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Cell & Gene Therapy International
September 16-18, 2025
Hynes Convention CenterBoston, MA
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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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Showing 1 of 1 Streams
8:30am - 8:55am
Registration & Morning Coffee
Showing 3 of 3 Streams
8:55am - 9:00am
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
  • Nathan Yozwiak - Head of Research, Gene and Cell Therapy Institute, 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
  • 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
10:00am - 10:30am
Manufacturing of LNPs, from pDNA and mRNA to LNP with Multiple Nucleic Acids Payloads
  • Aleš Strancar, PhD - Managing Director, Sartorius BIA Separations
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

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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
10:00am - 10:30am
Building Next Generation Platforms for Gene Therapies: Novel Solutions to Address Common Development Challenges
  • Vijetha Bhat - Cell and Gene Technical Expert, Lonza
Showing 1 of 1 Streams
10:30am - 11:15am
Networking Refreshment Break in the Exhibit Hall
Showing 3 of 3 Streams
11:15am - 11:45am
Discovery and Development of Next Generation TCR-T Cell Therapies Against Mutant KRAS for the Treatment of Advanced Pancreatic Cancer
  • Hugh Salter - Chief Scientific Officer, Anocca AB
11:45am - 12:15pm
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.
12:15pm - 12:30pm
Next Generation Cell and Gene Therapies - Sagittarius Bio
  • Shahrooz Rabizadeh - CEO & Co-Founder, Sagittarius Bio
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
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
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
AAV Therapies – Developing Effective Analytical Strategies for In-Depth Empty vs Full Capsid Characterization
  • Shaun Smith - Scientist, Intertek Pharmaceutical Services (Manchester)
Showing 1 of 1 Streams
12:45pm - 2:00pm
Lunch in the Exhibit Hall (Last Chance to Meet with Exhibitors)
Showing 2 of 2 Streams
2:00pm - 2:05pm
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
  • Nathan Yozwiak - Head of Research, Gene and Cell Therapy Institute, Mass General Brigham
2:05pm - 2:20pm
Small Molecule-Controlled Genetic Neuromodulation: Combining the Tunability of Pharmacotherapy and Precision of Gene Therapy
  • Tamás Kitka - Founder, Managing Director, CREATe Therapeutics
2:20pm - 2:35pm
Development of an Expandable and Functional Hepatocyte Cell Therapy
  • Marcus Lehmann - Associate Director, Drug Product Process Development, Satellite Bio
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
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
  • Jared Auclair, PhD - Dean College of Professional Studies and Director of Bioinnovation, College of Science at Northeastern University
  • Bao Nguyen - Senior Scientist, Analytical Sciences Operations, AstraZeneca
Showing 1 of 1 Streams
3:05pm - 3:10pm
Close of Cell and Gene Therapy International 2025 – See You Next Year!
Wednesday, September 17th, 2025 - Main Conference Day One
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