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Human Gene Therapy Journal Expands to Cover Clinical Development in Early 2013
12 October 2012
Mary Ann Liebert, Inc., Publishers
Human Gene Therapy (http://www.liebertpub.com/hum) is expanding its editorial coverage with the launch of Human Gene Therapy Clinical Development early next year. The Journal will provide a critical forum for publishing data relevant to the regulatory review and commercial development of cell and gene therapy products. Editor-in-Chief James M. Wilson, MD, PhD, University of Pennsylvania, outlines his vision for this new resource in an Editorial (http://online.liebertpub.com/doi/full/10.1089/hum.2012.2520) in the October issue. Barry J. Byrne, MD, PhD, University of Florida, Gainesville will assume the role of Clinical Development Editor. Human Gene Therapy and its other sister publication, HGT Methods, are published by Mary Ann Liebert, Inc., publishers (http://www.liebertpub.com).
“Scientific journals value and preferentially publish paradigm-changing papers. However, in areas of novel therapy development such as gene and cell therapy, standard data such as toxicology, vector distribution, time course of gene expression, and vector persistence are essential and valuable information,” says Yuman Fong, MD, Murray F. Brennan Chair in Surgery, Memorial Sloan-Kettering Cancer Center and Chair of the NIH Recombinant DNA Advisory Committee (RAC). “The initiation of a Journal such as Human Gene Therapy Clinical Development aimed at publication of such data is a forward-thinking project that will speed translation of novel vector and cell systems to accepted therapies for human disease.”
HGT Clinical Development published in print and online, will include pre-clinical papers focusing on pharmacology/toxicity/bio-distribution experiments used in the review of proposed clinical trials and will contain sufficient information to allow referencing between products within the same technology platform when appropriate. Recognizing the importance of all clinical data in the formative stages of the field, the Journal will publish clinical trials of gene and cell therapy including those which are confirmatory or negative. Coverage will include pre-clinical animal and in vitro studies to assess the safety of gene and cell therapy products used to support clinical applications; production and characterization data of gene and cell therapy products; selected clinical protocols which describe first-in-human applications of cell and gene therapy; and topical issues related to the commercial development of gene and cell therapy products.
Human Gene Therapy