Key Sessions
Fouad Atouf
PLENARY KEYNOTE: Evolving Pharmacopeial Standards to Shape the Future of Biological Medicines
US Pharmacopeia
Amy Shaw
Scale-Out Versus Scale-Up Strategies for Maximizing Cellular Therapies
Takeda, USA
Kelvin Lee
KEYNOTE: The Future of Biopharmaceutical Manufacturing: Innovation and Collaboration
NIIMBL
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Wednesday 17th September - Main Conference Day Two - ET (Eastern Time, GMT-05:00)
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Wednesday 17th September - Main Conference Day Two - ET (Eastern Time, GMT-05:00)
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Manufacturing Strategy & Digitalization
11:25am - 11:30am
Chairperson Remarks: Manufacturing Strategy & Digitalization
- Shanta Boddapati, PhD - Associate Director, Upstream PD, Immunome, Inc
11:30am - 12:00pm
KEYNOTE: The Future of Biopharmaceutical Manufacturing: Innovation and Collaboration
- Kelvin Lee - Institute Director, NIIMBL
12:00pm - 12:30pm
AI-Enhanced Smart Workflows: Unlocking Speed and Insight in Process Development and Manufacturing
- Mark Duerkop - Chief Executive Officer, Novasign, Austria
Showing 1 of 1 Streams
Manufacturing Strategy & Digitalization
2:10pm - 2:15pm
Chairperson Remarks: Manufacturing Strategy & Digitalization
- James Kranz - VP and Head of CMC, Compass Therapeutics
2:15pm - 2:45pm
CMC in the Age of Personalized Medicine: Meeting the Unique Challenges of Small Batch Manufacturing
- Gregory Zarbis-Papastoitsis, Ph.D - Chief Process and Manufacturing Officer, Ankyra
2:45pm - 3:15pm
CMC Regulatory Filings for NCE’s – How to Develop Module 3 for the FDA and the EU/UK without constraining Development Efforts
- Jack Greene - Chief Technical and Manufacturing Officer, JucaBio
Showing 1 of 1 Streams
Manufacturing Strategy & Digitalization
4:30pm - 5:00pm
Creating a Winning Target Product Profile: A Roadmap for Successful Biopharmaceutical Development
- Regina Au - CEO, New Product Planning/Strategic Planning, BioMarketing Insight
5:00pm - 5:30pm
Overcoming Challenges in an ADC Process Performance Qualification Campaign
- Siu-Man (Kelvin) Lau - Principal Engineer, Abbvie
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