A Changing World In Gene Therapy Research: Exciting Opportunities For Medical Advancement And Biosafety Challenges

By Daniel Eisenman, James Riddle, and Shaun Debold

Our IBC experts authored the article “A Changing World in Gene Therapy Research: Exciting Opportunities for Medical Advancement and Biosafety Challenges” in Applied Biosafety. 

The United States regulatory environment is evolving to accommodate an emerging boom in gene therapy research due to the coronavirus disease 2019 (COVID-19) pandemic and the drive for large-scale testing of vaccines containing recombinant or synthetic nucleic acid molecules. In this report, we highlight key developments in the field with a focus on biosafety and provides guidance for performing risk assessments on the currently approved gene therapy products as well as the most utilized types of investigational products in clinical trials.