Accelerating the Development of Biomarkers for Drug Safety: by Institute of Medicine, Board on Health Sciences Policy,

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By Institute of Medicine, Board on Health Sciences Policy, Development, and Translation Forum on Drug Discovery, Robert Giffin, Sally Robinson, Steve Olson

Biomarkers might be outlined as symptoms of any biologic kingdom, and they're principal to the way forward for medication. because the expense of constructing medications has risen in recent times, lowering the variety of new medications licensed to be used, biomarker improvement could be a method to lower bills, increase protection, and supply a extra centred and rational pathway to drug improvement. On October 24, 2008, the IOM's discussion board on Drug Discovery, improvement, and Translation held "Assessing and Accelerating improvement of Biomarkers for Drug Safety," a one-day workshop, summarized during this quantity, at the price of biomarkers in aiding to figure out drug defense in the course of improvement.

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Extra resources for Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary

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Both of these documents stated that cardio­ vascular safety testing should be performed on new drugs, but provided no specific guidance on how this testing should be conducted. In 2001, the FDA announced that in fall 2002, it would begin collecting raw electrocardiogram (ECG) data from sponsors, and in 2002 a “points to consider” document was jointly authored by the FDA and Health Canada (FDA, 2002). This was followed by FDA/ICH guidance documents providing more specific recommendations regarding clinical (E14) (FDA, 2005a) and preclinical (S7B) (FDA, 2005b) testing approaches.

Organizational updates from HESI and CSRC summarized the challenges of and solutions to data-sharing processes, and presented the first proof-ofconcept report illustrating the sharing of data from a number of companies in the ECG warehouse. The forum’s agenda encompassed the exploration of a number of potential biomarkers in addition to QTc, and included discussion of the following questions: • • • • • • Cardiotoxicity and troponin: Where do they fit in drug development? Preclinical and clinical testing for QTc proarrhythmia: How do they relate to one another and to the risk of life-threatening arrhythmic events?

Speaker presentation at the Institute of Medicine Workshop on Assessing and Accelerating Development of Biomarkers for Drug Safety, October 24, Washington, DC. WHO (World Health Organization). 2002. The world health report 2002: Reducing risks, promoting healthy life. Geneva, Switzerland: WHO. 3 Cardiac Safety Biomarkers In the 1990s, reports of potentially fatal cardiac arrhythmias in adverse event data focused attention on the potential of several drugs to cause cardiac toxicity. One effect of these drugs was to prolong the interval between the onset of the Q wave and the conclusion of the T wave in the heart’s electrical cycle—which is known as QTc when corrected for heart rate.

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