The first WCG IRB webinar will discuss “IRB and IBC Required Approvals in Gene Therapy: Addressing Challenges in a Growing Market.” It will be co-presented by Riki Cullingford, Clinical Project Manager at REGENXBIO Inc., and Daniel Kavanagh, PhD, Senior Scientific Advisor, Gene Therapy at WCG IRB. REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy.
Recent gene therapy regulatory approvals have caught attention and dramatically increased biopharmaceutical developers’ interest in the field. As a result, the gene therapy industry is expected to grow 30% year over year in research and development spending in multiple therapeutic areas.
Therefore, it is increasingly likely that sponsors, CROs and institutions will begin to participate in gene therapy trials and their IRBs will be asked to review those protocols. This webinar will cover the relevant regulatory guidelines and offer practical strategies for ensuring adherence. Dr. Kavanagh will explain when an IBC review is needed, what that entails, and how to coordinate the IBC and IRB review of the protocol to ensure an efficient trial startup. Ms. C...
Note: If you need assistance with your subscription or would like to discuss a corporate subscription for more than 10 employees please contact us or use the chat (bottom right).