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Medical Technology Enterprise Consortium (MTEC) -- Anti-Scar Treatment for Deep Partial-Thickness (DPT) Burns RPP
The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Proposals (RPP) focused on the development of a pharmacotherapy (i.e., drug treatment) for the acute management and prophylactic treatment of deep partial-thickness (DPT) burn wounds that is conducive to operations in combat theatre as well as fixed medical facilities. The Government seeks to rapidly advance the development of prototype drug therapy treatment(s) to U.S. Food and Drug Administration (FDA) approval for use in DPT burn-injured patients to enhance recovery, improve outcomes, and limit scarring.
The current standard of care for DPT-burn injury remains supportive in nature, based on management of symptoms, with no prophylactic and drug therapies that address the scarring. Despite numerous clinical trials on potential therapies, no drug is approved by the FDA for the prophylaxis or treatment of wound scarring. DPT-burn injury is associated with significant long-term morbidity requiring costly corrective surgeries. Up to $7.5 billion is spent annually on treatment of burns in the United States, and much of this cost is related to treatment of the resulting scar and contracture (Marshall et al., 2018, PMID: 29392092). Therefore, it is important to develop a therapy that will mitigate the life-long disability and rehabilitation costs associated with these post-injury conditions.
The United States Army Institute of Surgical Research (USAISR) has developed a novel anti-scarring therapy and demonstrated proof-of-concept in murine and swine models of DPT thermal burn. Additional information regarding this novel anti-scarring drug will be provided in the upcoming RPP. MTEC is seeking a team to accomplish the strategizing, planning, and implementation of manufacturing, IND-enabling studies, and early phase 0/1 clinical trials of this anti-scarring drug prototype developed by the USAISR.
Offerors should propose against the following technical needs and are encouraged to bring partnerships to their proposals to meet these needs. Infrastructure shall not require funding for standup. The Offeror’s team shall be led by a centralized point of contact that integrates multiple partners and the Government Steering Committee (GSC) in a comprehensive strategy for accomplishing the work.
Proposal Due Date: Feb. 28, 2019, Noon Eastern Time
Offerors must be MTEC Members in good standing.