FDA to Host Workshop on Integration Site Analysis for Gene Therapies

The FDA’s Center for Biologics Evaluation and Research, Office of Therapeutic Products (OTP), will hold a virtual workshop Nov. 14 focused on the use of integration site analysis (ISA) in long-term follow-up of gene therapies that use integrating viral vectors.

The workshop will cover risks like insertional mutagenesis and discuss best practices for ISA method design, data analysis and clinical interpretation. The event will feature external experts, including researchers and clinician-scientists, who specialize in these areas.

The workshop will take place virtually from 9:30 a.m. to 5 p.m. ET. Registration is complimentary but required to attend.