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CASSS Community News - October 11, 2018
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NORCAL REGIONAL FORUM | MIDWEST REGIONAL FORUM | CMC JAPAN | CASSS COMMUNITY NEWS

Northern California Regional Forum Program Updates  

Join us on Thursday, November 8, 2018 as we explore the topic of cell and gene therapies. This forum will provide practical discussions on CMC considerations, challenges and opportunities as more cell & gene therapies gain regulatory approval.

   

Talk titles include:

Navigating Unique Analytical Challenges in the Development of Autologous Chimeric Antigen Receptor T-cell Therapies
Khandan Baradaran, Ultragenyx Pharmaceutical

Process Considerations for Cryogenic Shipping
Craig Vermeyen, Kite, a Gilead company

Unique Considerations for AAV Gene Therapy Manufacturing
Jeffrey Teoh, Juno Therapeutics

Click here to view the preliminary program, talk titles and abstracts. 


Midwest Regional Forum Program in Chicago 
Work Smarter Not Harder - Leveraging Prior Knowledge to Accelerate CMC Programs   

  Online registration for this program closes Monday!
Don’t miss out!

 

Please join us in Chicago on Tuesday, October 23. This forum 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.  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.)

Previous regional forum attendees have said:

  “Great opportunity to network with industry colleagues and opportunity to share knowledge.” – Eric M.

      “Topics are very relevant to my projects and work responsibilities.” – Don E.

  “The chance to discuss relevant topics in the pharmaceutical/regulatory environment openly with colleagues and regulators is so valuable.” – Todd M. 

 

 

 

 



CMC Strategy Forum Japan – Register Now!

Join CASSS for the CMC Strategy Forum Japan on 3-4 December 2018 at the Tokyo Marriott Hotel in Tokyo, Japan. The Forum enables in-depth discussions of global CMC issues with special emphasis on Japan and Asia-Pacific. The technical sessions will include discussions on new trends for quality control of biopharmaceutical products; new trends in manufacturing of biologics; technologies involved in continuous manufacturing and regulatory perspectives; and CMC development of regenerative medicines regulations.

Regulatory speakers confirmed to participate at CMC Strategy Forum Japan 2018:

   Ayako Enokida, PMDA, Japan
   Steffen Gross, Paul-Ehrlich Institut,Germany
   William Hallet, CDER, FDA, USA
   Gi Hyun Kim, MFDS, Republic of Korea 
   Robin Levis, CBER, FDA, USA
   Scott Nichols, CDER, FDA, USA 
   Kyoko Sakurai, PMDA, Japan 

 



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