CBRN Medical Countermeasure PBA Opens a Pathway for Therapeutics, Diagnostics, and Development Partners

Opportunity at a Glance

Submission details are provided in the special program announcement.

An Integrated Approach to Medical Defense

The CBRN MCM PBA aims to build a comprehensive portfolio of medical devices, drugs, and biologics across the continuum of care. The announcement covers capabilities ranging from rapid prototyping to late-stage development and FDA licensure or clearance, including pre-exposure and post-exposure prophylaxis, acute treatments, and diagnostic tools that support timely intervention.

Operational suitability is central to the opportunity. The government is seeking ruggedized formulations, simplified delivery methods, and adaptable technologies that can respond to emerging threats without depending on specialized medical infrastructure. Diagnostics are an integrated priority, reflecting the connection between identifying a threat or physiological response and delivering an effective treatment.

Priority Capability Areas

The announcement identifies three major areas of interest:

• Host-targeted resilience. Threat-agnostic countermeasures that protect or treat critical physiological systems, including neurological protection, respiratory stabilization, immune modulation, vascular function, and cellular repair. The government also welcomes investigational drugs with potential applications in civilian critical care. Priority is placed on candidates suitable for rapid use in austere settings, including oral, intranasal, or autoinjector delivery.

• Threat-targeted neutralization. Broad-spectrum countermeasures and adaptable platforms for prophylaxis or acute treatment. Desired capabilities include rapid threat clearance, agent inactivation, and interruption of injury processes. The announcement emphasizes environmental stability, reduced reliance on cold-chain logistics, and simplified dosing.

• Diagnostics and decision support. Agent-specific, host-directed, and pathogen-agnostic technologies that enable timely medical intervention. Areas of interest include infection detection, antimicrobial resistance or susceptibility, illness severity, and toxin exposure. Preferred systems are portable, simple to operate, and suitable for point-of-need use by minimally trained personnel.

Who Should Consider Participating?

The PBA invites participation from both product developers and organizations that help move products toward deployment:

• MCM developers with candidates in advanced development, from Phase I-enabled products through Phase II/III clinical trials and FDA licensure.

• CROs, CDMOs, and development support firms with capabilities in preclinical testing, clinical trials, cGMP manufacturing, regulatory submissions, and advanced modeling.

• Academic, industry, and nonprofit diagnostic developers working on platforms, assays, sensors, host-response technologies, and supporting tools.

• Diagnostic support partners with expertise in clinical samples, validation, BSL-3/4 testing, FDA clearance, and software or tactical-network integration. The announcement also welcomes technology partners willing to sell or share intellectual property with the government to accelerate assay development and expand diagnostic targets on fielded systems.

What to Include in the White Paper

Interested organizations must submit a white paper of no more than five pages, excluding a cover page, and state their willingness to team or collaborate with other entities within the PBA. Content should reflect the organization’s role:

• MCM developers should address the product and mechanism of action, intended use and proposed FDA indication, efficacy evidence, regulatory and clinical status, manufacturing capacity, and relevant development experience and intellectual property rights.

• Development support organizations should summarize core capabilities, relevant experience, regulatory expertise, infrastructure, and capacity to accelerate MCM development.

• Diagnostic developers should describe platform and assay specifications, analytical and clinical performance, operational ruggedness, regulatory status, and data-interface and cybersecurity capabilities.

What PBA Participation Means

Acceptance into the PBA allows for the award of project orders under programs supported by the agreement. It is not a guarantee of funded work. The announcement identifies authorities under 10 U.S.C. §§ 4021, 4022, and 4023 for potential project awards.

For prospective participants, the white paper should connect technical capabilities to the announcement’s operational priorities. That means showing not only what a product or platform can do, but how its evidence base, development readiness, manufacturing approach, or field usability could support CBRN medical defense.