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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 28, 2016 FBO #5392
SOURCES SOUGHT

Q -- Testing of ML290 compound in the mouse SUGEN-Hypoxia model of pulmonary hypertensionq

Notice Date

8/26/2016
 

Notice Type

Sources Sought
 

NAICS

541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 3155, MSC 9593, Bethesda, Maryland, 20892, United States
 

ZIP Code

20892
 

Solicitation Number

HHS-NIH-NIDA-SSSA-SS-2016-556
 

Archive Date

9/15/2016
 

Point of Contact

Stacey M Polk,
 

E-Mail Address

spolk@nida.nih.gov
(spolk@nida.nih.gov)
 

Small Business Set-Aside

N/A
 

Description

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: The National Institutes of Health (NIH) is the largest biomedical research agency in the world. A part of the U.S. Department of Health and Human Services, it is the federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and apply that knowledge to enhance health, lengthen life, reduce illness and disability, conduct, support and make medical discoveries that improve people's health and save lives. The National Center for Advancing Translational Sciences (NCATS) focuses on getting more treatments to more patients more quickly. Several thousand genetic diseases affect humans, of which only about 500 have any treatment. A novel drug, device or other intervention can take about 14 years and $2 billion to develop, with a failure rate exceeding 95 percent. NCATS is directly addressing this problem by discovering new technologies and other approaches that could greatly accelerate the process of developing and deploying solutions that can be used by all translational researchers. The NCATS Chemical Genomics Center (NCGC) is tasked with identifying and developing novel small molecule leads against a wide spectrum of human disease targets, which it accomplishes by screening thousands of small molecules in collaboration with both intra-and extramural researchers. In pursuit of this goal, the Center has a strong internal transdisciplinary team of scientists who continually discover novel small molecules for application against a wide range of human diseases. As an ongoing high priority project for NCGC, we are in need of testing ML290 in the mouse SUGEN-Hypoxia model of pulmonary hypertension. ML290 was declared as a probe as part of the NIH Molecular Libraries Program that set out to discover, optimize, and assess biological activity of small molecules agonists of human relaxin receptor 1 (RXFP1). The peptide hormone relaxin has been clinically investigated as a beneficial treatment for acute heart failure (AHF). Relaxin has been shown to reduce blood pressure and promote vascular compliance in clinical studies, in addition to being able to remodel heart lesions. The target of relaxin's action is the class B G-protein coupled receptor RXFP1. Here we present the discovery of the first small- molecule agonists of RXFP1 disclosed in the literature. Optimized compounds from this series are potent and highly selective RXFP1 agonists with similar efficacy as the natural hormone in functional assays. These molecules are easy to synthesize and the represented analog ML290 showed excellent in vitro ADME data and in vivo pharmacokinetic (PK) properties. From our studies, we conclude that this probe, ML290, should be a very useful tool for the study of RXFP1 activation in pre-clinical disease models of heart failure and other diseases, and might provide a lead for the development of a small-molecule drug as an alternative to the current expensive recombinant human relaxin therapy. To further understand the effect of ML290, NCGC is in need of studying ML290 in a hypertensive mice model to assess fibrosis, heart compliance, and pulmonary function. The SUGEN-Hypoxia model of pulmonary hypertension is the established standard animal model for this biology and is predictive of human efficacy. The outcome of this experiment will be critical in determining whether this program should be further developed and/or intellectual property from this program be licensed for commercialization. One complication of the required study design is that ML290 is not an agonist of the mouse RXFP1 receptor, and a humanized knock-in human-RXFP1 transgenic mouse will have to be substituted in the protocol for the experiment. Purpose and Objectives: NCGC is in need of testing services to assess ML209 in a SUGEN-Hypoxia model of pulmonary hypertension to assess fibrosis, heart compliance, and pulmonary function in mice, using humanized-RXFP1 mice. Scope of Work NCGC is need of very specific testing that meets the following requirements: 1.Procuring and having access to 72 knock-in human-RXFP1 mice and sourcing breeding mice 2.Be able to house mice for 90 days in 15 cages (21 days quarantine and 69 days mouse model) 3.Do echocardiography in 36 mice 4.Data analysis to asses fibrosis, heart compliance, and pulmonary function 5.Provide invasive hemodynamic measurements for pulmonary hypertension in 72 mice 6.Conduct histology, gene, and protein expression studies and provide data Anticipated Period of Performance/Delivery Date: Within one year ARO Capability statement /information sought. Contractors that believe they possess the ability to provide the requirement should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. The response should directly and specifically state in the, capabilities statement, which project requirements you can supply. Contractors must also provide their Company Name, DUNS Number, Physical Address, Point of Contact, and Size and Type of Business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. The information submitted must be must be in an outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses (capability statements) sent in response to this Sources Sought Notice must be submitted electronically (via e-mail) to the Contract Specialist. Facsimile responses are NOT accepted. The response must be submitted to Stacey Polk, Contract Specialist at spolk@nida.nih.gov. The response must be received on or before August 31, 2016, 2 pm Eastern Standard Time. "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 pre-solicitation synopsis and 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

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA-SSSA-SS-2016-556/listing.html)
 

Place of Performance

Address: National Institutes of Health, 9800 medical Center Drive, Bethesda, Maryland, 20850, United States

Zip Code: 20850
 

Record

SN04243247-W 20160828/160826235019-dc4484a1be841ff1dd5eeb0fd7911f81 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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