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Northeast Regional Forum November 2020
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NORTHEAST REGIONAL FORUM VIRTUAL MEETING
Tuesday, November 10, 2020
Start Time: 11:00 am Eastern Daylight Time

 

  


CMC ASAP: Accelerated and Streamlined CMC Development for Emerging and Rare Diseases

Co-chairs: Chi-Ting Huang, CTH Consulting and Jennifer Schlegel, Magenta Therapeutics
 
CMC development is often rate limiting for initiation of first in human studies, continuation to late stage development, and ultimately commercialization. The challenge is particularly acute for emerging and rare disease indications. Developing efficient and streamlined CMC strategies are imperative to quickly delivering therapeutics and diagnostics to patients while maintaining patient critical safety and quality standards.

 

Planned Topics:

• Strategies for rapid development across CMC functions
• Robust and efficient assay development throughout product lifecycle
• Leveraging past-experience to optimize process development strategies (e.g., process analytical tools)
• Regulatory-CMC considerations for accelerated development
• Diagnostic kit development

 


About the Regional Forums:

The CASSS 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 virtual regional forum will feature presentations, a panel discussion and peer-to-peer learning

 



 
 

Want more information? Contact CASSS at 510-428-0740 or kbertani@casss.org 


    

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