D_SOW_NNMT_DYT1PK.pdf
PDF 1 MB Posted
- Solicitation number
- 75N95021Q00256
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 pharmacokinetics of compounds from dystonia project In the DYT1 dystonia project, the National Center for Advancing Translational Sciences (NCATS) has discovered several small molecules that are able to rectify the mislocalization of Torsin A protein in cells where the Torsin A is mutated as found in DY T1 dystonia patients. The NCATS needs to determine the exposure levels of lead compounds from this project in multiple tissues in mice, especially the levels in the brain. This will help us rank order compounds that have oral bio availability with high exposure in plasma and most importantly compound that is available in the brain.
In DYT1 dystonia there is a delta E mutation in the torsin A protein that leads to its mislocalization, that is, instead of having a diffuse distribution it forms dots (puncta) with cells. With the NCATS collaborators at Duke University, the NCATS embarked on a high throughput screening campaign followed by the identification of hit compounds that were further optimized by medicinal chemistry into compounds that are able to rectify torsion a mislocalization at less than 100 nanomolar concentrations. In vitro, these compounds have a range of stabilities in mouse liver microsomes and a range of permeabilities as determined by a PAMPA BBB assay. However, the NCATS needs to determine their actual levels in mice in order to discover a compound that is ready for proof of concept in a relevant dystonia animal model. This requirement also seeks to determine the partition coefficient of the free fractions in brain versus free fraction in plasma which is an important parameter to rank order compounds that are predicted to have better efficacy specially in neurological diseases such as dystonia.
12 months with periodic updates after award Contractor shall perform the following:
1. Receive compounds over a period of 12 months from NCATS and dose male C57/BL6 mice at a predetermined dose, route of administration, and formulation.
2. Harvest plasma, brain, heart, kidney, and liver after dosing at 8 time points (5 min, 15 min, 30 min, 1, 2, 4, 8, 24 hr) with N=3 per time point
3. Develop a method to determine concentration of compounds in all tissues
4. Plot concentration vs time graphs, calculate PK parameters, note in life clinical observation and provide them in a report to NCATS
5. Complete Kpuu studies on an ad hoc basis, if needed NCATS will supply compounds from the dystonia project and a study design to the contractor.
Periodic reports via emails showing determination of pharmacokinetics and Kpuu are required.
Progress reports of pharmacokinetics and Kpuu of different compounds are required.
N/A Samarjit Patnaik; patnaiks@mail.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 .