Preclinical Pharmacokinetic and Pharmacological Studies of Anticancer and Other Therapeutic Agents

The mission of the Developmental Therapeutics Program (DTP), DCTD, NCI centers on the discovery and preclinical development of agents with clinical anticancer potential. Preclinical pharmacokinetic and metabolism studies are an early and integral part of the overall drug development process and contract resources for preclinical development studies have existed in DTP continuously since the late 1970s. Characterization of the pharmacokinetics of new compounds provides important information for the selection of optimal drug development candidates and for the design and interpretation of preclinical efficacy studies, including the selection of formulations, routes, and schedules of administration. Moreover, one objective of preclinical toxicology evaluations is the correlation of toxic effects of a compound with plasma concentrations and/or area under the curve (AUC). The successful outcome of these studies thus depends heavily on the availability of sensitive methods for quantifying compounds in biological fluids and the careful integration of preclinical pharmacology and toxicology data.


Project Requirements

Activities of any contract awarded from the proposed solicitation will include, but not be limited to, the following tasks:

(1) Development of sensitive analytical methods to quantify compounds in plasma, urine, tissues, and other biological matrices;

(2) Plasma stability and protein binding studies, which are conducted at an early stage of compound development to ensure proper sample handling and to aid in the interpretation of in vivo studies;

(3) Pharmacokinetic evaluation of test compounds following administration to animals by various routes and schedules, including a determination of bioavailability by various routes;

(4) Quantification and identification of drug metabolites generated in vivo and in various in vitro systems (S9 fractions,


Anticipated Period of Performance

The anticipated period of performance will consist of five (5) years, from December 15, 2010 through December 14, 2015.

Mandatory Qualification/Mandatory Exclusion Criteria

Supporting documentation demonstrating compliance with the Mandatory Qualification and Mandatory
Exclusion Criteria listed below must be included with the initial proposal submission.

1. Mandatory Qualification Criterion

The offeror must possess a valid Nuclear Regulatory Commission (NRC) license, a license issued by a state that has entered into an agreement with the NRC, or an equivalent foreign license at the time of proposal submission permitting the purchase, storage, and use of radioisotopes (e.g., 3H, 14C, 35S) likely to be used in the proposed pharmacological research.

2. Mandatory Exclusion Criterion

The offeror may not be a pharmaceutical, chemical, or biotechnology firm. For purposes of this RFP, a pharmaceutical, chemical or biotechnology company is defined as an organization which sells drugs and/or chemicals to the general public for profit or is engaged in research leading to such products.

NAICS for this acquisition is 541712.

The solicitation is scheduled for release on or about April 30, 2010. The RFP may be accessed through the NCI Office of Acquisitions homepage located as http://rcb.cancer.gov/rcb-internet/index.jsp. It is the offeror's responsibility to monitor the above internet site for the release of this solicitation as well as any amendments. ALL OFFERORS WILL BE RESONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. IN ADDITION, ALL QUESTIONS MUST BE SUBMITTED ELECTRONICALLY.  NO COLLECT CALLS WILL BE ACCEPTED. ALL QUESTIONS SHALL BE SUBMITTED IN WRITING TO THE CONTRACT SPECIALIST.