Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The BARDA Broad Agency Announcement (BAA-23-100-SOL-00004, Amendment 7) is a continuously open funding vehicle supporting advanced R&D of medical countermeasures (MCMs) for CBRN threats, pandemic influenza, and emerging infectious diseases. This is one of the most flexible and recurring federal funding pathways for biotech, diagnostics, and platform companies.

The submission deadline is September 25, 2028, at 4:30pm Eastern Time, unless otherwise indicated in an AOI.

This is not a traditional one-time grant—BARDA accepts submissions on a rolling basis and invites full proposals after an initial screening. Companies with relevant technologies should engage early to maximize alignment and feedback.

How much funding would I receive?

• Not specifically stated, but most awards range between $500k - $5m.

• BARDA states:

  • “Multiple awards of various values are anticipated”

  • Funding depends on:

    • Program priorities

    • Technical merit

    • Fit to Areas of Interest (AOIs)

    • Available funds

What could I use the funding for?

AOI #1: CBRN Vaccines

• 1.1. [SUSPENDED] Needle-Free Technologies to Administer Licensed Vaccines

• 1.2. Sudan Virus and Marburg Virus

  • Advanced development of monovalent vaccines against Sudan virus and Marburg virus

  • Candidate must have:

    • Demonstrated protection from lethal challenge in non-human primate studies

    • Phase 1 clinical safety data

  • Goal includes completion of Phase 2 clinical study(ies) and manufacture of sufficient clinical trial material to support outbreak response

• 1.3. Flexible Vaccine Manufacturing Platform Technologies

  • Antigen production technologies that can:

    • Progress from gene sequence to IND submission in <6 months

    • Be successfully applied to multiple infectious disease targets

    • Scale to >1 million doses

  • Proposals should address at least two CBRN threats, with optional work for additional threats

AOI #2: CBRN Antivirals and Antitoxins

• 2.1. [SUSPENDED] Anthrax Antitoxins

• 2.2. Botulism Antitoxins

  • Next-generation MCMs against botulinum neurotoxins

  • Priority for products with efficacy against serotypes A-G

  • Includes antibody-based products, small molecules, or syndrome-based therapeutics

• 2.3. Smallpox Antivirals

  • Next-generation antiviral therapeutics against smallpox

  • Preference for products with a different class or mechanism than existing FDA-approved smallpox therapeutics

  • Combination therapy potential is preferred

• 2.4. Filovirus Antivirals

  • Therapeutics for Ebolavirus and Marburgvirus

  • Includes:

    • Broad-spectrum antivirals

    • Monoclonal antibodies and related products

    • Syndrome-based therapeutics

    • Post-exposure prophylaxis products

AOI #3: Antimicrobials

• 3.1. MDR Bacteria and Biothreat Pathogens

  • Drug candidates active against biothreat pathogens and/or drug-resistant secondary infections during a CBRN, pandemic influenza, or emerging infectious disease incident

• 3.2. MDR Fungal Infections

  • Broad-spectrum antifungal candidates with novel mechanisms of action

  • Includes Candida species, including Candida auris, drug-resistant Aspergillus species, and rare molds

AOI #4: Radiological/Nuclear Threat Medical Countermeasures

• 4.1. Acute Radiation Syndrome (ARS)

  • Therapeutics for:

    • Thrombocytopenia

    • Pancytopenia

    • Endothelial and vascular injury

    • GI or lung injury

    • Delayed effects of acute radiation exposure

    • Cellular therapies and hematopoietic stem/progenitor cell technologies

• 4.2. Uncontrolled Hemorrhage

  • Blood products and related technologies

  • Therapeutics that replace blood products or extend the resuscitation window

  • Therapies for cellular metabolism and hemostasis dysfunction

• 4.3. Radiation Injury and Trauma Pathophysiologies

  • Biomarker assays

  • Imaging and diagnostic tools

  • Therapeutic solutions targeting injury pathophysiology

• 4.4. Enabling Technologies and Platforms

  • Tissue chips and microphysiological systems

  • Platforms for easier therapeutic use in resource-limited settings

  • Potency assays for cellular therapies and next-generation blood products

• 4.5. [SUSPENDED] Decorporation Agents

AOI #5: Chemical Medical Countermeasures

• 5.1. Pulmonary Agents

  • MCMs to prevent and treat lung damage from agents such as chlorine and phosgene

