Areas of Interest

Flexible Therapeutic and Vaccine Platforms 

Innovative systems that support the rapid development and deployment of medical countermeasures in response to emerging health threats. These platforms are designed to be adaptable, allowing for quick pivots to address new pathogens or variants as they arise. 

We are specifically interested in platforms that have: 

• Easily definable inputs 

• Logistically useful footprint 

• Minimal to no release testing 

• Small-scale validation 

• In-line formulation capabilities 

• Plug and play capability 

Next generation COVID-19 vaccine candidates utilizing any of the following platforms will be considered: 

• mRNA 

• Recombinant protein 

• Virus-like particle 

• Viral vector 

Broad-Spectrum Antimicrobials—Antivirals, Antibacterials, and Antifungals 

Antivirals, antibacterials, and antifungals, as essential medical countermeasures that address the medical consequences of biothreats, pandemic influenza, and emerging infectious diseases, including antimicrobial resistance. 

Solutions include, but are not limited to: 

• Broad-spectrum next-generation antifungal drugs to treat high-priority fungal infections following a public health emergency. 

Host-Directed Diagnostics and Therapeutics (HDTs) 

Treatments aimed at modulating the body's response to infection, insult, or injury. These therapies are designed to fortify and restore balance, promoting a balance of healthy cells, tissue, immune system, or organ function. HDTs represent a threat-agnostic approach, offering a significant advantage for pandemic preparedness by eliminating the need for pathogen identification and pathogen-specific treatment, which is critical when facing an emerging or previously unknown pathogen. 

Solutions can include, but are not limited to: 

• Interventions to prevent or reduce infection progression to severe outcomes. 

• Therapies that improve long-term outcomes and prevent health deterioration. 

• Patient stratification to subtype populations for improved clinical management. 

• Developing threat-agnostic approaches for health security. 

• Demonstrating the clinical utility of HDTs in mitigating severe patient outcomes, such as ARDS and sepsis. 

• Improving patient outcomes from home to hospital. 

• Leveraging HDTs to build resilience and restore homeostasis across the care continuum. 

• Tailoring therapeutic interventions to patients and subtype populations most likely to benefit from HDTs 

Radiological/Nuclear/Chemical Threat Medical Countermeasures 

Products developed to treat the acute effects of high dose, whole-body radiation exposure and trauma to save lives in radiological or nuclear incidents. These countermeasures are designed to address the medical consequences of exposure to ionizing radiation that can damage organs, blood vessels, and bone marrow due to severe cellular injury.  

Solutions can include, but are not limited to: 

• Stem/Progenitor Cell Stimulation or Cellular Regeneration: Targeting the regeneration of cell populations in the bone marrow that give rise to blood cells, which are highly sensitive to radiation and vulnerable to cell death. 

• Next Generation Blood Products: Developing advanced blood products to support medical interventions following radiation exposure 

• Decorporation Agents: Agents that can remove or neutralize radioactive substances from the body. 

• Enabling Technologies: Technologies that enhance the delivery and effectiveness of medical countermeasures. 

Burn/Blast/Trauma Countermeasures 

We are looking for solutions to reduce morbidity and mortality from injuries caused by burn and blast trauma, which can occur during natural and man-made disasters, including forest fires, improvised nuclear detonations, and explosions. This includes addressing resource constraints anticipated during an emergency and reducing bottlenecks in the delivery of care to facilitate more efficient management of burn and blast trauma injuries. 

Solutions must address at least one of the following: 

• General Burn and Blast Traumatic Injuries: Developing medical countermeasures (MCMs) that can detect, mitigate, and manage the consequences of physical trauma, such as extremity fractures, internal and junctional hemorrhage, lacerations, penetrating trauma, and crush injuries. 

• Head and Neck Injuries in Trauma: Addressing specific injuries to the head and neck region. 

• Hemorrhage from Non-Compressible Trauma Wounds: Managing bleeding from wounds that cannot be easily compressed. 

• Airway Access Complications in Trauma: Ensuring airway access in traumatic situations. 

• Non-Autologous Topical Products for Burn Wounds: Developing topical treatments for burn wounds that do not require the patient's own cells. 

