{"product_id":"9781119852780-drug-development-for-gene-therapy-tran","title":"Drug Development for Gene Therapy","description":"\u003cmeta content=\"text\/html; charset=utf-8\" http-equiv=\"Content-Type\"\u003e\u003cp\u003e\u003cspan\u003eTranslational Biomarkers, Bioanalysis, and Companion Diagnostics\u003cbr\u003e\u003cb\u003eDrug Development for Gene Therapy\u003c\/b\u003e \u003cp\u003e\u003cb\u003eIndustry-centric perspective on translational and bioanalytical challenges and best practices for gene therapies\u003c\/b\u003e \u003c\/p\u003e\n\u003cp\u003e\u003ci\u003eDrug Development for Gene Therapy\u003c\/i\u003e focuses on the translational and bioanalytical challenges and best practices for gene therapy modalities, presenting a significant body of data, including information related to safety and efficacy, necessary to advance through the development pipeline into clinical use. The text covers bioanalytical methods and platforms including patient screening assays, different PCR tests, enzyme activity assays, ELISpot, NGS, LC\/MS, and immunoassays, with FDA and EMA guidelines on gene therapy safety and efficacy, along with companion diagnostics regulations from US and EU perspectives. \u003c\/p\u003e\n\u003cp\u003eThe chapters offer an in-depth discussion of the basics and best practices for translational biomarkers, bioanalysis, and developing companion diagnostics \/ lab tests for gene therapies in the pharma and biopharma industries. To aid in reader comprehension, the text includes clinical examples of relevant therapies in related chapters. Some of the core topics covered include study design, immunogenicity, various bioanalytical methods and their applications, and global regulatory issues. \u003c\/p\u003e\n\u003cp\u003eWritten by two highly qualified authors with significant experience in the field, \u003ci\u003eDrug Development for Gene Therapy\u003c\/i\u003e includes information on: \u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eBioanalytical methods to detect pre-existing antibodies against adeno-associated viruses (AAV) capsids\u003c\/li\u003e\n\u003cli\u003eDetection of cellular immunity and humoral response to viral capsids and transgene proteins, and immunogenicity of gene therapy products\u003c\/li\u003e\n\u003cli\u003eNonclinical and clinical study considerations and methods for biodistribution and shedding\u003c\/li\u003e\n\u003cli\u003eQuantification of transgene protein expression and biochemical function, and substrate and distal pharmacodynamic biomarker measurements for gene therapy\u003c\/li\u003e\n\u003cli\u003eDetection and quantification of rAAV integration and off-target editing\u003c\/li\u003e\n\u003cli\u003eCurrent regulatory landscape for gene therapy product development and the role of biomarkers and general regulatory considerations for gene therapy companion diagnostics\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003eWith comprehensive coverage of the subject, \u003ci\u003eDrug Development for Gene Therapy\u003c\/i\u003e is a must-have resource for researchers and developers in the areas of pharmaceuticals, biopharmaceuticals, and contract research organizations (CROs), along with professors, researchers, and advanced students in chemistry, biological, biomedical engineering, pharmaceuticals, and medical sciences.\u003c\/p\u003e\n\u003cbr\u003e\u003cbr\u003e\u003c\/span\u003e\u003c\/p\u003e","brand":"Rarewaves","offers":[{"title":"Default Title","offer_id":41557438824545,"sku":"9781119852780","price":210.25,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0092\/7504\/8033\/files\/orig_28056203.jpg?v=1722276631","url":"https:\/\/www.rarewaves.com\/products\/9781119852780-drug-development-for-gene-therapy-tran","provider":"Rarewaves.com","version":"1.0","type":"link"}