Introduction to AAV-based in vivo gene therapy -- Recent development in in vivo clinical gene therapy platforms -- Overview of biomarkers for AAV gene therapy -- Nonclinical and Clinical Study Considerations for Biodistribution, Shedding and Pharmacokinetics / Pharmacodynamics -- Immunogenicity of gene therapy products -- Bioanalytical Methods To Detect Pre-existing and Post-administration Humoral Immune Responses Against AAV Capsid Proteins -- Bioanalytical methods to study biodistribution and shedding of AAV-based gene therapy vectors -- Transgene mRNA expression analysis -- Quantification of transgene protein expression and biochemical function -- Substrate and Distal Pharmacodynamic Biomarker Measurements for Gene Therapy -- Detection of cellular immunity to viral capsids and transgene proteins -- Detection of humoral response to viral capsids and transgene proteins -- rAAV integration : Detection and Risk Assessment -- Gene modification and integration for patient monitoring -- Introduction to companion diagnostics for gene therapy -- Validation for Gene Therapy Companion Diagnostics -- Regulatory considerations for gene therapy companion diagnostics -- Current regulatory landscape for gene therapy product development and the role of biomarkers.