ISCT Webinar: Preparing the Lab for a New Clinical Trial
Presented by the ISCT Lab Practices Committee
Please open the PDF slides and click the link on the first page to access the Digital Recording.
Date: November 6th, 2013
Time: 12pm ET to 1:00pm ET
Chair: Joseph Mierski, MSc, Hematopoietic Cell Therapy Lab Coordinator, Penn State Hershey Medical Center
Speaker(s): Todd Schuesler, Supervisor, Hoxworth Cellular Therapy Department; Chris Bruns, Clinical Manufacturing Manager, Athersys, Inc.
About the Webinar:
In recent years the number of cellular based clinical trials has increased dramatically. As these types of studies continue to be developed there will be a need for cellular therapy laboratories to acquire the administrative, technical, and regulatory knowledge to be successful. The presenters of this webinar will discuss the necessary steps involved in preparing your laboratory for supporting both internally and externally sponsored clinical trials. The presentation includes speakers providing insight from both the cell therapy laboratory and industry perspectives.
Experiences and lessons learned from the preparation of a CT Lab for an internally sponsored clinical trial.
What to expect when participating in a clinical trial with an external sponsor.
Quality Assurance and Regulatory considerations from both internally and externally sponsored clinical trials.