Pathogen-Agnostic Diagnostic Technologies 

We are looking for powerful tools that can detect any pathogen, known or unknown, from the very start of a disease outbreak. These technologies, particularly next-generation sequencing (NGS), are capable of identifying any pathogen present in a sample, which includes emerging pathogens. The focus is on technological advancements that facilitate agnostic metagenomic NGS-based diagnostics for viral pathogens in clinical laboratories and point-of-care settings.  

Solutions can include, but are not limited to: 

• Developing novel, accurate, and portable sequencing hardware. 

• Enhancing the speed, efficiency, and integration of sample preparation methods. 

• Promoting user-friendly, automated, and platform-agnostic bioinformatics approaches. 

• Developing a sample-to-answer system that runs in under 24 hours. 

• Creating assays compatible with both short and long-read sequencers. 

• Facilitating commercialization and gaining acceptance in clinical laboratory settings. 

At-Home Diagnostic Technologies 

We are looking for a suite of fast, accurate, and affordable diagnostic tools that individuals can use at home. These technologies are designed to increase access to testing by reducing the need for travel and thereby minimizing the potential for contagion. 

Possible solutions can include, but are not limited to: 

• Development of tests that use noninvasive specimens. 

• Ability to provide sample to answer in less than 30 minutes. 

• Entire test process performed at home. 

• Development of small, easy-to-use devices. 

• Novel assay reagents, formats/designs, and detection modalities that can provide superior sensitivity and specificity with shorter time to result. 

• Innovative use of communication technology to assist in assay interpretation and HIPAA-compliant transmission of results. 

• Completion of clinical trial and submission of EUA application to FDA within 6 months. 

• Development of systems that are affordable for the average American and robust enough for home use 

On-Demand Manufacturing Technologies 

Through the power of advanced manufacturing technologies and streamlined supply chain systems, this program aims to break down the barriers that have historically impeded timely vaccine access and distribution. Solutions aiming to facilitate the rapid production of vaccines during outbreaks or pandemics by progressing toward decentralized vaccine manufacturing. Specifically, solutions using flexible, self-contained, and portable manufacturing systems capable of producing thousands of doses of a vaccine at or near the point of distribution in a community setting. This approach is envisioned to complement existing production capabilities and focuses on capability demonstrations and research to either scale-up or scale-down these small-scale production processes. 

Key features of these On-Demand systems should include: 

• The ability to rapidly pivot toward novel pathogens/variants. 

• Capacity for in-line formulation and product release testing. 

• Minimal requirement for operator input, monitoring, and/or intervention. 

• A small physical footprint that enables unit transport, installation, and operation in areas of critical need during public health emergencies. 

Microphysiological Systems (MPS) or Tissue Chips 

Also known as tissue chips, such as 3D models of human and animal tissues. These systems are designed to significantly accelerate the discovery and validation of vaccines and therapeutics by replicating the structure and function of tissues. We are especially interested in solutions developing MPS with fully integrated immune system components to reproduce the pathology of infectious diseases and exposure to other Chemical, Biological, Radiological, and Nuclear (CBRN) threats.We are hoping applicants will be able to create new 3D tissue models that faithfully recapitulate components of the human body, which can be an integral part of the medical countermeasure development process. 

Possible solutions can include, but are not limited to: 

• Immune system modeling 

• Long-term tissue monitoring 

• Integration of multiple tissue models 

• Characterization of existing platforms and tissue models 

Our efforts aim to address challenges such as immune system modeling, long-term tissue monitoring, integration of multiple tissue models, and characterization of existing platforms and tissue models. 

Digital Health Tools Focused on Health Security Preparedness and Response 

These tools are intended to support the development, evaluation, validation, and commercialization of medical countermeasures (MCMs), which include therapeutics, vaccines, diagnostics, medical devices, and enabling technologies. Specifically, we are seeking purely digital solutions, such as smartphone applications or web-based platforms, that can serve as the first line of defense and also augment existing MCMs in a future outbreak. These digital health tools are aimed at detecting, preventing, or responding to medical consequences that result from health security threats, thereby enhancing public health preparedness and response capabilities. 

Possible solutions can include, but are not limited to: 

• Research and development of novel physiological sensors 

• Data analytics platforms to collect and interpret physiological data 

• Algorithms capable of Identifying any major health status changes 

The initiative emphasizes the importance of agile and scalable mechanisms to support innovation, drawing lessons from the COVID-19 pandemic and the need for adaptable, scalable, sustainable, accessible, and equitable health security solutions.