National Cancer Institute, Research Contracts Branch, TCS 6120 Executive Blvd, EPS/RM 603 Bethesda, MD 20892-7220

A -- PRECLINICAL TOXICOLOGY & PHARMACOLOGY OF DRUGS DEVELOPED FOR CANCER, AIDS AND AIDS-RELATED ILLNESSES SOL NCI-CM-77028-30 DUE 120796 POC Elsa B Carlton, Contract Specialist, (301) 496-8620, FAX: (301) 402-6699. The National Cancer Institute (NCI), Division of Cancer Treatment, Diagnosis and Centers (DCTDC), Development Therapeutics Program (DTP) anticipates the award of five (5) cost-reimbursement contracts, for a five (5) year period beginning August 30, 1997. As a minimum requirement, the contractors must perform all toxicology studies in accordance with the FDA's current Good Laboratory Practice (GLP). Contractors must also indicate their willingness to sign a confidentiality of information statement. The proposed awarded contract will be administered on a work assignment managed basis. Offerors are required to proposed levels of effort for both levels: Level A: 46,875 labor hours, and Level B: 93,750 hours over a 5 year period. DTP is seeking organizations to carry out pharmacology and toxicology studies, the data from which must be suitable for filing with the FDA as part of Investigational New Drug Applications. Offerors should have the facilities and staff to carry out such studies and the management expertise to analyze and evaluate the data. Work assignments are estimated to involve two or three chemical agents annually per contract. The objectives of the assignments in relative order of importance are: 1) assessment of acute and subacute toxicity in rodents and dogs including determination of a maximumn tolerated dose (MTD), of dose limiting toxicities (DLT), schedule-dependent toxicity, of the reversibility of adverse effects and of a safe clinical starting dose; 2) validation of analytical methodology to quantitate plasma drug levels in preclinical animal models and to measure plasma drug levels in rodents, dogs and/or non-human primates treated with the agent under study; 3) determination of bioavailability of drug after parenteral and/or oral administration, of efficacious drug levels can be attained in plasma in vivo and if the drug crosses the blood-brain barrier; 4) the use of pharmacokinetic information to permit extrapolation of toxic effects across species by relating plasma drug levels to the time of appearance and severity of toxicity, and to establish the safety of potentially efficacious doses. The Principal Investigator should have a doctoral degree in pharmacology/toxicology plus at least five years experience in directing, implementing and evaluating drug toxicity studies in experimental animals. The pathologist, pharmacokineticist and analytical chemist should likewise have credentials which illustrate their competence and accomplishment in serving as critical team members in the conduct of such studies. This is a recompetition of a group of 5 contractors currently performing these activities. The Request for Proposal will be available on or about October 18, 1996. No collect calls accepted. (0275)

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