Abstract
The year 2015 marked the 40th anniversary of the Asilomar Conference leading to the first biosafety guidelines for research with recombinant DNA molecules,1 as well as the 25th anniversary of the first human gene transfer clinical trial approved by the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC).2 Since that time, the field has seen tremendous growth, with more than 1,500 human gene transfer (HGT) trials reviewed by the RAC to date. This has been accompanied by significant advances in the efficiency and efficacy of gene transfer tools, as well as our understanding of the biological risk profiles for these tools.
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