RPP # | Description | Requiring Office | Submission Due Date | |
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Upcoming Opportunity | Prize Administration for Innovation in Clinical Manufacturing | BARDA anticipates requesting project proposals for a partner(s) that has the expertise to design, promote, and administer effective prize competitions. With this prize approach, BARDA aims to spur participation from a broad range of organizations, including nontraditional private partners, to develop technical solutions that thrive beyond prize award. The objective of the prize competitions would be to catalyze innovation in new manufacturing technologies that will improve access and enable faster, lower cost, rapid, and flexible production of medical countermeasures for health security threats. BARDA anticipates to support at least two prizes through the Prize Administrator selected through this Request for Project Proposals (RPP). The topics for those prizes are anticipated to be: (1) advance clinical testing of vaccines that leverage new GMP manufacturing approaches for single dose vaccines and (2) innovative approaches to improve the speed, yield, and scale up of non-vector/non nucleic acid-based vaccine manufacturing platforms (i.e., not RNA/DNA or viral-based) to enable rapid sequence-to-release of GMP clinical trial material in line with 100-day mission goals and Phase 1 testing. | Tentative Release Q2-Q3FY25 | |
Upcoming Opportunity | ASSURE | Announcing an upcoming opportunity to partner with BARDA to develop novel immune assays to be able to more broadly assess protective immunity after pathogen exposure and/or vaccine administration. BARDA seeks innovative, multiplexed, high-throughput, scalable and sample sparing assays that can help draw a more comprehensive picture of what constitutes a broad, durable and protective immune response. Beyond antibody titers, this new program will focus on developing assays that can inform on mucosal and cell-mediated immunity and improving sample collection and processing technologies compatible with novel and existing assays. To learn more, join us at the RRPV annual meeting on 8/26-8/27. | Q4FY25 (GMM) | |
Upcoming Opportunity: RFI | Rapid Antibody Production | Antibody development for emerging threat diagnostics is too slow. BARDA is developing a program concept that aims to address this critical bottleneck by funding the R&D and pilot testing of adaptable systems that can fast-track development, screening, and production of antibody or protein binders against biothreats and emerging infectious diseases for use in antigen-based diagnostic tests. The BARDA Diagnostics team will introduce the program concept and engage with consortium members at the 2025 RRPV General Membership Meeting and will subsequently release a request for information (RFI) through the RRPV. | Q4FY25 (GMM); Q1FY26 (RFI) | |
Upcoming Opportunity | Agnostic Diagnostics | The Agnostic Diagnostics program will solicit new metagenomic Next Generation Sequencing (mNGS) solutions that are capable of identifying known pathogens (within 8 hours from sample-to-answer is preferred). The mNGS device/platform should identify viral and bacterial pathogens utilizing a comprehensive, regulatory-grade database (e.g., detection/identification of all viral and bacterial pathogens in a respiratory specimen) that can quickly be adapted, in collaboration with the FDA, to detect new viral and bacterial pathogens, and initially including either influenza viruses with pandemic potential and other respiratory viral and bacterial pathogens, or Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) biothreats to include Bacillus anthracis (anthrax), Burkholderia mallei (glanders) and Burkholderia pseudomallei (melioidosis), filoviruses (Ebola virus disease and Marburg virus disease), Francisella tularensis (tularemia), Rickettsia prowazekii (epidemic typhus), Variola virus (smallpox; orthopox genus virus assays acceptable), and Yersinia pestis (plague). While mNGS technology has demonstrated the ability to detect and analyze a plethora of pathogen genomes, the translation of this technology into an FDA-cleared/approved diagnostic for the agnostic detection of any pathogen has met multiple challenges. Therefore, the overall goal of this program is to establish a foundational FDA-cleared mNGS testing capability for known pathogens (within 8 hours from sample-to-answer is preferred). Once this foundation is established, modifying the product to detect a new, novel pathogen can be achieved quickly during a public health emergency. |
RPP # (Date) | Requirement Topic | Closed Date |
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RPP-25-06-DxR2 | Biothreat Diagnostic Rapid Response | 8/4/2025 |
RPP-24-07-CentralIEIDLab (5/7/2025) | Central Influenza and Emerging Infectious Diseases Vaccine Immunoassay Laboratory Services | 5/30/2025 |
RPP-24-08-mRNALongTerm (08/30/2024) | Rapid Pandemic Influenza and Emerging Infectious Disease Vaccine Development and Response Capability | 2/28/2025 |
RPP-24-02-OralVx (09/09/2024) | NextGen Oral Formulation Vaccines for COVID-19 | 11/15/2024 |
RPP-24-02-ODM (08/13/2024) | On-Demand Manufacturing | 9/25/2024 |
RPP-24-03-SmMol (08/05/2024) | COVID-19 Small Molecule Therapeutics for PrEP | 9/20/2024 |
RPP-24-06-DxR2 (3/27/2024) | Biothreat Diagnostic Rapid Response | 5/17/2024 |
RPP-24-03-Treatment (02/21/2024) | Project NextGen: Therapeutics | 5/13/2024 |
RPP-24-05-NGClinMfg (01/16/2024) | Project NextGen: Innovation in Clinical Manufacturing of COVID-19 Vaccines | 04/19/2024 |
RPP-24-04-NGVxStats (2/23/2024) | NextGen Vaccines: Statistical Support, Correlates of Protection, and Meta-analysis | 03/27/2024 |
RPP-24-04-NGVxAssays (2/15/2024) | NextGen Vaccines: Immune Assays | 3/22/2024 |
RPP-24-02-Retail (2/2/2024) | Enabling Technology – Decentralized Clinical Trial – Retail/Pharmacy Focus | 03/20/2024 |
RPP-24-02-HomeFocus (11/30/2023) | Enabling Technology – Decentralized Clinical Trial – Home Focus | 01/19/2024 |
RPP-24-03-PrEP (11/30/2023) | COVID-19 Monoclonal Antibody Therapeutics for PrEP | 01/19/2024 |
RPP-24-04-NGVx (11/30/2023) | NextGen Vaccinations: Phase 2B Clinical Trial Execution | 01/10/2024 |
RPP-24-01-mRNA | Accelerating Near-Term Availability of mRNA-based Pandemic Influenza Vaccine | 12/4/2023 |