Key Sessions
Hari Pujar
Keynote: In Vivo CAR-T Therapies Product Development and Clinical Advances
Tessera Therapeutics
Arvind Natarajan
Keynote Panel Discussion: Scaling Cell Therapies- Lessons from Pioneers for Smarter, Faster, and More Affordable Ex Vivo Cell Therapy Manufacturing
Iovance Biotherapeutics
Sheila Sharifzad
Automated Closed-System Expansion of Pluripotent Stem Cells: Enhancing Process Consistency and Reproducibility for Cell Therapy Manufacturing
Bayer
Tiffany D Rau, PhD
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
University College Cork, Ireland
Thursday 24th September - Conference Day Two - ET (Eastern Time, GMT-05:00)
Thursday 24th September - Conference Day Two - ET (Eastern Time, GMT-05:00)
8:00am - 8:50am50 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
- Amy Shaw - Head of Process Development, Takeda Pharmaceuticals
8:50am - 9:00am10 mins
Gene Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
9:00am - 9:30am30 mins
Development of Emerging Cell & Gene Therapies
Keynote: In Vivo CAR-T Therapies Product Development and Clinical Advances
- Hari Pujar - Chief Operating Officer, Tessera Therapeutics
9:00am - 10:00am60 mins
Cell Therapy Manufacturing & Analytics
Keynote Panel Discussion: Scaling Cell Therapies- Lessons from Pioneers for Smarter, Faster, and More Affordable Ex Vivo Cell Therapy Manufacturing
- Arvind Natarajan - Senior Vice President, Technical Development, Iovance Biotherapeutics
9:00am - 10:00am60 mins
Gene Therapy Manufacturing & Analytics
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
- Tiffany D Rau, PhD - Principal Consultant BioPharma Technical Consulting and Rau Consulting, Adjunct Professor Biochemistry and Cell Biology, University College Cork, Ireland
- Craig Malzahn - EVP, Product Development and Chief Technology Officer, Regenxbio
- Phillip Ramsey - CTO, SVP Technical Operations, Sangamo Therapeutics
- Kumar Dhanasekharan, PhD - President and CEO, Gokyo Biosciences Inc.
- Jared Simons - VP, Manufacturing, Solid Biosciences Inc.
- Keenan Bashour - VP, Manufacturing & Process Development, 4D Molecular Therapeutics
9:30am - 10:00am30 mins
Development of Emerging Cell & Gene Therapies
Revolutionizing In Vivo Delivery: Overcoming Challenges and Advancing Therapeutic Impact
10:00am - 10:30am30 mins
Development of Emerging Cell & Gene Therapies
Panel Discussion: Scale-Up Strategies: Navigating the Road Ahead for In Vivo CAR-T
- Christopher Bravery - Consulting Regulatory Scientist, Advbiols
- Stephen Kennedy - Head of Technical Operations, CRISPR Therapeutics
10:00am - 10:30am30 mins
Cell Therapy Manufacturing & Analytics
Building Toward Commercial Readiness: How Comparability and Process Improvements Enable Scalable and Robust TCR-T Manufacturing?
- Elisaveta Todorova - Associate Director of Process Development and Technology Innovation, TScan Therapeutics
10:00am - 10:30am30 mins
Gene Therapy Manufacturing & Analytics
Building an AAV Production Strategy Utilizing Stable Producer Cell Lines for Scalable, Gene Therapy Manufacturing
- Ryan Schweller - Associate Director, Process Development, AskBio Inc.
10:30am - 11:30am60 mins
Break
Networking Refreshment Break in the Exhibit Hall
11:30am - 12:00pm30 mins
Development of Emerging Cell & Gene Therapies
Optimizing LNP Delivery and Non-Viral Vector Manufacturing as Scalable, Redosable Alternatives to Viral Vectors
- Ratnesh Joshi - Associate Director, Downstream Process Development, Editas Medicine
11:30am - 12:00pm30 mins
Cell Therapy Manufacturing & Analytics
Process Development to Commercial Scale: Overcoming Manufacturing Bottlenecks in Next-Generation Allogenic Cell Therapies
- Nafees Rahman - Senior Director, Process Development, Nkarta, Inc.
