With BARDA Industry Day kicking off on November 3, 2021, new opportunities abound for organizations supporting the pandemic response. These include an updated BARDA Broad Agency Announcement (“BAA”), a new Commercial Solutions Opening (“CSO”) from the Department of the Air Force Acquisition COVID-19 Task Force (DAF ACT) with three new Areas of Interest, and a potential for $1,300,000,000 in additional funding in the Build Back Better Act, otherwise referred to as the reconciliation bill.
Funding Opportunities with Updates to BARDA BAA
Sweeping changes were incorporated into the BAA in the last few weeks. Those changes included the following:
1. Updates to Area of Interests 1 CBRN Vaccines
- Revised 1.2 Ebola and Marburg virus
- Deleted 1.3 Antimicrobial Resistant Threats
2. Updates to Area of Interest #2: CBRN Antivirals and Antitoxins
- Revised 2.1 Anthrax Antitoxins
- Revised 2.2 Botulism Antitoxins
- Revised 2.3 Smallpox Antiviral
- Deleted 2.4 Viral Hemorrhagic Fevers Antiviral
- Added New 2.4 Filovirus Therapeutics
3. Updates to Area of Interest #3: Antibacterials
- Deleted 3.1 Develop antibacterial products for post exposure prophylaxis (PEP) and treatment of one or more biothreat pathogens
- Deleted 3.2 Develop new drugs that treat or prevent resistant bacterial infections either alone or in combination with other therapeutics
- Deleted 3.3 Develop non-traditional therapeutics that treat or prevent resistant infections
- Added New 3.1 Develop products for treatment of MDROs and biothreat pathogens
4. Updates to Area of Interest #4: Radiological/Nuclear Threat Medical Countermeasures
- Revised 4.1 Advanced Development of MCMs to treat radiation injury due to acute exposure to ionizing radiation
- Revised 4.2 Blood Products
5. Updates to Area of Interest #5: Chemical Threat Medical Countermeasures
- Revised 5.1 Pulmonary Agents
- Revised 5.2 Opioids
- Revised 5.3 Vesicants
- Revised 5.4 Blood/Metabolic Agents
- Revised 5.5 Nerve Agents and Organophosphorus (OP) Pesticides
- Revised 5.6 Novel MCM Delivery Mechanisms
6. Updates to Area of Interest #6: Burn Medical Countermeasures
- Deleted 6.1 Non-autologous products to prevent or reduce burn wound conversion
- Deleted 6.3 Products promoting wound closure
- Deleted 6.4 Products for temporizing burn injuries
- Deleted 6.5 Countermeasures for Cutaneous Radiation Injuries (CRI)
- Deleted 6.6 Products for treatment of pulmonary inhalation and blast related injuries
- Added New 6.1 Enabling Technologies to Address General Burn & Blast Traumatic Injuries
- Added New 6.2 Head & Neck Injuries in Trauma
- Added New 6.3 Detection and Management of Internal or External Hemorrhage from Non-Compressible Trauma Wounds
- Added New 6.4 Detection and Management of Airway Access Complications in Trauma
- Added New 6.5 Non-autologous topical products to prevent or reduce burn wound conversion (defined as a worsening of a burn wound from its original depth)
7. Updates to Area of Interest #7: Diagnostics
- Revised 7.2 Biothreat Agent Diagnostics
- Revised 7.3 Antibiotic Resistance Diagnostics for priority bacterial
- Revised 7.4 Radiation Exposure (Biodosimetry) Diagnostics
- Revised 7.6 Influenza Diagnostics
- Revised 7.7 Emerging Diseases Diagnostics
- Revised 7.8 Sequencing System Development
8. Updates to Area of Interest #8: Influenza and Emerging Infectious Diseases (IEID) Vaccines
- Revised 8.2 Innovative vaccine production enhancements
9. Updates to Area of Interest #9: Influenza and Emerging Infectious Diseases (IEID) Therapeutics
- Revised 9.1 Influenza Antiviral Therapeutics
- Deleted 9.2 COVID-19 Therapeutics
- Revised 9.3 Immunomodulators or therapeutics targeting lung repair
- Deleted 9.4 Innovative approaches to improve clinical trial execution for hospitalized influenza patients
10. Deleted Area of Interest #10
- Respiratory Protective Devices
11. Deleted Area of Interest #11
- Ventilators
12. Deleted Area of Interest #13
- Modeling as an Enabling Technology for Influenza, Emerging Infectious Disease, and CBRN Threats
13. Deleted Area of Interest #14
- Visual Analytics an Enabling Technology for Influenza, Emerging Infectious Disease, and CBRN Threats
14. Area of Interest 10-17
- Renumbered to remove deleted AOIs.
