D_SOW for Hesperos Inc.pdf
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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:
Execution of statement of work for phase II extension: Gathering remaining data for manuscript submission as well as screening of drug compounds to ameliorate NGLY1 mediated disfunction.
This requisition is to have Hesperos Inc. complete and initiate screening of our potential drug compounds to ameliorate the NGLY1 mediated phenotypes in motoneurons and neuromuscular junction (NMJ) models.
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. 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.
NGLY1 deficiency include abnormal tear production, a movement disorder, and liver disease. Additionally developmental delay, hypotonia, peripheral neuropathy, EEG abnormalities, and microcephaly.
The Therapeutic Develop Branch (TDB) program’s mission is to encourage and speed the development of new treatments for diseases with high-unmet medical needs. NGLY1 deficiency is greatly involved with motor neurons malfunction and therefore we have been collaborating with Hesperos Inc. in phase 1 to differentiate all motor neurons from NGLY1 patient lines. We found very interesting results in our patient lines motor neurons. Currently we are in phase 2 of the project and completing the remaining experiments to be able to publish our data and also screening some of the candidate compounds.
The period of performance is eight (8) months.
Milestone 1: Collect remaining data necessary to develop the first draft of a complete manuscript
• Motoneuron characterization: Immunocytochemistry for other motoneuron specific markers (ChAT, SMI-32)
• NMJ characterization: Immunocytochemistry for Synaptophysin and Bungarotoxin
• Defining potential target: Immunocytochemistry and Western Blot analysis for NKCC1
Milestone 2a: Measure the changes in patch clamp electrophysiology readouts of 4 drugs (2 fast-acting, 2-slow acting) at one timepoint post dosing at 5 concentrations in one diseased line. Cultures will be tested in singlet per experiment across 3 biological repeats.
Motoneurons derived from diseased lines (X2-9) will be dosed at 5 different concentrations of a drug and measured at 2 minutes (fast acting) or 24-hours (slow acting) post dosing. A dose response curve for each line will be built for the following patch-clamp parameters:
• Ion channel currents (Including Na+ and K+)
• Spontaneous action potential firing frequency
• Resting membrane potential
Milestone 2b: Measure the changes in NMJ function of 4 drugs (2 fast-acting, 2-slow acting) at one timepoint post dosing at 5 concentrations in all three diseased lines. Cultures will be tested in singlet per experiment across 3 biological repeats.
Motoneurons derived from diseased lines (X2-9, 594A, and 592D) will be cultured with healthy skeletal muscle in Hesperos’ NMJ chambers. These cultures will be dosed at 5 different concentrations of a drug and measured at 2 minutes (fast acting) or 24-hours (slow acting) post dosing.
Project Timeline:
- Milestone 1: two months
- Milestone 2a and 2b: 4 months from receipt of drug Government will be responsible for providing any potential iPSC lines needed and potential compounds to be tested.
Milestone 1: Sending data necessary to develop the first draft of a complete manuscript and drafting the manuscript.
Milestone 2a: Results of measuring the changes in patch clamp electrophysiology readouts of 4 drugs (2 fast-acting, 2-slow acting) at one timepoint post dosing at 5 concentrations in one diseased line.
Milestone 2b: results of measuring the changes in NMJ function of 4 drugs (2 fast-acting, 2-slow acting) at one timepoint post dosing at 5 concentrations in all three diseased lines.
Hesperos will deliver to TDB a complete data package including spreadsheet of raw data (viability counts, immunocytochemistry quantification, etc.) as well as a complete data work-up and full report for four patient lines and two WTs.
N/A N/A N/A All data produced, used and analyzed is sole property of the government. Contractor has no right to do any analysis with iPSCs lines provided by TDB rather than indicated in SOW and must keep all the data and information confidential.
N/A We will collaborate with Hesperoc Inc. to publish a paper for NGLY1 motor neurons and the phenotypes.
All the data will be confidential.
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| 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.: |
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