The overall goal of this proposed program project is to delivera new agent to clinical trials each year for patients with pancreatic cancer that hits a target discovered and validated in one of the three Projects. This is a very aggressive goal and it will take a very efficient and concentrated effort, particularlyof this Core, to attain that goal. This Drug Development Core has the overall responsibility to provide the drug development tools and services to develop anew therapeutic agent each year based on a target found in one of the three Projects.
The specific aims for this Core include: 1. To provide compound libraries, robotic and other services for screeningthese libraries to find a lead agent against each new target. 2. To provide synthetic chemistry capabilities as well as molecular modeling capabilities to optimize activity of lead compounds. 3. To provide formulation capabilities for any lead or candidate compounds. 4. To provide in vitro and in vivo testing in a variety of pancreatic cancer models as needed for each lead. 5. To provide pharmacologic assays and pharmacodynamic assays as needed for each project. 6. To provide initial toxicology studies of drug candidates produced by each project. 7. To provide a regulatory package (IND) for submissionto the regulatory authorities to initiatea phase I trial of the new agent. This package will include a clinical development plan for the compound. 8. To secure a long-term commercial sponsor for.each compound so the compound will proceed smoothly through phase I, II and III clinicaltrials. This Core is essential for the translation of biology performed in the Projects into new therapeutic agents for patients with pancreatic cancer.
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