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Midwest Regional Forum November 2019
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Wednesday, November 6, 2019

Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285


Reference Standards, Critical Reagents and Assay Controls – How to Manage and Case Studies

Co-Chairs: Qin Sheng, Eli Lilly and Company and Amy St. Charles, Pfizer, Inc.

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? Contact CASSS at 510-428-0740 or



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