PRECLINICAL PHARMACOLOGICAL STUDIES OF ANTITUMOR AND ANTI-HIV AGENTS

Release Date:  January 29, 1999

RFP AVAILABLE:  N01-CM-97019-58

P.T.

National Cancer Institute

The Developmental Therapeutics Program (DTP), Division of Cancer Treatment and
Diagnosis (DCTD), National Cancer Institute (NCI) of the National Institutes of
Health (NIH)  is soliciting organizations having the necessary experience,
scientific and technical personnel and facilities to conduct a series of
preclinical pharmacokinetic and other pharmacology studies in animals on agents
having demonstrated antitumor or anti-HIV activity and considered by DCTD to
merit further development.  The studies to be performed will include:  the
development of methodology for the quantitative measurement of test agents and/or
metabolites in body fluids and tissues; stability studies of test agents in
biological fluids; plasma protein binding determinations; characterization of in
vivo plasma concentration-time profiles and calculation of relevant
pharmacokinetic parameters; determination of test agent levels in samples
provided by other DTP contractors;  determination of the most effective mode of
agent administration to achieve and maintain effective concentrations in body
fluids and tissues; bioavailability studies following administration of an agent
by various routes; tissue distribution and urinary excretion studies; structural
determination of metabolites and/or degradation products of parent agents
produced in animals and in model in vitro systems (e.g., animal and/or human
liver slices, hepatocytes, S9 fractions, and microsomal preparations).  Where
appropriate, this information will be related to mechanisms of antitumor or
antiviral action.  The Government will supply all animals (mice, rats, dogs, non-
human primates), test agents, and radiolabeled test agents.  Contractors will be
expected to provide all equipment, solvents, reagents and animal facilities
needed to conduct this type of work.  AAALAC accreditation is highly desirable. 
It is anticipated that five or six awards will be made as a result of the Request
for Proposal (RFP), each for a five-year, incrementally-funded completion type
contract.  Offerors have the opportunity to propose studies at two levels: one
compound per year or equivalent or two compounds per year or equivalent.  Only
one award will be made to an institution.  The following Mandatory Qualification
Criteria will apply:  (1) the Contractor may not be a pharmaceutical or chemical
firm since agents of a commercially confidential nature (discreet) may be
evaluated; (2) the Contractor must possess a valid NRC license permitting the
purchase, storage and use of typical quantities of radioisotopes (e.g., 3H, 14C,
35S) likely to be used in the proposed pharmacological research.  SIC for this
acquisition is 8731.  The solicitation is scheduled for electronic release on or
about February 16, 1999.  The RFP may be accessed through National Cancer
Institute's Research Contracts and Acquisition Branch homepage by using the
following internet address - http://amb.nci.nih.gov/appl/rfp/rfps_published.jsp.  It is the Offeror's
responsibility to monitor the above internet site for the release of this
solicitation and amendments, if any.  Potential offerors will be responsible for
downloading their own copy of the solicitation and amendments.

INQUIRIES

Inquiries may be directed to:

Michael Veesart
Research Contracts and Acquisition Branch
National Cancer Institute
6120 Executive Boulevard, Room 603, MSC 7220
Bethesda, Maryland 20892-7220
Telephone: (301) 435-3815
FAX:  (301) 402-6699
Email:  mv64b@nih.gov

No collect calls will be accepted

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