SOURCES SOUGHT
B -- Therapeutics Testing In Murine Models of Bacterial Thigh & Lung Infections
- Notice Date
- 11/10/2016
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIAID-SBSS-17-NIHAI2017088
- Point of Contact
- Jason Alexander Aroz, Phone: 3017617468, George W Kennedy, Phone: 240-669-5170
- E-Mail Address
-
Jason.Aroz@nih.gov, kennedyg@mail.nih.gov
(Jason.Aroz@nih.gov, kennedyg@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION/SYNOPSIS This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. BACKGROUND This National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) project is for work related the evaluation of new antibacterial therapeutic candidates. A critical step in the evaluation these therapeutic candidates involves demonstrating in vivo efficacy in rodent models. A commonly used assay measures reduction of bacteria or colony-forming units (CFU) in infected thigh or lung tissue in mice over a 24-hour dosing period. For approved drugs, pharmacokinetic/pharmacodynamic (PK/PD) relationships obtained from these models historically have been shown to correlate well with plasma exposures required to treat bacterial infections in the clinic. Therefore, these results provide critical data to de-risk development of new therapeutics. PURPOSE AND OBJECTIVES The purpose of this Small Business Sources Sought Notice (SBSS) is to identify qualified small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. The objective of this acquisition is to perform testing of new antibacterial therapeutic candidates provided by the NIAID (or a designee) in murine models of thigh and lung infections in neutropenic mice that have been previously established and validated with known drugs. The NIAID seeks to acquire this testing capability against a specified selection of drug-susceptible and drug-resistant strains of bacteria using models that measure reduction of bacterial burden in infected thigh or lung tissue in mice over a 24-hour dosing period. In addition to the CFU reduction data, the NIAID seeks to acquire data on preliminary drug tolerability in mice to assist with dose selection for follow up efficacy studies. Required capabilities also include determination of drug concentrations in plasma of infected mice to enable correlation of PK exposure data with efficacy. PROJECT REQUIREMENTS The NIAID intends to solicit proposals for the performance of approximately twenty-five (25) assessments of therapeutic candidates in murine models of thigh and lung infections in neutropenic mice to be requested over a period of twelve (12) months. A typical assessment for each therapeutic will include determinations of MIC against specified strains available in the models and MTD/tolerability over a range of doses in infected mice, measurement of CFU reduction in thigh or lunch tissue over a 24-hour period of dosing, and plasma analysis for drug exposure in infected mice from doses that parallel the efficacy study. Of critical importance is the availability of thigh and lung infection models for a range of bacterial strains (specified below) that have already been established and validated using known drugs as positive controls. These models should be available using mice made neutropenic by standard methods of treatment with cyclophosphamide prior to bacterial challenge and drug dosing. The capability for dosing compounds using multiple routes of administration (PO, IP, IV) and a range of dosing intervals (qd, bid, tid) is required. Bacterial (CFU) burden must be evaluated after a period of 24 hours of drug dosing using standard methods involving tissue (thigh or lung) homogenization followed by dilution plating to permit accurate colony counts. The specific strains of bacterial pathogens (clinical isolates are preferred) for which the NIAID requires validated models include the following: - K. pneumonia - drug susceptible isolate; carbapenem-resistant metallo-beta-lactamase (MBL+) isolate; carbapenem-resistant (KPC-2+) isolate (not MBL+) - E. coli - drug-susceptible isolate; extended-spectrum beta lactamase (ESBL+) isolate; carbapenem-resistant metallo-beta-lactamase (MBL+) isolate - P. aeruginosa - drug-susceptible isolate; carbapenem-resistant, multidrug-resistant (MDR) isolate - A. baumannii - drug-susceptible isolate, multidrug-resistant (MDR) isolate - S. aureus - USA300 Methicillin-resistant (MRSA) isolate CAPABILITY STATEMENT/INFORMATION SOUGHT Sources are expected to have the expertise, personnel, and facilities to meet the requirements of this project. Tailored Capability Statements submitted in response to this announcement should demonstrate the offerors' qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following areas: - Evidence of prior validation of reliable performance for the requested models, such as statistical analysis of the reproducibility of infection (from evaluation of challenge material, CFU burden immediately prior to drug treatment and vehicle control after 24 hours), as well as statistical analysis of the CFU reduction from a range of doses of positive control drugs. - Thigh or lung models for the strains listed above must be available as already validated, "off the shelf" assays for immediate testing of candidate therapeutics. - Demonstrated efficacy model capabilities described above. - Expertise and capacity for conducting ascending-dose tolerability studies in infected mice to assist with dose selection for efficacy studies. - Plasma sampling over multiple time points after dosing and bioanalysis capability, in order to provide plasma drug exposures and PK data for correlation to CFU reduction data from validation studies with known drugs. - The capability to provide validated neutropenic murine models of thigh and lung infections for testing candidate therapeutics against the bacterial pathogens identified above. HOW TO SUBMIT A RESPONSE / PAGE LIMITATIONS Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed five pages, excluding resumes, describing the company's experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed or being performed; (2) demonstrated scientific and technical ability to carry out the work; (3) the professional qualifications and specific experience of staff who may be assigned to the requirement; (4) a general description of the facilities and other resources needed to perform the work. Tailored capability statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement. REQUIRED BUSINESS INFORMATION - DUNS; - Company Name; - Company Address; - Company Point of Contact, Phone and Email address; - Current GSA Schedules appropriate to this Sources Sought; - Small Business Status. NUMBER OF COPIES AND DELIVERY POINT Please submit one (1) electronic copy of your response to the following email address: Jason Aroz Jason.Aroz@nih.gov DISCLAIMER AND IMPORTANT NOTES This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
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- SN04325559-W 20161112/161110233949-ed9ec8535683e0694e28a12a5ea8068f (fbodaily.com)
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