Published on 16/11/2017
The Biomedical Advanced Research and Development Authority (BARDA) is soliciting proposals for the advanced research and development of medical countermeasures (MCM) as part of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).
The Broad Agency Announcement (BAA-18-100-SOL-00003) aims for advanced research and development of MCMs for chemical, biological, radiological, nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases.
Research and development general areas of interest include:
- CBRN Vaccines
- Antitoxins and Therapeutic Proteins
- Radiological/Nuclear Threat Medical Countermeasures
- Chemical Threat Medical Countermeasures
- Burn Medical Countermeasures
- Influenza and Emerging Infectious Diseases (IEID) Vaccines
- Influenza and Emerging Infectious Diseases (IEID) Therapeutics
- Respiratory Protective Devices
- MCM Production Platform Systems
- Modeling as an Enabling Technology for Influenza, Emerging Infectious Disease, and CBRN Threats
- Visual Analytics an Enabling Technology for Influenza, Emerging Infectious Disease, and CBRN Threats
BARDA priorities for influenza vaccines are focused on those vaccines that induce long-lasting and broad (heterotypic and/or heterosubtypic) immunity in all populations compared to currently licensed influenza vaccines. Also, BARDA will prioritize support for vaccines that induce broad immunity to prime the population against newly emerging influenza viruses or other respiratory viruses of pandemic potential.
BARDA is also prioritizing broadly reactive immunotherapeutics, such as monoclonal antibodies, that will be effective in treating severely ill, hospitalized patients of all ages who infected with influenza or other emerging infectious diseases. Such therapeutics will demonstrate effectiveness when given later than 48 hours after onset of symptoms.
Select Agent Vaccines
BARDA is interested in advanced development projects for monovalent vaccines against Sudan ebolavirus and Marburg virus. The proposed vaccine candidate must have demonstrated protection from lethal challenge in non-human primate studies. The objective of this program is to advance projects through the end of Phase 2 clinical development.
Programs are sought to expand the availability of licensed anthrax and smallpox vaccines for at-risk populations, e.g., pediatric populations.
Select Agent Antitoxins and Therapeutic Proteins
Also of interest is the development of peptide or small molecule antitoxins, and other novel compounds, with innovative formulations offering enhanced long-term stability; viral hemorrhagic fevers therapeutics; and antibody treatments and other therapeutic agents against smallpox.
Select Agent Antibacterials
Post-exposure prophylaxis (PEP) and treatment efficacy against one or more of the following biodefense threat agents: Bacillus anthracis, Yersinia pestis, Francisella tularensis, Burkholderia mallei, and Burkholderia pseudomallei.
Of interest are new small molecule drugs that treat or prevent resistant bacterial infections either alone or in combination with other therapeutic; and development of non-traditional antibacterial therapeutics that treat or prevent resistant infections.
Examples include, but are not limited to antibody-based approaches, host-directed therapies including immune modulators, antimicrobial peptides, bacteriophage, microbiome approaches, and inhibitors of quorum sensing or expression of a bacterial virulence factor.
Diagnostics – Select Agents and CBRN Threats
BARDA seeks advanced development, clinical evaluation, and FDA clearance/approval of rapid, accurate POC diagnostic systems for the following threat agents: Bacillus anthracis (anthrax), Botulinum toxin (botulism), Burkholderia mallei (glanders) and Burkholderia pseudomallei (melioidosis), ebolaviruses and Marburg virus, Francisella tularensis (tularemia), Rickettsia prowazekii (typhus), Yersinia pestis (plague) and smallpox (orthopox genus virus assays acceptable).
Other highlighted areas of interest for advancing diagnostics include:
- Development and evaluation of innovative sample collection devices
- Novel device technology that helps move diagnostics closer to POC and home use
- Characterization of host biomarkers of early infection that would apply to biothreats and influenza and may also have utility for emerging diseases
- Wearable biometric sensors or monitors that can reliably detect clinically relevant biomarkers that are detectable in early stages of disease/infection
- Development of improved assay chemistry for shorter testing times, improved sensitivity/specificity, higher throughput and reduced cost and footprint
- Automated, high-throughput diagnostic assays for determining infection
- Antibiotic resistance diagnostics for priority bacterial pathogens
Also of priority interest is the development of radiation exposure (biodosimetry) diagnostics. Chemical agent diagnostics are not specifically sought in this BAA.
Diagnostics – Influenza
Supported influenza assays must provide results that prompt early consideration for antiviral drug use, and at a minimum, differentiates Influenza A and B. Development should include evaluation of reactivity to emerging novel, avian and swine influenza viruses.