11:30am - 12:00pm30 mins
Gene Therapy Manufacturing & Analytics
Cell Culture Advances in Recombinant AAV Manufacturing for Gene Therapy Leveraging Systems Biology and Modelling
- Madhuresh Sumit - Associate Director, Genomic Medicine CMC, Sanofi
12:00pm - 12:30pm30 mins
Development of Emerging Cell & Gene Therapies
Novel Delivery Approaches: Beyond the Liver
12:00pm - 12:30pm30 mins
Cell Therapy Manufacturing & Analytics
Modular Process Development of HSC-derived CAR-NK Cell Therapies
- Rui Tostoes - CTO, ImmuneBridge
12:00pm - 12:30pm30 mins
Gene Therapy Manufacturing & Analytics
Expanding the Upstream Toolbox: Enabling High Productivity, Robust, and Scalable AAV Production
- Sha Sha - Senior Scientist, Ultragenyx
12:30pm - 1:00pm30 mins
Development of Emerging Cell & Gene Therapies
Sponsored Scientific Track Presentation: Revolutionizing Targeted Delivery: Emerging Technologies to Enhance Precision & Minimize Off-Target Effects
12:30pm - 1:00pm30 mins
Cell Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation
12:30pm - 1:00pm30 mins
Gene Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation
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
2:10pm - 2:15pm5 mins
Gene Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
2:15pm - 2:45pm30 mins
Development of Emerging Cell & Gene Therapies
Leveraging Platform-Based, Multi-Attribute LC Assays to Characterize Multi-components Prime Editing (PE) RNA-LNP
- Minjia Wang - Analytical Development Scientist II, Prime Medicine
2:15pm - 2:45pm30 mins
Cell Therapy Manufacturing & Analytics
An Integrated Analytical Control Strategy - Execution Roadmap to Support Automation for Cell Therapies
- Stephen Krause - Executive Director, Analytical Strategy, Cell Therapies Global Quality, Bristol Myers Squibb
2:15pm - 2:45pm30 mins
Gene Therapy Manufacturing & Analytics
Process Intensification for Affinity Capture of AAV Gene Therapies
- Lukas Maloney - Process Development Engineer I, Regeneron
2:45pm - 3:15pm30 mins
Development of Emerging Cell & Gene Therapies
Harnessing AI and Machine Learning for the Future of Cell & Gene Therapy Development
2:45pm - 3:15pm30 mins
Cell Therapy Manufacturing & Analytics
Automated Closed-System Expansion of Pluripotent Stem Cells: Enhancing Process Consistency and Reproducibility for Cell Therapy Manufacturing
- Sheila Sharifzad - Process Development Scientist - Cell Therapy, Bayer
2:45pm - 3:15pm30 mins
Gene Therapy Manufacturing & Analytics
Development of Membrane Processes for Continuous Purification of Adeno-associated Virus for Gene Therapies
- Andrew Zydney, Ph.D. - Bayard D. Kunkle Chair, Chemical Engineering, Penn State University
3:15pm - 3:45pm30 mins
Development of Emerging Cell & Gene Therapies
Sponsored Scientific Track Presentation: A Representative from ProBio
3:15pm - 3:45pm30 mins
Cell Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation
3:15pm - 3:45pm30 mins
Gene Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation: A Representative from Solventum
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: Starting with the End in Mind: Designing Smart and Phase Appropriate Manufacturing for Successful Cell and Gene Therapy Development
- Khandan Baradaran - Principal, Mill Creek Consulting LLC
- Guillaume Cornelis - Senior Director, AD and Global Head of AS&T, Cellectis
- Bo Yan, PhD - Senior Director, Analytical Development, Beam Therapeutics
- Shankar Swaminathan, PhD - Team Lead, Drug Product Development, CMC-Tech Ops, Astellas Institute for Regenerative Medicine
- Amy Shaw - Head of Process Development, Takeda Pharmaceuticals
4:30pm - 5:00pm30 mins
Cell Therapy Manufacturing & Analytics
Case Study: Harnessing AI & Digitalization for Cell Therapy Manufacturing Optimization and Process Control
- Rashed Harun - Scientist, Genentech
4:30pm - 5:00pm30 mins
Gene Therapy Manufacturing & Analytics
Effective Tech Transfer of Manufacturing Processes to CDMO Partners
- Hunter Reese - Senior Scientist, AskBio
5:00pm - 5:30pm30 mins
Cell Therapy Manufacturing & Analytics
Case Study from Arcellx: Application of MOI Titrations to Evaluate Vector Lots and Aid Process Decisions and Process Control
- Brian Murphy - VP Cell Process Science, Arcellx
5:00pm - 5:30pm30 mins
Gene Therapy Manufacturing & Analytics
Analytical Control Strategy for Successful Method Transfer to Commercial Testing Lab
- Rajeev Boregowda - Associate Director, Bioassay & Molecular Analytical Development, Genomic Medicine CMC, Sanofi
5:30pm - 7:30pm120 mins
Break
Close Of Day Agenda - Biotech Week Boston Party
* 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。