Applications Closed

Patient Subtyping Technologies to Drive Therapeutic Efficacy

Non-dilutive funding for approaches to predicting treatment-responsive patients to enable therapeutic efficacy of BARDA medical countermeasure products for national health security. Applications closed. Schedule a call to find out more about future opportunities.

Non-dilutive Funding to Advance Patient Subtyping Technologies

VITAL and BARDA are seeking technologies and approaches that can predict and enable treatment benefit among patients for new or existing therapeutics that treat CBRN (chemical, biological, radiological or nuclear) threats, injuries, insults, infection or severe disease from other health security threats.

Context and Background

Variability in treatment effect across patients has consistently been observed.

In some fields, like oncology, companion and complementary diagnostics have been developed to drive patient subtyping approaches to inform who will benefit from specific therapeutics. There is interest in now applying these strategies to other scenarios, like critical care, relevant to BARDA’s mission space. Such approaches may enable therapeutic efficacy in clinical trials and guide therapeutic use after market approval.

As part of BARDA DRIVe’s Type to Treat Program.

As part of BARDA DRIVe’s Type to Treat Program, this funding opportunity aims to leverage such strategies to support clinical use of FDA-approved medical countermeasures or development of new therapeutics relevant to BARDA’s mission space – CBRN threats, pandemic influenza, and emerging infectious diseases.

Key Focus Area

VITAL and BARDA seek technologies and approaches that can predict treatment benefit among patients to increase the probability of demonstrating therapeutic efficacy during clinical development and to guide treatment decisions during clinical care for improved patient outcomes.

These technologies may be based on phenotyping, sub-phenotyping, endotyping, genotyping, and/or other approaches to identify patients likely to benefit from specific treatments. Example technologies may include but are not limited to assays, lab tests, and software as medical devices.

Addressing Heterogeneity of Treatment Effect in Health Security Threat Indications: Patient subtyping technologies to improve treatment decision-making and patient outcomes.

Funding Guidelines & Duration

Applications Are Now Closed

Applications for Type Funding
Are Now Closed

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Type Teaming

Please Note

Please note that by publishing the teaming profiles list, neither VITAL nor BARDA is endorsing, sponsoring, or otherwise evaluating the qualifications of the individuals or organizations included. Additionally, completing the form does not constitute an application for the TyPe funding opportunity, but rather, provides you an opportunity to partner and collaborate with other potential applicants to strengthen the quality of the submission. Submissions to the teaming profiles list are reviewed and updated periodically.

Omphalos Lifesciences

Contact

Donghoon Lee

Website

Relevant Technology

Our technology is a simulation-based patient subtyping and validation platform that creates virtual human models with customizable organs, genetic traits, and clinical phenotypes. These models allow mechanistic testing of therapeutic responses across diverse patient subgroups, enabling a filtering step before clinical trials. Unlike purely statistical or AI-driven approaches, our platform integrates biological knowledge with real-world data to generate mechanistic predictions, offering insights into why treatments succeed or fail in specific patient populations. By training simulations with retrospective and prospective datasets, we can stratify patients linked directly to therapeutic mechanisms of action, strengthening trial design, improving efficacy readouts, and de-risking development. The system is modular and adaptable, capable of pivoting across BARDA-relevant threats, from pandemic pathogens to severe injury indications, providing a sustainable platform technology. This approach enhances biodistribution and durability assessments by simulating treatment dynamics in silico, reducing development cost, risk, and timelines while improving regulatory credibility.

Potential for Teaming

We are seeking prime contractors and collaborators who can provide the clinical and therapeutic anchors to complement our simulation platform. Specifically, we aim to partner with therapeutic developers (biologics, small molecules, or devices) who have BARDA-relevant products in development or on market, and clinical or diagnostic partners with access to retrospective datasets or prospective patient samples. These partners provide the data and validation channels necessary to tie our simulations directly to therapeutic effects. We are also interested in teaming with diagnostic developers who can translate our virtual subtyping results into measurable biomarkers and regulatory-grade RUO prototypes. In return, we contribute a unique capability: simulation-based validation that generates predictive foresight, reduces trial risk, and accelerates demonstration of therapeutic efficacy. Our ideal partners are organizations that see value in integrating mechanistic modeling with their therapeutic pipeline, enabling stronger BARDA proposals and more efficient paths to approval and commercialization.