  • Includes ARDS, pulmonary edema, pulmonary endothelial vascular injury, chemical pneumonitis, reactive airway syndrome, and pulmonary fibrosis

• 5.2. Pharmaceutical-based Agents, including Opioids and Other Respiratory Depressants

  • MCMs for life-threatening overdose from PBAs, respiratory depressants, and/or multi-drug toxicity

  • Threat-agnostic respiratory stimulants are of particular interest

  • Candidates not involving opioid receptor antagonism are prioritized

• 5.3. Vesicants

  • MCMs to ameliorate harmful effects of sulfur mustard and lewisite

  • Preference for drugs that prevent or ameliorate chronic effects

• 5.4. Nerve Agents and Organophosphorus (OP) Pesticides

  • Repurposing or label expansion of already FDA-approved medications

  • Includes treatment of muscarinic, nicotinic, seizure-causing effects, and benzodiazepine-refractory seizures

• 5.5. Knockdown Agents/Cellular Asphyxiants

  • MCMs for cyanides, hydrogen sulfide, phosphine, and related threats

  • Preference for treatments also safe and effective against smoke inhalation-related cyanide exposure

• 5.6. Novel MCM Delivery Mechanisms

  • Improved methods and/or routes of administration for new and existing MCMs

• 5.7. Innovative Approaches to Understanding Chemical Injury in Humans

  • In vitro humanized systems, organoids, organ chips, microphysiological systems, and human-relevant animal models

  • Goal is to identify therapeutic targets and support new treatment development

Under AOI #5, BARDA states that all aspects of advanced clinical stage drug development are permissible for funding, including:

• Nonclinical studies

• Safety

• Toxicology

• PK/PD

• Manufacturing

• Analytical assay development and validation

• Clinical studies, including pediatric studies

• Regulatory submission preparation

• Post-approval requirements

AOI #6: Burn and Blast Medical Countermeasures

• 6.1. Burn and Blast Traumatic Injuries Management

  • Products for full-thickness burns, severe lacerations, penetrating trauma, crush injuries, nerve and vascular trauma

  • Includes enabling technologies such as devices, software, AI-assisted capabilities, pain management, and clinical guidelines

• 6.2. Management of Head Injuries in Trauma

  • Non-invasive or minimally invasive technologies to detect neurotrauma

  • Triage tools for acute traumatic brain injuries

  • Special interest in technologies detecting/localizing internal brain hemorrhage and elevated intracranial pressure/edema

• 6.3. Hemorrhage Control

  • Gels, devices, and other adoptable MCMs for severe hemorrhage from lacerations and junctional wounds

  • Also includes technologies for early detection/localization of internal hemorrhage

• 6.4. [SUSPENDED] Non-Autologous Topical Products to Prevent or Reduce Burn Wound Conversion

• 6.5. Management of Thoracoabdominal Trauma Injuries

  • Detection/diagnosis of internal injuries

  • Portable point-of-care ultrasound and similar technologies

  • Tools to improve management, monitoring, prognosis, and treatment decisions for blunt trauma

• 6.6. Musculoskeletal Injuries

  • Technologies to evaluate, diagnose, triage, and manage traumatic MSK injuries

  • Includes complex fractures, soft tissue injuries, tendons, ligaments, and AI-enabled imaging improvements

• 6.7. [SUSPENDED] Special Instruction for Health Economic Impact Assessment of Burn MCMs

• 6.8. Platform Agnostic Software for AI Augmentation of Ultrasound Imaging Data

  • Software connecting ultrasound devices with minimal API development

  • AI/ML support for EMS and ED triage

  • Product should seek FDA clearance as required

AOI #7: Diagnostics

BARDA divides diagnostics into four threat areas:

• 7.1. Biothreats

• 7.2. Antibiotic resistance

• 7.3. Pandemic influenza

• 7.4. Threat-agnostic diagnostics

Subpoints:

7.1. Biothreat Agent Diagnostics

• 7.1.1. Biothreat Agent Diagnostics: Point-of-Care

  • Rapid point-of-care diagnostic systems for listed biothreats

  • TRL 4 or greater required

• 7.1.2. Biothreat Agent Diagnostics: Laboratory

  • Automated laboratory assays for listed biothreats

  • Single-threat and multiplex assays will be considered

  • TRL 4 or greater required

• 7.1.3. Biothreat Agent Diagnostics: Filovirus Point-of-Care and Remote Settings

  • Rapid, accurate, CLIA-waivable, field-useable molecular diagnostics for filoviruses

