Key Sessions
Nelly Viseux
Keynote: Journey from R&D to Clinical Manufacturing
Regeneron
Silviu Itescu
Keynote Presentation: Lessons Learnt of the Path to Commercialisation
Mesoblast
Robert Hofmeister
Keynote: Programming Immunity In Vivo: Targeted RNA-LNP Platforms for Precision CAR Engineering
CREATE Medicines
Therese Choquette
Panel Discussion: Decentralized Manufacturing in Cell Therapy: Overcoming Implementation Challenges and Enhancing Patient-Centric Solutions
Tigen Pharma SA
Friday 25th September - Conference Day Three - ET (Eastern Time, GMT-05:00)
Friday 25th September - Conference Day Three - ET (Eastern Time, GMT-05:00)
8:20am - 8:50am30 mins
Registration Break
Registration & Morning Coffee
8:50am - 9:00am10 mins
Development of Emerging Cell & Gene Therapies
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
8:50am - 9:00am10 mins
Cell Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
- Mariana Loperfido - Senior Expert - Cell & Gene Therapy - Analytical Development, Novartis
8:50am - 9:00am10 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
Keynote: Journey from R&D to Clinical Manufacturing
- Nelly Viseux - Vice President, Cell Therapies Development, Manufacturing, Supply & Quality, Regeneron
9:00am - 10:00am60 mins
Cell Therapy Manufacturing & Analytics
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)
9:00am - 9:30am30 mins
Gene Therapy Manufacturing & Analytics
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 - 10:00am30 mins
Development of Emerging Cell & Gene Therapies
Keynote: Programming Immunity In Vivo: Targeted RNA-LNP Platforms for Precision CAR Engineering
- Robert Hofmeister - Chief Scientific Officer, CREATE Medicines
9:30am - 10:00am30 mins
Gene Therapy Manufacturing & Analytics
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 - 10:30am30 mins
Development of Emerging Cell & Gene Therapies
Moving Gene Editing Beyond the Liver
- Devyn M. Smith - Chief Executive Officer, Arbor Biotechnologies
10:00am - 10:30am30 mins
Cell Therapy Manufacturing & Analytics
Enabling sgRNA Release and Stability Testing with a ddPCR-Based Potency Assay
- Hugh Gannon - Associate Director, KSQ Therapeutics
10:00am - 10:30am30 mins
Gene Therapy Manufacturing & Analytics
From Vial to Brain: Demonstrating AAV Gene Therapy Stability During Convection-Enhanced Delivery
- Nathalie Clement - SVP, Vector Development, Siren Biotechnology
10:30am - 11:15am45 mins
Break
Networking Refreshment Break in the Exhibit Hall
11:15am - 11:35am20 mins
Development of Emerging Cell & Gene Therapies
Development of Next Generation Cell Therapies for Autoimmune Disease
- Mayo Pujols - CTO, Kyverna
11:15am - 11:45am30 mins
Cell Therapy Manufacturing & Analytics
Culture and Non-Culture-Based Approaches to Cell Therapy Potency
- Ronnie Lum - Director Analytical Development, Analytical and Quality Control, BlueRock Therapeutics
11:15am - 11:45am30 mins
Gene Therapy Manufacturing & Analytics
ddPCR-Based Vector Genome Titer and Integrity Assays for Adeno-associated Virus
- Rishi Kothari - Process Development Engineer, Regeneron Pharmaceuticals
11:35am - 11:55am20 mins
Development of Emerging Cell & Gene Therapies
Case Studies: Development of Next-Gen Cell & Gene Therapies - Overcoming Challenges and Breakthroughs
- Daniel Shelly - Chief Business Development Officer, Immuthera/PolTREG
11:45am - 12:15pm30 mins
Cell Therapy Manufacturing & Analytics
Progress toward Standards and Reference Materials for Cell Viability
- Laura Pierce - Biomedical Engineer, NIST
11:45am - 12:15pm30 mins
Gene Therapy Manufacturing & Analytics
Machine Learning and Mechanistic Modeling Approaches Within Upstream Process Development to Improve AAV Product Quality
- Stephanie Klaubert - Scientist II, Solid Biosciences
11:55am - 12:15pm20 mins
Development of Emerging Cell & Gene Therapies
The Siren Experience: Advancing SRN-101 for High Grade Gliomas
- Lauren Kelly - Director of Translational Research, Siren Biotechnology
12:15pm - 12:35pm20 mins
Development of Emerging Cell & Gene Therapies
Gene Therapy for Immune Reprogramming and the Treatment of Inflammatory Diseases
- Shahrooz Rabizadeh - CEO & Co-Founder, Sagittarius Bio, Inc
12:15pm - 12:35pm20 mins
Gene Therapy Manufacturing & Analytics
Predictive Modeling and Process Interdependency: A Strategic Approach to Late-Stage AAV Purification Development
- Chen Wang - Principal Scientist, GMU CMC Purification Process Development, Sanofi
12:45pm - 2:00pm75 mins
Break
Lunch in the Exhibit Hall (Last Chance to Meet with Exhibitors)
2:00pm - 2:05pm5 mins
Keynote Plenary
Chairperson’s Opening Remarks
2:05pm - 2:45pm40 mins
Keynote Plenary
Keynote Presentation: Lessons Learnt of the Path to Commercialisation
- Silviu Itescu - CEO, Mesoblast
2:45pm - 2:50pm5 mins
Close of Event 2026 - See You Next Year!
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