George Mason University

Contact

Virginia Espina

Website

Relevant Technology

Our relevant technologies are:

  1. A CAP/CLIA accredited proteomics lab for diagnostic testing & method development.
  2. Reverse phase protein array (RPPA) to quantify on and off target therapeutic effects, using antibodies to measure cell signaling proteins and their post-translational modified forms.
  3. A patented & commercialized tissue/cell fixative that inactivates viral pathogens and preserves tissue histomorphology and proteins.
  4. Laser capture microdissection to procure enriched cell populations from tissue sections.
  5. Mass spectrometry for protein sequencing and identification.
  6. Protein painting to identify protein hot spot interaction sites.

Potential for Teaming

Potential partners would provide samples for analysis and/or provide complimentary technologies to develop a complete molecular profile of the sample. Example complimentary technologies include microbiome analysis, whole genome sequencing, epigenetic and transcriptomic analyses.

Clairyon

Contact

Hari Kolasani

Website

Relevant Technology

Our platform builds on COMPOSER and COMPOSER-LLM (Nature Digital Medicine) to enable real-time, data-driven phenotyping of sepsis patients. COMPOSER models dynamic physiological trajectories using multimodal EHR data, while COMPOSER-LLM integrates structured and unstructured clinical inputs to refine patient subtypes. These technologies identify latent sepsis phenotypes and map them to historical treatment response patterns. This allows for predictive enrichment in clinical trials and individualized treatment guidance in care settings. By modeling counterfactual outcomes and estimating treatment benefit per phenotype, our platform increases the probability of demonstrating therapeutic efficacy and improves patient outcomes.

Potential for Teaming

We seek partners who bring complementary strengths in therapeutic development, clinical trial execution, and regulatory strategy—especially those committed to precision medicine. We’re particularly interested in teams developing or validating therapies for Sepsis, ARDS or other syndromic conditions where phenotypic heterogeneity limits efficacy.

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Application Review Criteria

Applications will be reviewed in whole based on responses to the questions in the application and all information submitted, with focus on alignment to the program requirements and program strategy, innovation and quality of data presented, technical approach and milestones to be achieved with the proposal, team and resources available, ability to transition and commercialize the product, and cost/price reasonableness for the proposed use of funds.

The TyPe awards are anticipated to be multi-year awards for development activities taking approximately 1-3 years; however the exact timeline for each project will be finalized during negotiations.

There will be reporting requirements on a monthly or quarterly basis, annual reports, and final reports. The applicant and VITAL will agree during negotiations and before final award which standard reporting requirements and other deliverables are necessary as determined by the final, mutually agreed-upon Statement of Work, project deliverables.

No. SAM.gov registration is not required.

The Influenza & Emerging Infectious Diseases (EID) Therapeutics Program within BARDA focuses on development of 1) novel antivirals to treat seasonal and pandemic influenza in outpatient settings; 2) immune modulators and other host-directed therapeutics promoting lung repair to treat and improve clinical outcomes of acute lung injury (ALI)/acute respiratory distress syndrome (ARDS) caused by pandemic and seasonal influenza and other viral pathogens of pandemic potential; and 3) long-acting antivirals to provide pre-exposure prophylaxis (PrEP) options against pandemic and seasonal influenza before vaccine availability and for people whose immune systems may not generate a sufficient response to available vaccines.

This funding opportunity does not support gain of function research or research that involves the manipulation of pathogens resulting in potential gain of function.

Proposals will be evaluated for the appropriate use of strain(s) in proposed studies.