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Northeast Regional Forum November 2019
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Monday, November 18, 2019

Pfizer, Inc.
1 Burtt Rd
Andover, MA 01810
Building F, Room F1300

 

  


CMC Strategies for Novel Biologic Modalities – Blending External and Internal Development 
 
Co-Chairs: David Cirelli, Pfizer, Inc. and Chi-Ting Huang, Surface Oncology
 
Multiple well-established CMO/CRO partners are available within the U.S. and globally to support outsourcing of monoclonal antibody development. However, new modalities present unique challenges in finding skilled partners to co-develop complex and new therapeutic products, including viral vectors, cell and gene therapies, microbiomes, as well as novel protein and conjugate formats. Availability of external expertise for research, process & formulation development, clinical manufacturing, analytical testing, and sourcing of raw materials is currently limited. In addition, approaches for blending internal and external development may be different for large and small companies when selecting external partners. This forum will feature discussions about the interaction between industry sponsors and CMO/CROs on the outsourcing strategies for technical (process development, analytics, manufacturing, formulation & drug delivery), business, quality, and regulatory components of drug development for new modalities.

 

 

 


About the Regional Forums:

The CASSS Northeastt 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, an interactive panel discussion, roundtable discussions, peer-to-peer learning and networking opportunities.

 

 

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


    

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