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    Can Drug Development be Accelerated? FDA Wants Help

    The US Food and Drug Administration (FDA) is soliciting input on how it might accelerate the development of certain drug products through the use of new and emerging biomarkers. Background In FDA's telling, a qualified biomarker —"an objective characteristic that is measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to treatment"—can help drug development in several ways. For example, a biomarker migh...
  • C-Path Initiative's Work on Personalized Medicine Starts to Get Results

    The Critical path Institute (C-Path), the US Food and Drug Administration (FDA)-supported public-private initiative working to advance personalized medicine, is advancing quickly and is bearing results, reports The Arizona Star . C-Path, now under the leadership of President and CEO Dr. Carolyn Compton, is working with numerous private companies to create technologies to develop safer, more effective drugs. "The idea here is, through the creation of new tools, new meas...
  • Europe: European Medicines Agency Adopts Two Alzheimers Biomarkers

    Under a voluntary new scientific pathway, the European Medicines Agency (EMA) adopted two innovative biomarkers for use in the development of new medications for Alzheimers submitted by Bristol-Myers Squibb: PET amyloid imaging (positive/ negative) as a biomarker for enrichment for use in predementia AD clinical trials , and use of CSF AB 1-42 and t-tau and/or PET-amyloid imaging (positive/ negative) . The new process can lead to either a Committee for Medicinal Produ...
  • EMA Publishes Pharmacogenetics Guideline for Evaluation of Medicines

    The European Medicines Agency (EMA) published a new guideline on the use of pharmacogenetics in evaluating pharmacokinetics of medicines on 10 February. The guideline provides specific requirements and recommendations for designing, conducting, dosing, and evaluating clinical studies. The guideline also discusses how to use information obtained in clinical studies for labeling and treatment recommendations. The guideline notes that "genetic variation can affect the ab...
  • EMA Calls for Guidelines on the Use of Pharmacogenomics in Pharmacovigilance Evaluation

    The European Medicines Agency (EMA) issued a concept paper on 23 January that calls for a new guideline to be issued on the use of pharmacogenomics in the conduct of pharmacovigilance. The concept paper notes that the response most individuals have to drug therapy is highly variable, and a prominent component of this variability is related to genetic variations. This can relate to drug disposition (pharmacokinetics) or drug action (pharmacodynamics). Accurate knowledg...