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Tuesday March 10 - PT (Pacific Time, GMT-08:00)
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Tuesday March 10 - PT (Pacific Time, GMT-08:00)
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Cell & Gene Therapy Production & Commercialization
8:55am - 9:00am
Chairperson's Opening Remarks: Cell & Gene Therapy Production & Commercialization
9:00am - 9:30am
Cell & Gene Therapy State of the Industry
9:30am - 10:00am
Cell & Gene Therapy State of the Industry
10:00am - 10:30am
Manufacturing a AAV gene product to treat muscle disorders
- Mahendra Rao - Chief Scientific Officer, Vita Therapeutics/Forza
Showing 1 of 1 Streams
Cell & Gene Therapy Production & Commercialization
11:15am - 11:45am
AAV Manufacturing: Planning ahead for streamlined path to commerecialization and increased patient access
- When and how to plan for commercialization of your product
- Modeling supply needs and COGS of your product
- Key supply chain consideration to study early in development to improve patient access
- Jenny Holt - Chief Development Officer, Ray Therapeutics
11:45am - 12:15pm
Future Directions – Making Cell & Gene Therapies More Accessible and Attractive
A forward-looking discussion on how manufacturing innovation, digitalization, and improved supply chains can expand patient access and to viable business cases.
12:15pm - 12:45pm
Sponsored Talk
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Cell & Gene Therapy Production & Commercialization
2:00pm - 2:30pm
Improving Efficiency of Cell Therapy Manufacturing Through Full Automation
- Mahesh Bule - Associate Director, Kite Pharma a Gilead Company
2:30pm - 3:00pm
End-to-End Process Development for Autologous CAR-T Cells: Early-Phase Concepts to Late-Stage Manufacturing
- Carlos Arbelaez - Associate Director, Johnson & Johnson
3:00pm - 3:30pm
Sponsored Talk
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Cell & Gene Therapy Production & Commercialization
4:15pm - 4:45pm
Analytical Strategy to Ensure the Quality and Consistency in Cell Products
- Develop risk-based and science-based analytical control strategy
- Considerations for assay development, qualification and validation
- Considerations for stability and shelf-life studies
- Common pitfalls & how to avoid them
- Jie Wei - Director of Bioanalytical Sciences, Tr1x, Inc.
4:45pm - 5:15pm
Ensuring Viral Safety in AAV9 Gene Therapy Program: Potentially Platformable Approach that Delivers Robust Clearance
- Srivatsan Ramesh - Scientist, BridgeBio Gene Therapy
5:15pm - 5:45pm
Allogeneic vs. Autologous – Manufacturing Strategy Showdown
A comparative panel on the unique manufacturing, supply chain, and scalability challenges of autologous vs. allogeneic approaches, with emphasis on future trends and digital tools for decision-making.
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