SOW_12-1.DOCX

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Acquisition of testing services: Proteomics experiments on 60 canine blood samples and matched control(s).

Statement of Need and Purpose:

The vendor is to run proteomics experiments to identify up to 50 proteins present in the blood samples from 60 canines with various tumors and one to several control samples from canines with no tumor evident. One goal of this project is to discover diagnostic biomarkers for various cancers. Diagnosis is most easily done by taking blood samples and testing for cancer marker proteins, rather than using more invasive procedures such as extraction of tissue. We have identified 50 canine proteins specific to one or another of 5 canine studied cancer types from previous work. In order to determine if these proteins could have potential use as diagnostic biomarkers for the studied cancers, we need to determine if said proteins are present in blood extracted from dogs with the studied cancer types.

Background Information and Objective:

Spontaneous cancers in dogs and cats are an underused group of naturally occurring malignancies that share many features with human cancers such as osteosarcoma, prostate and breast cancers, non-Hodgkin's lymphoma, melanoma, soft tissue sarcoma, head and neck carcinoma, and virally induced lymphomas. Treatment of pet animals -primarily dogs- with naturally occurring cancer helps researchers better understand the biology of cancer and to improve the assessment of novel treatments for humans.

The NIH Comparative Oncology Program has a collection of cancer tissue samples from dogs that span five different histologies (Pulmonary neoplasms, melanoma, osteosarcoma, B cell lymphoma, and T cell lymphoma) with anywhere from ~100-500 patients (dogs) per histology. Each patient has tumor and normal tissue, serum, plasma, whole blood, and urine. Tissue samples are flash-frozen, in OCT, and formalin-fixed. All patients are treatment-naïve and have clinical outcome data (e.g. Were they treated for their cancer, and if so, with what treatment regime and what happened to them?).

Previously, the lab has performed RNA-Seq experiments on selected tissue samples from these tumor classes, then performed bioinformatics analysis and interpretation of the RNA-Seq data to develop diagnostic biomarker panels specific to each tumor type. The aim of the current acquisition is to validate these hypotheses. To validate the biomarker hypotheses, we will perform proteomics experiments on blood matched to the tumor samples. Positive validation will be achieved if we find biomarkers only in blood associated with tumors to which the biomarker has been matched (according to the bioinformatics analysis).

Period of Performance:

The anticipated Period of Performance for the services is effective for three (3) months from receipt of samples after date of contract award.

(i) Each of the 50 proteins in question is identified as being specific or not to each of 5 cancer types studied by the vendor, who then will subsequently submit the information to NCATS).

(ii) Vendor shall provide a complete report of the work done to NCATS

(iii) Vendor shall return any remaining materials to NCATS

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:

(1) The Contract Research Organization (CRO) will receive one group (12 canine tumor tissue samples and 12 matched whole blood samples) for each of 5 tumor tissue types (Osteosarcoma, melanoma, pulmonary neoplasms, B cell lymphoma and T cell Lymphoma). The total number of samples will be 60 tissue and 60 blood samples.

(2) The CRO will also receive the identities of 50 proteins predicted to be associated with each of the cancer types outlined in (1). The CRO shall check for the presence or absence of these proteins in each of the 60 blood samples. The CRO shall use the tissue samples, the blood samples, or some combination thereof, to design a suitable reference sample as they see fit.

(3) The CRO shall perform proteomics experiments to identify the presence or absence of the 50 proteins from (2) in each of the 60 blood samples. The methods of analysis vary greatly but shall generally include the following:

(3.a) Separation: Separate the blood into serum and plasma

(3.b) Enrichment: Increase concentration of low abundance proteins relative to high abundance proteins

(3.c) Depletion: Removal of ubiquitous blood proteins such as albumin, etc.

(3.d) Protein identification: Custom antibody synthesis, plating, array analysis, bioinformatics

(3.e) Report and material return: Upon completion of services, the CRO will deliver to the Customer (NIH/NCATS/DPI) any remaining sample, other relevant experimental constructs, e.g., remaining antibodies, and a full report detailing the work done. The report shall at minimum specify the list of target proteins expressed in serum for each of the 60 blood samples.

LEVEL OF EFFORT:

Labor category: Senior researcher; anticipated number of labor hours: 480

GOVERNMENT RESPONSIBILITIES

NIH/NCATS/DPI will provide to the CRO the following items:

(1) One group (12 canine tumor tissue samples and 12 matched whole blood samples) for each of 5 tumor tissue types (Osteosarcoma, melanoma, pulmonary neoplasms, B cell lymphoma and T cell Lymphoma). The total number of samples will be 60 tissue and 60 blood samples.

(2) The identities of 50 proteins predicted to be associated with each of the cancer types outlined in (1).

