October 30 @ 8:00 AM – November 1 @ 5:00 PM
Twelve gene therapies have been approved by the FDA to date to treat a variety of diseases, including the first ever gene edited therapeutic. The CMC package required to effectively demonstrate safety and efficacy of increasingly complex gene therapy products to regulators needs to keep pace.
The 6th Gene Therapy Analytical Development & CMC Summit will unite 250+ analytical development, CMC, QC, and process development experts to showcase innovative analytical and process development methods, assess their readiness, and ultimately guarantee safety, quality, efficacy, and consistency of gene therapies to regulators.