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CASSS Northern California Regional Forum Fall 2019
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Wednesday, November 13, 2019

South San Francisco Conference Center
255 South Airport Boulevard
South San Francisco, CA 94080

 


 

Fast-to-Market CMC Strategies

Co-Chairs: Trevor Swartz, Genentech, a Member of the Roche Group and Shelley Suggett, Themistry, Inc.
 

Join the CASSS Northern California Regional Forum in November to discuss CMC strategies to enable fast-to-market applications. Companies are driven by clinical development plans to rapidly bring drugs to patients. Efficient CMC strategy is a part of your company’s success! In this forum we will look at different perspectives and molecules, and evaluate the different deliverables required throughout development through initial licensure. CASSS is committed to bringing job-relevant education and regulatory trends for biopharmaceuticals to CASSS members through meeting programs Content may include information from other regional, national or international forums organized by CASSS and speakers from industry and FDA. The program will also provide a platform for networking with both peers and regulatory authorities.

Learning Objectives: 
1. What CMC strategies can be applied to enable fast-to-market drug development. 
     a. Employing these strategies while staying resource lean. 
     b. Gating accelerated CMC strategies to clinical readouts.
2. BTD what CMC work packages can be negotiated, e.g., what is non-negotiable, can some work packages be PMCs.
3. Explore various situations that necessitate unique and fast-to-market approaches, such as:
     a. CMC strategies to “catch-up” when surprised by stellar clinical results.
     b. Challenges of new modalities (i.e., gene therapy, T-cell therapies) in fast-to-market scenarios.
     c. Unique challenges for functional areas in fast-to-market scenarios (cell-culture, purification, analytical, and formulation).

The CASSS Northern California Regional Forum is committed to bringing job-relevant education and regulatory trends for biopharmaceuticals to CASSS members through meeting programs. The November forum will focus on CMC strategies to enable fast to market applications. The discussion will include content from other regional, national or international forums organized by CASSS. The program will also provide a platform for networking with both peers and regulatory authorities.

 


  

About the Regional Forums:
CASSS began as a local, non-profit chromatography discussion group in the San Francisco Bay Area. Although the society's offerings have now grown to include multiple North American and international scientific symposia and its members span the globe, CASSS still provides local educational and networking opportunities for scientists in regions across the US. The CASSS Regional Forums are your opportunity to meet others who understand what you do, in an informal setting, and exchange new ideas.

 

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

 


 

 

 

 
 
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