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Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)
Deadline: Rolling Deadline
Funding Award Size: $500k - $5m
Description: Apply for BARDA BAA-23-100-SOL-00004 funding for advanced medical countermeasures. Rolling submissions through September 25, 2028 at 4:30pm ET.
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):
Stage 1 – Pre-submission call (optional)
Can occur anytime
Response within ~1 week
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
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):
Program relevance
Scientific and technical merit
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
Production of Drug Substances and Drug Products at Commercial Scale: Anti-Microbials and Large Volume Parenterals
Deadline: March 9, 2026
Funding Award Size: $250k to $10 million
Description: This BARDA BioMaP solicitation funds U.S.-based manufacturing projects that can scale antimicrobials and large volume parenterals to population-level production within 24 months. Deadline: March 9, 2026.
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
BARDA (through the BioMaP-Consortium) is looking to fund commercial-scale (“population scale”) domestic production of at least one (1) key starting material (KSM), drug substance, and/or drug product—with a stated preference for Anti-Microbials and Large Volume Parenterals (LVPs). This is an Enhanced White Paper solicitation, and the deadline is March 9, 2026, 1:00 PM ET (late submissions may not be evaluated).
How much funding would I receive?
Total estimated funding (all projects): approximately $200 million (subject to availability and adjustment).
Award size per project is not specified in the RPP.
The Government anticipates making multiple awards and also reserves the right to make one, multiple, or no awards.
What could I use the funding for?
Below are the uses that map directly to the RPP’s objectives and deliverables.
1) Objective A: Engineering design + study phase (design/refine the approach)
You can propose work to design and refine an end-to-end, scalable manufacturing concept that supports population-scale production, including:
Select at least 1 target drug substance jointly with the Government (minimum entry: MRL 6), including selection rationale.
Build a detailed list of molecules/molecule classes, required materials, systems, and equipment across manufacturing phases.
Develop and refine an analytical/characterization and manufacturing plan for population-scale production with automated and integrated processes across design, manufacturing, testing, and analysis—intended to increase MRL to 10 and meet U.S. Pharmacopeia standards and ICH guidelines for purity, potency, safety, validation, quality, etc.
Include an infrastructure governance framework (management structure, partnerships, scheduling considerations).
Assess domestic market maturity and conduct a risk assessment of domestic capabilities.
Present Objective A results and a plan for Objective B for Government approval to proceed.
2) Objective B: Demonstrate the model + population-scale manufacturing
If approved to proceed after Objective A, you can propose to:
Develop and execute an analytical model and demonstrate manufacturing of a KSM/API progressing from MRL 6/7 to MRL 10, in compliance with USP and ICH expectations.
Run multiple scenarios/production runs to test assumptions and identify conditions that improve or worsen:
Shortest time to market
Lowest development/deployment costs
Optimal time-to-market with cost tradeoffs
Key drivers of time and cost
Recommendations for future investment to enable population-scale production in real markets
Produce required program outputs (e.g., technical batch reports, final technical report with variables/assumptions/model runs).
The RPP also lists deliverables tied to drug products, including registration batches, completion of environmental/engineering/registration batch runs, and ANDA filings for each drug product (as applicable to your scope).
3) Program management + risk + schedule deliverables
You can include work to:
Manage the full program (integration, coordination, milestone schedule, critical path, go/no-go criteria).
Maintain a risk register and report risk changes.
Deliver required monthly technical progress reports and other specified deliverables.
4) Domestic industrial base / capacity expansion (U.S. soil)
The RPP states proposals are expected to be focused on United States investments, and capacity expansion work must be executed within the continental U.S. and its Territories (even for overseas-based companies).
Are there any additional benefits I would receive?
This is under BARDA’s BioMaP-Consortium OTA vehicle (OTA Number 75A50123D00003) and executed via Project Agreements under the consortium framework.
Proposals rated Acceptable through Excellent but not immediately funded may be placed into an electronic “Basket” for up to 2 years, remaining eligible for award during that time (if funding becomes available and after review of a Full Cost Proposal and SOW).
What is the timeline to apply and when would I receive funding?
