Attachment A - Statement of Objectives

Attachment A – Statement of Objectives (SOO)
Statement of Objectives (SOO)
for
Battlefield Wound Infection Prevention and Treatment (BWI P&T) Barrier Combination (BC)

1.0 PURPOSE

The purpose of this requirement is for the development of a Barrier Combination product in support of the Battlefield Wound Infection Prevention and Treatment (BWI P&T) program. The Barrier Combination product is defined as being composed of both a physical barrier to protect a wound and an antibacterial and/or antifungal activity released from the barrier to prevent the spread of organisms and avoid systemic infections. This requirement aims to advance the development of novel medical countermeasures for the treatment of battlefield wounds. Technologies starting at a Technology Readiness Level (TRL) 5 or higher are preferred to achieve this goal.
Work under this requirement is intended to result in one award (i.e. Other Transaction Agreement (OTA)) for a prototype for a Barrier Combination product, which shall include Food & Drug Administration (FDA) regulatory communications, Chemistry, Manufacturing, and Controls (CMC) of Drug Substance and Drug Products, and clinical trials.
Upon prototype completion of Objective 3, the Government intends to assess whether this prototype is successful for a separate follow-on production acquisition between the Government and the Performer. Success is established when the Performer: (1) met the “key technical goals” of the prototype project, (2) satisfied “success metrics” incorporated into the pOTA and/or (3) accomplished a particularly favorable or unexpected result that justifies the transition to production.
All data is anticipated to support a future New Drug Application (NDA), Premarket Approval Application (PMA) and anticipated FDA approval and/or clearance. It is the government preference that the Prime Performer serve as the Regulatory Sponsor.

2.0 BACKGROUND

The BWI P&T program is focused on identifying potential medical products for maturation that can prevent and treat infections in wounds sustained in combat. Current battlefield wound management care is governed based on the possibility of timely evacuation of wounded Service Members to a higher echelon of care. However, it is anticipated that future combat operations will require prolonged casualty care rather than immediate evacuation. Organisms commonly cultured from BWI include both bacterial and fungal species, and some are difficult to treat with