  • Must at minimum detect Ebola virus, Sudan virus, Bundibugyo virus, Taï Forest virus, and Marburg virus

  • TRL 3 or greater, with expectation of advancing to TRL 4 and regulatory submission

7.2. Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens

• 7.2.1. Bacterial Antimicrobial Resistance (AMR) Testing Direct from Specimen

  • Rapid ID and AMR testing from primary clinical specimens

  • Broad pathogen coverage

  • TRL 4 or greater required

• 7.2.2. [SUSPENDED] Bacterial vs. Viral Infections: Point-of-Care

• 7.2.3. AMR Sequencing Solutions

  • Sample-to-answer sequencing solutions for identifying pathogens with known and/or novel resistance determinants

  • TRL 4 or greater required

7.3. Influenza Diagnostics

• 7.3.1. Influenza Testing in an OTC and CLIA-waived environment

  • Molecular or high-sensitivity antigen tests for influenza A and B

  • Point-of-care and home-use

  • TRL 4 or greater required

• 7.3.2. [SUSPENDED] Pan-Influenza Diagnostics: Point-of-Care or Laboratory

• 7.3.3. [SUSPENDED] Point-of-Care Multiplex Assay for Detection of Influenza Virus

7.4. Threat-Agnostic Diagnostics

• 7.4.1. Metagenomic Next-Generation Sequencing (mNGS)-Based Diagnostic for Viral and Bacterial Pathogens

  • Advanced development, clinical evaluation, and FDA clearance of mNGS-based assays

  • Laboratory and point-of-care tests are sought

  • TRL 4 or greater required

AOI #8: IEID Vaccines

• 8.1. Advanced Development of Faster or More Effective Vaccines

  • 8.1.1. Faster Vaccines

    • Licensed, domestically manufactured vaccines with goals of:

      • 100 days from sequence availability to release of first doses

      • 130 days from sequence availability to doses sufficient to immunize the U.S. and global population

  • 8.1.2. More Effective Vaccines

    • Products or formulations such as adjuvants or other technologies that:

      • Elicit a priming and protective response in immunologically naïve recipients with a single dose

      • Improve stability, sustainability, and/or utility of stockpiled vaccines

  • 8.1.3. Clinical trials to expand the age range on the label of currently licensed vaccines

• 8.2. Innovative Vaccine Product and Production Enhancements

  • 8.2.1. Platform technologies

  • 8.2.2. Manufacturing

  • 8.2.3. Assays for product release

  • 8.2.4. Administration

AOI #9: IEID Therapeutics

• 9.1. Broad Spectrum Antiviral Therapeutics for Influenza

  • New broad-spectrum direct- or indirect-acting antivirals for respiratory viral infections including influenza in outpatient settings

• 9.2. Immune Modulators or Therapeutics Promoting Lung Repair

  • Therapeutics to prevent, treat, and/or improve outcomes of ARDS caused by pandemic or seasonal influenza and other respiratory infections

• 9.3. Pre-exposure Prophylaxis – Influenza

  • Antivirals for pandemic preparedness and for people with inadequate influenza vaccine response

  • Preference for long-acting products providing at least one month of protection from a single dose

• 9.4. [SUSPENDED] COVID-19 Monoclonal Antibody Therapeutics for Treatment

AOI #10: ImmuneChip+

BARDA seeks advanced microphysiological systems and tissue-chip technologies.

Offerors should address two or more of these five components:

• 1) Infection with a relevant pathogen, insult with toxins/toxicants, exposure to acute ionizing radiation, or exposure to chemical agents

• 2) Integration of at least two different tissues in addition to immune component(s)

• 3) Near-continuous monitoring of the MPS for at least two weeks

• 4) Semi-automated or automated manufacturing of the device

• 5) Biological characterization of the MPS and recapitulation of existing clinical data in response to injury/morbidity and various MCMs

BARDA also explicitly encourages proposals in these topic areas:

• Development of modular multi-tissue systems

• Characterization studies on known approved and unapproved therapeutic candidates

• Natural history studies of acute radiation syndrome in target organ systems

• Natural history studies in animal chip models

• Vascularized models with endothelial cells that can model vascular injury

AOI #11: [SUSPENDED] COVID-19 Immune Assay(s) Development and Implementation

AOI #12: Flexible and Strategic Therapeutics (FASTx)

BARDA seeks adaptable antiviral platforms.

