Medical Countermeasure PBA SAM Announcement updated 21Oct2026.pdf

CBRN MCM Participant Basic Agreement (PBA)

SPECIAL PROGRAM ANNOUNCEMENT

Participant Basic Agreement (PBA)

Opportunity Title Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasure (MCM) Participant Basic Agreement (PBA)

Issuing Organization Capability Program Executive for Chemical, Biological, Radiological, and Nuclear Defense (CPE

CBRND)

Program Website https://www.jpeocbrnd.osd.mil/

Table of Contents

Table of Contents

1. Strategic Opportunity

2. Program Vision: Building Holistic Threat Resilience

3. Call for Collaborators: Who Should Apply?

4. Submission Requirements & Process

5. Administrative Information & Organizational Background https://www.jpeocbrnd.osd.mil/

1. Strategic Opportunity

The Capability Program Executive for Chemical, Biological, Radiological, and Nuclear Defense (CPE

CBRND) invites interested parties to enter into the CBRN Medical Countermeasure (MCM) Participant

Basic Agreement (PBA) ecosystem. To maximize the efficacy of the advanced MCMs detailed in this agreement, the CPE CBRND recognizes that therapeutic intervention is intrinsically linked to rapid, and effective patient diagnosis. Consequently, this PBA includes an integrated focus on diagnostics. This PBA establishes a unified, open, and continuous network of pre-qualified partners to accelerate the development, testing, and fielding of next-generation CBRN medical defense solutions. The goal is to create a streamlined framework for awarding follow-on project agreements, fostering a long-term, collaborative relationship with the Government.

2. Program Vision: Building Holistic Threat Resilience

The overarching goal of the CBRN MCM PBA is to develop and field a comprehensive suite of MCMs, inclusive of medical devices, drugs and biologics, to protect the warfighter within a complex and evolving CBRN threat space. This PBA is designed as an agile agreement supporting a wide range of acquisition strategies and technologies, from rapid prototyping to late-stage development and FDA licensure or clearance. To build an integrated layered defense, the Government seeks innovative solutions across the continuum of care. This includes both pathogen or agent-based and host-based diagnostics, treatments, pre-exposure or post-exposure prophylactic countermeasures, as well as ruggedized formulations, novel drug delivery systems, and adaptable platform technologies capable of rapidly pivoting to address new and emerging threats. This integrated approach will ensure the development of a diverse and robust portfolio of MCM capabilities, preserving the Joint Force through enhanced resilience.

Examples of capabilities sought under this PBA include, but are not limited to:

• Host-Targeted Resilience: Development efforts focus on providing layered physiological protection and treatment by targeting critical host systems. The Government welcomes innovative, threat-agnostic MCM candidates that enhance host resilience, including investigational drugs with multi-indication potential in civilian critical care, establishing a sustainable, long-term therapeutic pipeline.

To meet the demands of far-forward operations, priority is placed on drug candidates designed for rapid employment in austere environments. This includes formulations featuring simplified routes of administration (such as oral, intranasal, or autoinjector delivery) that can be administered without specialized medical infrastructure. Examples of sought-after mechanisms of action include, but are not limited to, neurological protection, respiratory stabilization, immune modulation, hematologic and vascular function, and cellular stress and repair pathways.

• Threat-Targeted Neutralization: Complementing host resilience, efforts focus on developing broad-spectrum medical countermeasures designed to rapidly target, neutralize, and mitigate the effects of CBRN threats. The Government welcomes MCMs and adaptable platform technologies utilized for pre-exposure prophylaxis, post-exposure prophylaxis, or acute treatment. Preferred therapeutic candidates must possess robust environmental stability, eliminating reliance on cold-chain logistics, and be designed for immediate employment in austere, operational environments. This includes formulations featuring simplified routes of administration (such as oral, intranasal, or autoinjector delivery) that can be administered without specialized medical infrastructure. Therapeutic solutions that offer rapid threat clearance, agent inactivation, disruption of lethal injury cascades, or the immediate cessation of cellular damage through highly simplified dosing regimens are highly sought after to preserve combat power and maximize return-to-duty rates.

• Diagnostic Development: Host-Directed, Agent-Specific, and Pathogen Agnostic Solutions and

Diagnostic Decision Support Tools: Efforts focus on developing and maturing agile, far-forward medical diagnostic capabilities. An additional area of interest is diagnostic decision support tools.

The Government welcomes innovative, platform-agnostic diagnostic instrument and/or assay prototypes designed for immediate employment in austere, operational environments without reliance on specialized laboratory infrastructure. Preferred diagnostic systems must be optimized for point-of-need use (simple, portable, battery operable or unpowered) and feature simplified sample-collection to enable employment in austere medical environments while being operated by minimally trained users. Specific areas of testing interest include pathogen specific tests, host-response tests to identify infection or physiological dysregulation due to infection, tests that assess antimicrobial resistance or susceptibility, severity of illness, and tests that diagnose toxin exposure in a timeline that supports medical intervention. Of additional interest are test modalities that allow the earliest possible medical intervention relative to the onset of clinical symptoms.

3. Call for Collaborators: Who Should Apply?

This announcement serves as an invitation to the full spectrum of MCM developers and support organizations to join the CBRN MCM PBA partner ecosystem.

• A. MCM Development Collaborators: We invite submissions from developers of MCM candidates relevant to CBRN defense at all stages of advanced development (from Phase I-enabled products through Phase II/III clinical trials and FDA licensure).

