B SOW Statement of Work (1).pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Malaria Asexual Cuture Service

Statement of Need and Purpose:

The Developmemntal Branch (TDB) at NCATS require services for a 6 month malaria culture service that will provide asexual blood stage cultures human blood and complete culture medium on a monthly basis.

Monthly asexual stage parasites for use in viability assays:

1. Plasmodium falciparum asexual parasites (30 mL), with ring stages >90%.

2. Complete medium (100mL) for asexual parasites.

3. 50% Blood (1-5 mL)..

Background Information and Objective:

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

Malaria affects an estimated 250 million people worldwide, particularly in the tropical regions of Sub- Saharan Africa and approximately 650,000 patients die each year. Even while on current therapies, patients remain infectious for a period of time, allowing further mosquito-borne transmission to others.

Control of parasite transmission is critical for elimination and eradication of malaria. Torin2 was identified in NCATS as a lead molecule in a new class of antimalarial drugs.

As part of a lead optimization program, researchers are using a malaria asexual parasites viability assay to optimize the Torin2 series and advance a drug candidate through pre-clinical development and early clinical development.

Monthly, 30 ml asexual parasites at 1% parasitemia and 4% hematocrit are needed for this project. Ring stages must be >90%. The culture has to be maintained at 37 degree under hypoxia conditions (90% N2, 5% CO2, and 5% O2) all the time during the shipment. Additionally, 100 ml complete medium and 1-5 ml human blood are needed for the assay. The cultures will be used in house for viability assays for 72 hour drug sensitivity tests. TDB has developed assay for the drug viability test. The viability assay prefer to >90% ring stage in asexual parasite culture for a successful assay. Additional 1-5 ml of 50% blood and 100 ml complete medium are required for assay dilution. The culture has to be maintained at 37 degree under hypoxia conditions (90% N2, 5% CO2, 5% O2) all the time during the shipment. Delivery is on Tuesday or Friday.

If assay fail because of lower than 90% ring stage provided. Sanaria will provide another 30 ml asexual culture in the following week or two until the drug efficacy assays work. Any additional asexual culture will be provided at no additional cost. If the drug efficacy assays fail because of TDB biology related issues, Sanaria will not provide additional culture. Therepeutic Developmemntal Branch (TDB) has an option to order 5 additional supply of 30ml of the asexual cultures, blood and medium due to project needs. The contract will be 6 month. TDB will order asexual parasites monthly. TDB may terminate the contract at any time.

Period of Performance:

Period of performance is 6 month service after receipt of award.

SCOPE OF WORK

General Requirements:

Instructions: Include the following:

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:

All work must be conducted with strict compliance to vendor Standard Operating Procedures (SOP), with all excursions from these SOP immediately reported to TDB and comprehensively noted in the final report.Monthly, 30 ml asexual parasites at 1% parasitemia and 4% hematocrit are needed for this project.

Ring stages must be >90%. The culture has to be maintained at 37 degree under hypoxia conditions (90% N2, 5% CO2, and 5% O2) all the time during the shipment. Additionally, 100 ml complete medium and 1-5 ml human blood are needed for the assay. The cultures will be used in house for viability assays for 72 hour drug sensitivity tests. TDB has developed assay for the drug viability test. The viability assay prefer to >90% ring stage in asexual parasite culture for a successful assay. Additional 1-5 ml of 50% blood and 100 ml complete medium are required for assay dilution. The culture has to be maintained at 37 degree under hypoxia conditions (90% N2, 5% CO2, 5% O2) all the time during the shipment. Delivery is on Tuesday or Friday.

If assay fails because of lower than 90% ring stage provided. The Contractor will provide another 30 ml asexual culture in the following week or two until the drug efficacy assays work. Any additional asexual culture will be provided at no additional cost. If the drug efficacy assays fail because of TDB biology related issues, The Contractor will not provide additional culture. TDB has an option to order 5 additional supply of 30ml of the asexual cultures, blood and medium due to project needs. The contract will be 6 month. TDB will order asexual parasites monthly. TDB may terminate the contract at any time.