Required elements in Market Research Abstract and Proposal submissions:

• Preliminary platform data demonstrating in vitro efficacy of a candidate against filoviruses

• Proposal to develop and advance candidates against two unique targets:

  • 1 filovirus

  • 1 “to be determined” HHS priority threat

• Identification of technical gaps/challenges, such as:

  • Formulation

  • Manufacturability

  • Safety and toxicity

  • Delivery to target tissues

  • Pharmacokinetics

  • Efficacy

• Justification of how common aspects of the platform can accelerate regulatory review of later products

Additional guidance:

• Therapeutic indications are preferred

• Post-exposure prophylaxis will only be considered for filovirus targets

• For this AOI, BARDA states that potential offerors must request a pre-submission call before submitting an MRA

• MRAs must be received by April 24, 2026 for consideration of an award in the 2026 fiscal year

Are there any additional benefits I would receive?

Yes. BARDA provides non-dilutive capital plus strategic support, including:

• Access to:

  • Animal study networks

  • Flexible manufacturing facilities

  • Regulatory and clinical expertise

• Potential progression through:

  • FDA approval, licensure, or clearance

• Engagement with:

  • BARDA experts

  • Interagency partners (PHEMCE)

What is the timeline to apply and when would I receive funding?

Submission deadline:

• September 25, 2028, at 4:30pm Eastern Time, unless otherwise indicated in an AOI.

Process (3 stages):

1. Stage 1 – Pre-submission call (optional)

   • Can occur anytime

   • Response within ~1 week

2. Stage 2 – Quad Chart + Market Research Abstract

   • Submit anytime before September 25, 2028, at 4:30pm Eastern Time, unless otherwise indicated in an AOI

   • BARDA response: within 120 days

3. Stage 3 – Full Proposal (by invitation or direct submission)

   • Deadline: September 25, 2028, at 4:30pm Eastern Time, unless otherwise indicated in an AOI

   • Response: within 120 days

Where does this funding come from?

• U.S. Department of Health and Human Services (HHS)

• Administration for Strategic Preparedness and Response (ASPR)

• Biomedical Advanced Research and Development Authority (BARDA)

Authorized under:

• Federal Acquisition Regulation (FAR)

• Pandemic and All-Hazards Preparedness legislation

Who is eligible to apply?

• Open to ALL responsible sources, including:

  • Private companies

  • Startups

  • Academic institutions

  • Government labs

  • Teams/consortia

Requirements:

• Must be registered in SAM.gov

Special cases:

• FFRDCs and government entities must justify eligibility

Encouraged participants:

• Small businesses

• Women-, minority-, veteran-owned firms

• HBCUs and other underserved institutions

What companies and projects are likely to win?

BARDA prioritizes:

Strong alignment with AOIs, including:

• Vaccines, therapeutics, diagnostics, and platforms for:

  • CBRN threats

  • Pandemic influenza

  • Emerging infectious diseases

High-performing proposals typically have:

• Advanced development stage (clear TRL justification)

• Strong technical and clinical data

• Clear FDA regulatory pathway

• Scalable manufacturing plan

• Commercial viability and sustainability

Evaluation criteria (in order):

1. Program relevance

2. Scientific and technical merit

3. Team capabilities and experience

Are there any restrictions I should know about?

Key restrictions include:

• No gain-of-function research

• All submissions must be unclassified

• Must comply with:

  • FDA regulations (GCP, GMP, GLP)

  • Export control laws

• Proposals must follow strict formatting and submission rules

• Costs to prepare proposals are not reimbursable

How long will it take me to prepare an application?

• Stage 2 (Quad Chart + Abstract):

  • Relatively lightweight (≤14 pages total)

• Stage 3 (Full Proposal):

  • Highly detailed and complex (up to ~120+ pages)

  • Includes:

    • Technical proposal

    • Cost proposal

    • Regulatory, manufacturing, and clinical plans

Estimated effort:

• Not specified in the solicitation

How can BW&CO help?

BW&CO can support you across all three BARDA stages:

• AOI targeting and fit assessment

• Stage 1 strategy and positioning

• Quad Chart + Market Research Abstract development

• Full proposal writing (technical + cost volumes)

• Regulatory and commercialization narrative alignment

• Review and red-teaming for BARDA evaluation criteria

How much would BW&CO Charge?

We have both fractional engagements ($250 an hour) and full engagements ($13,000 + 5%) available.

Additional Resources

Review the solicitation here.