Name
Gene Therapy: Unique Operational Aspects of Gene Therapy Research
Date & Time
Tuesday, October 18, 2022, 10:45 AM - 11:30 AM
Location Name
Melrose 3
Description
This session will cover points to consider when sites are preparing to start clinical trials involving gene therapy or molecular vaccines. What special facilities and procedures may be required? What is involved in Institutional Biosafety Committee (IBC) review, and when is an IBC review required? What are the best practices for engaging with sponsors and CROs conducting this kind of research?
Speakers
Daniel Kavanagh - Senior Scientific Advisor - WCG
Karen McCulloch - Chair, IBC Services - WCG IBC Services
Steven Schmid - Senior Director, Laboratory Strategic Planning and Development - Flourish Research
Karen McCulloch - Chair, IBC Services - WCG IBC Services
Steven Schmid - Senior Director, Laboratory Strategic Planning and Development - Flourish Research
Learning Objectives
1. Define cell therapy and gene therapy and identify how they apply to human gene transfer research.
2. Identify the operational considerations and the regulations and guidelines to consider for HGT research that is subject to the NIH Guidelines.
3. Determine the items that allow sites to facilitate the IBC review process.