The Biomedical Advanced Research and Development Authority (BARDA), a USG agency that operates within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), has recently released a new, modernized Broad Agency Announcement (BAA) with the goal of enhancing efficiency, improving responsiveness, and reducing time to award.
The BAA has been updated to include both revised and new areas of interest (AOIs) related to the development of medical countermeasures (MCMs), including vaccines, drugs, therapies, and diagnostic tools. A brief summary of each AOI is provided in the sections below. New AOIs include Needle-Free Technologies to Administer Licensed Vaccines (#1.1), Flexible Vaccine Manufacturing Technologies (#1.3), Uncontrolled Hemorrhage (#4.2), Radiation Injury and Trauma Pathophysiology (#4.3), and Knockdown Agents/Cellular Asphyxiants (#5.5).
The application process under the new BAA involves three stages:
- Stage 1: Pre-submission call with the AOI Technical Point of Contact.
- Stage 2: Submission of a Quad Chart/Market Research Abstract.
- Stage 3: Submission of the final proposal.
The BAA will remain open for a span of five years and will be periodically amended to reflect BARDA’s changing research and development priorities. After October 2, 2023, all submissions must be made via the BARDA Digital Resources (BDR) Portal.
AOI #1: CBRN Vaccines
- The goal of CBRN Vaccines Program is to develop vaccines for diseases like smallpox and anthrax, with an emphasis on advancements in needle-free vaccine technologies.
- Seeks to foster partnerships between vaccine sponsors and technology developers to address bottlenecks in vaccine administration and hasten the development of vaccines, notably against Sudan ebolavirus and Marburg virus.
- A preference is expressed for flexible, especially mRNA-based, manufacturing technologies that can adapt rapidly to emerging threats and do not rely heavily on ultra-low temperatures for storage.
- Proposals should focus on single-dose protection, accelerated clinical development, and technologies that are adaptable to on-demand manufacturing.
AOI #2: CBRN Antivirals and Antitoxins
- The CBRN Antivirals and Antitoxins (AVAT) program is concentrated on creating therapies against toxins from pathogens like Bacillus anthracis and variola virus, recognized as significant threats by the U.S. Department of Homeland Security.
- The program emphasizes formulating extensive strategies against anthrax, exploring next-gen antitoxins for botulinum neurotoxins, and developing antivirals for smallpox and filoviruses like Ebola, emphasizing broad-spectrum efficacy.
- Competitive proposals should feature operational improvements like non-intravenous administration and increased shelf-life, and should prioritize innovative manufacturing to reduce costs.
- Proposals should also focus on broad antiviral activity or host-directed products with potential commercial applications.
AOI #3: Antimicrobials
- The Antimicrobials Program aims to advance the development of antimicrobial drugs to counter multidrug-resistant organisms (MDROs) and biothreat pathogens to enhance national health security.
- The program prioritizes developing first-in-class, broad-spectrum antimicrobials focusing on bacterial pneumonia and fungal infections like those caused by Candida and Aspergillus.
- Competitive proposals should offer significant improvements over existing products, focus on at-risk populations, show notable development progress, and have robust commercialization and sustainability strategies.
- Special interest is given to candidates addressing infections listed as serious threats by the CDC and those that have undergone and completed some clinical development studies.
AOI #4: Radiological/Nuclear Threat Medical Countermeasures
- The Radiological and Nuclear Countermeasures Branch is developing medical countermeasures (MCMs) for severe health effects, such as Acute Respiratory Syndrome (ARS), thrombocytopenia, and vascular injury, from a nuclear detonation.
- The focus is on addressing the health consequences like radiation injuries, blast trauma, and burns resulting from acute radiation exposure.
- The program emphasizes novel therapeutics and technologies to tackle sustainability issues of blood supply during mass casualty incidents.
- Strategies to improve the safety, availability, shelf-life of blood products, and to optimize transfusion medicine are highly valued.
AOI #5: Chemical Medical Countermeasures
- BARDA’s Chemical MCM Program is focused on developing easy-to-administer medical countermeasures (MCMs) for chemical threats, prioritizing areas like pulmonary agents, opioids, and nerve agents.
- The program values innovative approaches to understanding chemical injury and seeks proposals that expand the use of already approved drugs to meet varied population needs, including vulnerable groups like infants and the immunocompromised.
- Preferred proposals will offer multifunctional treatments and address corporate sustainability and commercialization strategies.
- The program encourages proposals that incorporate cost-sharing and address the needs of diverse populations, including pregnant individuals.
AOI #6: Burn and Blast Medical Countermeasures
- BARDA’s Burn and Blast MCM program focuses on developing Medical Countermeasures (MCMs) to manage burn and blast trauma from nuclear detonation or other threats to enhance national preparedness.
