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CMC Strategy Forum Summer 2018
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Online registration for the CMC Strategy Forum Summer 2018 is now closed. 


Forum Co-chairs:
Sarah Kennett, Genentech, a Member of the Roche Group
Anthony Mire-Sluis, AstraZeneca


Scientific Organizing Committee:
Siddharth Advant, Celgene Corporation
Cristina Ausin, CDER, FDA
Barry Cherney, Amgen Inc.
Steve Falcone, Sanofi
Jie He, CBER, FDA
Alexey Khrenov, CBER, FDA
Mike Tarlov, NIST-National Institute of Standards and Technology


This topic provides for an exciting opportunity to focus an entire meeting on the forefront of CMC opportunities and challenges in today’s pharmaceutical industry. The topic should promote an intensely forward-looking forum consisting of very timely cross-industry discussions that can serve to both inform and learn from colleagues across the spectrum and to seed regulatory paths forward to make the most effective use of novel technologies and developments in product and process understanding. The many topics– including upstream manufacturing, downstream manufacturing, and different types of controls and analytical methods - under one umbrella aspect may allow for numerous novel presentations that would not be repetitive across sessions but would be somewhat interlaced and would complement each other to further advance each successive discussion session.

This meeting's presenters and panelists have been selected to set the stage for collaborative technical and regulatory interactions to support the drive to improve product development and manufacturing capabilities to more rapidly bring new and high quality products to patients. In addition to large pharma presenters and panelists, we have participation from smaller and more specialized companies and from leading academic institutions for advanced technologies. This meeting’s regulatory presenters and panelists will also span a diversity array of functions to complement the diversity of the specific topics. Ten regulators from Health Canada and FDA, including OBP/CDER, OPF/CDER, OTR/CDER, OBRR/CBER, OCBQ/CBER, and the Emerging Technology Team, are scheduled to be joining us at the podium.

 


 

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