The Biomedical Advanced Research and Development Authority (BARDA) has released an essential Request for Project Proposals (RPP) aimed at the preparation for and response to public health emergencies through On-Demand Manufacturing. The RPP, numbered 24-02-ODM, focuses advancing manufacturing technologies that will improve access and enable faster, cheaper, more rapid, and flexible production of vaccines and other biologics.
Key Information and Deadlines
The RPP was officially issued on August 13, 2024, with a firm proposal submission deadline set for 1 PM Eastern on September 25, 2024. Applicants seeking to clarify technical details or any aspect of the proposal requirements must submit their questions by August 30, 2024, to ensure a timely response from the government.
Project Scope and Objectives
The primary aim of this RPP is to revolutionize the way medical countermeasures are produced, moving away from centralized large-scale manufacturing to a more decentralized, flexible, and rapid production model. This shift addresses several critical challenges in the current manufacturing landscape, such as supply chain disruptions, bottlenecks, and the inability to quickly adapt to new threats.
The On-Demand Manufacturing (ODM) Program is structured into three sequential phases, each focused on advancing the development and readiness of innovative manufacturing solutions for medical countermeasures. Offerors may begin at either Phase 1 or Phase 2, with the opportunity to propose work for the subsequent phase. The program aims to develop and optimize decentralized manufacturing technologies, with each phase building on the previous one to ensure the feasibility and scalability of the proposed solutions. Key elements of the strategy include:
- Phase 1: Engineering & Prototyping – Develop early-stage technologies or processes that are not yet integrated into a complete manufacturing system, focusing on aligning with the Target Platform Profile (TPP). Infrastructure Maintenance: Ensuring that physical manufacturing facilities remain in good working order and compliant with health and safety regulations.
- Phase 2: Integration & Proof-of-Concept (POC) Run in Non-GMP Conditions – Integrate and demonstrate an end-to-end manufacturing system through a proof-of-concept run under non-GMP conditions, while planning for system optimization.
- Phase 3: Optimization & Initial Small Quantity Production Run – Optimize the manufacturing system and conduct a small-scale production run to validate feasibility, scalability, and meet Chemistry, Manufacturing, and Controls (CMC) objectives.
Eligibility and Proposal Requirements
Respondents to this RPP are expected to be members of the Rapid Response Partnership Vehicle Consortium (RRPV-Consortium) at the time of their proposal submission.
Abstracts on the following topics will be considered out of scope and removed from consideration:
- Development and optimization of novel devices or formulations for therapeutic/vaccine delivery.
- Preclinical development or clinical evaluation of therapeutic/vaccine candidates.
- Development of manufacturing technologies or systems targeted toward disease indications that are not within the BARDA mission space: https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/default.aspx
- Applications of Artificial Intelligence / Machine Learning that do not include efforts in the development and evaluation of actual products or processes.
This solicitation presents an essential opportunity for consortium members to contribute significantly to national health security by establishing and sustaining a network of deployable, responsive, and automated manufacturing systems that can produce medical countermeasures during pandemics and other public health emergencies. All interested parties are urged to review the detailed requirements and guidelines provided on the BioMaP-Consortium website and to prepare their submissions thoughtfully and thoroughly.
If your company has considered applying for BARDA funding, your federal funding journey starts here.
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