Bioanalytics
Jim McNally, PhD
Chief Scientific Officer
BioAgilytix
Durham, North Carolina
Maria Jadhav, PhD
Director
Novartis Institutes for BioMedical Research, Inc.
Cambridge, Massachusetts
“Impact of Immunogenicity on Gene Therapy Development – Science, Regulatory and Patients”
Immunogenicity testing has become a key element of patient enrollment in Gene Therapy clinical trials. Over the past 5 years, we have seen a significant increase in the number of gene therapy programs enter the clinic with an almost staggering amount of innovative approaches being taken. However, simultaneously there has been an evolution in the regulatory expectations for assays that are being used to identify patients for inclusion/exclusion into these studies. The presentation will provide an overview of the biology, regulatory evolution and it's impact on patients.