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Introduction to Developing a Clinical Trial Application (CTA) for Cell-Based Therapies

Date

June 13-14, 2011

 

Location

The Philip Orsino Cell Therapy Facility, Princess Margaret Hospital, 610 University Ave, Toronto, Ontario, Canada.

 

Confirmation

There is no attendance fee, however, travel and accommodation costs will not be covered. Space is limited so please confirm your company representative’s attendance to rahul.sarugaser@ccrm.ca.

 

Workshop Audience
This introductory workshop will benefit scientists, research associates, managers, quality assurance, cell manufacturing personnel, analytical personnel and regulatory officers with an interest in moving their stem cell-based research to the clinic and who have minimum experience in developing clinical trials

 

Workshop Purpose
Based on a combination of lectures, practical experience and case studies, this workshop is specifically designed to facilitate an understanding of the process for developing a cell-based clinical trial in Canada and how this process parallels the Investigational New Drug submission process through the FDA in the United States. The workshop will also provide an opportunity to meet and network with other investigators who have a similar interest in the clinical translation of their research. Additionally, the workshop will enable interactions with representatives from Health Canada’s Biologics and Genetic Therapies Directorate.

 

Workshop Key Learning Objectives

  • Participants will gain an understanding of the Health Canada Biologics and Genetic Therapies Directorate (BGTD) requirements and approval process for a Clinical Trial Application (CTA)
  • Participants will be introduced to the parallels between the CTA approval process in Canada and the IND approval process in the United States
  • Participants will gain an understanding of the manufacturing process, quality issues, release assays, etc. associated with a translating a cell-based product into the clinic for clinical evaluation.
  • Participants will participate in a practical lab component covering an example of closed system cell culture in a clean room environment including preparing standard operating procedures (SOPs), worksheets and gaining practical experience manipulating cells in a clean room environment
  • Participants will learn from case studies of other investigators who are applying for or have successfully obtained Health Canada approval for conducting a Phase I trial
  • Examples of practical hurdles encountered when developing a cell therapy product clinical evaluation.


Workshop Organizers and Sponsors
The workshop is organized by Dr Sowmya Viswanathan of the Cell Therapy Program at the University Health Network in partnership with the Stem Cell Network, and Centre for Commercialization of Regenerative Medicine (CCRM).

 
Other Workshop Partners
  • GE
  • Fisher Scientific
  • VWR
  • Endosafe
  • Beckman Coulter

 

Eligibility
•    CCRM consortium membership


For further information on course content, please contact Dr. Sowmya Viswanathan, Associate Director of the Cell Therapy Program at the University Health Network at sowmya.viswanathan@uhnresearch.ca.