Time: 1:45pm to 3:00pm
Content level: Basic
Gene therapy studies are becoming increasingly common as the US FDA (Food and Drug Administration) and other countries have begun issuing approvals for gene therapies, particularly in the field of oncology. Gene therapy studies pose exciting advancements for clinical research but also involve additional risks and regulatory requirements.
This presentation will summarize the current state of gene therapy research and the associated risks as well as the evolving regulatory environment in the U.S. Attendees will learn how to obtain the necessary regulatory approvals and prepare sites to conduct gene therapy research. The presentation will begin by defining gene therapy and summarizing the current state of the field including previous failures, current successes and the emerging regulatory and scientific environment that are resulting in a boom in gene therapy research.
The presentation will provide an introduction, intended for non-scientists, to the science of genetic engineering and gene therapy. This portion of the presentation will utilize graphics, videos and refer to major advances covered in the media to illustrate general concepts. The presentation will then detail the risks and associated regulatory hurdles for gene therapy research as well as outlining strategies for obtaining approval to perform gene therapy research at clinical research sites.
- Understand what is gene therapy research and the associated federal requirements.
- Understand how to request approval for gene therapy research.
Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Director of Biosafety Services, Advarra