Purpose
The Biomedical Advanced Research and Development Authority (BARDA), under the Administration for Strategic Preparedness and Response (ASPR) has issued a Sources Sought Notice (SSN). The subject of this SSN is Marburg virus (MARV) and Sudan virus (SUDV) vaccines in active or completed Phase 2 clinical trials. Insights on current and prospective MARV and SUDV vaccine development partners resulting from this SSN will support BARDA’s ongoing market research for potential future acquisitions and programs. BARDA seeks information on qualifications, experience, and capabilities from both Small Businesses (SB) and Other than Small Businesses (OTSB).
Important Deadlines
Responses are due no later than 18 November 2024 by 3PM US EDT.
Requested Information
In 5 pages or less, respondents should provide the following information in separate sections for each virus (up to 10 pages if information for both viruses is provided):
- Overview of the vaccine candidate in active Phase 2 Trial
- Viral antigen target
- Antigen delivery construct
- Adjuvant (if used)
- Number of doses required to achieve protection
- Protection onset
- Target product profile
- Overview of clinical development
- Phase 1 trial(s)
- Trial design, endpoints, and enrollment target summary
- Summary of safety and immunogenicity data
- Phase 2 trial(s)
- Summary of trial design and endpoints
- Dates of enrollment and completion (or anticipated completion date)
- Immunogenicity assay validation status
- Supporting assay status
- Phase 1 trial(s)
- Overview of nonclinical studies and status
- Summary of NHP efficacy and immunogenicity data
- Manufacturing
- Product characterization – current status and plan summary with anticipated timelines
- Summary of stability data for drug substance and drug product
- Summary of demonstrated and planned manufacturing scale
- Status of contract manufacturing organization, with information about location and summary of approach to onshore manufacturing (if applicable)
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