Request for Information (RFI): Development of Broad-Spectrum Therapeutic Countermeasures Effective against Viral Threat Agents


Notice Number: NOT-AI-12-009

Key Dates

Release Date:  September 14, 2011
Response Response Receipt Date: Date:   November 13, 2011

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

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.

NIAID is seeking information from pharmaceutical and biopharmaceutical product developers on broad spectrum anti-viral agents with therapeutic activity against more than one of the of the following viral pathogens: Ebola virus, Marburg virus, Junin virus, Variola major, Dengue virus, Venezuelan encephalitis virus, Western Equine encephalitis virus, Eastern Equine encephalitis virus, or other NIAID Category A, B and C viral threat agents.  In addition, NIAID is seeking information on new antiviral drugs and compounds for the treatment and/or post-exposure prophylaxis of epidemic or pandemic influenza infection.  The therapeutic agent may be active against virus-specific targets, or target pathways necessary for viral pathogenesis, including host factors and responses that contribute to disease progression.

Background:

The NIAID has been conducting and supporting research and development for biodefense with a defined research priority against select Category A, B, and C bio-threat agents. The NIAID’s Strategic Plan for Biodefense Research establishes a broad-spectrum strategy to develop new and improved medical countermeasures that are effective against an array of biological threats, and emerging and re-emerging infectious diseases. NIAID’s plan supports the national biodefense strategy and reflects the Institute’s partnerships to develop countermeasures in tandem with HHS’ Biomedical Advanced Research and Development Authority (BARDA) via the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and Department of Homeland Security. This request for information specifically focuses on examining the “state of the science” in the field of biodefense therapeutic products with broad-spectrum activity against viral agents.  

Information requested:

Organizations are invited to submit a white paper describing their research efforts involving broad-spectrum therapeutic products active against more than one viral threat agent or against influenza viruses. The paper should describe their product in terms of: a) the planned indications for use; b) the product’s relevant chemical, physical chemical or immunological characteristics; c) product’s mechanism of action; d) the product’s proposed formulation, dosage and route of administration; e) a statement of the proposed production process and the current state of validation or GMP compliance; h) the overall stage of product development including the current status of preclinical and clinical safety and efficacy studies. Responses should be limited to 5 pages for any given therapeutic product, not including cover page, cover letter and table of contents. Any proprietary information should be clearly identified as such and will be kept confidential as allowed by relevant federal law.  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) Email address and phone number of the primary point of contact. Responses are due by November 13, 2011.

Inquiries

Please direct all inquiries to:

Inquiries and RFI responses should be directed to the NIAID Division of Microbiology and Infectious Diseases, Office of Biodefense Research Affairs at: NIAIDCOUNTERMEASURESRFI@niaid.nih.gov.


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