) the product’s proposed formulation, dosage and route of administration;
e) the overall stage of product development including the current status of preclinical and efficacy studies and description of the major activities being undertaken in terms of medicinal chemistry and other preclinical development pursuits in the translational development of lead compounds into clinical drug candidates.
Responses should be limited to 5 pages for any given therapeutic product, not including cover page, cover letter and table of contents. Submitted data and information will not be returned.
RFI response must include: 1) name and title of the primary point of contact for the response; 2) name and address of the institution or company; 3) e-mail address and phone number of the primary point of contact
RFI responses should be directed to the NIAID Division of Microbiology and Infectious Diseases, Office of Acquisitions, Contracting Officer, Mr. Sevag Kasparian, firstname.lastname@example.org by April 14, 2014.
This Notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this Notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.
Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. However, responses to this Notice will not be considered adequate responses to a solicitation.
Any proprietary information should be clearly identified as such and will be kept confidential as allowed by relevant federal law. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Responses to this RFI should only be submitted to the email address noted above in “Responses”.
Questions about this RFI may be directed to:
Mr. Sevag Kasparian
National Institute of Allergy and Infectious Diseases (NIAID)