15. Extended Submission
- This amendment extends the submission deadline to May 2, 2022
16. Adds Part IV K
- Implementation of Executive Order 14042
Department of the Air Force Acquisition COVID-19 Task Force CSO
A new CSO was issued that will focus on the replenishment of the Strategic National Stockpile (SNS) and expand and preserve the domestic manufacture of key medical personnel protective equipment (PPE) items, screening and diagnostics instruments and supplies, finished drugs and active pharmaceutical ingredients and the associated finishing and delivery capabilities.
The Department of the Air Force Acquisition Task Force will lead rapid solicitation and execution of contracts in support of their mission. They anticipate soliciting solution briefs through separate and periodically published Areas of Interest (AOI) to meet Department of Health and Human Services (HHS) COVID-19 response priorities, with an emphasis on SNS goals that achieve (1) more coverage to ensure sufficient inventory of major PPE, equipment and drugs associated with COVID-like pandemics, (2) greater insight to forecast requirements, (3) use various inventory management strategies and improved visibility into supply and demand, and (4) enhance manufacturing capacity to reduce dependency on foreign sources of supply.
Currently, three AOIs have been published. Those are as follows:
- AOI 1: NBR Domestic Production of Raw Glove Material
- AOI 2: Key Chemicals for Domestic Production for NBR
- AOI 3: N95 Respirator Domestic Production Capacity Preservation
Build Back Better Act
The new Build Back Better Act, or the Reconciliation Bill, appropriates $1,300,000,000 of funding in Fiscal Year 2022 for a variety of needs:
- To support surge capacity, including through construction, expansion, or modernization of facilities, to respond to a public health emergency, and for development, procurement, and domestic manufacture of drugs, active pharmaceutical ingredients, vaccines and other biological products, diagnostic technologies and products, medical devices (including personal protective equipment), vials, syringes, needles, and other components or supplies for the Strategic National Stockpile.
- To support expanded global and domestic vaccine production capacity and capabilities, including by developing or acquiring new technology and expanding manufacturing capacity through construction, expansion, or modernization of facilities.
- To support activities to mitigate supply chain risks and enhance supply chain elasticity and resilience for critical drugs, active pharmaceutical ingredients, and supplies (including essential medicines, medical countermeasures, and supplies in shortage or at risk of shortage), drug and vaccine raw materials, and other supplies, as the Secretary determines appropriate, including construction, expansion, or modernization of facilities, adoption of advanced manufacturing processes, and other activities to support domestic manufacturing of such supplies;
- To support activities conducted by the Biomedical Advanced Research and Development Authority for advanced research, standards development, and domestic manufacturing capacity for drugs, including essential medicines, diagnostics, vaccines, therapeutics, and personal protective equipment; and
- To support increased biosafety and biosecurity in research on infectious diseases, including by improvement of facilities.
It is evident that this administration is focused on facilities, domestic capacity, and domestic manufacturing, all of which will lead to thousands of new jobs here in the US and new funding opportunities. If this bill passes, there will be substantial activity at both BARDA and other Agencies to spend this appropriation in this fiscal year, so planning white papers and solutions briefs now is key.