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Cell and Gene Therapies Workshop — Manufacturing and Regulatory Issues

The Cell and Gene Therapies Workshop is taking place in Whistler at the Hilton Whistler Resort & Spa from October 26-27, 2016, directly following the 2016 Till & McCulloch Meetings. This workshop facilitates an understanding of the multiple aspects of conducting clinical trials in cell and gene therapies and will give participants a strong foundation in the cell manufacturing principles necessary to deliver safe, efficacious and cost-effective cell therapies. 

This workshop offers you the opportunity to learn from experts spanning academia, industry and regulatory agencies across North America. It begins with a reception and keynote dinner on October 26, and ends with an off-site networking dinner on October 27. And in the moments in between, you can share ideas and interact with a distinguished lineup of speakers and workshop participants — a great chance to network and make lasting professional contacts. Check back often as confirmed speakers and the agenda will be added soon!

To register for the workshop, please click here

Agenda Highlights

  • Quality-by-design
  • Automation
  • Closed-systems
  • Clinical translation and trial design
  • Pitfalls and bottlenecks
  • Regulatory and reimbursement considerations

Confirmed Speakers

  • Harold Atkins, Ottawa Hospital Research Institute
  • Lee Buckler, RepliCel
  • Aaron Dulgar-Tulloch, GE Healthcare
  • Christopher McCabe, University of Alberta
  • Michael Mendicino, Hybrid Concepts International, LLC
  • ​Michael Rosu-Myles, Health Canada
  • Greg Russotti, Celgene
  • Nick Timmins, CCRM
  • Sowmya Viswanathan, University Health Network/CCRM
  • Kim Warren, CCRM/AVROBIO
  • Terry Yau, University Health Network

Preliminary Agenda
Subject to change.

Workshop Introduction –
Wednesday, October 26




7:00 PM - 10:00 PM

Networking reception and keynote dinner

Keynote talk: Planning for manufacture of your cell & gene therapy product

Cell and Gene Therapies Workshop –
Thursday, October 27



8:30 AM - 9:30 AM

Welcome Breakfast


9:30 AM - 9:55 AM

Talk 1 – Why are we here? We should you care? Cell & gene therapies 2016

Nick TimminsCCRM

9:55 AM - 10:20 AM

Talk 2 – Methodologies and examples of cell therapy scale-up

Gregory Russotti, Celgene Cellular Therapeutics

10:20 AM - 10:45 AM

Talk 3 – Industrial cell manufacturing: The vision of closed systems

Aaron Dulgar-Tulloch, GE Healthcare

10:45 AM - 11:00 AM

Coffee Break


11:00 AM - 12:00 PM

Panel Discussion: Cell therapy manufacturing Hope or hype? 

Panelists: Kim Warren, Nick Timmins and Gregory Russotti

Moderator: Aaron Dulgar-Tulloch

12:00 PM - 1:00 PM Lunch  
1:00 PM - 1:25 PM Talk 5 – 

 Clinical and regulatory issues in the design and conduct of cardiac stem cell therapy trials

Terry Yau, University Health Network
1:25 PM - 1:50 PM Talk 6 – Using HCST for immune repair: New tricks from a veteran Harold Atkins, Ottawa Hospital Research Institute
1:50 PM - 2:15 PM Talk 7 – Approaches to improve the development of cell & gene therapies via regulatory science and advocacy Michael Mendicino, Hybrid Concepts International
2:15 PM - 2:45 PM Talk 8 – A perspective on the commercial impacts of clinical development strategy – The RepliCel experience Lee Buckler, RepliCel
2:45 PM - 3:00 PM Break  
3:00 PM - 3:45 PM

Panel Discussion: Clinical trial design & clinical studies – What does Health Canada/FDA want to see?

Panelists: Terrence Yau, Harold Atkins and Michael Mendicino

Moderator: Lee Buckler

3:45 PM - 4:00 PM Break  
4:00 PM - 4:25 PM Talk 9 – Health Canada’s perspective on cell and gene therapies Michael Rosu-Myles, Health Canada
4:25 PM - 4:50 PM Talk 10 – Preclinical development, an iterative process: Lessons from osteoarthritis trial

Sowmya Viswanathan, University Health Network/CCRM

4:50 PM - 5:15 PM Talk 11 – Innovation costs: The economic challenges to sustainable implementation of cell and gene therapies

Chris McCabe, University of Alberta

5:15 PM - 6:00 PM Panel Discussion: Quality, regulatory and reimbursement

Panelists: Michael Rosu-Myles, Sowmya Viswanathan and Chris McCabe

Moderator: Sowmya Viswanathan

6:00 PM - 6:30 PM Problem solving exercise breakdown and
7:00 PM - 10:00 PM Off-site networking dinner