Role of biomarkers in drug development and regulatory decision making

Biomarkers in Medicine, a leading MEDLINE-indexed journal, has published a special focus issue exploring the increasingly important role of biomarkers in both drug development and regulatory decision making. Biomarkers in Medicine is published by Future Science Group.

The special focus issue is guest edited by William Slikker (Director of the FDA's National Center for Toxicology Research, USA) and Huixiao Hong (also of FDA's NCTR). The editors open the issue with a scene-setting foreword which explains, "the motivation behind this issue of Biomarkers in Medicine is to provide a contemporary summary of advances in the translation of biomarkers into regulatory science."

The special issue includes original research, review articles and editorials focused on developments in biomarker research in regulatory science. Articles review the latest advances across a broad range of biomarkers, including miRNA, transcriptomic markers and mechanism-based markers.

Biomarkers, the physical, functional or biochemical indicators of physiological or disease processes, can provide vital information in disease prognosis, in predicting response to therapies, adverse events and drug interactions, and in establishing baseline risk. Biomarkers are being used to develop new predictive, diagnostic and prognostic products, and are playing an increasingly important role in the discovery and development of new drugs.

"I am delighted to have worked with experts from the FDA and numerous other institutions to produce a timely and comprehensive special focus issue discussing the latest advances and next steps for biomarker translation in regulatory science," stated Hannah Wilson, Managing Commissioning Editor of Biomarkers in Medicine.

Source: Future Science Group

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