Dodge, Robert (2019) Gene Therapy: Bioanalytical Support and Strategies. AAPS Training webinar, NA (NA). NA-NA. ISSN NA

Abstract

Gene and nucleic acid therapies have demonstrated patient benefit in specific areas of therapeutics to address unmet medical needs. An increasing number of gene- and nucleic acid-based products have been advanced in clinical development phases. Unlike other conventional drugs, a gene therapy medicinal product (GTMP) contains both vector and transgene. This webinar will present the current practices in bioanalytical methods as well as pharmacokinetic /pharmacodynamical and immunogenicity evaluation for a number of gene and nucleic acid programs. The challenges, considerations, and regulatory aspects in this specific filed will be presented and discussed.

Item Type:	Article
Date Deposited:	18 May 2019 00:45
Last Modified:	18 May 2019 00:45
URI:	https://oak.novartis.com/id/eprint/39818