|Agency:||Department of the Army|
|Type of Government:||Federal|
|Posted Date:||Dec 12, 2018|
|Due Date:||Jan 11, 2019|
|Bid Source:||Please Login to View Page|
|Contact information:||Please Login to View Page|
|Bid Documents:||Please Login to View Page|
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.
1) Technical need for expertise in selecting dosage formulation (e.g., emulsion, film) and manufacturing of topical drug products; IND-enabling studies, including strategy, planning, and execution; chemistry, manufacturing, and control (CMC); and, clinical strategy and protocol development and implementation of early clinical trials (Phase 0 and/or Phase 1) for wound healing treatments, including patient recruitment, clinical trial data management, interactions with FDA for regulatory compliance - for assessing safety, tolerability, and potential efficacy.
2) Existing clinical trial centers with a proven history of burn-wound patient recruitment and integration of Contract Resource Organization, with infrastructure already in place with no funding needed for standup.
3) Team of subject matter experts that shall produce and design standardized, exploratory and adaptive studies to answer, dose, duration of treatment, pharmacokinetics (PK), and pharmacodynamics (PD) status of the drug prototype(s) in wound-injured subjects.
4) Determine evaluation criteria and strategy (cost, schedule, feasibility, pre-clinical data analysis, etc.) for the entire advanced development after dose-ranging animal studies and up to and including Phase 0, 1, and/or Phase 2 clinical trials.
5) Determine and defend study design concepts for anti-scar drugs including type of wounds and dosage, methods for analysis, and population enrichment.
6) Describe and determine criteria for moving promising anti-scar drug therapy prototypes further into advanced development.
7) Determine strategy and manage relationships among partners including non-disclosure agreements, intellectual property rights, regulatory sponsorship and strategy, indications for use, anticipated or known side effects with current standard of care for wounds, and regulatory milestones for FDA approval.
8) Determine evaluation criteria and strategy for anti-scar treatment manufacturing timeline and costs, methods to ensure Good Manufacturing Processes, product quality assurance and testing, strategy for initial manufacturing lots for clinical trial testing, long term manufacturing and sustainment.
The end-goal of the work funded by this upcoming RPP is the completion of a Phase 0/1 clinical trial.
Potential Funding Availability:
The U.S. Department of Defense (DoD) currently has available approximately $2 Million (M) for this effort. A period of performance of up to 4 years is allowable, but a faster timeline is acceptable. It is expected that MTEC will make a single award to a qualified team to accomplish all tasks.
The MTEC will use a streamlined, accelerated approach for this acquisition. This approach will consist of the following steps:
Step 1: MTEC members who wish to offer a solution to the RPP must submit a Solutions Brief. The Solutions Brief will contain the MTEC Offeror's technical concept and approach along with their viability toward the specific effort. To meet the statutory requirement of the Other Transaction Authority, Offeror Solutions Briefs will also have to address the significant participation of a Nontraditional Defense Contractor or Nonprofit Research Organization on the team or the willingness to provide 1/3 cost share to the project. The Offeror will also be expected to present a rough order of magnitude (ROM) cost and schedule.
Step 2: As part of the Government review of the Solutions Brief, MTEC members who have submitted a favorable Solutions Brief based on the RPP criteria may be invited to present and discuss their solution with the Government sponsors for the research via a virtual or in-person "pitch" of the proposed project along with a SOW/Milestone Payment Schedule and cost information.
Step 3: MTEC Offeror(s) will be notified of the down select recommendation(s), and if selected, will be invited to submit a detailed Cost Proposal in accordance with the MTEC Proposal Preparation Guide (PPG).
Because of the nature of the requirements set forth in the forthcoming RPP, this streamlined, interactive approach is anticipated to be a better means to highlight company methodologies and skills and allow the government to gain a fuller appreciation of the work required to be completed. It provides more freedom and initiative to the Offeror to describe how they would approach and solve such an action. The full description of this contracting approach will be included in the RPP.
The MTEC mission is to assist the U.S. Army Medical Research and Materiel Command (USAMRMC) by providing cutting-edge technologies and supporting the transition of medical solutions to industry that protect, treat, and optimize Warfighters' health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, "nontraditional" government contractors, academic research institutions and not-for-profit organizations.
The upcoming RPP will be posted to the MTEC website (mtec-sc.org) and a notice will be posted on FedBizOpps (fbo.gov) to notify interested parties. MTEC membership is required for the submission of a Solution Brief in response to this upcoming MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/.
For inquiries regarding this pre-announcement, please direct your correspondence to the following contacts:
? Technical questions - Dr. Lauren Palestrini, MTEC Director of Research, email@example.com
? Administrative questions - Ms. Kathy Zolman, MTEC Program Manager, firstname.lastname@example.org
? Membership questions - Ms. Stacey Lindbergh, MTEC Executive Director, email@example.com
|Jan 17, 2019||[Special Notice] Anti-Scar Treatment for Deep Partial-Thickness (DPT) Burns|
|Feb 8, 2019||[Special Notice] Anti-Scar Treatment for Deep Partial-Thickness (DPT) Burns|
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