- The program prioritizes innovative technologies improving efficiency in care delivery during mass casualty incidents, with emphasis on early detection, triage, and treatment, and seeks integration of MCMs into routine care for commercial sustainability.
- Candidate MCMs should address challenges in delivering care for burn or blast trauma, be supported by proof-of-concept data, and exhibit practicality, clinical benefits, and stability.
- Proposals should illustrate a comprehensive development pathway, regulatory correspondences, and a commitment to resource contribution from the Offeror in terms of cost-sharing.
AOI #7: Diagnostics
- BARDA AOI #7 focuses on fostering innovations in clinical diagnostics, emphasizing rapid, user-friendly, and FDA-compliant solutions suitable for non-laboratory settings, targeting biothreats, antibiotic resistance, influenza, and novel pathogens.
- The initiative prioritizes diagnostics that provide quick results at point-of-care and for home-use, aiming to advance beyond existing technologies in detecting various biothreat agents.
- Desired solutions should reach at least Technology Readiness Level (TRL) 4, have clinical relevance, ideally be manufacturable in the U.S., and emphasize early detection of diseases.
- Priority is given to solutions that are affordable, portable, and operable in varied environments.
AOI #8: IEID Vaccines
- BARDA, under AOI #8, is seeking proposals for innovative solutions focusing on the swift development of effective vaccines and supportive technologies to enhance preparedness against pandemic influenza and emerging infectious diseases.
- Priority is placed on vaccines that can be rapidly developed and manufactured, offer broad and lasting protection, and feature operational advantages like easy storage and administration.
- Proposals should be at or above TRL 6, supported by extensive preclinical and clinical data, evidence of scalable manufacturing, and have a clear plan for regulatory approval and commercialization.
- BARDA has a keen interest in innovations enhancing vaccine production, administration, and robust assay development for product release, aiming for rapid deployment in diverse settings to curb outbreaks.
AOI #9: IEID Therapeutics
- The IEID Therapeutics Program focuses on creating novel therapies for influenza and potentially pandemic diseases, emphasizing antivirals for outpatient settings, immune modulators for lung repair, and long-acting pre-exposure prophylaxis.
- Desired antivirals should exceed existing ones in broad strain activity and safety, with a favorable toxicology profile.
- Immune modulators or therapies should be aimed at enhancing the clinical outcomes of acute lung injuries and acute respiratory distress syndromes, with a preference for those in late-stage development or repurposed products.
- To be competitive, proposals must be well-formulated, meet distinct development and manufacturing standards, and address commercial viability and sustainability strategies.
AOI #10: ImmuneChip+
- AOI #10 focuses on the development of advanced microphysiological systems (MPS), or “organ-on-a-chip” platforms, designed to accurately simulate human tissues and their interactions under various conditions.
- These platforms should incorporate components of the human immune system and various tissues, be preferably 3-D, and allow monitoring of responses to different threat agents, adding immune components to existing MPS models.
- Proposals should demonstrate the capability to test candidate therapeutics and vaccines using human tissue models, with a preference for primary cells, organ explants, or pluripotent stem cells.
- Proposals must include well-defined milestones and commercialization plans, and those focusing on 2D tissue models or trans-well platforms are considered out of scope.
AOI #11: COVID-19 Immune Assay(s) Development and Implementation
- AOI #11 focuses on the development of advanced immunogenicity assays to analyze immune responses to licensed and developmental COVID-19 vaccines and to SARS-CoV-2 infections, considering various strains.
- Developed assays must focus on different T cell subsets and meet regulatory and quality standards, including FDA validation and documentation in the Drug Master File (DMF).
- Assays should be adaptable to new SARS-CoV-2 variants and include technology transfer plans to government-designated testing labs, ensuring adaptability.
- Offerors are required to establish laboratory testing capabilities, making sure the data from these assays are up to regulatory standards for use in vaccine clinical studies, supporting FDA EUA or BLA.
AOI #12: Flexible and Strategic Therapeutics (FASTx)
- AOI #12 seeks proposals for versatile therapeutic platforms, to include, but not limited to, bi- or multi-specific antibodies, nucleic acid expressed antibodies, Vhh/single-domain antibodies (sdAbs), double-stranded RNA-mediated interference (RNAi), antisense oligonucleotides (ASOs), and clustered regular interspaced short palindromic repeat-associated proteins (CRISPR-Cas).
- The platforms should concentrate on priority pathogens like filoviruses, orthomyxoviruses, and others, and can incorporate technologies like multi-specific antibodies and CRISPR-Cas.
- Submissions should outline plans through Phase 1 studies for a selected pathogen, considering aspects like manufacturing, regulatory paths, risks, and development timelines.
- Specific additional requirements and considerations apply for proposals focusing on SARS-CoV-2 and monoclonal antibodies, emphasizing efficacy against the newest variants and innovative manufacturing methods, respectively.
BARDA Areas of Interest Updated
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