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7:30 – 8:15 AM |
Breakfast & Registration |
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Welcome |
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8:15 – 8:25 AM |
Anthony J. Sinskey
Professor, Department of Biology; Faculty Director, CBI, MIT
view bio |
Keynote Introductions |
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8:25 – 8:30 AM |
Stacy L. Springs
Director, BioMAN; Executive Director, CAACB, CBI, MIT
view bio |
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Keynote Presentations |
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8:30 – 9:15 AM |
Mirrors and Reflections: Perspectives on the Development and Manufacture of Biologic Medicines in the United States
Jeffrey C. Baker
Deputy Director, Office of Biotechnology Products, CDER, FDA
view bio | view abstract |
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9:15 – 10:00 AM |
Next Generation Manufacturing in Biogen’s Hybrid Biomanufacturing Network
Jorg Thommes
Senior Vice President, Engineering & Technology, Biogen
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10:00 – 10:15 AM |
Morning Refreshment Break |
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Session 1: Current and Emerging Approaches to Manufacturing Biologics |
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Session Chair: James C. Leung, Senior Research Fellow, CBI, MIT
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10:15 – 10:45 AM |
Facility Considerations - Planning for the Future
James Bouressa
Senior Director, Clinical Manufacturing, Pfizer
view bio | view abstract
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10:45 – 11:15 AM |
Scale-out with Disposable Manufacturing
Jie Chen
Vice President, CMC Operations, WuXi Biologics
view bio | view abstract |
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11:15 – 11:45 AM |
Manufacturing Strategy and Facilities for a Diverse World - Avoiding Facility Obsolescence
Parrish M. Galliher
Chief Technology Officer, Upstream, GE Healthcare Life Sciences
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11:45 AM – 12:15 PM |
Game of Clones
PJ Millan
Head of Process Automation, R&D Platform Technology & Science, GlaxoSmithKline
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Christopher Stevens
Senior Director, Operations, Planning, and Strategy - Biopharm and Cell & Gene Therapy, GlaxoSmithKline
view bio | view abstract |
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Session 2: Innovative Technologies for Manufacturing Traditional Biologics |
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Session Chair: Stacy L. Springs, Director, BioMAN; Executive Director, CAACB, CBI, MIT |
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1:15 – 1:45 PM |
Biogen’s Approach to Advanced Process Control in Biomanufacturing
Eliana Clark
Vice President, Manufacturing Sciences, Biogen
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1:45 – 2:15 PM |
Advanced Process Control Opportunities for Biologics
Shekar Ganesa
Executive Director, Process Development, Amgen
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2:15 – 2:45 PM |
Upstream Options for Process Intensification: Perfusion, Metabolism Meddling for Growth Inhibitor Control, Hybrid Processes, and Anything Else to Get More Cells for More Stuff
Gregory Hiller
Associate Research Fellow, Culture Process Development, Pfizer
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2:45 – 3:15 PM |
Advances in Microbioreactor and Analytic Platforms for Bioprocess Support
Rajeev Ram
Professor, Department of Electrical Engineering and Computer Science, MIT
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3:15 – 3:45 PM |
Sutro’s Cell Free Manufacturing Systems - Platforms Well Suited for the Flexible Manufacture of the Protein Therapeutics of Today and Tomorrow
Stuart Bussell
Senior Director, Process Development, Sutro Biopharma
view bio | view abstract |
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3:45 – 4:00 PM |
Afternoon Refreshment Break |
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4:00 – 4:30 PM |
Challenges and Opportunities for Distributed Manufacturing of High-Quality Biopharmaceuticals
J. Christopher Love
Associate Professor, Department of Chemical Engineering, MIT
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4:30 – 5:00 PM |
Impact of Vaccine Manufacturing Excellence on Global Health
Rahul Singhvi
Senior Vice President and Chief Operating Officer, Global Vaccine Business Unit, Takeda Pharmaceuticals International
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5:00 – 5:30 PM |
Just Add Water: Portable, On-Demand Biomolecular Manufacturing
Peter Nguyen
Technology Development Fellow, Laboratory of James Collins, Wyss Institute of Biologically Inspired Engineering, Harvard University
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5:30 – 6:00 PM |
Manufacturing Biologics Using Tobacco Plants
Hugh A. Haydon
President, Kentucky BioProcessing
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Closing Remarks |
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6:00 – 6:05 PM |
Stacy L. Springs
Director, BioMAN; Executive Director, CAACB, CBI, MIT
view bio |
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6:05 – 7:00 PM |
Cocktail Reception |
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