SOLICITATION NOTICE
D -- NCI PK/PD Modeling: Erythropoietin & Darbepoietin
- Notice Date
- 5/20/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Minerals Management Service GovWorks (Franchise) 381 Elden Street, MS 2500 Herndon VA 20170
- ZIP Code
- 20170
- Solicitation Number
- 1435-04-03-RP-72743
- Response Due
- 6/23/2003
- Archive Date
- 5/19/2004
- Point of Contact
- Shanda Georg Business Specialist 7037871758 Shanda.Georg@mms.gov;
- E-Mail Address
-
Email your questions to Point of Contact above, or if none listed, contact the IDEASEC HELP DESK for assistance
(EC_helpdesk@NBC.GOV)
- Small Business Set-Aside
- N/A
- Description
- THIS NOTICE IS A COMBINED SOLICITATION - AND IS THE ONLY NOTICE THAT WILL BE PROVIDED. PLEASE READ CAREFULLY. This is a combined synopsis/solicitation for commercial items prepared under FAR Part 13.5 - Test Program for Certain Commercial Items, and prepared in accordance with the format in Subpart 12.6, as supplemented with additional information in this request. This requirement is for the National Institute of Health, National Cancer Institute, Division of Cancer Treatment and Diagnosis. The National Cancer Institute (NCI) wants to evaluate the feasibility of a clinical trial that might determine optimal doses and schedules of 2 agents used to support erythropoiesis in patients receiving chemotherapy. Two agents that stimulate erythropoiesis are currently approved for the treatment of patients receiving chemotherapy who develop anemia. Recombinant human erythropoetin (epoetin alpha, rHuEPO, Procrit, Ortho Biotech Products, L.P. Raritan, NJ) is indistinguishable from the endogenously produced human protein. Darbepoetin alpha (Aranesp, Amgen, Inc, Thousand Oaks, CA) is a hyperglycosylated analog with 2 extra oligosaccharide chains at sites of amino acid substitutions, producing a higher MW agent with a longer circulating half life and somewhat decreased binding efficiency. In order to explore the most effective approaches to treating patients with agents that support erythropoiesis, NCI is requesting a contract to perform modeling and trial simulations. Given that the full surface of dosage regimenresponse patterns of the two drugs cannot easily be estimated by a single clinical trial _ indeed it may be impossible, due to the inherent complexities of the dosage regimens for maintenance and recovery periods _ NCI has determined the need for access to mechanistically oriented pharmacokinetic (PK)-pharmacodynamic (PD) modeling to enable simulations of different dosage regimens of darbepoetin alpha and epoetin alpha that would predict the range of outcomes that an actual clinical trial might produce. The goal of the modeling is to estimate the effects of varying the dose and schedule of each drug on clinically important endpoints and to estimate for various trial designs, the width of the confidence interval on the conversion ratio (the ratio of minimum total dosage per week of the two products, darbepoetin alpha and epoetin alpha, that provides a given level of clinical response [see below] in a specified fraction of patients with chemotherapy induced anemia). This modeling-simulation approach will (i) make extensive use of prior data that will be made available to the simulation contractor by both Ortho Biotech and Amgen in agreement with the National Cancer Institute and (ii) allow deviations from protocol to influence trial design, yielding more realistic estimates of design. The clinical response endpoints will be defined by NCI, and will be a weighted combination of clinically important endpoints (e.g., percentage of patients with an increase > 2 g/dL in serum hemoglobin [Hb] level at weeks 4, 8, 12, 16, 20, 24 without transfusion, L, the lag time for Hb increase and rate of increase over specified intervals, mean change in Hb from baseline, percentage of patients who require red blood cell transfusions at various time points, etc.). The scope of work is described in detail in the Statement of Work, particularly in sections 3.0 (Scope) and section 4.0 (Specific Tasks). If you are interested in this acquisition, you may locate the RFQ instructions and statement of work documents on the following website: http://www.govworks.gov/vendor/csolicit.asp The documents will be available on the govworks website in the late pm of May 20, 2003. The documents are in Microsoft Wordr The solicitation documents (solicitation instructions and the statement of work) are located at: http://govworks.gov/vendor/csolicit.asp, and identified as: RFQ 1435-04-03-RP-72743, NCI PK/PD Modeling: Erythropoietin & Darbepoietin , National Institute of Health, National Cancer Institute, Division of Cancer Treatment and Diagnosis Important Due Dates: 1. Technical Questions Due: June 03, 2003 no later than 2:00PM Eastern Standard Time. No questions will be accepted after the June 03, 2003 date and time. The Government response will be posted on the FedBisOpps website. 2. Technical and Cost Proposal Due June 23, 2003 on or before 2:00PM Eastern Standard Time
- Web Link
-
Please click here to view more details.
(http://ideasec.nbc.gov/ecprod/owa/ec$cbd.sypfirstcount?P_SERVER_ID3=MM143501&P_OBJ_ID1=95474)
- Record
- SN00328922-W 20030522/030520214717 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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