MODIFICATION
A -- Military Infectious Disease - Prototype Innovation Program (MID-PIP) - Amendment 1
- Notice Date
- 9/4/2019
- Notice Type
- Modification/Amendment
- NAICS
- 54171
— Research and Development in the Physical, Engineering, and Life SciencesT
- Contracting Office
- Department of the Army, US Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- MTEC-19-10-MID-PIP
- Archive Date
- 10/23/2019
- Point of Contact
- Rebecca Harmon,
- E-Mail Address
-
rebecca.harmon@ati.org
(rebecca.harmon@ati.org)
- Small Business Set-Aside
- N/A
- Description
- Amended FBO Notice This amendment extends the due date to October 8, 2019. The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Proposals (RPP) focused on the development of the following 4 prototypes: • FOCUS AREA #1 (Diagnostic): A point-of-care device to detect the presence of microbial infection. • FOCUS AREA #2 (mAbs): Generation of high affinity monoclonal antibodies to four bacterial antigens for the prevention and treatment of bacterial wound infections and sepsis. • FOCUS AREA #3 (HIV): A single administration escape-resistant therapy for human immunodeficiency virus (HIV) control. • FOCUS AREA #4 (Biofilm): Clinical evaluation of products to treat biofilm-mediated antibiotic-resistant infections in non-healing chronic wounds PROGRAM BACKGROUND: The U.S. Army's Military Infectious Diseases Research Program's (MIDRP's) mission is to plan, coordinate and oversee for the U.S. Department of Defense (DoD), a focused and responsive world class infectious diseases Science and Technology (S&T) program, leading to fielding of effective, improved means of protection and treatment to maintain effective global operational capability by maximizing Warfighter readiness and performance. DETAILED REQUIREMENT: The MIDRP has identified four focus areas for funding under the Military Infectious Disease - Prototype Innovation Program (MID-PIP). To meet the intent of this RPP, each proposal MUST specifically address only ONE of the four MID-PIP Focus Areas described below. Offerors are not limited to a single proposal submission. It is expected that MTEC will make a total of 4 awards - a single award for each focus area. 1) FOCUS AREA #1 (Diagnostic): A point-of-care device to detect the presence of microbial infection. OBJECTIVE: Delivery of a diagnostic device to detect physiological status as related to medical readiness in an individual. DESCRIPTION: A Point-of-Care (PoC) device that performs real-time monitoring of an individual's physiological status using minimally-invasive techniques. The physiological status is to be monitored for "active microbial infection" status. The device should be painless, easy to apply and remove from the skin, and should use no power source. The device and associated reagents should be shelf stable for at least one year at ambient temperatures and should have a low footprint. The device should be coupled to a lateral flow assay or a similar low-complexity (potentially CLIA-waived) device to detect molecules that provide reliable information on the infection status of the individual. The device should provide results within 30 minutes, with the results being easy to interpret by non-laboratory personnel. Information obtained from the device would be used to determine the status of medical readiness of deployable/deployed personnel. During the PoP, the Awardee will be expected to develop a working prototype, perform testing in animals, and perform a preliminary evaluation in humans. 2) FOCUS AREA #2 (mAb): Generation of high affinity monoclonal antibodies to four bacterial antigens for the prevention and treatment of bacterial wound infections and sepsis OBJECTIVE: Generation of at least four monoclonal antibody products against two Staphylococcus aureus and two Pseudomonas aeruginosa targets ready for testing in preclinical wound models. DESCRIPTION: A cocktail of monoclonal antibodies against at a minimum of two antigens of Staphylococcus aureus and two antigens of Pseudomonas aeruginosa, engineered to be stable in blood no less than 4 months, intended to be used for therapeutic use post-exposure to limit disease progression at Role of Care 1 and Role of Care 2. During the PoP, the Awardee will be expected to conduct all relevant prototype development work and testing. At the end of the PoP, the Awardee will be expected to deliver the four end products to the Walter Reed Army Institute of Research (WRAIR)/Naval Medical Research Center (NMRC) team for testing in animal infection models. 3) FOCUS AREA #3 (HIV): A single administration escape-resistant therapy for HIV control OBJECTIVE: Development of a novel therapeutic for the treatment of HIV. DESCRIPTION: An HIV therapeutic to reduce and control systemic viral loads, halt viral transmission and disease progress is required. Efficacy of the proposed HIV therapeutic should have previously been demonstrated in small animal models of HIV. During the PoP, the Awardee will be expected to perform studies that assess dose, time of treatment, biodistribution, genotoxicity, and transmission potential of therapeutics in humanized mice models and non-human primates (NHPs). Simian immunodeficiency virus (SIV)-infected Rhesus macaques (RM) animal models used for testing safety and efficacy of experimental HIV interventions should be used to test therapeutic safety (genotoxicity and immunogenicity). 4) FOCUS AREA #4 (Biofilm): Clinical evaluation of products to treat biofilm-mediated antibiotic-resistant infections in non-healing chronic wounds OBJECTIVE: Development of a safe and efficacious topical product that inhibits and disrupts biofilms formed by multiple drug resistant (MDR) pathogens for the management of chronic wound infections. DESCRIPTION: • Prototype for the treatment of biofilm-containing infected wounds to be used topically. • Prototype must be capable of eradicating bacterial pathogens from infected wounds containing biofilms formed by MDR pathogens. Examples of target wound-associated bacteria are: Acinetobacter baumannii, Staphylococcus aureus, E. coli, and Klebsiella pneumoniae. • Prototype should cause biofilm destabilization by specifically hydrolyzing the glycosidic linkages of poly-beta 1,6 N-acetyl glucosamine (PNAG), a major matrix polysaccharide of biofilms. • Offerors must have a prototype at a minimum technology readiness level (TRL) of 3 at the time of submission. Offerors should already have the following preliminary data on the topical prototype formulation before submitting a proposal: o Demonstrated non-cytotoxicity to multiple human cells lines in vitro o Completed and passed a 3-month biocompatibility and toxicity test in vivo o Demonstrated long-term stability o Demonstrated that the topical prototype potentiates the activity of antibiotics and antimicrobials in preclinical (animal) wound models During the PoP, the Awardee will be expected to: • Develop a prototype formulation for topical application to infected wounds. • Demonstrate stability of prototype formulation across a range of temperatures (20C to 45C) for a minimum of 6 months. • Conduct pre-clinical (in vivo) biocompatibility studies by a good laboratory practice (GLP)-compliant contract research organization (CRO). • Conduct proof of concept study in a large animal model (e.g., porcine) by a GLP-compliant CRO to demonstrate efficacy, safety, drug distribution and penetration into the tissue, and drug pharmacokinetics. • Conduct safety study in human subjects with chronic wounds. • Obtain feedback on usability of topical prototype formulation from potential users. PERIOD OF PERFORMANCE PLAN: The anticipated Period of Performance (PoP) for each focus area is not to exceed the following: 1) FOCUS AREA #1 (Diagnostic): 4 years 2) FOCUS AREA #2 (mAb): 2 years 3) FOCUS AREA #3 (HIV): 1 year 4) FOCUS AREA #4 (Biofilm): 3 years See the attachment for the details of the RPP. MTEC membership is required for the submission of a full proposal in response to this MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/ For more information about the RPP, please visit the MTEC website (a link is included in the attachment incorporated into this posting). Full proposals are due no later than October 8, 2019 at 12:00pm Eastern Time.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/MTEC-19-10-MID-PIP/listing.html)
- Record
- SN05430372-W 20190906/190904231139-730372efc31c141bc10954c172315708 (fbodaily.com)
- Source
-
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