Host Directed MCM PBA.pdf

Notice Type: Special Program Announcement - Participant Basic Agreement (PBA) Opportunity

Title: Threat Agnostic Host-Directed Therapeutics

Issuing Organization: Capability Program Executive for Chemical, Biological, Radiological, and Nuclear Defense (CPE CBRND) (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 participate in the HEALER portfolio, a next-generation host directed medical countermeasure initiative.

HEALER seeks to develop a diverse portfolio of threat agnostic, host-directed therapeutics that enhance the body’s ability to withstand, mitigate, and recover from the complex physiological impacts of CBRN threats. Because the underlying pathophysiology of injury following CBRN exposure and civilian critical care challenges are often governed by convergent host response mechanisms, this program creates a viable commercial opportunity that exceeds the traditional CBRN mission space. This initiative represents a significant opportunity for industry collaborators by focusing on dual-use therapeutics.

This alignment of national security priorities with commercial market incentives offers a path to sustainable product development.

2. Program Vision: Building Threat-Agnostic Host Resilience

The goal of the HEALER portfolio is to create a new generation of therapeutics enabling the 'Host' to recover from physiological impacts and maintain operational effectiveness even under duress. The program focuses on delivering medical countermeasures that provide layered physiological protection to the Warfighter by targeting one or more of the following critical host systems:

• Neurological Protection

• Respiratory Stabilization

• Immune Modulation

• Hematologic & Vascular Function

• Cellular Stress & Repair Pathways

This integrated approach will ensure the development of a diverse and robust portfolio of threat-agnostic capabilities, empowering the host through enhanced resilience.

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3. Call for Collaborators: Who Should Apply?

This announcement serves as an invitation to the full spectrum of drug development organizations.

• A. Therapeutic Development Collaborators: We invite submissions from developers of host-directed therapeutic candidates.

• B. Drug 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 within the HEALER portfolio.

4. Submission Requirements & Process

The HEALER portfolio will be executed under the terms of a Participant Basic Agreement

(PBA). 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 that may also have a PBA for the HEALER portfolio.

A. For Therapeutic Development Collaborators:

Your submission should provide a comprehensive overview including:

• Product Description: A clear description of the product, its host-directed mechanism of action, the physiological pathways it targets, and its intended use and proposed FDA indication.

• Efficacy Data: A summary of all significant in vivo and in vitro data and a description of any well-controlled 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 Drug 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 for the

HEALER portfolio.

5. Administrative Information & Organizational Background

• 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.

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