Release Date:  April 30, 2002

NOTICE:  NOT-GM-02-003

National Institute of General Medical Sciences (NIGMS)

The National Institute of General Medical Sciences (NIGMS) will 
participate in the recently released program announcement PA-02-075 
"Innovative Toxicology Models: SBIR/STTR" 

NIGMS has an established interest in understanding interactions of 
therapeutic drugs or their toxic metabolites with cellular components 
that may result in the development of toxic effects. This is 
complementary to the goal of the announcement, namely, the discovery, 
development and validation of new assays and procedures to determine 
the toxicological profiles of potential therapeutic drugs.  It is 
expected that a molecular definition of toxicity in the affected organ, 
tissue or cell would be a component of the procedure.  As stated in PA-
02-075, "Approaches for new toxicology assays in response to this 
initiative are broad and are determined by the creativity of the 
applicant. Genetically modified animals or cell lines, various non-
mammalian organism, in vitro assays utilizing primary mammalian cells 
(human cells are of particular interest), tissue slices, isolated 
organs, subcellular fractions, or purified enzymes could be utilized 
for the model. Computer modeling utilizing existing biological and 
toxicological data bases would be appropriate. Genomic and proteomic 
technology could be exploited to profile total gene activity or protein 
expression and thereby establish molecular correlations with specific 
toxicities. Molecular endpoints to evaluate toxicity and high 
throughput toxicity screening could be used to help decide which agent 
of a chemical series could be pursued, to allow exploration of toxicity 
at an earlier stage in drug development, to define the toxicity profile 
of agents selected for clinical trial or for which there is significant 
environmental exposure."  

For further information, contact:

Richard T. Okita, Ph.D. 
Pharmacology, Physiology & Biological Chemistry Division, NIGMS 
45 Center Drive, Room 2AS-49A 
Bethesda, MD 20892-6200 
Phone:  301-594-1826 
Fax:  301-480-2802 

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