• B. MCM Development Support Collaborators: We also invite participation from organizations specializing in contract research, development, and manufacturing (CROs/CDMOs) and other firms with expertise in preclinical testing (e.g., efficacy, pharmacology, toxicology), clinical trial execution, cGMP manufacturing, regulatory submissions, and advanced modeling. Collaboration with expert service providers is essential to accelerate development.

• C. Medical Diagnostics Collaborators: We explicitly invite submissions from academic, industry, and non-profit developers of diagnostic platforms, assays, and supporting technologies. This includes developers of:

• Host-Response Technologies: High-throughput transcriptomic sequencing, host-biomarker assay panels, machine-learning algorithms for physiological anomaly detection, and point-of-care host-response devices.

• Agent-Specific Technologies: Multiplexed PCR/nucleic acid tests, advanced antigen-detection systems, hand-held or wearable diagnostic sensors, and rapid metagenomic sequencing technologies optimized for austere environments.

• Enabling Support Partners: Organizations specializing in clinical sample acquisition and biorepository management, analytical/clinical validation of diagnostic devices, biosafety level

(BSL-3/4) testing, regulatory FDA clearances for IVDs (In Vitro Diagnostics), and software/data integration for tactical networks.

• Technology development partners: Organizations willing to sell or share IP with the USG. This IP would be shared with vendors of fielded systems for the purpose of accelerating early assay development and diagnostic target expansion on fielded systems.

4. Submission Requirements & Process

Interested entities shall submit a white paper (not to exceed five pages, not including a cover page) that addresses the areas outlined below. In addition, companies shall state entity’s willingness to team or collaborate with other entities within this PBA.

• A. For MCM Development Collaborators: Your submission should provide a comprehensive overview including:

• Product Description: A clear description of the product, its mechanism of action, intended use and proposed FDA indication.

• Efficacy Data: A summary of all significant in vivo and in vitro data and a description of well-controlled and/or good laboratory practices (GLP) data generated in validated animal models against CBRN threats.

• Regulatory & Clinical Status: A history of U.S. Food and Drug Administration (FDA) sponsor experience and engagements (including IND status), and a summary of completed or ongoing clinical trials (Phase I, II, III), including safety and pharmacokinetic/pharmacodynamic (PK/PD) data.

• Manufacturing: A description of current manufacturing capacity (scale, good manufacturing practices (GMP) status) and the strategy for scaling production.

• Company Profile: A summary of your company’s experience in advanced product development, commercialization, and relevant intellectual property rights.

• B. For MCM Development Support Collaborators: Interested service providers should submit a summary of their core capabilities, relevant experience with complex biologics or small molecules, FDA regulatory experience, available infrastructure, and capacity or technology that can accelerate the development of advanced medical countermeasures.

• C. For Medical Diagnostics Collaborators: Your submission should provide a comprehensive overview of your diagnostic capabilities, including:

• Platform & Assay Specifications: A clear description of the diagnostic system (e.g., point-of-need, wearable, laboratory-based, or high-throughput platform), its detection mechanism

(agent-specific, host-directed biomarker, or multiplexed), sample input requirements (such as blood, saliva, or non-invasive matrices), and time from patient sample collection to result.

• Analytical & Clinical Performance: A summary of analytical sensitivity/specificity (limit of detection), dynamic range, and any clinical or mock-clinical performance data (including GLP or non-GLP laboratory evaluation data) using engineered targets, surrogates, or active CBRN agents.

• System Ruggedization & Logistics: An evaluation of the platform’s suitability for far-forward or austere environments, including environmental stability (storage temperature and shelf-life of reagents without a cold chain), physical footprint, power requirements, and ease of use by non-specialized personnel.

• Regulatory Pathway & Cybersecurity: Current FDA regulatory status (e.g., Investigational Device

Exemption [IDE], Pre-Submission, 510(k), or De Novo status), and a description of data interface capabilities, including compatibility with military tactical networks and cybersecurity compliance protocols (e.g., Risk Management Framework [RMF] standards).

• D. Awards: Acceptance into the PBA allows for award of project orders under any program supported by this PBA.

5. Administrative Information & Organizational Background

• Submission of White Papers: Please submit all white papers to: usarmy.detrick.cpe-cbrnd.mbx.cbrn-mcm-pba@army.mil

• Points of Contact: Please direct all technical and administrative questions to:

• Hunter Robinson (hunter.t.robinson4.civ@army.mil)

• Alexander Mayatte (alexander.z.mayatte.civ@army.mil)

• Issuing Organization Mission: CPE CBRND advances the development of CBRN defense capabilities to enable the Joint Force to fight and win in a CBRN contested environment, contributing toward

National Defense Strategy priorities.

• Authority: Projects may be awarded under the authority of 10 U.S.C §4021, 10 U.S.C. §4022, and 10

U.S.C. §4023. These agreements are not subject to the provisions of the Competition in Contracting

Act of 1984.

• SAM Registration: Prospective awardees MUST be registered in the System for Award Management

(SAM) database prior to submitting an invoice and through final payment.

mailto:usarmy.detrick.cpe-cbrnd.mbx.cbrn-mcm-pba@army.mil mailto:usarmy.detrick.cpe-cbrnd.mbx.cbrn-mcm-pba@army.mil mailto:hunter.t.robinson4.civ@army.mil mailto:alexander.z.mayatte.civ@army.mil