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Cellular Therapies Manufacturing and Clinical Trials in Canada

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Date and Location:

 

June 25 - 26, 2012

Rosebrugh Building, Room 211

164 College Street, Toronto, ON

 

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:

 

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.

 

 

Registration and Application, Fees and Deadlines:
The registration information appears at the bottom of this page. (click here)

 

Register by June 15, 2012 - Space is Limited!

Industry - $500 

Academic - $500 

Student - $250 

 

Financial support available to eligible participants through the Stem Cell Network (SCN). Applications now close May 17, 2012. The deadline has been extended. Visit SCN for details and application form. Click here.

 

For sponsorship or questions, contact us at: registration@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 sponsors and hosts: Centre for Commercialization of Regenerative Medicine, Stem Cell Network and Cell Therapy Program at the University Health Network.

 

AGENDA

 

Cellular Therapies Manufacturing and

Clinical Trials in Canada

 June 25 - 26, 2012

Rosebrugh Building, Room 211

164 College Street, Toronto, ON

 

 

Monday

 

Time

Item

Presenter

8.00-8.30 am

Breakfast/Registration

Sponsored by Fisher Scientific Canada

8:30-9:00 am

Welcome and Introduction to Cell Therapy Program/CCRM and Objectives of Workshop

Dr. Armand Keating

Dr. Sowmya Viswanathan

Dr. Nick Timmins

9:00-10:00 am

Cellular Therapy in the Clinic

Dr. Armand Keating, Director, Cell Therapy Program, University Health Network, Toronto

10:00-10:15 am

Break

Sponsored by VWR

10:15-11:30 am

Preparing Clinical Trial Applications: Pre-Clinical Studies, CMC and Process

Dr. Sowmya Viswanathan, Associate Director, Cell Therapy Program, University Health Network, Toronto

11:30-1:00 pm

Lunch with Bioreactor touch’n’play

Sponsored by Fisher Scientific Canada

1:00-2:00 pm

 

Case Study I – A Decade of DC Manufacturing: Lessons Learned

 

Dr. Ronan Foley, Associate Professor of Pathology and Molecular Medicine, McMaster University, Hamilton

2:00-2:30 pm

Virtual Tour of Orsino Facility and Refreshments

Dr. Sowmya Viswanathan, Associate Director, Cell Therapy Program, University Health Network, Toronto

2:30-3:30 pm

Case Study II - Phototherapy for Hematological Malignancies (Moving from the bench to clinical trials: Mission possible)

Dr. Denis Claude Roy, Director, Cellular Therapy Laboratory, Centre de Recherche Hôpital Maisonneuve-Rosemont, Montreal

3:30-4:30 pm

Cell Manufacturing – Quantity and Quality

Dr. Nick Timmins, Director, Cell Manufacturing, Centre for Commercialization of Regenerative Medicine, Toronto

 

6:30 pm

Networking Dinner 

Adega Restaurant - 33 Elm Street Sponsored by EMD Millipore

 

Tuesday

 

Time

Item

Presenter

8:30-9:00 am

Breakfast

Sponsored by Charles River

9:00-10:00 am

Guidelines for Clinical and Quality Aspects of Cell Therapy – Health Canada’s Perspective

Dr. Michael Rosu-Myles, Research Scientist, Centre for Biologics, Health Canada, Ottawa

10:00-10:50 am

Critical Culture Parameters

Dr. Nick Timmins, Director, Cell Manufacturing, Centre for Commercialization of Regenerative Medicine, Toronto

10:50-11:00 am

Break

Sponsored by VWR

11:00-12:00 pm

Bioreactor Basics

Dr. Ricardo Baptista, Development Scientist, Cell Manufacturing, Centre for Commercialization of Regenerative Medicine, Toronto

12:00-1:30 pm

Lunch with Bioreactor touch’n’play

Sponsored by Applikon Biotechnology, Inc.

1:30-2:30 pm

Development of a Scalable System for Production of Functional Pancreatic Progenitors from Human Embryonic Stem Cells

Dr Tom Schulz, Associate Director of ES Cell Technology and Scale Up, ViaCyte Inc., Athens, GA

 

2:30-3:30 pm

The Manufacturing Process

Dr. Nick Timmins, Director, Cell Manufacturing, Centre for Commercialization of Regenerative Medicine, Toronto

3:30-3:45 pm

Break

 

3:45-4:45 pm

Design and Construction of a cGMP Cell and Tissue Processing Facility in Canada – Key Considerations

Gayle Piat, Project Manager, Cell and Tissue Innovative Research Centre (CTIRC), University of Alberta

4:45-5:15 pm

Wrap-up, Feedback and Farewell

Dr. Sowmya Viswanathan

Dr. Nick Timmins

 

 

Bioreactor touch’n’play:

A chance to get up close and personal with bioreactors and associated technologies. During lunch sessions, several types of bioreactors and accessories will be on-hand for participants to interact with. We invite you to disassemble vessels, push buttons, navigate control systems, weld tubes and ask questions.

 

Registration Form