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Cellular Therapies Manufacturing and Clinical Trials in Canada

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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.)

 

Introduction:

 

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

1530        Break        

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              

0700        Breakfast

0800        Preclinical and quality considerations - Dr. Sowmya Viswanathan, University Health Network/CCRM

0900        CTA pitfalls - Health Canada representative (Dr. Francisca Agbanyo)

1000        Break        

1030        Clinical trial case study (Dr. Francois A. Auger)

1130        Lunch      

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        

1430        Wrap-up  

 

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: info@ccrm.ca

 

Workshop Leaders and Hosts:

 

Cellular Therapies Manufacturing and Clinical Trials in Canada is led by Drs. Sowmya Viswanathan, Cell Therapy Program, University Health Network (UHN), and Nick Timmins, CCRM.

 

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