Key Sessions
Kristy Wood
Leveraging Gene Editing Technologies for Precision and Efficiency in Cell and Gene Therapy Development
Intellia Therapeutics
Ying Cai
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
Ultragenyx Pharmaceutical
Wednesday, September 17th, 2025 - Main Conference Day One - ET (Eastern Time, GMT-05:00)
Wednesday, September 17th, 2025 - Main Conference Day One - ET (Eastern Time, GMT-05:00)
8:00am - 8:55am55 mins
Registration Break
Registration & Morning Coffee
8:55am - 9:00am5 mins
Development of Emerging Cell & Gene Therapies
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
8:55am - 9:00am5 mins
Cell Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
- Mahesh Bule - Associate Director, Kite Pharma a Gilead Company
8:55am - 9:00am5 mins
Gene Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
9:00am - 9:30am30 mins
Development of Emerging Cell & Gene Therapies
Harnessing AI and Machine Learning for the Future of Cell & Gene Therapy Development
9:00am - 9:30am30 mins
Cell Therapy Manufacturing & Analytics
Scale-Out Versus Scale-up Strategies for Maximizing Cellular Therapies
- Amy Shaw - Head of Process and Product Development, Takeda, USA
9:00am - 9:30am30 mins
Gene Therapy Manufacturing & Analytics
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
- Ying Cai - MSAT Executive Director, Ultragenyx Pharmaceutical
9:30am - 10:00am30 mins
Development of Emerging Cell & Gene Therapies
Redosable DNA Delivery Systems Designed by Machine Learning
- Shashi Murthy - CTO and Co-Founder, Nanite Inc.
9:30am - 10:00am30 mins
Cell Therapy Manufacturing & Analytics
Scaling Out Cell Therapy Manufacturing
- Mark Farmery - Chief Development Officer, Anocca AB
9:30am - 10:00am30 mins
Gene Therapy Manufacturing & Analytics
Case Study on Tech Transfer and Scale Up – How to Translate from Small to Large Scale / GMP
- Phillip Ramsey - Senior Vice President, Technical Operations, Sangamo Therapeutics
10:00am - 10:30am30 mins
Development of Emerging Cell & Gene Therapies
Revolutionizing Targeted Delivery: Emerging Technologies to Enhance Precision & Minimize Off-Target Effects
10:00am - 10:30am30 mins
Cell Therapy Manufacturing & Analytics
Panel Discussion: Bringing Cell Therapy to the Patient—Implementing Decentralized Manufacturing
10:00am - 10:30am30 mins
Gene Therapy Manufacturing & Analytics
Tech Transfer Best Practices in Gene Therapy
- Jordan Ball - Sr. Manager, Technology Transfer, Regeneron
10:30am - 11:30am60 mins
Break
Networking Refreshment Break in The Exhibit Hall
11:30am - 12:00pm30 mins
Development of Emerging Cell & Gene Therapies
Leveraging Gene Editing Technologies for Precision and Efficiency in Cell and Gene Therapy Development
- Kristy Wood - SVP, Technical Operations, Intellia Therapeutics
11:30am - 12:00pm30 mins
Cell Therapy Manufacturing & Analytics
Strategies for Success Implementation of Automation at Scale in Cell Therapy Manufacturing
- Shawn (Xueyuan) Wang - Director, Process Development, Kite Pharma
11:30am - 12:00pm30 mins
Gene Therapy Manufacturing & Analytics
Revolutionizing Large Scale Gene Therapy Production: Boosting Cell Density and Cell Specific Productivity with Advanced Producer Cell Lines
12:00pm - 12:30pm30 mins
Development of Emerging Cell & Gene Therapies
Next-Gen Gene Editing – Pushing Boundaries for Enhanced Therapeutics
12:00pm - 12:30pm30 mins
Cell Therapy Manufacturing & Analytics
Scalable and Cost-Effective Pluripotent Stem Cell Expansion: Enabling Commercialization
- Wonjong Si - Associate Director, Cell Therapy Platform Process, Bayer
12:00pm - 12:30pm30 mins
Gene Therapy Manufacturing & Analytics
Expanding the Upstream Toolbox: Enabling High-Productivity, Robust, and Scalable AAV Production
- Huize Yan - Sr. Process Development Scientist – Upstream, Spark Therapeutics
12:30pm - 1:00pm30 mins
Development of Emerging Cell & Gene Therapies
Application of Next Generation Editing Technologies
12:30pm - 1:00pm30 mins
