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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 will open soon, please check back often.


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 (Phse 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

Talk 1 5 Ws of cell and gene therapies; what is your product? Defining TPP. The future.

10:00 AM - 10:25 AM

Talk 2 Manufacturing principles - COGs, GMP, validating a process, etc.

10:25 AM - 10:45 AM

Coffee Break

10:45 AM - 11:10 AM

Talk 3 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 Talk 4 – Scale-up and scale-out framework fundamentals
1:30 PM - 1:55 PM Talk 5 Preclinical studies needed to get a cell/gene therapy product into the clinic
1:55 PM - 2:15 PM Coffee Break
2:15 PM - 2:40 PM Talk 6 How many cells do we need? Dosing and efficacy trials (Phase 0, I); Efficacy trials (Phase II, III)
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 Talk 7 – Regulatory overview
9:00 AM - 9:25 AM Talk 8 Reimbursement 101
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 Lunch To-Go