August 30 to 01 2016, Santa Clara, USA.

Speakers

Speaker "Dave Williamson" Details

Name :
dave williamson
Company :
Title :
Director
Topic :

Driving Yield and Quality through Data Analytics

Abstract :

Over the last seven (7) years Biogen has developed a variety of analytics platform in support of our clinical and commercial biological manufacturing. The primary objectives of this work has been to increase yield and ensure process quality and control. I will share specific use cases with outcomes such as >100% increases in yield and adjusting for process variability during execution. While these techniques are quite developed for solid dose manufacturing within the biotech arena this is still an immature capability. Biogen has been a leader and continues to push forward innovation in this area. I will conclude with discussing where our current efforts are underway in the area of predictive models in support of Continuous Process Validation (CPV).

Profile :
Dave Williamson has spent his career working in the biopharma industry focused on improving and transforming manufacturing and quality processes. He has extensive experience in implementing and managing a variety of shopfloor, laboratory and quality assurance technologies. He currently serves as the Functional Lead for the Global Biologics Manufacturing and Technical Operations function within the Pharmaceutical, Operations &Technology group. In that role he is working to integrate our new internal drug product capability and implement disruptive innovations around our manufacturing processes for Aducanumab and anti-LINGO. Prior to his time at Biogen Dave held several business facing roles for manufacturing, quality and supply chain at pharmaceutical, biotech and generic manufacturers. In these roles Dave led global teams in transforming business processes in support of mergers, product launches and other business challenges. Dave holds a Chemistry degree from Rensselaer Polytechnic Institute and an MBA from Carnegie Mellon University’s Tepper school.
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