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Wednesday 11th March - Main Conference Day Two - PT (Pacific Time, GMT-08:00)
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Wednesday 11th March - Main Conference Day Two - PT (Pacific Time, GMT-08:00)
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Manufacturing Strategy & Bioprocessing 4.0
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Manufacturing Strategy & Bioprocessing 4.0
11:15am - 11:45am
Maximizing CMC Efficiency through In-house AD/PD Optimization for External Tech Transfers
- Discuss the challenges of external tech transfers when outsourcing CDMOs for clinical manufacturing.
- How to condense timelines and reduce costs through in-house utilization of AD/PD teams to perform parallel development with external partners.
- Strategies to identify and mitigate risks for allogeneic therapies.
- Isaura (Alex) Villalba - Senior Research Associate, Tr1X Bio
11:45am - 12:15pm
Fast-Tracking CMC for Accelerated Product Launch
12:15pm - 12:45pm
Sponsored Talk
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Manufacturing Strategy & Bioprocessing 4.0
2:00pm - 2:30pm
Keynote Address - Topic to be Determined
- Paul Hanson - Head of Lifecycle Management, Innovation, and Strategy, Interim Head of, Business Excellence, Global Manufacturing Sciences, Takeda Pharmaceuticals
2:30pm - 3:00pm
Topic to be Determined
- Jim Fries - CEO, RX-360
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Manufacturing Strategy & Bioprocessing 4.0
4:15pm - 4:45pm
Topic to be Determined
- Ken Hamilton - Director of Process Engineering, Genentech
4:45pm - 5:15pm
Strategy for High-Concentration Sub-Q Biologics – Manufacturing and Device Co-Development
Integrated CMC strategies aligning formulation, device development, and manufacturing planning. Case studies will highlight how modeling and analytics enable cross-functional collaboration, accelerating delivery of combination products.
5:15pm - 5:45pm
Panel Discussion: Sustainable and Flexible Upstream Facilities
A panel exploring how facility design and process strategies maximize sustainability, flexibility, and multiproduct capabilities. Discussions will include modeling and digital tools to enable agile facility operations.
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