SOLICITATION NOTICE
A -- Pharmacokineticist
- Notice Date
- 8/8/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-RFQ-20055-NV
- Response Due
- 8/26/2002
- Point of Contact
- Deborah Moore, Purchasing Agent, Phone (301) 402-4509, Fax (301) 402-4513, - David Keefer, Contracting Officer, Phone (301) 435-3801, Fax (301) 480-0309,
- E-Mail Address
-
dm170b@nih.gov, dk63h@nih.gov
- Description
- This solicitation is issued with the simplified procedures authorized in FAR Part 13. This solicitation no. NCI-RFQ-20055-NV includes all applicable provisions and clauses in effect through FAR FAC 2001-07. The North American Industry Classification code is 541690, and the business size standard is 6 million dollars. However, this solicitation is not set-aside for small business. Background: The Clinical Pharmacology Scientific Core (CPSC), Medical Oncology Clinical Research Unit, Center for Cancer Research, National Cancer Institute (NCI) has, as its primary research interest, the use of pharmacokinetic and pharmacodynamic methods to develop new anticancer and antiretroviral agents. Within the CPSC, we are utilizing compartmental and non-compartmental methods to define the therapeutic range for these agents. Moreover, several of our clinical trials have utilized adaptive control with feedback mechanisms. Likewise, the CPSC collaborates with numerous intramural and extramural groups by providing pharmacokinetic and analytical support. Because utilizing these techniques to optimize the development of new anticancer agents requires a team of individuals with specialized skills (i.e., pharmacokinetic modeling techniques, analytical techniques, pharmacodynamic techniques, etc.) success is dependent on a coordinated effort between the disciplines. The CPSC requires the skills of a pharmacokineticist to participate in the analysis of metabolism and protein binding of CC-5013. This will require microsome experiments as well as individual isozymes. This will require a considerable amount of technical knowledge and expertise in assessing pharmacogenetic polymorphisms that may predispose one to increased toxicity or lack of efficacy. As we are aware, thalidomide undergoes CYP450 2C19 metabolism which is deficient in 2-3% of the Caucasian population. We are very concerned that CC-5013 will undergo the same degree of metabolism. This expertise is not currently available elsewhere in the Clinical Center or the Institute. Background information of CC-5013: CC-5013 is an analogue of thalidomide which is under development for potential use in the treatment of inflammatory conditions and myeloma (MM). Thalidomide?s pleiotrophoc effects are mediated, at least in part, through its ability to down-regulate the pathogenic overproduction of a pro-inflammatory cytokine called Tumor Necrosis Factor alpha (TNF). In vitro models of anti-TNF secretion have shown that CC-5013 has IC50s of ~100nM (25.9 ng/mL) and ~480nM (103.6 ng/mL) against TNF produced by LPS-stimulated human peripheral blood mononuclear cells and LPS-stimulated human whole blood respectively. Thalidomide, by comparison, has a TNF IC 50 in human peripheral blood mononuclear cells of ~194?M (50.2 ?L). CC-5013 has been evaluated in a series of pre-clinical studies designed to evaluate safety and suitability for use in human volunteers. The vendor shall: 1) Develop a model to analyze the metabolism of CC5013; 2) Validate the model; 3) Identify and characterize the metabolites of this compound that are formed; 4) Utilize ADAPT to NLS fit the data; 5) Organize the data in Excel spreadsheets; 6) Utilize IT2S to develop a population model; 7) Utilize good laboratory safety skills and handle all blood samples with universal precaution; 8) Utilize good laboratory techniques ; 9) Collect, tabulate and organization pharmacokinetic data; 10) Develop, organize, and maintain a patient demographic data base; 11) Quality Control data base for errors; 12) Provide support documents to validate the clinical data base; 13) Assess for drug interactions; 14) Determine whether CC-5013 is metabolized by the liver, and if so, which isozymes; 15) Determine whether there are potential drug interactions if metabolized by the liver. Requirements: The vendor must provide the end-user with the results e-mailed within forty-eight hours of receiving the samples. The contractor will receive the samples from NCI via fedex on dry ice. (This is important because these samples are for clinical trial analysis in pharmacokinetic dosing. The vendor must be a Good Laboratory Practices standard laboratory since most of the data will be part of ultimate submissions of New Drug Applications to the FDA. The technical portion of quotations will receive paramount consideration in selecting a vendor. However, price will also be a significant factor in the event that two or more vendors are determined to be essentially equal following the evaluation of technical factors. The technical portion of quotations shall be evaluated based on the following technical evaluation criteria: 1) Previous experience in quantitating pharmacokinetic samples ( 40 %); 2) Capacity to do HPLC with diode array detection aw well as MS (40 %); 3) previous experience in generating QC?s under 10% (10%); 4) Ability to keep solid records and excellent documentation of results (10%); In addition to a price quotation, quoters shall provide a written technical quotation with sufficient descriptive literature, materials and other information to demonstrate that they can perform the foregoing requirements. The technical quotation shall also provide curriculum vitae for all proposed staff documenting experience pertinent to this project. Offers are due August 26 at 1:00 p.m. EDT. Facsimile submission are not authorized. Offers must be in writing and should be submitted as follows: (1) one original and two copies technical and cost quotations, signed by an individual authorized to bind the organization; (2) completed Representations and Certifications ? Simplified Acquisition, with DUNS Number addendum; (4) descriptive literature indicating that the offer meets the stated requirements; (5) acknowledgment of amendments, if any. The Representations and Certifications must be signed by an authorized representative of the offeror. Full text copies of the Representations and Certifications or other cited provisions and clauses may be obtained from Debbie Moore, Purchasing Agent, on (301) 402-4509 or by fax on (301) 402-4513. Offers and related materials must be submitted to Debbie Moore at the listed address. Offers that fail to furnish the required information or reject the terms and conditions of the solicitation may be excluded from consideration. Please cite the solicitation number on your offer. Any questions must be submitted in writing and may be e-mailed to dm170b@nih.gov or faxed to 301-402-4513. It is the vendors responsibility to call 301-402-4509 to insure questions have been received. No collect calls will be accepted.
- Record
- SN00136018-W 20020810/020808213301 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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