SPECIAL NOTICE
A -- Dengue Human Infection Model (DHIM) Prototype Development
- Notice Date
- 1/31/2017
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of the Army, U.S. 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-17-01-Dengue_Human_Infection_Model(DHIM)_Prototype_Development
- Archive Date
- 3/28/2017
- Point of Contact
- Lisa A. Fisher, Phone: 843-760-3356
- E-Mail Address
-
lisa.fisher@ati.org
(lisa.fisher@ati.org)
- Small Business Set-Aside
- N/A
- Description
- The Medical Technology Enterpise Consortium (MTEC) is excited to announce a solicitation focused on accelerating ongoing development by USAMRMC of a dengue human infection model (DHIM) regulated by the U.S. Food and Drug Administration (FDA) that aims to safely and reproducibly create uncomplicated dengue infections in human volunteers using live, attenuated, well-characterized dengue virus (DENV) challenge material. The DHIM will be achieved when each of the four DENV challenge strains (serotypes 1-4) is characterized via FDA Phase 1 clinical studies. Dengue viruses (DENVs) are flaviviruses transmitted by infected mosquitoes that cause a clinical spectrum of human disease ranging from mild viremia to severe intravascular volume depletion and hemorrhage. Efforts are underway worldwide to develop safe, effective anti-viral drugs and vaccines against Dengue but significant technical barriers impede progress including the immunologic complexity of the disease and lack of a correlate of protection or validated animal models of disease. Consequently, medical product developers must rely primarily on the conduct of large clinical studies in endemic regions (typically in pediatric volunteers) at great expense and financial risk. The DHIM represents an opportunity to reduce overall risk during clinical development. For example, medical product developers may leverage the DHIM to explore pre-infection immune profiles and correlate results with post-experimental infection clinical outcomes across a range of conditions and scenarios. It also may clarify how human humoral- and/or cellular-immune responses are associated with protection against DENV disease progression and, therefore, reduce the size and scope of future clinical trials and facilitate an improved use of existing laboratory animal models. In the long term, the DHIM could become a validated tool recognized by the FDA to fill gaps in medical product efficacy data from DENV field studies. This MTEC solicitation requests project proposals focused on the following major tasks: 1) Establish FDA-regulated Investigational New Drug (IND) Application for DHIM-2 and DHIM-4. Serve as FDA Sponsor with all attendant responsibilities. Devise and/or complete the Chemistry, Manufacturing, and Controls (CMC) section for the live, attenuated DHIM-4 (dengue serotype 4) and DHIM-2 (dengue serotype 2) challenge materials, in accordance with regulatory standards. This is envisioned as a partnership with the USAMRMC through a Letter of Authorization mechanism to an existing, ongoing IND effort. 2) Characterize DHIM-4 Challenge Material. Develop and execute DHIM-4 clinical characterization protocol; acquire clinical trial support; implement all necessary safety, pharmacovigilance and clinical services using intramural or Contract Research Organization (CRO) resources to carry out DHIM-4 to completion; complete all activities to develop final report and close-out the DHIM-4 study. 3) Complete DHIM-2 Manufacturing. Partner with U.S. government to manufacture, vial, and release DHIM-2 challenge material. 4) Characterize DHIM-2 Challenge Material. Develop and execute an FDA-regulated DHIM-2 clinical characterization protocol; acquire clinical trial support; implement all necessary safety, pharmacovigilance and clinical services using intramural or CRO resources to carry out DHIM-2 to completion; complete all activities to develop final report and close-out the DHIM-2 study. We encourage partnerships that pool available funding and in-kind contributions toward developing and characterizing a modular, serotype-based DHIM that can be made available to advance the field of DENV vaccines and therapies. MTEC anticipates that a single award will be made to a qualified team composed of multiple investigators/institutions responsible for partnering with the USG to accomplish all tasks. However, if an optimal team is not identified, then MTEC may make multiple, individual awards to Offeror(s) to accomplish subset(s) of the key tasks. To view this solicitation, please visit the MTEC solicitation website at http://mtec-sc.org/active-solicitations/ Sincerely, MTEC Project Team
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/MTEC-17-01-Dengue_Human_Infection_Model(DHIM)_Prototype_Development/listing.html)
- Record
- SN04386603-W 20170202/170131235014-0e6493375c4f03f58b644c9bd9e33c50 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |