SOLICITATION NOTICE
A -- MTEC Pre-Announcement: Development of Oral Immunotherapy for the Prevention of Bacterial Diarrheal Disease
- Notice Date
- 12/9/2021 6:29:44 AM
- Notice Type
- Presolicitation
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- W4PZ USA MED RSCH ACQUIS ACT FORT DETRICK MD 21702-5014 USA
- ZIP Code
- 21702-5014
- Solicitation Number
- MTEC-22-03-Diarrheal
- Response Due
- 1/8/2022 9:00:00 AM
- Archive Date
- 01/23/2022
- Point of Contact
- Gage Greening
- E-Mail Address
-
gage.greening@mtec-sc.org
(gage.greening@mtec-sc.org)
- Description
- The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an Other Transaction Agreement (OTA) for prototype projects Request for Project Proposals (RPP) which will be focused on the development of a prophylactic oral immunotherapy to prevent bacterial diarrheal disease. Prevention of bacterial diarrheal disease would curtail a considerable source of lost duty days. _____________________________________________________________________________________ Background: The mission of the U.S. Army Medical Research & Development Command (USAMRDC) Military Infectious Diseases Research Program (MIDRP) is to plan, coordinate and oversee for the Department of Defense (DoD) requirements-driven medical solutions that PREVENT, PREDICT, and TREAT infectious disease threats to the total force, maximizing Warfighter readiness and performance. The vision of the MIDRP is to defeat infection: prevent and/or treat naturally occurring infectious disease threats to eliminate their impacts on operational readiness of DoD personnel. MIDRP�s Endemic Diarrheal Diseases research program focuses on non-vaccine prophylactics for the prevention of endemic diarrheal diseases, with a focus on bacterial diarrheal diseases. Past conflicts demonstrate that endemic diarrheal disease contribute to significant morbidity, high logistical burden for care, and combat ineffectiveness. Acute episodes of diarrheal diseases remain a leading cause of lost-duty days and deployment hospitalizations. Deployment-related endemic diarrheal diseases continue to pose a challenge to maintaining an operationally ready and capable Joint Force in future conflicts and consistently ranks as a top infectious disease threat to military operations. Bacterial pathogens endemic to overseas locations account for the majority of diarrheal diseases in military populations. The DoD currently lacks the ability to prevent endemic diarrheal diseases to counter the impacts of illness and performance degradation in Warfighters. In addition to diarrhea, illnesses caused by these pathogens can result in vomiting, dehydration, and other debilitating symptoms for several days or more. The most prevalent bacterial pathogens are enterotoxigenic Escherichia coli (ETEC), Campylobacter, and Shigella. Despite having controlled food and water distribution practices among which military populations operate, studies have found that diarrheal illness still occurs making prevention and treatment a high priority to Combatant Commands (COCOM). Prevention, rather than treatment, is desirable to minimize lost duty days and possible sequelae following infection. To effectively prevent infectious diarrhea in the deployed setting, the U.S. military needs products and technologies that adequately address a medical syndrome caused by a wide variety of pathogen species and types. �Off-label� use of antibiotic prophylaxis with licensed antibiotics has been available for decades but is generally discouraged by medical authorities due to concerns over antimicrobial resistance as well as adverse effects from the antibiotics themselves. At this time, there is no licensed vaccine for the prevention of endemic diarrheal disease. Currently, there are no U.S. Food and Drug Administration (FDA) approved prophylactics available for use in the United States for a travelers� diarrhea indication. Therefore, the development of an oral immunotherapeutic to prevent travelers� diarrhea caused by endemic diarrheal pathogens is a priority for the MIDRP. Solution Requirements: The overall goal of this RPP will be to develop a self-administered oral immunotherapy as a prophylactic against bacterial diarrheal disease caused by multiple pathogens (including ETEC). The expected Technology Readiness Level (TRL) at the time of submission of the Enhanced White Paper proposal (see the �Acquisition Approach� section below for more details on the anticipated proposal submission requirements) is at least TRL 4 and, at the end of the Period of Performance (PoP), TRL 6/7. By the end of the PoP the performer is expected to deliver/demonstrate completion of the following: GLP-compliant studies demonstrating acceptable safety and efficacy profile in relevant animal model(s), human dose equivalent, and route of administration as intended for human use. A completed Trial Master File (TMF) based on the Drug Information Association (DIA) TMF model. The Trial Master File shall allow for remote review by the government throughout the award. Phase 1 and/or Phase 2 clinical trial data demonstrating adequate safety profile in optimized dose and schedule. An adequately defined, detailed regulatory pathway towards a Medical Device, Biologics License or New Drug Application, including (but not limited to) a Phase 2 or Phase 3 study plans validated by formal communication with the FDA. In addition, the performer must provide evidence that production is capable of scale up and available quantities of the product are adequate to support the remainder of clinical development. The oral immunotherapy product must have demonstrated stability and have a long shelf life for the potential to be used directly by the Warfighter in austere environments. Scope of Work: The following technical requirements are required to be delivered/demonstrated by the end of the proposed PoP. Therefore, Offerors shall address within the Enhanced White Paper proposal submission how and when each of these will be accomplished during the PoP. An ideal solution would meet the following requirements (not listed in order of importance): [Note: Although Enhanced White Papers that propose to meet all of the product requirements outlined below are preferred, the Government may consider responses demonstrating only a portion of the final product attributes if the team�s approach can address how the remaining requirements can be met over time. Therefore, it is expected that an Offeror�s Enhanced White Paper will describe in detail what they plan to accomplish and how they plan to satisfy all of the product requirements either during the proposed PoP or beyond that period (Offerors should specify the projected timeline), as applicable.] An immunotherapy product in an oral formulation for delivery to the gut. An oral immunotherapy product that prevents diarrhea attributable to ETEC and one or more other pathogens with evidence that multiple pathogens are feasibly targeted. The oral immunotherapy product would be self-administered, before or during deployment, offering protection throughout a routine deployment period (6 weeks � 6 months). The requiring