The Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), is issuing this Request for Information (RFI) to collect feedback from current and potential biopharmaceutical partners. Information collected from this RFI will serve as continued market research for a possible program where BARDA would partner with organizations to validate immunological assays for a filovirus vaccine program and utilize Master Files with the Food & Drug Administration (FDA) to leverage data across vaccine programs. Background: Within the United States Government (USG), HHS/ASPR/BARDA is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures to treat the adverse health effects resulting from intentional exposure to biological agents, including natural exposure(s) to pandemic influenza, SARS-CoV-2, and other emerging infectious diseases. In 2003 the Department of Homeland Security (DHS) identified hemorrhagic fever viruses as a class A Material Threat to the population of the United States (US). Among the viruses in this class are the filovirus family, a class of filamentous RNA viruses including the Zaire ebolavirus (EBOV), Sudan ebolavirus (SUDV), and Marburg virus (MARV) responsible for sporadic limited outbreaks with a high mortality rate and no treatment for MARV or SUDV except for palliative care. While major advances have been made in medical countermeasures against EBOV in the context of the recent outbreaks, medical countermeasures (MCM) against MARV and SUDV are much further behind. In the absence of a predictable or large outbreak, we expect any MCM against MARV or SUDV will require non-traditional regulatory pathways for approval, such as the FDA Animal Rule. Application of the Animal Rule requires 1) a reasonably well-understood mechanism of pathogenesis and its prevention or substantial reduction by the countermeasure, 2) demonstration of the effect of the countermeasure in one or more animal species sufficiently well characterized to predict the response in humans, 3) the animal study endpoint to be clearly related to the desired benefit in humans, and 4) sufficient data to select an efficacious dose in humans. As a result, there is an urgent need for optimized and qualified assays and reagents to support immunological analyses in both clinical and nonclinical studies. The subject of this RFI covers assays to measure the immunological responses including the anti-GP ELISA and pseudovirion neutralization assay for both MARV (Angola) and SUDV (Gulu). Description: BARDA is issuing this RFI to assist in understanding the developmental landscape of assays and reagents to support development of MCMs to combat infection with MARV and SUDV and to submit and maintain a Type V Master File with the FDA to support MCM development through the Animal Rule. BARDA is particularly interested in the developmental landscape of pan-primate anti-GP ELISAs, pseudo-virus neutralization assays, and associated reagents for MARV and SUDV. Respondents are asked to provide the following information (Note: respondents do not have to have information on all assays below in order to respond): Current status of ELISA and pseudovirion neutralization assays (developed, qualified, or validated for human and/or nonhuman primate samples) and critical reagents, including description of sources of rGP stocks. Short description of plans to qualify and validate a pseudovirion neutralization assay for MARV. A similar description should be provided for a pseudovirion neutralization assay for SUDV, if different. Short description of plans to qualify and validate a pan-primate MARV anti-GP ELISA. A similar description should be provided for an SUDV anti-GP ELISA, if different. Current status of cell mediated immune response assays i.e. ELISpot and ICS. Status of freedom to operate with the assays, or short description of any intellectual property constraints, for any assays noted above. Status of electronic Common Technical Document (eCTD) publishing capabilities. Technical documents (i.e., development, qualification, and validation reports) must be in formats compliant with technical specifications supporting regulatory submissions to FDA. eCTD regulatory submissions must comply with PDF Technical Specifications (v4.1) referenced in the Guidance for Industry Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications . Responses should be limited to 10 pages (or less) and shall be sent electronically to
[email protected]. Responses are due no later than 12pm Thursday May 19, 2022 US EDT. THIS INFORMATION IS REQUESTED FOR INFORMATION GATHERING PURPOSES ONLY. The information provided in the RFI is subject to change and is not binding on the Government. BARDA has not made a commitment to procure any of the services discussed, and release of this RFI should not be construed as such a commitment or as authorization to incur cost for which reimbursement would be required or sought. All submissions become Government property and will not be returned. Please note that contractors performing advisory and assistance services that support BARDA will have access to any submission under this RFI. Please do not include proprietary information in response to this RFI.