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Points to Consider for the Submission of Chemistry, Manufacturing, and Controls CMC Information in Oligonucleotide Based Thera

Points to Consider for the Submission of Chemistry, Manufacturing, and Controls CMC Information in Oligonucleotide Based Thera

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Hello my name is Andrew burns, and I'm chief of the gene transfer and immunogenicity branch in the division of cellular and gene therapies the goal of this presentation is to explain the basics of how to put together the CMC section of a gene therapy IND particularly for phase one trials human gene therapy Beds are submitted to the office of cellular tissue and gene therapies and the CMC information is then evaluated by reviewers in the division of cellular and gene therapies so what are gene therapy products gene therapies are quite different from traditional small molecule drugs or even other biologics they work by delivering genetic material or less commonly they work by modifying the sequence of the human genome gene therapy products consist of genetically modified nucleic acids viruses or microorganisms and gene therapies often mediate their effects by transferring genetic material when this genomic material is transcribed or translated inside a cell result as new RNA or protein p

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