Biomarkers in Drug Development

Philadelphia, United States 21 23 May / 2012

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About the trade show

Everyone here knows that drug development and regulatory review is challenging, complex and changing at an unprecedented pace. Industry and FDA, while being different enterprises, have a common goal of reliance on biomarkers to empower people to make better decisions. Drug developers and regulators may choose to use biomarkers differently given their respective missions, but together we now have to face the challenge that there is an increasingly sophisticated array of technology to discover and develop new biomarkers. This will change how we plan to obtain biomarker information and how we will analyze our biomarker data. In the future, there will be a greater emphasis on using biomarkers for clinical differentiation of products, comparative effectiveness, targeted therapies, rare disease drug development and chronic disease management. FDA is committed to meeting these new demands for biomarkers and promoting partnerships to work together with industry, academe and NIH to benefit the ultimate stakeholders — the patients who depend on us for good medicines with optimal benefit/risk profiles for them.
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Venue: Loews Philadelphia Hotel
Address: 1200 Market Street , Philadelphia, United States
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