RESUMEN
With recent successes in gene therapy trials for hemophilia and retinal diseases, the promise and prospects for gene therapy are once again garnering significant attention. To build on this momentum, the National Institute of Neurological Disorders and Stroke and the Muscular Dystrophy Association jointly hosted a workshop in April 2014 on "Best Practices for Gene Therapy Programs," with a focus on neuromuscular disorders. Workshop participants included researchers from academia and industry as well as representatives from the regulatory, legal, and patient advocacy sectors to cover the gamut from preclinical optimization to intellectual property concerns and regulatory approval. The workshop focused on three key issues in the field: (1) establishing adequate scientific premise for clinical trials in gene therapy, (2) addressing regulatory process issues, and (3) intellectual property and commercialization issues as they relate to gene therapy. The outcomes from the discussions at this workshop are intended to provide guidance for researchers and funders in the gene therapy field.
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Terapia Genética/métodos , Terapia Genética/normas , Enfermedades Neuromusculares/genética , Enfermedades Neuromusculares/terapia , Ensayos Clínicos como Asunto , Terapia Genética/legislación & jurisprudencia , Regulación Gubernamental , Humanos , Propiedad IntelectualRESUMEN
This article describes the nontechnical skill set, and behavioural rating tool, for scrub practitioners/nurses (e.g. perioperative registered nurses; operating room technicians) known as the Scrub Practitioners' List of Intraoperative NonTechnical Skills or the SPLINTS system. The SPLINTS system was developed at the Industrial Psychology Research Centre of the University of Aberdeen, Scotland, by a research team comprising psychologists, scrub nurses, and a surgeon. Details of the system were presented, by Rhona Flin, at the ORNAC National and International Conference with IFPN, in Ottawa, in April of 2013. This article outlines the background of the research project and the method used to develop the SPLINTS system and suggests why it might be a valuable training and assessment tool for scrub practitioners in Canada.
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Competencia Clínica , Personal de Enfermería , Quirófanos , Recursos HumanosRESUMEN
Strategies are needed for drafting miRNA patent applications, in light of the existing patent landscape and genomic patent strategies of the past decades.