DELIVERY OR DELIVERABLES

Upon completion of services, the CRO will deliver to the Customer (NIH/NCATS/DPI) any remaining samples, other relevant experimental constructs (e.g., remaining antibodies) and a full report detailing the work done. The report shall at minimum specify the list of target proteins expressed in serum for each of the 60 blood samples provided.

REPORTING REQUIREMENTS

Updates by email and phone as needed

OTHER CONSIDERATIONS

Travel:

NA

Key Personnel:

Information System Security Plan:

Section 508—Electronic and Information Technology Standards:

Publications and Publicity:

Confidentiality of Information:

No data of a personal nature, or proprietary information will be provided to the CRO.

NIH/NCATS/DPI will set up secure access to one of its on-site servers. The CRO will be given access to this server and will be able to securely upload the data to NIH/NCATS/DPI.

Evaluation Criteria

The Government will award a purchase order resulting from this requirement on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price. The technical evaluation factors are as follows:

Factor 1: Technical Capability

The Contractor’s proposal shall address each area of the statement of work requirements:

· Two related but alternative scenarios for completing the work.

· Pilot study details for each scenario: to evaluate/discover optimal parameters/conditions for experiments.

· Assay development details for each scenario

· Protein quantification details for each scenario

· Definition and use of controls/reference samples These requirements must be in sufficient detail to demonstrate a clear understanding of the statement of work and compliance with requirements. The proposal shall also include a period of performance lasting not longer than 3 months upon receipt of blood samples. The study is considered complete when:

· Each of the 50 proteins in question is identified as being specific or not to each of 5 cancer types studied by the vendor and this information is subsequently received by NCATS from the vendor.

· A complete report of the work done is received and any remaining materials are returned to NCATS.

Factor 2: Key Personnel Qualifications

Offerors proposals shall be evaluated for level of conformance to the key personnel qualifications identified in this statement of work. Offeror proposals must contain a resume/CV. Exceeding requirements shall be viewed favorably.

Factor 3: Organizational Experience

The Contractor shall provide a list of two (2) past performance references with knowledge of the contractor’s relevant skills and experience related to the requirements outlined in this Statement of Work. References shall include the following information:

1. Name of Organization

1. Type of Work Performed

1. Contract Period of Performance

1. Contact Name and Title

1. Telephone Number

Past Performance shall be evaluated for relevance to the current requirement.

Evaluation Ratings

Technical proposal will be evaluated using a summary adjectival rating in accordance with the following scale and definitions:

Excellent

The proposal has exceptional merit and reflects an excellent approach which will clearly result in the superior attainment of all requirements and objectives. This clearly achievable approach includes several advantageous characteristics of substance, and very few disadvantages, which can be expected to result in outstanding performance. The risk of unsuccessful performance is very low as the proposal provides solutions which are unquestionably feasible and practical. These solutions are further considered very low risk in that they are exceptionally clear and precise, fully supported, and demonstrate a clear understanding of the requirements. Risk Level: Very Low

Good

The proposal demonstrates a sound approach which is expected to meet all requirements and objectives. This sound approach includes advantageous characteristics of substance, and few relatively minor disadvantages, which collectively can be expected to result in satisfactory performance. The risk of unsuccessful performance is low as the proposal contains solutions which are considered feasible and practical. These solutions are further considered to reflect low risk in that they are clear and precise, supported, and demonstrate an understanding of the requirements. Risk Level: Low

Acceptable

The proposal demonstrates an approach which is capable of meeting all requirements and objectives. The approach includes both advantageous and disadvantageous characteristics of substance, where the advantages are not outweighed by the disadvantages. Collectively, the advantages and disadvantages are likely to result in acceptable performance. The risk of unsuccessful performance is moderate, as the proposal solutions are generally feasible and practical. These solutions may also be considered to reflect moderate risk in that they may be somewhat clear and precise, partially supported, and/or demonstrate a general understanding of the requirements. Risk Level: Neutral

Marginal

The proposal demonstrates an approach which may not be capable of meeting all requirements and objectives. The approach has disadvantages of substance and advantages, which if they exist, are outweighed by the disadvantages. Collectively, the advantages and disadvantages present a low or questionable likelihood of resulting in satisfactory performance. The risk of unsuccessful performance is high as the proposal contains solutions which may not be feasible and practical. These solutions may also be considered to reflect high risk in that they lack clarity and precision, are generally unsupported, and/or do not demonstrate a complete understanding of the requirements. Risk Level: High

Unacceptable

The proposal demonstrates an approach which, based on a very high risk, will very likely not be capable of meeting all requirements and objectives. This approach has several disadvantages of substance, and advantages which, if they exist, are outweighed by disadvantages. Collectively, the advantages and disadvantages are unlikely to result in satisfactory performance. The risk of unsuccessful performance is very high as the proposal contains solutions which are not feasible and practical. The solutions may also be considered to reflect very high risk in that they lack any clarity or precision. Risk Level: Very High

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