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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!

Register for the workshop. 

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.

Time and Schedule for Workshop
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