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Articles in 2014

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  • The Clinical Trials Transformation Initiative (CTTI) identifies and promotes practices to increase the quality and efficiency of clinical trials through projects that generate empirical data on how trials are currently conducted, leading to recommendations for improvement.

    • Pamela Tenaerts
    • Leanne Madre
    • Robert M. Califf
    Comment
  • Improving the science of drug development and regulation is important in fulfilling the public health mission of the US Food and Drug Administration (FDA). A decade on from the launch of the Critical Path Initiative, the FDA's Center for Drug Evaluation and Research (CDER) is now participating in more than 20 science-driven consortia to achieve this goal.

    • Janet Woodcock
    Comment
  • TransCelerate BioPharma was formed in 2012 as a non-profit organization with a mission to collaborate across the biopharmaceutical research and development community to identify, prioritize, design and facilitate the implementation of solutions to drive efficient, effective and high-quality delivery of new medicines.

    • Dalvir Gill
    Comment
  • The International Serious Adverse Events Consortium is generating novel insights into the genetics and biology of drug-induced serious adverse events, and thereby improving pharmaceutical product development and decision-making.

    • Arthur L. Holden
    • Jorge L. Contreras
    • Matthew R. Nelson
    Comment
  • Keith Blundy, Chief Executive Officer of Cancer Research Technology, discusses new developments at the non-profit Cancer Research UK.

    An Audience With
  • The Biomarkers Consortium is a public–private biomedical research partnership that seeks to develop and qualify biomarkers across a broad range of diseases in order to accelerate the development of new medicines and improve patient care.

    • David Wholley
    Comment
  • Amgen's blinatumomab is setting the stage for a bispecific revival, enabled by new formats that may solve the field's long-standing problems.

    • Ken Garber
    News and Analysis
  • Hypoxia-inducible factors (HIFs) have important roles in ischaemic and inflammatory diseases and strategies aimed at therapeutically modulating hypoxia signalling pathways are gaining considerable attention. Here, Eltzschig and colleagues focus on a set of oxygen-sensing prolyl hydroxylases — which are responsible for marking HIFs for proteasomal degradation — and assess their emerging potential as therapeutic targets.

    • Holger K. Eltzschig
    • Donna L. Bratton
    • Sean P. Colgan
    Review Article
  • Checkpoint inhibitors, which stimulate the anticancer activity of T cells, are the most advanced class of cancer immunotherapies. This analysis examines the pipeline of agents in development and their market potential.

    • Rachel M. Webster
    From the Analyst's Couch
  • This analysis examines new classes of drugs that are in development for dyslipidaemia — in particular PCSK9 inhibitors and CETP inhibitors — and discusses their likely impact on the dyslipidaemia market, which is currently dominated by statins.

    • Victoria Hudson
    From the Analyst's Couch
  • Although previous attempts to therapeutically target RAS proteins — which are frequently mutationally activated in cancer — have been unsuccessful, recent advances in our understanding of these signalling proteins have led to a renewed interest in RAS-targeted therapies. Der and colleagues discuss progress with a range of established and emerging strategies to interfere with RAS function, and highlight the most promising avenues for future anticancer drug discovery efforts.

    • Adrienne D. Cox
    • Stephen W. Fesik
    • Channing J. Der
    Review Article

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