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 Two - ET (Eastern Time, GMT-05:00)
Thursday 18th September, 2025 - Main Conference Day Two - ET (Eastern Time, GMT-05:00)
8:30am - 8:55am25 mins
Registration Break
Registration & Morning Coffee
8:55am - 9:00am5 mins
Development of Emerging Cell & Gene Therapies
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
8:55am - 9:00am5 mins
Cell Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
8:55am - 9:00am5 mins
Gene Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
- Rajeev Boregowda - Associate Director, Bioassay & Molecular Analytical Development, Genomic Medicine CMC, Sanofi
9:00am - 9:30am30 mins
Development of Emerging Cell & Gene Therapies
Panel Discussion: Starting with the End in Mind: Designing Smart for Successful Cell & Gene Therapy Development
- Jeffrey Masten - Senior Vice President CMC, Secretome Therapeutics
9:00am - 9:30am30 mins
Cell Therapy Manufacturing & Analytics
Expanding Access to CAR-T cell Therapies by Manufacturing CRISPR Engineered Allogeneic Cell Therapies
- Justin Skoble - Vice President of Technical Development, Caribou Biosciences, Inc.
9:00am - 9:30am30 mins
Gene Therapy Manufacturing & Analytics
Fast Forward – CMC Planning and Execution to Support an Accelerated Approval Pathway
- Sarah Ralston Thomas - SVP, Quality, REGENXBIO
9:30am - 10:00am30 mins
Development of Emerging Cell & Gene Therapies
Development of Next-Gen Cell & Gene Therapies - Gamma-Delta T Cell Engager Technology Case Study
- Kate Rochlin - Chief Operating Officer, IN8bio
9:30am - 10:00am30 mins
Cell Therapy Manufacturing & Analytics
Scale Up and Manufacturing Challenges of Next-Generation Allogeneic Cell Therapies
- Monica Raimo - Director, Product and Process Development, Glycostem Therapeutics
9:30am - 10:00am30 mins
Gene Therapy Manufacturing & Analytics
BLA Filing and Process Characterization
- Ying Cai - MSAT Executive Director, Ultragenyx Pharmaceutical
10:00am - 10:30am30 mins
Development of Emerging Cell & Gene Therapies
Next-Gen Innovations: Cutting Edge Technologies Driving the Future of Cell and Gene Therapies
10:00am - 10:30am30 mins
Cell Therapy Manufacturing & Analytics
Scaling Up Allogeneic Cell Therapies: Cutting-Edge Technological Breakthroughs
10:00am - 10:30am30 mins
Gene Therapy Manufacturing & Analytics
Navigating Regulatory Pathways for Gene Therapy Success from R&D to BLA
10:30am - 11:15am45 mins
Break
Networking Refreshment Break in the Exhibit Hall
11:15am - 11:45am30 mins
Development of Emerging Cell & Gene Therapies
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.
11:15am - 11:45am30 mins
Cell Therapy Manufacturing & Analytics
From Bench to Bedside: Developing a Roadmap for Large Scale Manufacturing of iPSCs
- Nicole Santimauro - Senior Engineer, Manufacturing Science and Technology, Century Therapeutics, Inc.
11:15am - 11:45am30 mins
Gene Therapy Manufacturing & Analytics
Advances in Analytical Method Development for the Characterization of AAVs
- Wei-Chiang Chen - Associate Director, BioProcess Analytics, Genomic Medicine Unit, Sanofi
11:45am - 12:00pm15 mins
Development of Emerging Cell & Gene Therapies
INNOVATION HOUR: Development of Next-Gen Cell and Gene Therapies Case Studies
11:45am - 12:15pm30 mins
Cell Therapy Manufacturing & Analytics
Cryopreservation Development in Cell Therapy Manufacturing and Scale Up Challenges
- George Yuechen Zhu - Staff Scientist, Bayer AG
11:45am - 12:15pm30 mins
Gene Therapy Manufacturing & Analytics
Upstream and Downstream Process Characterization of UX701 AAV Gene Therapy for Wilson Disease
- Jun Li - Associate Director, Upstream Process Development, Gene Therapy, Ultragenyx Pharmaceutical
12:00pm - 12:15pm15 mins
Development of Emerging Cell & Gene Therapies
INNOVATION HOUR: Case Study from Satellite Bio
- Marcus Lehmann - Associate Director, Drug Product Process Development, Satellite Bio
12:15pm - 12:30pm15 mins
Development of Emerging Cell & Gene Therapies
INNOVATION HOUR: Sponsored Scientific Track Presentation
12:15pm - 12:45pm30 mins
Cell Therapy Manufacturing & Analytics
Next Generation Preservation and Storage Solutions for Cell Therapy Products
12:15pm - 12:45pm30 mins
Gene Therapy Manufacturing & Analytics
Novel Analytical Technologies to Enhance Gene Therapy Product and Process Characterization
12:30pm - 12:45pm15 mins
Development of Emerging Cell & Gene Therapies
INNOVATION HOUR: Sponsored Scientific Track Presentation
12:45pm - 2:00pm75 mins
Break
Lunch in the Exhibit Hall (Last Chance to Meet with Exhibitors)
2:00pm - 2:05pm5 mins
Development of Emerging Cell & Gene Therapies
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
2:00pm - 2:05pm5 mins
Cell Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
2:00pm - 2:05pm5 mins
Gene Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
2:05pm - 2:35pm30 mins
Development of Emerging Cell & Gene Therapies
Development of Next-Gen Cell and Gene Therapies Case Studies
- Reagan Jarvis - Chief Executive Officer and Co-founder, Anocca
2:05pm - 2:35pm30 mins
Cell Therapy Manufacturing & Analytics
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
2:05pm - 2:35pm30 mins
Gene Therapy Manufacturing & Analytics
Potency Assays – Ensuring Consistency and Reliability for Gene Therapies – From Development to Standardization
2:35pm - 3:05pm30 mins
Keynote Plenary
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 - 3:35pm30 mins
Keynote Plenary
Panel Discussion: Harnessing AI & Digitalization for Cell and Gene Therapy Manufacturing – Unlocking Efficiency, Control and Scalability
- Kat Kozyrytska - Managing Director, Kozyrytska Consulting
3:35pm - 3:40pm5 mins
Break
Close of Cell and Gene Therapy International 2025 – See You Next Year!
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。