Overview of Solicitation
The Rapid Response Partnership Vehicle (RRPV), on behalf of the Biomedical Advanced Research and Development Authority (BARDA), has released a Request for Information (RFI) focused on neuromuscular junction (NMJ) micro-physiological systems (MPS) for botulinum neurotoxin (BoNT) applications. Managed by Advanced Technology International (ATI), this RFI seeks to assess the current landscape of human-relevant NMJ platforms and their potential to support BoNT detection, potency measurement, and evaluation of medical countermeasure (MCM) neutralizing activity.
This effort reflects growing a interest in transitioning from traditional animal-based assays toward more predictive, human-relevant in vitro systems. BARDA is specifically exploring whether NMJ-based platforms can enable biologically meaningful, scalable, and relevant approaches to evaluating BoNT threats and corresponding countermeasures.
Requested Information
BARDA’s interest centers on existing NMJ systems that use human cells or tissues. The agency seeks to evaluate mature or near-mature systems that could be adapted for BoNT applications.
Responses should address the following requested information areas:
- Platform Description
Describe the NMJ platform type, components, development stage, and scalability. Systems should demonstrate the ability to generate dose-response data and, ideally differentiate between BoNT serotypes. - Biological System
Detail cell sources and evidence of functional NMJ formation. Platforms should demonstrate reproducibility, stability, and the ability to recover neuronal signaling after toxin exposure. - Functional Readouts
Outline available assays and quantitative outputs aligned with BoNT mechanisms, such as muscle contraction or electrophysiology, including how data is collected. - BoNT Experience
Provide any prior experience with BoNT, including potency or validation data. If none, describe readiness to adapt the platform for BoNT applications. - Regulatory Considerations
Include validation strategy and any experience with FDA engagement or qualification programs, along with the intended context of use. - Commercial/Manufacturing Considerations
Summarize intellectual property, commercialization approach, and scalability of manufacturing. - Operational Considerations and Challenges
Identify key challenges such as lab access, partnerships, throughput limitations, and potential regulatory hurdles.
Importantly, BARDA is also interested in whether these systems can demonstrate recovery of neuronal signaling following toxin exposure, which is critical for evaluating the effectiveness of medical countermeasures.
This RFI is for market research and planning purposes and does not represent a commitment to fund future work.
Submission Requirements
The RFI response deadline is May 11, 2026 at 1:00PM Eastern Time.
Responses should be no more than five (5) pages, excluding references, and must follow the formatting and content guidelines outlined in the RFI.
Responses must be submitted via email to [email protected].
Additional Information
Respondents are not required to be members of the RRPV consortium to submit to this RFI. However, consortium membership will be required to participate in any future Request for Project Proposals that may result from this effort. This distinction is important for organizations considering long-term engagement with BARDA through the RRPV contracting mechanism.
From a broader perspective, this RFI signals continued federal investment in alternative testing models that reduce reliance on animal assays while improving translational relevance. Success in this area could have far-reaching implications not only for biodefense, but also for drug development, toxicology, and regulatory science.
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