Agenda - Friday 25th September - Conference Day Three | Cell & Gene Therapy International

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Registration Break

8:20am - 8:50am

Registration & Morning Coffee

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Development of Emerging Cell & Gene Therapies

Cell Therapy Manufacturing & Analytics

Gene Therapy Manufacturing & Analytics

8:50am - 9:00am

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

9:00am - 9:30am

Keynote: Journey from R&D to Clinical Manufacturing

Nelly Viseux - Vice President, Cell Therapies Development, Manufacturing, Supply & Quality, Regeneron

9:30am - 10:00am

Keynote: Programming Immunity In Vivo: Targeted RNA–LNP Platforms for Precision CAR Engineering

Robert Hofmeister - Chief Scientific Officer, CREATE Medicines

10:00am - 10:30am

Moving Gene Editing Beyond the Liver

Devyn M. Smith - Chief Executive Officer, Arbor Biotechnologies

8:50am - 9:00am

Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics

Mariana Loperfido - Senior Expert - Cell & Gene Therapy - Analytical Development, Novartis

9:00am - 10:00am

Panel Discussion: Decentralized Manufacturing in Cell Therapy: Overcoming Implementation Challenges and Enhancing Patient-Centric Solutions

Therese Choquette - Chief Technical Officer, Tigen Pharma SA
Thorsten Gorba - VP, Process & Analytical Development, Aspen Neuroscience, Inc.
Tatyana Matveeva - Director of cGMP Operations, Regenerative Cell Therapy, Massachusetts General Hospital and Harvard Medical School
Richard McFarland - Chief Regulatory Officer, Advanced Regenerative Manufacturing Institute (ARMI)

10:00am - 10:30am

Enabling sgRNA Release and Stability Testing with a ddPCR-Based Potency Assay

Hugh Gannon - Associate Director, KSQ Therapeutics

8:50am - 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

Keynote Panel Discussion: Navigating BLA Success - Strategies for Streamlined Gene Therapy Approval Success

Tiffany D Rau, PhD - Principal Consultant BioPharma Technical Consulting and Rau Consulting, Adjunct Professor Biochemistry and Cell Biology, University College Cork, Ireland
Scott Jeffers - Chief Technology Officer, GenSight Biologics
Ying Cai - MSAT Executive Director, Ultragenyx Pharmaceutical
Corina McCarthy - Director, Technical Operations, Rocket Pharmaceuticals, Inc.

9:30am - 10:00am

Design with the End in Mind: CMC Reviewer Perspectives on Flow Cytometry Assay Validation for Cell and Gene Therapies

Athena Russell - Gene Therapy CMC/Product Reviewer, FDA CBER Office of Therapeutic Products

10:00am - 10:30am

From Vial to Brain: Demonstrating AAV Gene Therapy Stability During Convection-Enhanced Delivery

Nathalie Clement - SVP, Vector Development, Siren Biotechnology

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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 - 11:35am

Development of Next Generation Cell Therapies for Autoimmune Disease

Mayo Pujols - CTO, Kyverna

11:35am - 11:55am

Case Studies: Development of Next-Gen Cell & Gene Therapies – Overcoming Challenges and Breakthroughs

Daniel Shelly - Chief Business Development Officer, Immuthera/PolTREG

11:55am - 12:15pm

The Siren Experience: Advancing SRN-101 for High Grade Gliomas

Lauren Kelly - Director of Translational Research, Siren Biotechnology

12:15pm - 12:35pm

Gene Therapy for Immune Reprogramming and the Treatment of Inflammatory Diseases

Shahrooz Rabizadeh - CEO & Co-Founder, Sagittarius Bio, Inc

11:15am - 11:45am

Culture and Non-Culture-Based Approaches to Cell Therapy Potency

Ronnie Lum - Director Analytical Development, Analytical and Quality Control, BlueRock Therapeutics

11:45am - 12:15pm

Progress toward Standards and Reference Materials for Cell Viability

Laura Pierce - Biomedical Engineer, NIST

12:15pm - 12:45pm

Reading the Signal in the Noise: A Quantitative Framework for Understanding VCN–%CAR+ Relationships in CAR-T Manufacturing

Brian Murphy - formerly VP Cell Process Sciences, Arcellx

11:15am - 11:45am

ddPCR-Based Vector Genome Titer and Integrity Assays for Adeno-associated Virus

Rishi Kothari - Process Development Engineer, Regeneron Pharmaceuticals

11:45am - 12:15pm

Machine Learning and Mechanistic Modeling Approaches Within Upstream Process Development to Improve AAV Product Quality

Stephanie Klaubert - Scientist II, Solid Biosciences

12:15pm - 12:35pm

Predictive Modeling and Process Interdependency: A Strategic Approach to Late-Stage AAV Purification Development

Chen Wang - Principal Scientist, GMU CMC Purification Process Development, Sanofi

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Break

12:45pm - 2:00pm

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

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Keynote Plenary

2:00pm - 2:05pm

Chairperson’s Opening Remarks

2:05pm - 2:45pm

Keynote Presentation: Lessons Learnt of the Path to Commercialisation

Silviu Itescu - CEO, Mesoblast

2:45pm - 2:50pm

Close of Event 2026 – See You Next Year!

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Friday 25th September - Conference Day ThreeFriday, 25 September 2026 - ET (Eastern Time, GMT-05:00)