Cellular Therapies Manufacturing and Clinical Trials in Canada
Date and Location:
October 25-26, 2013
Fairmont Banff Springs Hotel
Banff, Alberta (site of the 2013 Till and McCulloch Meetings. Click here to register.)
Cellular therapies provide many exciting new opportunities to improve human health and treat disease. In order to realize the power of using cells as therapeutic tools, it is necessary to navigate the often daunting regulatory process of clinical trials and approval. As many therapies require large numbers of cells, consideration must also be given as to how they will be manufactured. Both aspects go hand-in-hand in the delivery of a safe, efficacious, and cost-effective therapy.
Description and Workshop Agenda:
This workshop combines lectures, case studies and demonstrations to facilitate an appreciation of the multiple aspects of conducting clinical trials in Canada including preclinical studies, quality control and regulatory approval, as well as basic cellular manufacturing principles. Learn from the experiences of national and international leaders in the field. Network with other investigators. Interact with representatives from Health Canada’s Biologics and Genetic Therapies Directorate. Get hands-on with some of the latest cell manufacturing technologies.
Please find a DRAFT agenda below.
Friday, October 25
1400 Welcome and intro - Dr. Peter Zandstra, CCRM/University of Toronto
1430 Manufacturing quantity and quality - Dr. Nick Timmins, CCRM
1600 Bioreactor basics - Dr. Ricardo Baptista, CCRM
1700 Manufacturing guest speaker from Industry - Dr. Tom Brieva, Celgene Corp.
1800 Group scenarios
1900 Dinner – interactive with equipment/vendors, sponsors, and speakers
Saturday, October 26
0800 Preclinical and quality considerations - Dr. Sowmya Viswanathan, University Health Network/CCRM
0900 CTA pitfalls - Health Canada representative (Dr. Francisca Agbanyo)
1030 Clinical trial case study (Dr. Francois A. Auger)
1230 Group work to prepare manufacturing and regulatory strategy pitch
1300 Team presentations of manufacturing and regulatory strategy pitches
1400 Panel feed-back/Q&A
Registration and Application, Fees and Deadlines:
Register by September 30, 2013 - Space is Limited!
Academic (student or principal investigator) - $500
CCRM Industry Consortium member - $500
Sponsors - $500
Industry - $750
Please see registration form for shuttle bus option, an additional $30 pp.
Financial support is available to eligible participants through the Stem Cell Network (SCN) here.
For sponsorship or questions, contact us at: firstname.lastname@example.org
Workshop Leaders and Hosts:
Thank you to our hosts and sponsor: Centre for Commercialization of Regenerative Medicine, Cell Therapy Program at the University Health Network and Stem Cell Network.http://ccrm.ca/oct_25th_workshop