Key Sessions
Jeron Chen
Application of AI and Machine Learning in Gene Therapy Capsid Development
Voyager Therapeutics
Sarah Ralston Thomas
Fast Forward – CMC Planning and Execution to Support an Accelerated Approval Pathway
REGENXBIO
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Thursday 18th September, 2025 - Main Conference Day Two - ET (Eastern Time, GMT-05:00)
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Thursday 18th September, 2025 - Main Conference Day Two - 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
- Nathan Yozwiak - Head of Research, Gene and Cell Therapy Institute (GCTI), Mass General Brigham
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
- Brian Laskowski - VP, Head of Quality Assurance CMC, Beacon Therapeutics
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
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
Closed-System Large-scale Manufacturing of Allogeneic Therapeutic NK Cells from Hematopoietic Stem Cells
- 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!
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.
Contact us today to learn more: Partners@informaconnectls.com
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
Upstream and Downstream Process Characterization of UX701 AAV Gene Therapy for Wilson Disease
- Jun Li - Associate Director, Upstream Process Development, Gene Therapy, Ultragenyx Pharmaceutical
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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
Small Molecule-Controlled Genetic Neuromodulation: Combining the Tunability of Pharmacotherapy and Precision of Gene Therapy
- Tamás Kitka - Founder, Managing Director, CREATe Therapeutics
12:00pm - 12:15pm
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
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
11:15am - 11:45am
Genome Integrity of rAAV Gene Therapy Vectors and Its Links to Functional Potency
- David Dobnik - Research Councillor, National Institute of Biology
11:45am - 12:15pm
Potency Assays – Ensuring Consistency and Reliability for Gene Therapies – From Development to Standardization
- Pierre-Axel Vinot - Director, CMC Portfolio Management, SparingVision
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)
Showing 3 of 3 Streams
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
- Nathan Yozwiak - Head of Research, Gene and Cell Therapy Institute (GCTI), Mass General Brigham
2:05pm - 2:35pm
Discovery and Development of Next Generation TCR-T Cell Therapies Against Mutant KRAS for the Treatment of Advanced Pancreatic Cancer
- Reagan Jarvis - Co-founder & CEO, Anocca AB
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
Application of AI and Machine Learning in Gene Therapy Capsid Development
- Jeron Chen - Head of Data Science and Payload Innovation, Voyager Therapeutics
Showing 1 of 1 Streams
Keynote Plenary
2:35pm - 3:05pm
Panel Discussion: Harnessing AI & Digitalization for Cell and Gene Therapy Manufacturing – Unlocking Efficiency, Control and Scalability
- Kat Kozyrytska - Founder, Cell Therapy Manufacturability Program
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Break
3:05pm - 3:10pm
Close of Cell and Gene Therapy International 2025 – See You Next Year!
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