SPECIAL NOTICE
A -- Small Molecule Antibiotic Drug Development for Combating Antibiotic Resistant Bacteria (CARB)
- Notice Date
- 12/10/2018
- Notice Type
- Synopsis
- NAICS
- 54171
— Research and Development in the Physical, Engineering, and Life SciencesT
- Contracting Office
- Attn: MCMR-AAA 820 Chandler Street Frederick, MD 21702-5014 MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- MTEC-19-04-WRAIR-CARB
- Response Due
- 1/24/2019
- Point of Contact
- Rebecca Harmon, Phone 843-760-3358
- E-Mail Address
-
rebecca.harmon@ati.org
- Small Business Set-Aside
- N/A
- Description
- The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Proposals (RPP) that aims to develop a lead prototype compound (pre-clinical candidate) that must be efficacious against clinically-relevant gram negative bacteria in animal infection models, have clinically acceptable pharmacokinetics (PK) and dynamics for oral or parenteral administration, and a low-to-acceptable toxicity profile. The focus of this RPP is to recruit a partner(s) (i.e., antibiotic (AB)-focused pharmaceutical companies and/or product-focused academic/non-profit research institutions) to move an AB hit or early lead molecule from lead optimization or early preclinical development to a preclinical decision. Technical Objective: The WRAIR CARB effort is a sub-set of the 2015 CARB Presidential initiative wherein WRAIR was tasked to develop a preclinical AB candidate within five years. The goal of this MTEC award is to develop a small molecule AB candidate or chemical series with the following characteristics: • Efficacious against clinically-relevant, MDR, Gram-negative bacteria in mean inhibitory concentration (MIC) 90 panels of relevant, MDR, clinical isolates. This efficacy can be either genus specific (narrow spectrum) for Klebsiella, Acinetobacter, or Pseudomonas species, or broadly effective against clinical Gram-negative pathogens. • Efficacious against clinically-relevant MDR Gram-negative bacteria in standard animal soft tissue infection models (e.g., thigh and lung). • In vitro and in vivo data supporting clinically acceptable PK and dynamics for oral or parenteral administration, an acceptable toxicity profile. Potential for Follow-on Work: The initial 24 month delivery schedule should be focused on the execution of animal testing and manufacturing required for an IND application for the desired indications. Follow-on work in subsequent years may be awarded to support: • Conduct of clinical trials pursuant to an FDA marketing approval (New Drug Approval). • Development of validated assays used to determine efficacy and potency of the product. • Development of a GMP manufacturing capability. • Conduct of collaborative animal testing to support FDA filings, such as toxicity studies. The Period of Performance (POP)/delivery schedule is not to exceed 24 months. Acquisition Approach This RPP will be conducted using a two-staged approach. In Stage 1, current MTEC members are invited to submit White Papers using the format contained in the RPP. The Sponsor (i.e., WRAIR) will evaluate White Papers submitted and will select White Papers that best meet their current technology priorities using the criteria in the RPP. Offerors whose technology solution is selected for further consideration based on White Paper evaluation will be invited to submit a proposal in Stage 2. Notification letters will contain specific Stage 2 proposal submission requirements. Offerors whose Stage 1 white papers are invited to Stage 2 of the RPP process for submission of full proposals will have an opportunity to interface directly with WRAIR so that they can provide the appropriate level of detail into their development plans. MTEC will make an introduction to the appropriate WRAIR contact to those Offerors that are invited to submit full proposals at Stage 2 of the RPP process. See the attachment for details of this RPP. Administrative Information White papers are due no later than January 24, 2019 at 12:00pm ET. The RPP is posted to the MTEC website (mtec-sc.org) and a summary notice is posted on FedBizOpps (fbo.gov) to notify interested parties. MTEC membership is required for the submission of a white paper in response to this upcoming MTEC RPP. Offerors submitting White Papers as the prime contractor must be MTEC members of good standing by January 21, 2019. To join MTEC, please visit http://mtec-sc.org/how-to-join/ A Proposers Conference via webinar will be held for interested parties to have their questions answered by the Government after the RPP is posted. MTEC Members will be notified when the Proposers Conference is scheduled. For more information about the RPP, please visit the MTEC website (a link is included in the attachment incorporated into this posting). NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (10-DEC-2018); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/MTEC-19-04-WRAIR-CARB/listing.html)
- Record
- SN05170362-F 20181212/181210230021 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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