SOW_Chemistry CRO.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:
Synthesis and bioanalytical analysis of small molecules and microbiome conjugates NCATS is in need of medicinal chemistry and bioanalytical services in the projects focused on the therapeutic areas of the microbiome, neurodegeneration, and addiction. Prior experience and exposure to medicinal chemistry campaigns and mass spec based assays in the microbiome therapeutic area are required.
NCATS needs medicinal chemistry services from a CRO that has concomitant capability of bioanalytical services. Iterative synthesis of rounds of analogs from multiple different series emerging from programs from the therapeutic areas of the microbiome, addiction, and neurodegenerative disorders will be required. Prior experience in medicinal chemistry campaigns and exposure to assays to the microbiome therapeutic area is required. In addition, capability of determining metabolites after compound incubation in assays is also required. Capability to generate in vitro ADME data in quick turnaround time as well mass spec capabilities to detect drug-conjugates from microbiome and microsomal assays is required. The services will augment existing medicinal chemistry campaigns within NCATS.
12 months after award Contractor shall ship 10 mg of analogs in iterative rounds of medicinal chemistry to NCATS. Depending on complexity of synthesis 50-100 analogs have to be synthesized. Simultaneously, contractor shall synthesize and ship 250 mg to 5 gram quantities of at least 5 intermediates that can be utilized for diversification at NCATS. In addition custom synthesis of prior art compounds from literature may also be required. Microsome stability for select compounds will be required. Metabolite identification and drug conjugate additions from microsome and microbiome assays for select compounds will be required.
NCATS will design and supply lists of analogs and intermediates for synthesis. NCATS will suggest candidates for bioanalytical experiments.
Intermittently and depending on complexity of synthesis a total of at least 50-100 analogs in 10-30 mg quantities with >95% purity as characterized by LCMS; as well at least 5-10 intermediates 250 to 5 gram quantities. LCMS and 1H NMR of key intermediates and analogs. Bioanalytical assay results of select compounds. Due within three (3) to four (4) months after receiving request from government.
Contractor shall present progress reports and meeting every 3-4 weeks with Samarjit Patnaik. Reports shall cover progress in the synthesis of analogs, discussion of issues with synthesis and possible solutions, and the prioritization of compounds to be synthesized. Reports will also contain data from bioanalytical experiments.
none N/A Data will belong 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.
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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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