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Cell and Gene Therapies 101

The Cell and Gene Therapies 101 Workshop is taking place in Mont-Tremblant at the Fairmont Tremblant, Quebec from November 8-10, 2017. CCRM's annual workshop will lead attendees through the steps involved in manufacturing a cell and/or gene therapy product and taking it through to clinical trials and beyond. Don't miss this opportunity to reach a highly-targeted audience of future scientists and network with leaders in the cell and gene therapies space, in the beautiful ski resort town of Mont-Tremblant, Quebec. This year's workshop features a cozy cafe-style reception on the opening day with a keynote fireside presentation, a case study competition, and talks delivered by industry and academic experts.

Registration is open at www.cgt101.ca


Agenda Highlights

  • 5 Ws of cell and gene therapies
  • Manufacturing principles
  • Validating a process
  • Choosing a bioreactor
  • Scale-up and scale-out framework fundamentals
  • Preclinical studies needed to get a cell/gene therapy into the clinic
  • Dosing and efficacy trials (Phase 0, I); efficacy trials (Phase II, III)
  • Regulatory & reimbursement

Preliminary Agenda
Subject to change.

Workshop Introduction –
Wednesday, November 8, 2017
Session

 

3:30 PM - 5:30 PM

Opening reception, case study distribution and keynote "fireside chat"

Cell and Gene Therapies 101 Workshop –
Thursday, November 9, 2017

Session
 

8:00 AM - 8:30 AM

Welcome Breakfast

8:30 AM - 9:00 AM

Groups Work on Case Studies

9:00 AM - 9:30 AM Activity 1

9:30 AM - 9:55 AM

5 Ws of cell and gene therapies; what is your product? Defining TPP. The future.

Speaker: Nick Timmins - VP Process Sciences, BlueRock Therapeutics

10:00 AM - 10:25 AM

Manufacturing principles - COGs, GMP, validating a process, etc.

Speaker: Steven Keizer - Senior Quality Assurance Manager

10:25 AM - 10:45 AM

Coffee Break

10:45 AM - 11:10 AM

What bioreactor should I use? Intoduction to bioreactors

11:10 AM - 11:20 AM

Activity 2

11:25 AM - 12:10 PM Panel Discussion
12:10 PM - 1:00 PM

Lunch

1:00 PM - 1:25 PM

Scale-up and scale-out framework fundamentals

Speaker: Aaron Dulgar-Tulloch - Director, BridGE at GE Healthcare, GE Healthcare

1:30 PM - 1:55 PM

Preclinical studies needed to get a cell/gene therapy product into the clinic

Speaker: Denis Claude Roy - Director, Centre de recherche de l'Hopital Maisonneuve-Rosemont

1:55 PM - 2:15 PM Coffee Break
2:15 PM - 2:40 PM

How many cells do we need? Dosing and efficacy trials (Phase 0, I); Efficacy trials (Phase II, III)

Speaker: Sowmya Viswanathan - Affiliate Scientist, Krembil Research Institute (University Health Network)

2:40 PM - 2:50 PM Activity 3
2:55 PM - 3:40 PM Panel Discussion
3:40 PM - 5:00 PM

Group Work on Case Studies

6:00 PM  Offsite Dinner
Cell and Gene Therapies 101 Workshop –
FRIday, November 10, 2017
Session
 
8:00 AM - 8:30 AM Breakfast
8:30 AM - 8:55 AM

Regulatory overview

Speaker: Francisca Agbanyo - Chief of Blood, Cells, Tissues and Organs Division, Health Products and Food Branch Health Canada, Government of Canada

9:00 AM - 9:25 AM

Reimbursement 101

Speaker: Chris McCabe - Executive Director and CEO, Institute of Health Economics

9:25 AM - 9:55 AM Group Work on Case Studies
9:55 aM - 10:15 AM Coffee Break
10:15 Am - 12:15 pM Case Study Presentations
12:15 PM - 12:30 PM Lunch To-Go