SOLICITATION NOTICE
A -- Pediatric Preclinical Testing Program
- Notice Date
- 3/26/2009
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- N01-CM-91001-03
- Point of Contact
- Erin Bain,, Phone: 301-435-3814, Richard L Hartmann,, Phone: (301) 496-8620
- E-Mail Address
-
bainerin@mail.nih.gov, Richard.Hartmann@nih.gov
- Small Business Set-Aside
- N/A
- Description
- Note—this synopsis follows a Sources Sought notice that was released on January 22, 2009 under Sources Sought Notice No. SS-ETSB-091001-48. The National Cancer Institute’s (NCI), Cancer Therapy Evaluation Program (CTEP), located in the Division of Cancer Treatment and Diagnosis (DCTD) is seeking a contractor to systematically test novel agents against childhood cancer preclinical models (both in-vivo and in-vitro, as well as specialized studies), with the overall objective being to assist CTEP in fulfilling its mission of identifying more effective treatments for children with cancer. The Contractor shall be responsible for the following tasks: TASK AREA 1 – IN VIVO TESTING --In vivo testing panel: The Contractor shall provide for testing and maintain a panel of preclinical models for approximately 10 childhood cancers, with each cancer type represented by 4-10 different xenograft lines deemed suitable for in vivo drug testing (henceforth termed the pediatric preclinical in vivo panel). --Stage 1 testing: The Contractor shall participate in the design of studies to test agents and shall conduct experiments to evaluate the therapeutic potential of ten to twelve agents (or combinations of agents) annually in the first stage of testing. Stage 1 testing of an agent shall involve evaluating the test agent’s activity at its maximum tolerable does (or the dose recommended by the pharmaceutical collaborator) against the entire pediatric preclinical in vivo panel. --Stage 2 testing: For agents for which antitumor activity is observed in Stage 1 testing, Stage 2 testing shall include a further evaluation of the antitumor activity of the agent against the selected tumor types for which activity was observed in Stage 1. Approximately 6 agents per year are anticipated to proceed to stage 2 testing because of activity observed in Stage 1 testing, and for each active agent there will be one to three tumor types for which further testing is warranted. Stage 2 testing will vary depending upon the agent and the responsive tumor types, but may include: developing a full dose-response curve for the agent against the tumor types for which activity was identified in Stage 1 testing; studying the activity of the agent in combination with either standard anticancer agents or with experimental agents; studying the pharmacokinetics of the agent to correlate antitumor activity with the agent’s blood levels; studying the agent in orthotopic mouse models and in models of metastatic disease; studying the agent in relevant genetically engineered mouse models; evaluating alternative schedules and/or routes of test agent administration; and, performing evaluations of pharmacodynamic markers of drug effect. TASK AREA 2 – IN VITRO TESTING --In vitro testing: The Contractor shall provide for testing and maintain a panel of in vitro models for selected childhood cancers to be used for in vitro testing of agents supplied to the Contractor. The pediatric preclinical in vitro panel may focus on a subset of the overall tumor types included in the in vivo testing panel (15 to 25 cell lines in toto) and should include a diversity of biological characteristics. --The Contractor shall utilize a standard protocol for in vitro testing for agents. --For agents (or combinations of agents), the Contractor shall participate in the design of studies and/or submission of protocols for testing of the agent against the in vitro cell line panel. TASK AREA 3 – SPECIALIZED STUDIES --Pharmacokinetic evaluations: For agents progressing to Stage 2 testing for which there are not sufficient extant data describing the pharmacology of the agent in murine models (estimated to be approximately 4 agents annually), the Contractor shall participate in the design of studies to determine systemic exposure and plasma elimination kinetics in appropriate animals and using the formulations and routes of administration used for drug testing. --Pharmacodynamic evaluations: For selected tested agents, the Contractor shall participate in the design of studies to establish whether agents have achieved target inhibition/modulation within tumor or leukemia cells under test conditions or have elicited a predicted pharmacodynamic effect related to the agent’s mechanism of action. --Molecular characterization and correlation of molecular characteristics with antitumor activity of tested agents: The Contractor will perform exploratory (hypothesis-generating) bioinformatics analyses to correlate the preclinical activity of tested agents against xenografts and cell lines to the baseline molecular characteristics of the preclinical models as defined by their gene expression profiles and chromosomal segment copy number changes. The anticipated period of performance for this requirement is November 1, 2009 – October 31, 2014, with a 1-year base period and 4, 1-year option periods. It is anticipated that the Request for Proposal (RFP) package will be available on or about April 10, 2009 with responses due within 30 calendar days following the actual date of issuance of the RFP. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. Full electronic copies will not be accepted, but portions of the proposal may be provided on disc. The reference number to be used for this announcement is: RFP N01-CM-91001-03. All correspondence must cite the reference number as provided.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=a483c07570c74948d7047a08b1a3f896&tab=core&_cview=1)
- Record
- SN01779208-W 20090328/090326221221-a483c07570c74948d7047a08b1a3f896 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |