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Pharmaceutical: The Association of American Medical Colleges (AAMC) and the FDA have published a report summarizing the results of a two-day conference identifying obstacles to drug development and how to encourage collaboration among government, academia and industry. Suggestions to address the gap between advancements in basic science and the discovery of new drug targets included an analysis of drug target failures, drawing upon information from several companies, and changes in early clinical development to encourage testing in humans. Collaborative approaches focused on pooling data are also advocated for pre-clinical toxicology testing, including the development of a pre-clinical toxicology database for organ-specific toxicity. Other proposals included the promotion of model-based drug development and the use of whole animal systems biology. The creation of a biomarker and surrogate endpoint inventory and establishment of standards for imaging biomarkers are among the suggestions for a collaborative approach to biomarker discovery and validation. New approaches to clinical trial design and execution should focus on patient selection, dosage regimen and trial modeling. Collaborative efforts could include consortiums to analyze clinical trial failures, standards for clinical data and for trial operation management, and increased reviews and training.

Source: AAMC
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Title Annotation:Industry Watch
Publication:Instrument Business Outlook
Date:Sep 30, 2005
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