Sample_Task_Order__1_REV_12-21-15.pdf

SAMPLE TASK ORDER REQUEST FOR PROPOSAL #1

NOTE: THIS IS ONLY A SAMPLE - NO TASK ORDER AWARD WILL BE MADE IN RESPONSE TO THIS

REQUEST

Contractor: _________TBD_____________

Contract No: ________TBD_____________

TORP No: _1__ Modification No: _____

Order Title: Pharmacokinetics and Bioavailability Evaluations of Selected Anticancer Compounds in Mice

Order Originator: ___________ Date Prepared: _ ________

Task Order Type: Cost Reimbursement (CR)

Part I. INITIATOR’S REQUEST

A. Period of Performance: TO BE DETERMINED

B. Statement of Work/Protocol/Project Description:

The purpose of this Task Order is to rapidly characterize the plasma pharmacokinetics and bioavailability of candidate anticancer compounds in mice as outlined below.

For the base period:

1. Use a standard LC-MS/MS bioanalytical approach, as directed by the COR, for quantification of a small drug-like molecule in mouse plasma. A “generic” assay platform is acceptable and validation to full FDA bioanalytical guidance is not required. An internal standard will be identified and used as a measure of acceptable assay performance. An LLOQ of <10 ng/mL is desirable.

2. Carry out the appended protocol for mouse PK and bioavailability evaluations with a small drug-like compound to be provided by NCI. Note for costing purposes that the protocol specifies 2 dose groups with two routes of administration, 8 time points, and 3 mice/time point, for a total of 48 plasma samples to be generated for analysis.

3. Pharmacokinetic data analysis should include standard non-compartmental modeling to determine Cmax(po), C0(iv), Tmax, AUC0∞

, AUClast, CL, and t½, Vss, and %F for each compound.

For Options 1 - 9:

1. Perform PK-bioavailability evaluations as above and per the attached protocol for one additional compound per option. Minor adjustments to the protocol that should not affect cost or schedule (e.g., routes of administration, specific sampling times) may be made. Options are considered additional quantities and are not directly related to specific dates. Options may be exercised at any time within the Task Order period of performance.

C. Deliverables:

A fully signed protocol shall be provided to the COR prior to initiation of each evaluation.

Summary data in tabular form (c vs. t and PK parameters, with suitable plots) for each compound shall be provided to the COR within two weeks of receipt of that compound.

Separate draft reports for the base period and for each of any options exercised will be due two weeks after completion of each evaluation. The reports will accurately and completely describe hudakad Typewritten Text RFP Number: N02CM67000-11 hudakad Typewritten Text Attachment 19-1 the experimental design and methods and present an analysis/summary of the data followed by the conclusions derived from the analyses.

The final report will be due two weeks after return of the draft report for revision. .

D. Additional Instructions:

As Task Orders may be competed among the contractors if multiple awards are made pursuant to this RFP, please consider and provide information in your response to address Items E and F.

E. Evaluation Factors:

Proposals will be evaluated on the following factors, in order of importance:

1) Turn-around time (weight 50%): Documented ability to perform protocol designated evaluations rapidly and submit summary data in tabular form (c vs. t and PK parameters) for each compound within two weeks of receipt of that compound. Evidence of experience and creativity in scheduling assigned work to meet or exceed on-time goals.

2) Cost (weight 40%): Reasonableness of labor mix, proposed hours, and total costs.

3) Technical (weight 10%): Ability to rapidly implement suitable LC/MS-MS methods for small drug-like molecules and apply them to analysis of plasma samples. Understanding of appropriate analytical method and validation procedures in context with experimental goals and the state of compound development (e.g., early screening PK vs. full GLP evaluations). Constructive suggestions on design elements in the attached protocol. Evidence of submission of complete, well-organized, and high-quality technical reports.

F. Order Response:

The Technical Proposal shall be 3-4 pages in length and consist of an outline of your approach to appended protocol. Specific procedural recommendations and/or alternative methods may be recommended. Include a proposed timeline for the work from protocol approval to submission of the final report. Briefly highlight your relevant experience with appropriate analytical method development and performing pharmacokinetic evaluations on similar timelines.

The Business Response shall at least include a Coversheet and a Budget (provided substantially as indicated in Part II of this form). The Coversheet shall at least consist of:

• RFP Number

• Task Order RFP Number

• Name, address, email and telephone number of point of contact

• Name, address, email and telephone number of contract Administration Office (if applicable)

• Date of submission

• Name, title, address, email, telephone and signature of authorized Business Representative

(person authorized to sign contracts on behalf of the organization).

Budgets for the base period and each Option should be provided separately. Note: this Order will initially be awarded for the base period and associated costs to conduct the appended protocol. The Government may decide to unilaterally exercise and fund one or more Options for additional work as listed above. A notice of intent to exercise each option would be sent seven days prior to unilateral exercise.

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

TASK ORDER REQUEST FOR PROPOSAL (TORP)

Contractor: _____________[fill in]____________________ Contract No: ___ __________________

TORFP No: __ 1___ Modification No: __ 0____ Date Prepared: ______________________

Part II. CONTRACTOR’s RESPONSE TO ORDER REQUEST (*The Contractor shall attach a detailed budget to this form to identify all proposed costs.)

A. Estimated Cost and Effort:

1. Labor hours – list order leader, specific individuals to be assigned, labor category, and estimated hours for each.

2. Labor costs – list by labor category and total.

3. Employee benefits.

4. Direct materials.

5. Travel.

6. Subcontracts.

7. Other direct costs.

8. Indirect costs.

9. Total estimated costs for this Order: ______________*

B. Detailed description of the approach to be used and of the deliverable(s). (Be specific):

APPROVAL TO PROCEED: The Contractor shall not exceed the estimated labor hours, estimated Order amount, or change the Order leader without the prior written approval of the Contracting Officer’s Representative and the Contracting Officer.

1. For the Contractor: _____________________________ Date: __________________

(Signature)

Typed Name: __________________________________

2. For the Government: ____________________________ Date: __________________ Contracting Officer’s Representative (COR)

____________________________ Date: __________________ Contracting Officer