activity (or end user) seeks to minimize in-theater dosing. If it must be administered in the field, three doses per day is the maximum frequency sought. Demonstration of less than three doses per day is highly favorable. Requirements for administration and re-supply storage must be consistent with prolonged care in austere environments, where evacuation and logistics capabilities will be minimal. The immunotherapy product: (1) would have ease of use (administration, easy-open packaging, components, suspension needs), (2) be usable and efficacious in austere environment conditions (packaging should maintain integrity in wide temperature ranges between 0-45�C, and in conditions of high and low humidity), (3) be small and lightweight without the need for additional logistic considerations, e.g., cold/warm storage, impact protection, additional supplies/products to enable use (for example �water based suspensions). At the end of the PoP, the Offeror(s) is expected to have successfully achieved the following milestones: Completed studies which refine and optimize the prototype immunotherapy to prevent endemic diarrheal disease: Completed proof of concept efficacy studies, dose-dependent efficacy studies (studies to minimize dosing while maintaining efficacy) Completed Good Laboratory Practice (GLP) compliant studies demonstrating sufficient safety and efficacy profile in relevant animal model(s), human dose equivalent, and route of administration as intended for human use Completed IND-enabling studies, including in vivo toxicity studies (if needed), human tissue cross reactivity studies, and stability studies A completed Phase 1 and/or Phase 2 clinical trial demonstrating adequate safety and preliminary efficacy profile against all target pathogens in optimized dose and schedule All completed clinical studies shall be reported in a Final Clinical Study Report following ICH E3 Structure and Content or its current iteration. Evidence that production is capable of scale up and available quantities of the product are adequate to support the remainder of clinical development Demonstrated stability of product(s) for at least one year at 0-45�C and under conditions of low and high humidity. Offerors should put accelerated conditions in their stability protocol to demonstrate limits of the technology A defined regulatory pathway: An adequately defined, detailed regulatory pathway towards a Medical Device, Biologics License or New Drug Application, including (but not limited to) Phase 2 and/or Phase 3 study plans validated by formal communication with the FDA. Additional Points of Consideration: Within the Enhanced White Paper, offerors must identify and describe any existing/previous industry or DoD partnerships. The Offeror must describe the role each partner had in existing/previous projects (including any resultant contracts/grants/awards and/or IP). Partnership with industry or the USG/DoD is not a requirement for award but must be identified. Potential Follow-On Tasks: There is potential for award of one or more follow-on tasks based on the success of any resultant Research Project Awards (subject to change depending upon Government review of completed work and successful progression of milestones). Note that any potential follow-on work is expected to be awarded non-competitively to resultant project awardees. Potential follow-on tasks include (but are not limited to) procurement and fielding of the oral immunotherapy product for the prevention of bacterial diarrheal disease. Potential Funding Availability and Period of Performance: The U.S. Government (USG) Department of Defense (DoD) currently anticipates $4.0 Million (M) for this upcoming program. The USG may apply additional dollars for follow-on efforts via post award modification to any resultant award(s) after the evaluation and acceptance of work and cost plan. Dependent on the results and deliverables, additional time may be added to the period of performance for non-competitive follow-on tasks. MTEC expects to make a up to two awards to qualified Offerors to accomplish the scope of work. However, as part of the award recommendations, if a single proposal is unable to sufficiently address the entire scope of the RPP, several Offerors may be asked to work together in a collaborative manner. See the �MTEC Member Teaming� section below for more details. The Period of Performance (POP) is not to exceed four years. Acquisition Approach: This upcoming RPP will be conducted using the Enhanced White Paper approach. In Stage 1, Offerors are invited to submit Enhanced White Papers using the mandatory format contained in this upcoming RPP. The Government will evaluate Enhanced White Papers and select those that best meet their current priorities using the evaluation criteria described in the upcoming RPP. Offerors whose proposed solution is selected for further consideration based on the Enhanced White Paper evaluation will be invited to submit a full cost proposal in Stage 2. Notification letters will contain specific Stage 2 proposal submission requirements. This upcoming RPP will be posted to the MTEC website (mtec-sc.org) and a summary version will be available on sam.gov to notify interested parties. The RPP is expected to be released as soon as possible and will have a short proposal preparation period (approximately 30 days). MTEC membership is required for the submission of an Enhanced White Paper in response to this upcoming MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/. MTEC Member Teaming While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to proposal submission) if they cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government. MTEC members are encouraged to use the MTEC Database Collaboration Tool to help identify potential teaming partners among other MTEC members. The Database Collaboration Tool provides a quick and easy way to search the membership for specific technology capabilities, collaboration interest, core business areas/focus, R&D highlights/projects, and technical expertise. Contact information for each organization is provided as part of the member profile in the collaboration database tool to foster follow-up conversations between members as needed. The Collaboration Database Tool can be accessed via the �MTEC Profiles Site� tab on the MTEC members-only website. MTEC The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting life cycle management to transition 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� defense contractors, academic research institutions and not-for-profit organizations. Point of Contact For inquiries regarding this pre-announcement, please direct your correspondence to Dr. Gage Greening, MTEC Biomedical Research Associate, gage.greening@mtec-sc.org�
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/1dce934ebf7b44f1a207aef834300d20/view)
- Place of Performance
- Address: Frederick, MD 21702, USA
- Zip Code: 21702
- Country: USA
- Zip Code: 21702
- Record
- SN06194680-F 20211211/211210201442 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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