Accelerating the Development of Biomarkers for Drug Safety Workshop Summary (2009) / Chapter Skim
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6 Future Considerations
6 Future Considerations
Pages 58-64
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From page 58... ...
CREATING INCENTIvES FOR COLLAbORATION Janet Woodcock noted that approximately half a million reports of drug-induced injuries are submitted to the Adverse Event Reporting System annually. These injuries represent both a major public health problem and substantial health care costs.
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From page 59... ...
In addition, Woodcock noted that the FNIH helped establish the Biomarker Consortium, a major public–private biomedical research partnership with participation from a broad and diverse group of stakeholders, including government, industry, academia, and patient advocacy and other nonprofit private-sector organizations. The goal of the Biomarker Consortium is to collaborate in rapidly identifying, developing, and qualifying potential high-impact biomarkers.
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From page 60... ...
Califf described his own experience with the recently launched David Murdock Research Institute as an example of the type of partnerships that will be required in the future. Created by a major philanthropic gift, the Institute is a collaboration among Duke University, the University of North Carolina (UNC)
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From page 61... ...
MOvING FORWARD WITHOuT uNDERSTANDING MECHANISMS As Califf pointed out, it is possible to make predictions with biomarkers that are probabilistically quite accurate without knowing much if anything about the mechanisms behind those biomarkers or the biological processes they reflect. This is already the case with cancer treatment, with physicians and patients being able to purchase multiple prognostic tests, each based on somewhat different arrays of biomarkers.
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DEVELOPMENT OF BIOMARKERS FOR DRUG SAFETY BOX 6-1 Systems Biology and Biomarker Development In his presentation, Ravi Iyengar described the challenges facing systems b iology, as well as the potential of this new perspective on biological processes to aid in the development of biomarkers. There are several definitions of systems biology.
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DEALING WITH DIFFERENT LEvELS OF RISk Bloomfield described a hypothetical scenario involving a drug that is effective at treating depression but causes a mean blood pressure rise of 2 millimeters (mm) of mercury in a test treatment population.
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It could occur as well for much broader groups, such as everyone with cardiovascular disease. Califf responded by saying that one of the most encouraging aspects of establishing the David Murdock Research Institute is that the organizers have been overwhelmed by calls from people in the surrounding region who want to be enrolled in epidemiological studies.
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