SOLICITATION NOTICE
Q -- Analytical Chemist
- Notice Date
- 6/26/2002
- 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
- RFQ-NCI-20068-NG
- Response Due
- 7/11/2002
- Archive Date
- 7/26/2002
- Point of Contact
- Malinda Holdcraft, Purchasing Agent, Phone (301) 402-4509, Fax (301) 402-4513, - Caren Rasmussen, Lead Contract Specialist, Phone (301) 402-4509, Fax (301) 402-4513,
- E-Mail Address
-
holdcram@exchange.nih.gov, rasmusc@mail.nih.gov
- Description
- The National Cancer Institute (NCI), Clinical Pharmacology Scientific Core (CPSC), intends to procure services for an Analytical Chemist in accordance with the simplified acquisition procedures authorized in FAR Part 13. This announcement constitutes the only combined synopsis/solicitation, and a separate written solicitation will not be issued. This solicitation includes all applicable provisions and clauses in effect through FAR FAC 06-02. The North American Industry Classification System code is 541380 and the business size standard is $5M. The CPSC, has as its primary research interest the use of pharmacokinetic and pharmacodynamic methods to develop new anticancer and antiretroviral agents. Within the CPSC, NCI is utilizing compartmental and non-compartmental methods to define the therapeutic range for these agents. Moreover, several 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 an analytical chemist to participate in the analytical development of CC-5013. This shall require LC Mass Spec experiments and validation. CC-5013 is a new compound that has entered clinical trials at the NCI. No analytical method has previously been developed. This shall require LC Mass Spec as NCI expects the plasma concentrations to be relatively low (ng/mL). Such a specialist is needed to characterize the pharmacokinetics in preclinical models. Contractor Requirements: NCI shall send the contractor samples from the clinical trials to be quantitated by the contractor's laboratory (the specific method used is LS/MS), approximately 5000 samples over a 10 month period of time, and need a turn around time of one week from the time of receiving a batch of samples. This is necessary to adjust dosing within the clinical trial. The results shall be sent electronically, via electronic mail and as a hard copy. 1) The contractor shall be required to model the data using ADAPT computer software program. It is critical that only ADAPT be used as this program fits into the overall scheme of the research program and allows for the flexibility of pharmacodynamic- modeling of outcome evaluation of metabolism of CC5013 using a method that would be developed in the contractors laboratory. The results shall be placed into the program for pharmacokinetic analysis. This is a specialized process that is important in understanding the results. 2) The contractor shall provide standard curves and quality controls as well as all of the raw chromatograms from these experiments. A full report shall be generated on the experiments done and the quality controls utilized. Full, weekly reports, shall combine all results and the ADAPT output at the end of the period of performance. SC and Qcs are how the contractor shall determine the quantitation from the LC/MS. SC is a series of spiked samples and the sample in question shall be compared to it. 3) All reports shall be provided in Microsoft Word. 4) All analytical equipment shall be done with Agilent and all records shall be transferred both electronically and by hard copy based on Agilent data methods. This includes diode array spectrums as well as Masspec results. The report shall include and shall be submitted at the end of the performance period of this contract: a) Validation assay and results; b) graphs of all the data; c) provide chromatograms of all samples; d) full documentation of methods utilized; e) full documentation of quality controls; f) utilization of good laboratory safety skills; g) utilization of good laboratory techniques; h) collection, tabulation, and organization of data; i) reporting the results in written form and; j) analyze 1,000 patient samples within 10 months. Period of Performance: Upon award of purchase order through 10 months. Technical Evaluation Criteria: 1) This contract shall be awarded based upon past track record in analytical methods development, validation, reporting, past track record in oncology analytical assessment as well as modeling of pharmacokinetic data. It is important to have not only expertise in developing different pharmacokinetic models but, also in incorporating pharmacodynamic endpoints into those models ( 30 points). 2) Previous experience in metabolism assessment, and the identification of cytochromic P450 isozymes responsible for the degradation of CC5013 ( 30 points). 3) The educational requirements for this contract shall be doctoral level, with expertise both in analytical chemistry as well as pharmacokinetic analysis ( 20 points). 4) Attention to detail, reporting, and record keeping is necessary ( 10 points). 5) Past performance ( 10 points). 6) Cost. Source selection will be based on best value (No points). Offerors must provide resumes`, and/or other materials in sufficient detail to demonstrate that their offer meets the foregoing requirements. The literature furnished must also show the service to which the specifications herein pertain to. The anticipated purchase order will be awarded to one responsible offeror that fully meets the above requirements of this solicitation. Provisions and clauses: the solicitation incorporates the NCI REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENT OF OFFERORS OR QUOTERS (SIMPLIFIED ACQUISITIONS). The award document will incorporate the requirements of the clause at FAR 52.213-4 (May 2002) TERMS AND CONDITIONS-SIMPLIFIED ACQUISITIONS. This solicitation incorporates one or more solicitation provision by reference, with the same force and effect as if they were given full text. Upon request, the Contracting Officer will make their full text available. Quotations must be in writing and should be submitted as follows: 1) a completed SF-18 that is signed by an authorized representative of the offeror, containing pricing information and if applicable and a delivery date; 2) completed REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS OR QUOTERS (SIMPLIFIED ACQUISITIONS); 3) resumes` and/or other materials as noted above; 4) acknowledgment of amendments, if any. The Representations and Certifications or other cited provisions and clauses may be obtained from Malinda Holdcraft, Purchasing Agent via electronic mail at holdcram@exchange.nih.gov or by fax at 301-402-4513. The price and technical quotations and related materials (one (1) original and two (2) copies) must be submitted by 1:00 PM EDT on or before July, 11 2002 to Malinda Holdcraft at the following address. Quotations that fail to furnish the required information or reject the terms and conditions of the solicitation may be excluded from consideration. All interested parties must mail quotation packages to: Malinda Holdcraft, NIH/NCI/RCB, 6120 Executive Blvd. Room 6072, Rockville, Maryland 20892-7194. No collect calls will be accepted. No faxed copies of quotation packages will be accepted.
- Place of Performance
- Address: NIH/NCI, 9000 Rockville Pike, Bethesda, MD
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN00099875-W 20020628/020626213157 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |