Key Sessions

Helen Sabzevari, PhD

Breakthrough Speed to Full Approval: How Extraordinary Collaboration with the FDA and NIH Helped Precigen Deliver a First and Only Treatment for RRP

Precigen

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

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 - VP Global head of Process and Analytical Development and Innovation (PADI), Minaris
Brian Laskowski - VP, Head of Quality Assurance CMC, Beacon Therapeutics
Sam Cooper - VP, Cell and Gene Logistics, Cardinal Health
Pratima Cherukuri - General Manager and Senior Vice President for the Plasmid Business, Bionova Scientific

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

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

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

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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

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

Gene Therapy for Immune Reprogramming and the Treatment of Inflammatory Diseases

Shahrooz Rabizadeh - CEO & Co-Founder, Sagittarius Bio

11:15am - 11:45am

Cryopreservation Development in Cell Therapy Manufacturing and Scale Up Challenges

George Yuechen Zhu - Staff Scientist, Bayer AG

11:45am - 12:15pm

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

The Need for an Unbiased Assay to Detect and Quantify Replication Competent AAV in Clinical Vector Products

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)

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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

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, 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

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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
Jared Auclair, PhD - Dean College of Professional Studies and Director of Bioinnovation, College of Science at Northeastern University
Aaron Edwards - CEO + Co-Founder, KiraGen Bio
Igor Gonzalez - Digital CMC Scientist - In Silico First Program, Takeda
Mark Duerkop - Chief Executive Officer, Novasign, Austria

3:05pm - 3:35pm

Breakthrough Speed to Full Approval: How Extraordinary Collaboration with the FDA and NIH Helped Precigen Deliver a First and Only Treatment for RRP

Helen Sabzevari, PhD - President and CEO, Precigen

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Break

3:35pm - 3:40pm

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