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Northeast Regional Forum October 2018: Scientific Program
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To view the final scientific program, click here.


Learning Objectives

The learning objectives of this forum will be comprised of:

     Regulators perspective on accelerated programs

     Process  validation  approaches  including  process  design,  qualification,  and  continuous verification

     Historical manufacturing experience

     Platform knowledge (process and analytical development), and application of PAT

     Post-registration approval challenges

     Early development of potency assay(s)



08:00 – 09:00
Registration and Breakfast

08:15 – 08:45
Sunrise Session: Accelerated CMC Development Primer

09:00 – 09:10
CASSS Welcome and Introductory Comments

09:10 – 09:20
Welcome to the Northeast Regional Forum

09:20 – 09:50
Leveraging mAb Platform to Control Product Quality
Chris Kwiatkowski, Biogen

09:50 – 10:20
Efficient Analytical Development Strategies to Support Accelerated CMC Development
Marc Verhagen, Sanofi

10:20 – 10:50
Efficient Process Validation Strategies for Accelerated Programs
Kartik Subramanian, AbbVie, Inc.

10:50 – 11:15
Networking Break

11:15 – 12:15
Panel Discussion

Panel Members:
Chris Kwiatkowski, Biogen
Jaclyn Moxham, Pfizer, Inc.
Kartik Subramanian, AbbVie, Inc.
Marc Verhagen, Sanofi

12:15 – 13:15
Networking Lunch

12:15 – 13:15
Career Development Roundtable
Click here for more information! 

13:15 – 14:30
Roundtable Discussion Session I
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14:30 – 14:45
Networking Break

14:45 – 15:30
Roundtable Discussion Session II
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15:30 – 15:40
Closing Remarks

15:40 – 16:45
Networking Reception


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