Drug Development for Gene Therapy Translational Biomarkers, Bioanalysis, and Companion Diagnostics

This book focuses on the translational and bioanalytical challenges and best practices for gene therapy modalities. Some of the topics covered include study design, immunogenicity, various bioanalytical methods and their applications, and global regulatory issues. Altogether, the 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 industry and research.