Key solicitation dates
RPP Issue Date: February 6, 2026
Virtual Teaming Speed Networking Event: February 12, 2026
Questions due: February 18, 2026 (by 1:00 PM ET) (submit via email to biomap-contracts@ati.org)
Enhanced White Papers due: March 9, 2026 (by 1:00 PM ET)
Award / performance timing
Anticipated Period of Performance: not to exceed 24 months.
Offerors should plan for PoP to begin in Quarter 3 of Government Fiscal Year 2026 (Government may change start date via negotiations).
Where does this funding come from?
Strategic oversight is provided by BARDA.
The RPP references program interests from:
ASPR IBMSC Office (Advanced Manufacturing Domain)
HHS Defense Production Act (DPA) Title III Program (with preference for projects strengthening security of supply for items on the FDA List of Essential Medicines).
Who is eligible to apply?
Minimum eligibility criteria (must meet):
You must be a BioMaP-Consortium member prior to award of a Project Agreement.
You must show demonstrated experience in scalable manufacturing of KSMs/APIs and finished product form drugs, specifically at or beyond MRL 6.
Cost share is required to be eligible (must describe amount, whether cash or in-kind, and valuation method).
What companies and projects are likely to win?
Based on the stated evaluation factors and technical objectives, the strongest submissions will typically be those that:
Propose a credible path to population-scale production (hundreds of millions of doses) with domestic production capacity.
Clearly align to the preference area: Anti-Microbials and Large Volume Parenterals.
Demonstrate capability to move from MRL 6/7 to MRL 10 with strong USP/ICH-aligned quality/compliance planning.
Present an integrated approach (automation, analytics, validation/QC, supply chain, and governance) with clear milestones and risk controls.
Show meaningful, well-supported cost share.
Bring a multidisciplinary team with relevant industrial execution experience, and (encouraged) small business utilization.
Are there any restrictions I should know about?
Yes—several are explicit:
Submission method: Enhanced White Papers must be submitted online via BIDS; no other submission methods accepted.
Deadline enforcement: Late Enhanced White Papers may not be evaluated.
Format limits: Enhanced White Paper maximum 15 pages (excluding cover page and specified appendices); mandatory template/headers required.
Domestic expansion requirement: Capacity expansion work must be executed within the continental U.S. and its Territories (per Base Agreement requirement referenced in the RPP).
DPA domestic source compliance: Offeror must be compliant with the DPA definition of a “domestic source” (50 U.S.C. 4552(7)).
Regulatory compliance: Expected compliance with relevant FDA, DEA, USP and cGMP practices.
Salary rate limitation: Direct salary above Federal Executive Schedule Level II is unallowable under the OTA.
SAM.gov / UEI: A UEI from SAM.gov is required prior to award.
Security requirements: Attachment B lists ASPR deliverables and security requirements that may be required for resulting projects.
How long will it take me to prepare an application?
What the RPP requires:
A compliant Enhanced White Paper using the mandatory template (plus required appendices).
Enough detail to be evaluated on Technical Approach/Solution, Relevant Experience, and a Cost/Price ROM estimate.
A clearly described cost share package (required for eligibility).
A credible timeline that addresses the stated Schedule Objectives (Objective A and Objective B planning within a total PoP ≤ 24 months).
Practically, teams that are already organized and have MRL 6+ manufacturing readiness typically need to pull: technical narrative, milestones, ROM build-up, teaming roles, and cost share substantiation—plus ensure consortium membership is in place prior to award.
How can BW&CO help?
BW&CO can support you by turning this RPP into a submission-ready package, including:
A compliance-driven Enhanced White Paper outline and draft aligned to Attachment A headers
A reviewer-style gap check against eligibility requirements (MRL, consortium membership timing, domestic source, cost share)
A strong Objective A/Objective B story with measurable milestones and deliverable mapping
ROM narrative support (assumptions, labor categories, subcontractor framing) and cost share packaging
Final “red team” editing for clarity and evaluator alignment.
How much would BW&CO Charge?
Fractional support is $300 per hour.
For startups, we offer a discounted rate of $250 per hour to make top-tier consulting more accessible while maintaining the same level of strategic guidance and proposal quality.
Additional Resources
Review the solicitation here.