Key Sessions

Jeron Chen

Application of AI and Machine Learning in Gene Therapy Process Development and Manufacturing

Voyager Therapeutics

Sarah Ralston Thomas

Fast Forward – CMC Planning and Execution to Support an Accelerated Approval Pathway

REGENXBIO

Thursday 18th September, 2025 - Main Conference Day TwoThursday, 18 September 2025 - ET (Eastern Time, GMT-05:00)

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Registration Break

8:30am - 8:55am

Registration & Morning Coffee

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Development of Emerging Cell & Gene Therapies

Cell Therapy Manufacturing & Analytics

Gene Therapy Manufacturing & Analytics

8:55am - 9:00am

Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies

9:00am - 9:30am

Panel Discussion: Starting with the End in Mind: Designing Smart for Successful Cell & Gene Therapy Development

Francesca Vitelli, PhD - Former, VP Cell Therapy and Viral Vector PD and MSAT, Intellia Therapeutics, Inc
Jeffrey Masten - Senior Vice President CMC, Secretome Therapeutics
A Representative - from, Cue Biopharma

9:30am - 10:00am

Development of Next-Gen Cell & Gene Therapies - Gamma-Delta T Cell Engager Technology Case Study

Kate Rochlin - Chief Operating Officer, IN8bio

10:00am - 10:30am

Next-Gen Innovations: Cutting Edge Technologies Driving the Future of Cell and Gene Therapies

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.

8:55am - 9:00am

Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics

Nicola Ambler - Co-Founder, CGT Circle

9:00am - 9:30am

Development of CRISPR Genome-Edited Allogeneic CAR-T Cell Therapies

Justin Skoble - Vice President of Technical Operations, Caribou Biosciences, Inc.

9:30am - 10:00am

Scale Up and Manufacturing Challenges of Next-Generation Allogeneic Cell Therapies

Monica Raimo - Director, Product and Process Development, Glycostem Therapeutics

10:00am - 10:30am

Scaling Up Allogeneic Cell Therapies: Cutting-Edge Technological Breakthroughs

Spotlight Presentation – Calling all Technology Thought Leaders!

8:55am - 9:00am

Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics

Rajeev Boregowda - Associate Director, Bioassay & Molecular Analytical Development, Genomic Medicine CMC, Sanofi

9:00am - 9:30am

Fast Forward – CMC Planning and Execution to Support an Accelerated Approval Pathway

Sarah Ralston Thomas - SVP, Quality, REGENXBIO

9:30am - 10:00am

BLA Filing and Process Characterization

Ying Cai - MSAT Executive Director, Ultragenyx Pharmaceutical

10:00am - 10:30am

Navigating Regulatory Pathways for Gene Therapy Success from R&D to BLA

Spotlight Presentation – Calling all Thought Leaders!

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Break

10:30am - 11:15am

Networking Refreshment Break in the Exhibit Hall

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Development of Emerging Cell & Gene Therapies

Cell Therapy Manufacturing & Analytics

Gene Therapy Manufacturing & Analytics

11:15am - 11:45am

Stromal-Free, GMP-Compatible Bioprocess for Generating Allogeneic CAR-γδ T Cells from Cord Blood CD34+ HSPC

Victor Manuel Diaz Cortes - Research Director, OneChain Immunotherapeutics S.L.

11:45am - 12:00pm

INNOVATION HOUR: Case Study from Cue Biopharma - Solid Tumours & Expanding Disease Areas (Autoimmune, Neurology, Cardiometabolic).

A Representative - from, Cue Biopharma

12:00pm - 12:15pm

INNOVATION HOUR: Development of an Expandable and Functional Hepatocyte Cell Therapy

Marcus Lehmann - Associate Director, Drug Product Process Development, Satellite Bio

12:15pm - 12:30pm

INNOVATION HOUR: Sponsored Scientific Track Presentation

12:30pm - 12:45pm

INNOVATION HOUR: Sponsored Scientific Track Presentation

11:15am - 11:45am

From Bench to Bedside: Developing a Roadmap for Large Scale Manufacturing of iPSCs

Nicole Santimauro - Senior Engineer, Manufacturing Science and Technology, Century Therapeutics, Inc.

11:45am - 12:15pm

Cryopreservation Development in Cell Therapy Manufacturing and Scale Up Challenges

George Yuechen Zhu - Staff Scientist, Bayer AG

12:15pm - 12:45pm

Next Generation Preservation and Storage Solutions for Cell Therapy Products

A Representative from Single Use Support

11:15am - 11:45am

Advances in Analytical Method Development for the Characterization of AAVs

Wei-Chiang Chen - Associate Director, BioProcess Analytics, Genomic Medicine Unit, Sanofi

11:45am - 12:15pm

Upstream and Downstream Process Characterization of UX701 AAV Gene Therapy for Wilson Disease

Jun Li - Associate Director, Upstream Process Development, Gene Therapy, Ultragenyx Pharmaceutical

12:15pm - 12:45pm

Novel Analytical Technologies to Enhance Gene Therapy Product and Process Characterization

A Representative from Intertek

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Break

12:45pm - 2:00pm

Lunch in the Exhibit Hall (Last Chance to Meet with Exhibitors)

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Development of Emerging Cell & Gene Therapies

Cell Therapy Manufacturing & Analytics

Gene Therapy Manufacturing & Analytics

2:00pm - 2:05pm

Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies

2:05pm - 2:35pm

Development of Next-Gen Cell and Gene Therapies Case Studies

Reagan Jarvis - Chief Executive Officer and Co-founder, Anocca

2:00pm - 2:05pm

Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics

2:05pm - 2:35pm

Visible Particles Within Cell Therapies- A Holistic and Strategic Approach to Characterize, Identify and De-Risk The Presence Of Visible Particulates In ATMP Drug Product Formulations

Shankar Swaminathan, PhD - Team Lead, Drug Product Development, CMC-Tech Ops, Astellas Institute for Regenerative Medicine

2:00pm - 2:05pm

Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics

2:05pm - 2:35pm

Potency Assays – Ensuring Consistency and Reliability for Gene Therapies – From Development to Standardization

Pierre-Axel Vinot - Director, CMC Portfolio Management, SparingVision

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Keynote Plenary

2:35pm - 3:05pm

Application of AI and Machine Learning in Gene Therapy Process Development and Manufacturing

Jeron Chen - Head of Data Science and Payload Innovation, Voyager Therapeutics

3:05pm - 3:35pm

Panel Discussion: Harnessing AI & Digitalization for Cell and Gene Therapy Manufacturing – Unlocking Efficiency, Control and Scalability

Kat Kozyrytska - Managing Director, Kozyrytska Consulting

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Break

3:35pm - 3:40pm

Close of Cell and Gene Therapy International 2025 – See You Next Year!