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Northeast Regional Forum October 2018
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Monday, October 8, 2018

Wyndham Boston Beacon Hill
5 Blossom Street
Boston, MA 02114

 

 




Accelerated CMC Development
 
Co-Chairs: Francis Poulin, Sanofi and Bernice Yeung, Shire Pharmaceuticals
 
The Northeast 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 from industry though leaders, an interactive panel discussion, roundtable discussions, and opportunities to network with peers.

This Forum will focus on technical and regulatory approaches to accelerate CMC development. To support development of new therapeutics addressing unmet medical needs, several health authorities have implemented expedited regulatory pathways. These programs focus on increasing communication between industry and health authorities to reduce review timelines and deliver transformative therapies to patients more rapidly. Shorter clinical trials result in condensed CMC timelines and increase pressures to deliver a commercializable process early in development. As a result, various CMC development strategies may have to be implemented to meet the needs of the product and indication. Roundtable discussions as well as speaker presentations will focus on a range of topics including: developability assessment, rapid process development, accelerated control strategies, setting specifications on small number of batches, authoring submissions with limited development and manufacturing experience, analytical assay development and bridging to enable commercial facilities earlier in development.

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


    

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