Development of Therapeutic Products for Biodefense and Emerging Infectious Diseases

Purpose 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. The NIAID is seeking information regarding efforts toward the development of therapeutic products 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 development of therapeutic candidates/products, which have 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. Candidate products of interest are those with broad spectrum therapeutic activity against viruses or bacterial pathogens and promising anti-toxins as therapeutic products. Background 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 known 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 as well as emerging and re-emerging infectious diseases such as MERS, Ebola Virus Disease, antibiotic resistant bacterial infections and pandemic influenza. Information requested Organizations are invited to submit a white paper describing their research efforts to develop therapeutic compounds as defined below: Products with in vitro and in vivo activity against two or more of the follow bacterial pathogens: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B. mallei, Rickettsia prowazekii and including urgent, serious and concerning drug-resistant bacterial threats as outlined by the CDC. http://www.cdc.gov/drugresistance/biggest_threats.html Products with in vitro and in vivo activity against two or more of the following viral pathogens: Ebola virus, Marburg virus, Variola major, Dengue virus, Chikungunya virus, MERS Coronavirus, and Influenza virus, including activity against discrete strains, species or serotypes within a virus genus. Products with in vitro or in vivo activity against ricin toxin. The paper should include but is not limited to: a) the spectrum of anti-microbial activity and planned indication(s) for use; b) the relevant therapeutic product 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 preclinical development activities being undertaken in terms of advancing product to IND and Phase 1 clinical studies. Responses should be limited to 5 pages for any given therapeutic product, not including the cover page, cover letter and table of contents. Submitted data and information will not be returned. RFI responses 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. Responses are due by March 13, 2015. Disclaimer and Important Notes 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. Confidentiality 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). Inquiries & Responses Inquiries and RFI Responses should be directed to the NIAID Division of Microbiology & Infectious Diseases, Office of Acquisitions, Point of Contact (POC): Alexandra J. Buck, at alexandra.buck@nih.gov. The alternate POC is George W. Kennedy, at kennedyg@niaid.nih.gov.