QUALITY CONTROL AND MODEL DEVELOPMENT IN RODENTS AND TUMOR CELLS

NIH GUIDE, Volume 22, Number 5, February 5, 1993



RFP AVAILABLE:  NCI-CM-47000-28



P.T. 34



Keywords:

  Disease Model 

  Animal Breed. & Facil., Scientific 

  Cell Lines 



National Cancer Institute



The Development Therapeutics Program (DTP), Division of Cancer

Treatment, (DCT), National Cancer Institute (NCI), is interested in

organizations that have the necessary experience, scientific and

technical personnel, and facilities to evaluate the activity of

potential anti-neoplastic compounds against in vitro cell lines and

in vivo tumor systems.  Maintenance of the integrity and reliability

of the in vivo tumor systems is necessarily dependent upon rigorous

quality control of the tumors and host animals.  Further, kinetic

data obtained during tumor analyses are used to assist in drug

treatment scheduling and interpretation of drug testing results.

This project is required so that variations in laboratory data can be

identified and analyzed as to cause, e.g., animal source, tumor

source, or laboratory technique.  In addition, in vivo testing

protocols must be established for candidate tumor models from the

human tumor cell disease-oriented screening panel to provide the

necessary follow-up of active materials identified for development as

candidates for possible clinical trial.



The Contractor will be required to perform the following specific

tasks:  perform tumor cell kinetic studies, including determination

of doubling times and labeling indices for all tumor lines available

for use in the in vivo testing program; develop working protocols

suitable for drug testing using tumor models designed by the NCI

Project Officer; test both standard agents and new agents identified

in the in vitro prescreen in in vivo protocols developed for DTP;

evaluate the response of host animals from all animal supply sources

to appropriate tumor lines; evaluate the drug response and growth

characteristics of tumors routinely used in the Program; evaluate the

efficacy of current and new COPs for maintaining pathogen-free tumor

lines and/or animals prior to their use in the Program; prepare and

maintain in vitro tumor cell cultures in support of the in vivo

program; and develop new or modify existing protocols with the goal

of establishing a minimal challenge model for use in early in vivo

screening of anticancer drug candidates.  The government will

designate and supply the agents to be tested.  The successful offeror

will be expected to provide all equipment, solvents, reagents, and

animal facilities needed to conduct this type of work.



It is expected that one cost-reimbursement contract, completion form,

will be awarded as a result of the solicitation.  This contract is

planned to be incrementally funded over a five-year period. The

proposed contract project represents a recompetition of Southern

Research Institute, Contract N01-CM-97553.



This project requires that the following restriction be applied:

"The NCI signs legally binding agreements with certain suppliers

(often pharmaceutical or chemical companies), these agreements state

that all information submitted by the supplier will be held

confidential.  Structural characteristics may have to be revealed in

the event that reformulation, solubility, or preliminary

pharmacokinetic studies are done to assure/improve proper dosing

regimens and treatment schedules.  Pharmaceutical or chemical

companies could obtain valuable data on new leads through this

mechanism.  Therefore, in order to honor the confidentiality

agreements made with suppliers, the NCI believes that such

information on compounds cannot be disclosed to potential competitors

of the supplier.  Thus, pharmaceutical and chemical companies must be

excluded from competition on the above referenced RFP.  For purposes

of this exclusion, a pharmaceutical or chemical company is defined as

"an organization that manufactures and/or sells drugs and chemicals

to the general public for profit."



All responsible sources may submit a proposal that will be considered

by the NCI.  This announcement is not a request for proposal (RFP).

RFP NCI-CM-47000-28 will be available on or about February 1, 1993,

with a response date of March 18, 1993, for the receipt of proposals.



INQUIRIES



Copies of the RFP may be obtained by written request to:



Ms. Carolyn Barker

Research Contracts Branch

Treatment Contracts Section

National Cancer Institute

Executive Plaza South, Room 603

Bethesda, MD  20892



.

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