Agenda - Wednesday, September 17th, 2025 - Main Conference Day One

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Cell Therapy Manufacturing & Analytics

8:55am - 9:00am

Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics

Mahesh Bule - Associate Director, Kite Pharma a Gilead Company

9:00am - 9:30am

Scaling Out Cell Therapy Manufacturing: Smarter, Faster, and More Affordable

Amy Shaw - Head of Process and Product Development, Takeda, USA

9:30am - 10:00am

Scaling Out Cell Therapy Manufacturing

Mark Farmery - Chief Development Officer, Anocca AB

10:00am - 10:30am

Panel Discussion: Bringing Cell Therapy to the Patient—Implementing Decentralized Manufacturing

Defining point-of-care manufacturing and decentralized manufacturing
Scaling with consistency: key elements for global standardization
Tech & innovation: cutting-edge solutions for safe, efficient, and cost-effective decentralized manufacturing
Overcoming obstacles to decentralised manufacturing to enable access to approved CGTs
Differences in systems across decentralized cell therapy manufacturing models - how can we harmonize?
Standardization vs a modular approach
Equipment, data, and technologies
Dialogue and collaboration between developer/practitioner to streamline eventual implementation
Improving worldwide access: how can local manufacturers and supplier help?
Real world experience with a decentralized cell therapy manufacturing platforms supporting Phase I/II clinical trials

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Cell Therapy Manufacturing & Analytics

11:30am - 12:00pm

Strategies for Success Implementation of Automation at Scale in Cell Therapy Manufacturing

Shawn (Xueyuan) Wang - Director, Process Development, Kite Pharma

12:00pm - 12:30pm

Scalable and Cost-Effective Pluripotent Stem Cell Expansion: Enabling Commercialization

Wonjong Si - Associate Director, Cell Therapy Platform Process, Bayer

12:30pm - 1:00pm

Automating the Future: Enabling Closed-System Cell Therapy Manufacturing

Spotlight Presentation – Calling all Technology Thought Leaders!

Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.

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Cell Therapy Manufacturing & Analytics

2:10pm - 2:15pm

Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics

Shashi Prajapati - Director, Cell & Gene Therapies Analytical Development, Vertex Pharmaceuticals

2:15pm - 2:45pm

Advanced Analytical Strategies for Cell Therapy Product Characterization

Lena Yang - Senior Scientist, Cell Therapy Analytical Development, Takeda

2:45pm - 3:15pm

Best Practices for Developing Robust Potency Assays for Cell Therapies

Mariska ter Haak - Senior Director Analytical Development, IN8bio

3:15pm - 3:45pm

Novel Analytical Technologies to Enhance Cell Therapy Product and Process Characterization

Spotlight Presentation – Calling all Technology Thought Leaders!

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Cell Therapy Manufacturing & Analytics

4:30pm - 5:00pm

Strategy for Cell Therapy Potency Assurance

Dong Xu, Ph.D. - Associate Director, Cell Therapy Analytical Development, TScan Therapeutics

5:00pm - 5:30pm

Robust Process Validation Strategies for Cell Therapies

Wednesday, September 17th, 2025 - Main Conference Day OneWednesday, 17 September 2025 - ET (Eastern Time, GMT-05:00)