• All work must be conducted with strict compliance to vendor Standard Operating Procedures (SOP), with all excursions from these SOP immediately reported to TDB and comprehensively noted in the final report.

LEVEL OF EFFORT:

Instructions: Specify labor category, e.g., scientific writer, editor, senior researcher, etc., and estimated number of labor hours for each period of performance..

GOVERNMENT RESPONSIBILITIES

Instructions: 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.

DELIVERY OR DELIVERABLES

Asexual parasites, blood and complete medium will be delivered Monthly. Asexual delivery is intended to be normal business days and on Tuesday or Friday of the month unless otherwise specified. The Subcontractor may suggest an alternative due date for any or all deliverables in their offer. The final schedule will be agreed to by TDB based on the Subcontractor’s proposed cost and proposed delivery schedule.

The following deliverables shall be developed in this project. The Offeror’s proposed Project Plan should clearly contain all tasks and milestones required to produce these deliverables.

All deliverables shall be developed according to constraints lists in the “Conformance and Compliance” section above where applicable.

Deliverable: Asexual stage parasites.

Description and Acceptance Criteria: The culture must be prepared at 1% parasitemia and 4% hematocrit. Ring stages must be >90%. It has to be maintained at 37 degree under hypoxia conditions (90% N2, 5% CO2, 5% O2) all the time during the shipment. Ring stages has to be more than 90%.

Deliverable: complete medium.

Description and Acceptance Criteria: the same batch of complete medium used for parasite culture are required. At least 100 ml of complete medium is required for asexual culture.

Deliverable: 50% human blood.

Description and Acceptance Criteria: 50% human blood is required for asexual culture and viability assay.

The human blood must be less than 3 weeks after withdrawing and must be able to maintain asexual parasite culture.

General Acceptance Criteria

• In addition to specific acceptance criteria listed above, general quality measures, as set forth below, will be applied to each deliverable received from the Subcontractor under this Statement of Work.

• Accuracy – Deliverables shall be accurate in presentation, technical content, and adherence to accepted elements of style.

• Clarity – Deliverables shall be clear and concise. Any/all diagrams shall be easy to understand and be relevant to the supporting narrative.

REPORTING REQUIREMENTS

Monthly Analytical Report The contractor shall document the analyses for each monthly delivery in a report due with each delivery.

It is expected that this report will include, but not be limited to:

• Document the percentage of ring stages for asexual culture.

• Document the percentage of hematocrite of the culture.

• Document the age of the blood (time since the blood was drawn) and the time since the parasites were thawed.

Final Report Contractor shall submit a Final Report within 30 days of subcontract completion and shall include the following:

• Subcontractor Name and Address

• Name of Person Submitting the Report

• Subcontract Number

• Report Date

• Period Covered by the Report

• A comprehensive Summary of Work performed during reporting period

OTHER CONSIDERATIONS

Travel:

The majority of the work will be performed at the vendor’s facilities; however, TDB may ask that specific tasks, such as testing and demonstrations, be performed at other locations.

Key Personnel:

Instructions: Specify any contractor key personnel by labor category that are considered to be essential to successful performance of the requirement.

Information System Security Plan:

Instructions: Specify if the statement of work requires the contractor to (1) develop, (2) have the ability to access, or (3) host and/or maintain a federal information system(s), the information security policies and procedures re 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]

Data Rights:

Contractor does not have permission to publish NCATS data.

Section 508—Electronic and Information Technology Standards:

Instructions: 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.

Publications and Publicity:

Instructions: Specify if the contractor will write and publish articles of data produced as a result of the requirements of the SOW.

Confidentiality of Information:

Instructions: 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 date which is confidential. Specify how the contractor should handle information or data prior to any release, disclosure, dissemination, or publication.

ATTACHMENTS

Instructions: Include the following attachments with all SOWs

1. Independent Government’s Cost Estimate

2. Evaluation / Selection Criteria