Sharing Data and Models to Improve Clinical Drug Development and Regulatory Decisions

Venue: Washington Marriott Hotel

Location: Washington, District Of Columbia, United States

Event Date/Time: Jan 24, 2007 End Date/Time: Jan 25, 2007
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Clinical trial failure in late development (Phase 3) is a risk that companies cannot afford, particularly if the failure is predictable. The FDA Critical Path Opportunities List recognizes several joint development paths that could improve pharmaceutical productivity and reduce failure rates. These paths include:

•Better understanding of prior information in making current drug development and approval decisions
•Better understanding of disease through biomarkers
•Application of modern bioinformatics to mine prior knowledge (e.g., NDAs) sources

Oftentimes, useful prior clinical trial information that could improve drug development efficiency is lost within companies and at the FDA. This information could help us to better understand the biomarker relationship to primary disease endpoints, disease change over time, placebo effect, and drug effect on disease. These quantitative relationships can help employ biomarkers (e.g., biochemical, imaging, genomic) in dose finding, the creation of new surrogate markers, planning of effective clinical trials, and making better clinical development and regulatory decisions.


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