Cell Therapy Manufacturing & Analytics
Automating the Future: Enabling Closed-System Cell Therapy Manufacturing
12:30pm - 1:00pm30 mins
Gene Therapy Manufacturing & Analytics
Next-Gen Innovations: Transforming Upstream Process Development in Gene Therapy
1:00pm - 2:10pm70 mins
Break
Lunch in the Exhibit Hall
2:10pm - 2:15pm5 mins
Development of Emerging Cell & Gene Therapies
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
2:10pm - 2:15pm5 mins
Cell Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
- Shashi Prajapati - Director, Cell & Gene Therapies Analytical Development, Vertex Pharmaceuticals
2:10pm - 2:15pm5 mins
Gene Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
- David Dobnik - Scientific Associate, National Institute of Biology
2:15pm - 2:45pm30 mins
Development of Emerging Cell & Gene Therapies
Panel Discussion: Viral vs. Non-Viral – The Future of In Vivo Delivery Systems
2:15pm - 2:45pm30 mins
Cell Therapy Manufacturing & Analytics
Advanced Analytical Strategies for Cell Therapy Product Characterization
- Lena Yang - Senior Scientist, Cell Therapy Analytical Development, Takeda
2:15pm - 2:45pm30 mins
Gene Therapy Manufacturing & Analytics
Rapid Development of AAV Purification Process Without Sacrificing Recovery
- Hunter Reese - Scientist II, AskBio
2:45pm - 3:15pm30 mins
Development of Emerging Cell & Gene Therapies
Optimizing LNP Delivery and Non-Viral Vector Manufacturing as Scalable, Redosable Alternatives to Viral Vectors
- Weiyi Li - Senior Manager, LNP Formulation, Prime Medicine, Inc.
2:45pm - 3:15pm30 mins
Cell Therapy Manufacturing & Analytics
Best Practices for Developing Robust Potency Assays for Cell Therapies
- Mariska ter Haak - Senior Director Analytical Development, IN8bio
2:45pm - 3:15pm30 mins
Gene Therapy Manufacturing & Analytics
Application of Novel Technologies to Deliver AAV Downstream Processes with Higher Yield and Better Quality
- Junfen Ma - Head of Genomic Medicine Purification Process Development, Sanofi
3:15pm - 3:45pm30 mins
Development of Emerging Cell & Gene Therapies
Utilizing Next-Gen Delivery Vehicles
3:15pm - 3:45pm30 mins
Cell Therapy Manufacturing & Analytics
Novel Analytical Technologies to Enhance Cell Therapy Product and Process Characterization
3:15pm - 3:45pm30 mins
Gene Therapy Manufacturing & Analytics
Optimizing AAV and LV Purification and Analytics: Accelerated High-Quality Processes using CIM® Monoliths and PATfix®
- Hana Jug - Product Manager (Enveloped viruses, VLPs and EVs), Sartorisu BIA Separations
3:45pm - 4:30pm45 mins
Break
Networking Refreshment Break in The Exhibit Hall
4:30pm - 5:30pm60 mins
Development of Emerging Cell & Gene Therapies
Panel Discussion: Cell and Gene Therapy CDMO Selection and External Manufacturing Best Practices
- Shankar Swaminathan, PhD - Team Lead, Drug Product Development, CMC-Tech Ops, Astellas Institute for Regenerative Medicine
- Jeffrey Masten - Senior Vice President CMC, Secretome Therapeutics
- Matthew Provencal - Executive Director Gene Therapy BDS Manufacturing, Sarepta
4:30pm - 5:00pm30 mins
Cell Therapy Manufacturing & Analytics
Strategy for Cell Therapy Potency Assurance
- Dong Xu, Ph.D. - Associate Director, Cell Therapy Analytical Development, TScan Therapeutics
4:30pm - 5:00pm30 mins
Gene Therapy Manufacturing & Analytics
Detectability and Propagation of MVM in HEK293 Cells: What it means for your Viral Safety Strategy
- Dana Schreffler - Sr. Manager QC Viral Safety, Regeneron
5:00pm - 5:30pm30 mins
Cell Therapy Manufacturing & Analytics
Robust Process Validation Strategies for Cell Therapies
5:00pm - 5:30pm30 mins
Gene Therapy Manufacturing & Analytics
Mastering hcDNA: A Harmonized CMC Approach in AAV Therapies
- Parag Kumthekar - Gene Therapy Downstream Process Development Lead, UCB Pharma
5:30pm - 7:30pm120 mins
Break
Innovation After Dark: Networking Party at the Museum of Science, Boston
7:30pm - 7:35pm5 mins
Break
Close of Day Two
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。