D_SOW_NNMT_Diabetes Obesity.pdf
PDF 1 MB Posted
- Solicitation number
- 75N95021Q00254
View the file
Other files
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
Please wait...
If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.
You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.
For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.
Windows is either a registered trademark or a trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.
9.0.0.2.20101008.1.734229 Statement of Work for Services (SOW) General Information:
Title of Project:
Statement of Need and Purpose:
Background Information and Objective:
Period of Performance:
Scope of Work:
General Requirements:
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:
Specific Requirements:
Level of Effort:
Government Responsibilities:
Delivery or Deliverables:
Reporting Requirements:
Other Considerations:
Travel:
Key Personnel:
Information System Security Plan:
Data Rights:
Section 508:
Publications and Publicity:
Confidentiality of Information:
Evaluating NNMT inhibitors in metabolic disorders NNMT is a methyltransferase that has been implicated in obesity and diabetes models. We have developed a series of potent and selective NNMT inhibitors that we would like to evaluate in these animal models of metabolic diseases for proof of concept.
NNMT is a methyltransferase, a metobolic enzyme that transfers a methyl group form SAM to nicotinamide. Its activity is upregulated in several diabetes and obesity models in preclinical studies and also been observed in humans. Successful proof of concept experiments by silencing the gene and with unoptimized small molecule inhibitors has been demonstrated in literature. In collaboration with the National Center Institute (NCI) and University of Chicago we have developed exquisitely potent selective and orally bioavailable small molecule inhibitors of NNMT. The NCATS would like to demonstrate proof of concept with lead compounds in multi-week dosing studies in four different animal models (diabetes induced obesity,ob/ob, db/db, Zrucker rat models).
12 months with periodic updates after award
Contractor will
1. Receive compound from NCATS and conduct the following studies sequentially in predetermined dose, formulation and route of administration for a period of 4 weeks:
Study-1: male C57 mice, n=8, 4 groups Group 1 = normal diet Group 2 = HFD + vehicle Group 3 = HFD +TA@ low dose Group 4 = HFD +TA@ high dose
Study-2: male ob/ob mice, n=8, 2 groups Group 1 = ob/ob mice + vehicle Group 2 = ob/ob mice + TA
Study-3: male db/db mice, n=8, 2 groups Group 1 = db/db mice + vehicle Group 2 = db/db mice + TA
Study-4: male ZDF rats, n=8, 2 groups Group 1 = ZDF rat + Vehicle Group 2 = ZDF rat+ TA
2. Shall provide periodic reports to NCATS with observations on food intake, body weight, glucose, insulin
3. Shall conduct histology on specific organs on a subset of animals at conclusion of study
4. Shall conduct test glucose tolerance test at the end of the study on a subset of animals on a specific arm of the study
5. Shall monitor compound and metabolite in plasma liver and white adipose tissue in specific arms of the study NCATS will supply compound, formulation, exposure study details and a study design to the contractor.
Periodic reports via calls and emails showing progress in each individual model are required.
Progress reports and meetings every 3-4 weeks between key personal at contractor site and NCATS. Reports shall cover progress in dosing, efficacy readouts, exposure, metabolite formation, clinical chemistry and histology.
N/A Samarjit Patnaik; patnaiks@mail.nih.gov; Matthew Hall; hallma@mail.nih.gov; Ke Kong; ke.kong@nih.gov>;
N/A Data belongs to NCATS N/A Contractor shall not publish any information without informing NCATS. All information is confidential and NCATS will solely determine date for publication or publicity or patenting.
All information shared between NCATS and contractor is confidential. The time or method for publication will be determined by NCATS.
| ResetButton: |
| SaveAsButton: |
| designer__defaultWidowOrphanSettings: |
| Enter the title of your project.: |
| Include a general narrative of the need of the project and the desired results.: |
| Include a brief history of the project, the importance of the project, and the overall program objectives.: |
| Specify base period of performance. If applicable, specify option periods (not to exceed sixty (60) months,) or options for additional quantities.: |
| Include a detailed description of the technical requirements. Provide sufficient detail to accurately reflect the Government’s requirement. State what is to be accomplished without prescribing the method the contractor is to use, and include performance standards, if applicable. See 307.104(b)(2) and FAR 37.602 for guidance on preparation of a PWS. You may include tasks and subtasks. The degree of breakout depends on the size and complexity of the project. Indicate whether the tasks are sequential or concurrent. Specify requirements clearly so all readers can understand them. Reference only the absolute minimum applicable specifications and standards needed. Tailor specifications and other documents. Separate general information from direction.: |
| Specify labor category, e.g., scientific writer, editor, senior researcher, etc., and estimated number of labor hours for each period of performance.: |
| List any government-furnished data, property or facilities; describe the government‘s responsibility for reviewing and approving reports and final products generated under the contract. Specify if the government will provide workspace, desktop computers and telephones for contractor personnel. Specify if the contractor will require access to government facilities and identify the facility location and specific area. Identify any federal holidays or other times when access may be restricted.: |
| Specify all deliverable requirements. Specify a completion time for the government’s review of the draft deliverable, e.g. within ___ calendar days from date of receipt. Specify the number of business days the contractor has to deliver the final deliverable from date of receipt of the government’s comments. Specify that the timely submission of deliverables is essential to successfully completing this requirement. Specify if deliverables are to be submitted in “hard copy” or “electronic copy.” : |
| Specify as applicable if the contractor is required to provide written progress reports. Specify the frequency of the reports, e.g. monthly, annually, etc. Specify the reporting periods. Specify what the reports will cover, e.g. accomplishments, problems encountered, problem resolution, unresolved problems, etc. Specify the number of copies required.: |
| Identify if contractor travel is required in the performance of the SOW. Specify locations involved, number of trips, and duration of anticipated travel. Specify responsibility for travel reimbursement, e.g., the contractor or the Government. If the travel will be reimbursed by the Government, discuss the method of reimbursement, e.g., in accordance with Federal/agency travel regulations. If applicable, state the Government official authorized to approve contractor travel, e.g., the Contracting Officer’s Representative (COR).: |
| Specify any contractor key personnel by labor category that are considered essential to successful performance of the requirement. : |
| Specify if the statement of work requires the contractor to (1) develop, (2) access, or (3) host and/or maintain a federal information system(s), the information security policies and procedures that are applicable to the requirement. A "federal information system" is defined as an information system used or operated by an executive agency, by a contractor of an executive agency, or by another organization on behalf of an executive agency. [40 U.S.C., Sec. 11331]: |
| Specify if data is to be produced, furnished, acquired, or used in meeting the requirement of the SOW. Specify the respective rights and obligations of the government and the contractor regarding the use, production, and disclosure of that data. Specify who will have limited or unlimited rights. : |
| Specify if the contractor is required to develop, procure, maintain, or use Electronic and Information Technology (EIT) in the performance of the SOW. Specify if the EIT will be used by federal employees with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by other Federal employees. Specify if the public will have access to the EIT. : |
| Specify if the government will provide to the contractor any information or data of a personal nature about individual(s) or proprietary information or data pertaining to an institution or organization which is confidential. Specify if the contract is expected to generate information or data which is confidential. Specify how the contractor should handle information or data prior to any release, disclosure, dissemination, or publication.: |
File details come from the government source that posted it. Updated .