Advanced development, clinical evaluation and FDA clearance/approval of CLIA waivable, low-cost influenza diagnostic tests suitable for use in POC settings are sought. These systems must differentiate Influenza A and B viruses, and seasonal influenza A viruses from non-seasonal influenza viruses.
Additionally, BARDA seeks rapid identification of novel influenza viruses, human-animal reassortant influenza viruses, or emerging respiratory viruses with the goal to identify and diagnose both seasonal and novel influenza infections. Methods such as targeted or whole genome nucleotide sequencing that can be readily used in clinical laboratory settings may be proposed.
Radiological/Nuclear Threat Medical Countermeasures
BARDA prioritizes MCMs that have the potential to treat multiple relevant indications or multiple threat areas (e.g., radiation injury combined with mechanical trauma; radiation and chemical injury).
Novel therapeutics to address thrombocytopenia due to acute exposure to ionizing radiation are sought, as are MCMs addressing systemic injury responses due to acute exposure to ionizing radiation. Priority target pathways include coagulopathy, fibrinolysis, vascular injury, and sepsis.
Repurposing of already approved therapies for a new Acute Radiation Syndrome (ARS) indication or advanced development of new therapies is also a priority. Desirable MCM characteristics to improve flexibility and usability in a mass casualty incident include ease of storage (e.g., storage at room temperature), favorable deployment and route of administration, and efficacy when administered a minimum of 24 hours or later after a radiation exposure.
BARDA seeks development of cell products derived from stem-cells and their progenitors to produce safe and non-alloimmunizing human red blood cell, platelet, or white blood cell products for use in transfusing humans.
Technologies for reliably producing hematopoietic stem cells and their progenitors, including optimization of directed differentiation and engraftment of functional and safe hematopoietic cells, are also sought.
The BAA supports the development of decorporation agents, which are either passive or active chelators. BARDA will continue to fund projects to support advanced research and development of Prussian blue formulations appropriate for children under the age of two years.
Burn Medical Countermeasures
BARDA has a responsibility to treat burn injuries and associated complications effectively in the civilian population resulting from natural calamities as well as various threats such as the detonation of a nuclear device.
Thermal burn product areas of specific interest include:
- Products to prevent or control burn wound conversion
- Smart imaging systems which are non-invasive and portable which can identify burn depth and assess wound healing potential without further intervention such as grafting.
- Products promoting wound closure
- Products for temporizing burn injuries
- Countermeasures for cutaneous radiation injuries
- Products for the treatment of inhalation injuries
Chemical Threat Medical Countermeasures
MCMs are sought that treat the acute health effects of chemical threats, are easy to administer in a mass-casualty situation, and are rapidly effective as post-exposure therapies.
Of specific interest are the following types of MCMs:
- Pulmonary Agents: Development of MCMs to prevent and treat lung damage (including pulmonary edema and fibrosis) resulting from exposure to agents such as chlorine and phosgene.
- Vesicants: Development of MCMs that limit harmful aspects of exposure to vesicating agents such as sulfur mustard and Lewisite. Needs include MCMs designed to treat lung, skin, and ocular as well as systemic effects.
- Blood/Metabolic Agents: Development of MCMs to treat acute poisoning from agents such as cyanides. Antidotes should be easily administered by first responders in personal protective equipment. Preference is given to those cyanide antidotes that are also effective against smoke inhalation-related exposure.
- Nerve Agents and Organophosphorus (OP) Pesticides: Development of MCMs to treat seizures that are refractory to treatment with benzodiazepines. These drugs, in most cases, will be used after benzodiazepine therapy has failed.
BARDA also seeks development of novel delivery methods of administration for new and existing chemical threat MCMs. The candidates should be amenable to use by emergency medical personnel or first responders dealing with large numbers of exposed individuals in mass casualty situations.
Respiratory Protective Devices (RPDs)
Support for advanced development of improved RPDs such as masks, surgical masks, PAPRs, elastomeric masks, elastomeric half mask, or respirators to reduce transmission of influenza virus and other infectious agents. These RPDs should demonstrate improved features over currently available products.
Examples of desirable improvements include reduced cost to order and stockpile, ability to decon and re-use, improved comfort, and fit flexibility to support a broad population.
All proposed products must have a clear path to NIOSH certification and FDA clearance as applicable. Proposed activities should offer beneficial clinical and public health impact with a TRL 4 or greater.
A Quad Chart and White Paper may be submitted on any day during the open period of the BAA. Submission deadlines are as follows:
- January 31, 2018
- April 30, 2018
- July 31, 2018
- October 31, 2018
- January 31, 2019
- April 30, 2019
- July 31, 2019
- October 31, 2019
Further details are available via Solicitation Number: BAA-18-100-SOL-00003 on FBO.gov.