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Midwest Regional Forum October 2018
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Tuesday, October 23, 2018 

Loews Chicago O'Hare Hotel
5300 North River Road
Rosemont, IL 60018

Onsite registration will be available.

 





Work Smarter Not Harder - Leveraging Prior Knowledge to Accelerate CMC Programs


 Co-Chairs: Sarah Demmon, Eli Lilly and Company, and Robert Seevers, Pearl Pathways

CMC programs are under intense pressure to deliver commercial ready manufacturing processes early in the project life cycle.  In this session, we will explore strategies to speed delivery of material to the clinic for FIH trials by using prior knowledge and project platform approaches.  Speakers will also discuss strategies about streamlining development studies to lock down process decisions earlier in the development cycle. Finally, we will discuss a case study to explore how companies are using prior knowledge.  The afternoon will feature two interactive case studies showing how risk-based approaches have been applied, the first on data needed to support shipping of temperature sensitive biologics, and the second on the development of antibody-drug conjugates (ADCs.)


The learning objectives for this forum are:

1.  Discuss current regulatory perspectives on leveraging prior knowledge to accelerate CMC development 
2. Gain industry perspective on accelerating formulation development and risk based approaches to streamlining CMC programs
3. 
Active participation in two afternoon case studies as a practical application of risk-based approaches for shipping validation and for development of ADCs. 
 

 


About the Regional Forums:

The CASSS Midwest Regional Forum is committed to bringing job-relevant education to the local biopharmaceutical and biotechnology community. These programs are dedicated to facilitating the sharing of information and best practices in order to advance scientific knowledge across industry, academia, and regulatory agencies. This full day program will feature presentations on utilizing prior knowledge for platform, an interactive panel discussion, a case study, peer-to-peer learning, and networking opportunities.

 


 

Want more information? Check out the "More in this Section" dropdown box at the top of the page!

Or contact CASSS at 510-428-0740 or cstewart@casss.org

 




 


 
 
 
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