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News: NIH Will No Longer Require Special Review for U.S. Gene Therapy Trials
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In a milestone for the field of gene therapy, the National Institutes of Health (NIH) will no longer subject all proposed gene therapy clinical trials to review by a special federal advisory committee. “Given the progress in the field, I am confident that the existing regulatory authorities can effectively review most gene transfer protocols and that a streamlined process will reduce duplication and delays in getting gene transfer trials initiated,” said NIH Director Francis Collins in a statement today. Instead, the 40-year-old Recombinant DNA Advisory Committee (RAC) will review only a few trials that pose special risks.
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Company: Cobra Biologics and Pharmaceutical Services
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Cobra provides a comprehensive biologics and pharmaceuticals service offering, with multi-functional and experienced project teams nurturing customers’ products from pre-clinical through to clinical and commercial manufacture within three GMP approved facilities.
Cobra has three GMP approved facilities in Sweden and the UK, each with expertise tailored to serving our customers around the world. Cobra offers a broad range of integrated and stand-alone contract services for clinical trials and the commercial market. As a trusted provider and a key partner in the drug development and commercialisation process, Cobra take pride in their manufacturing excellence and comprehensive range of services to the pharmaceutical and biotech industries
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Conferences
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21 – 23 July 2014, DNA Vaccines 2014, San Diego, CA |
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6 – 8 August 2014, The 20th Annual Meeting of the Japan Society of Gene Therapy (JSGT), Tokio, Japan |
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25 – 27 September 2014, 14th Annual Meeting of the International Society for Cell & Gene Therapy of Cancer, Amsterdam, The Netherlands |
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23 – 26 October 2014, XXII Congress of the European Society of Gene and Cell Therapy (ESGCT), The Hague, The Netherlands |
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27 – 29 October 2014, 3rd International Conference and Exhibition on Cell & Gene Therapy, Las Vegas, NV |
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November 2014, Formulation and Drug Delivery Congress, London, UK |
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November 2014, Cell Therapy Congress, London, UK |
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