Under the Project BioShield Act (2004) (PDF - 121 KB), Pandemic and All-Hazards Preparedness Act (2006) (PDF -248 KB), BARDA was charged with developing medical countermeasures (MCMs) to address material threats to the United States as determined by the Department of Homeland Security (DHS). The detonation of an improvised nuclear device (IND) in a metropolitan area is one such material threat which can have substantial medical consequences including trauma, radiation syndromes, and burn injuries. In alignment with the PHEMCE Strategy and Implementation Plan and the BARDA Strategic Plan (PDF - 2.31 MB), BARDA’s Burn Medical Countermeasures (MCM) Program addresses this threat and the treatment bottlenecks likely to be faced in a mass casualty by identifying and supporting the advanced development of MCM candidates with specific attributes. This program aims to improve burn treatment across the burn care spectrum by supporting MCM candidates that (when combined and incorporated into the mainstream marketplace) have broad, synergistic, and sustainable impact. Enhancing the spectrum of burn injury treatments will increase our preparedness and capacity to respond to the immediate, field care needs of patients after an IND event, as well as those needing further definitive care in hospital settings. Better triage and field care could also reduce patient surges into hospital settings, and new products under development would give burn care facilities more time, reduce burden and manage resources to treat those with the most serious injuries.
Given the complex injury progression and treatments necessary in burn care, no one product prepares us to meet the diverse needs of burn patients. To solve these unique challenges in mitigating burn injuries, BARDA’s Burn Program has leveraged knowledge gained from proactive engagement with the end-user community (from first responders to burn surgeons). Through these engagements, BARDA defined a continuum of definitive burn care that has the potential to synergistically improve burn care through the development of multiple well-targeted MCM candidates. BARDA’s current investment in products which target different areas of this continuum could enable the end-users to provide better quality care and value at a potentially lower overall cost. BARDA’s Burn Program currently supports the advanced development of seven (7) MCM candidates towards FDA approval and includes four (4) products supported under Project BioShield in 2015. Each of these products targets a unique aspect of burn injury, ranging from field to definitive care environments. Product candidates include antimicrobial barrier dressings that prevent infection, enzyme-enhanced wound debridement tools, and wound imaging technologies that can improve surgery outcomes for patients needing skin grafts. The near-term program focus is on ensuring regulatory approval for the new burn care treatments and positioning them for adoption in common clinical practice. Towards this end, BARDA supports use of products under Compassionate Use as well as Expanded Access programs when allowed by the FDA. These approaches save lives and engender clinical use prior to product approval. The program will also continue to explore synergies by combining treatments developed across the burn care continuum. Long-term plans include establishing a resilient burn care infrastructure by integrating products into commercial adoption to decrease the need for USG stockpiling. BARDA has also carefully chosen these candidates based on their potential for other clinical indications. By encouraging the adoption of candidate products into clinical practice for use in allied treatments (e.g., diabetic foot ulcers), BARDA will ensure their commercial sustainability while developing a bigger cache of products for use in a public health emergency.
Under the Burn Program, BARDA is also identifying candidates that mitigate cutaneous radiation injuries (CRI) which have a distinct etiology and result from exposure of skin to radiation, a likely scenario in an IND detonation. The Burn Program also works collaboratively with the Chemical Program and the new National MCM Response Infrastructure to evaluate thermal burn MCM candidates for their efficacy to also treat chemical burns resulting from exposure to agents like sulfur mustard. BARDA will continue to explore and leverage synergies by supporting development and regulatory approval of treatments across the burn care continuum. Long-term plans include establishing a resilient burn care infrastructure by integrating products into commercial adoption to decrease the need for stockpiling by the U.S. Government.