Attach 7 STO No. 4 Final.pdf

RFP 75N91021R00007

Attachment 7 – Sample Task Order #4 (11/20/2020)

SAMPLE TASK ORDER #4

STATEMENT OF WORK

NOTE: THIS IS ONLY AN SAMPLE TASK ORDER REQUEST FOR PROPOSAL. WHILE A RESPONSE IS

REQUIRED AS PART OF YOUR SUBMISSION AS REFERENCED IN SECTION L OF THE RFP, NO

ACTUAL TASK ORDER AWARD WILL BE MADE IN RESPONSE TO THIS SAMPLE TASK ORDER.

TORFP No: _#4__

Order Title: Clinical Pharmacology Support for an NCI Phase I Trial of NSC XXXXX_

Type of Order: Fixed-price type task order

Period of Performance: Eighteen months from date of award (estimated)

A. Statement of Work/Protocol/Project Description:

The purpose of this Task Order (TO) is to provide a resource for analytical and pharmacokinetic support to an NCI Phase I clinical trial with NSC XXXXX:

Phase I Trial of NSC XXXXX in Adults with Refractory Solid Tumors

The following specific elements are included:

• Develop and validate to LC-MS/MS methodology for the quantification of NSC XXXXX in human plasma and urine. Full GLP not required, but validation should follow FDA guidance for clinical pharmacology assays.

• Secure all needed internal approval(s) for receipt and analysis of human samples to be generated by this NCI Phase I trial. The clinical protocol and certification of NIH IRB approval will be provided to the Contractor.

• Determine levels of NSC XXXXX in human plasma and urine samples obtained from up to

30 patients in the clinical trial. It is anticipated that 12 plasma and 3 urine samples will be collected from each patient in cycle 1 only (= 360 plasma samples and 90 urine samples).

Samples sets will be shipped as patients are accrued and treated, so planning for intermittent analyses will be critical. For costing purposes, assume samples will be analyzed in five (5) batches over the course Task Order period of performance.

• Pharmacokinetic data analysis shall include standard non-compartmental modeling to determine Cmax, Tmax, AUC0∞, AUClast, CL, and t½, Vss, for each patient. Cumulative urinary excretion and clearance shall also be determined. Compartmental and population modeling approaches may be also proposed.

B. Deliverables:

• Bioanalytical Validation Report. A narrative report documenting the proposed assay for

NSC XXXXX in plasma and urine shall be submitted to the COR before clinical sample

RFP 75N91021R00007

Attachment 7 – Sample Task Order #4 (11/20/2020) analysis begins. Suitability for intended use (accuracy, precision, reproducibility, specificity, etc.) statistics shall be tabulated consistent with FDA guidelines.

• Preliminary Data File. Interim c vs. t data and preliminary PK parameter estimates for each patient shall be tabulated in Excel and sent to the COR within 14 working days after receipt of samples.

• Final Data File: The Preliminary Data File shall be updated to include an outline of methods used (analytical conditions and validation, etc.), results of any sample or PK re-analysis, and any changes requested by the COR. All information should be formatted on separate tabs in Excel. The Final Data File shall be due two weeks after receipt of comments on the Preliminary Data File.

• Monthly Reports: Monthly Technical Progress Reports are required for this task order.

These reports shall include: 1) a summary of progress on the study during the past month,

2) whether or not the project is on schedule, and (3) whether any problems were encountered in the collection, handling or processing of data, including resolution of the problems.

The reporting period shall consist of each calendar month. The first report shall cover the period consisting of the first full calendar month following the effective date of the task order and any fractional part of the initial month. Reports shall be due on or before the 15th of each month following the end of each reporting period. A Monthly Study Progress Report shall not be submitted when the Final Report is due

• Draft Final and Final Reports: A draft clinical pharmacokinetics final report containing summary data, analysis, graphs, and conclusions across all patients in the trial will be due one month after completion of the final patient sample set. The final report will be due 14 working days after receipt of comments from the COR on the draft report.

C. Evaluation Factors

The evaluation criteria found in Section M of the ID/IQ RFP will govern the evaluation of responses received to this Sample Task Order Request for Proposals or TORFP (see Section M).

In an actual TORFP competed under any resultant IDIQ contract, study-specific evaluation criteria will be provided in this section.

D. Order Response Due Date: Responses to this Task Order shall be included in your technical and business proposals for this RFP.