September 22-25, 2026 as part of Biotech Week Boston
Hynes Convention CenterBoston, MAKey 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
Craig Malzahn
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
Regenxbio
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Thursday 24th September - Conference Day Two - ET (Eastern Time, GMT-05:00)
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Thursday 24th September - Conference Day Two - ET (Eastern Time, GMT-05:00)
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Fun Run
6:45am - 7:45am
Cell & Gene International 2026 Fun Run
Kick off your morning the right way with our 5K Fun Run/Walk.
Join us for a refreshing guided run/walk along the Boston waterfront, where you’ll soak in beautiful waterfront views and energize yourself for the day ahead.
Stretching: 6:45 AM
Departure: 7:00 AM
Meeting Point: Registration Desk, Hynes Convention Center (start and end will be at Hynes). Whether you’re a seasoned runner or just looking for a fun way to get moving, this is the perfect way to connect with fellow attendees and enjoy the city. All participants will receive an official event run shirt, subject to availability so don't be late!
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Registration Break
8:15am - 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
- Nicola Ambler - Co-Founder, CGT Circle
9:00am - 9:30am
Keynote: In Vivo CAR-T Therapies Product Development and Clinical Advances
- Hari Pujar - Chief Operating Officer, Tessera Therapeutics
9:30am - 10:00am
Revolutionizing In Vivo Delivery: Overcoming Challenges and Advancing Therapeutic Impact
10:00am - 10:30am
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
8:50am - 9:00am
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
- Amy Shaw - Head of Process Development, Takeda Pharmaceuticals
9:00am - 10:00am
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
- Pooja Sabhachandani - Associate Director, Science and Technology, Novartis
- Shashi Murthy - Vice Provost for Global Innovation and Head, Dublin Innovation Institute, Northeastern University
10:00am - 10:30am
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
8:50am - 9:00am
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
9:00am - 10:00am
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
- 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
- Tiffany D Rau, PhD - Principal Consultant BioPharma Technical Consulting and Rau Consulting, Adjunct Professor Biochemistry and Cell Biology, University College Cork, Ireland
10:00am - 10:30am
Building an AAV Production Strategy Utilizing Stable Producer Cell Lines for Scalable, Gene Therapy Manufacturing
- Ryan Schweller - Associate Director, Process Development, AskBio Inc.
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Break
10:30am - 11:30am
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
11:45am - 12:00pm
High-Throughput Signal Peptide Engineering for Cell and Gene Therapy: From Single Chains to Multichain Biologics
- Tero-Pekka Alastalo - CEO, Avenue Biosciences
12:00pm - 12:30pm
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 - 12:00pm
Process Development to Commercial Scale: Overcoming Manufacturing Bottlenecks in Next-Generation Allogenic Cell Therapies
- Nafees Rahman - Senior Director, Process Development, Nkarta, Inc.
12:00pm - 12:30pm
Modular Process Development of HSC-derived CAR-NK Cell Therapies
- Rui Tostoes - CTO, ImmuneBridge
12:30pm - 1:00pm
Sponsored Scientific Track Presentation
Spotlight Presentation – Calling all Technology Thought Leaders!
This session is your platform to demonstrate leadership and technical expertise. Present your data, case studies, and innovative solutions to a targeted audience of senior scientists and engineers looking to solve hurdles in their production processes.
To learn more about sponsoring this session, contact us at Partners@informaconnectls.com
11:30am - 12:00pm
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 - 12:30pm
Expanding the Upstream Toolbox: Enabling High Productivity, Robust, and Scalable AAV Production
- Sha Sha - Senior Scientist, Ultragenyx
12:30pm - 1:00pm
Sponsored Scientific Track Presentation
Spotlight Presentation – Calling all Technology Thought Leaders!
This session is your platform to demonstrate leadership and technical expertise. Present your data, case studies, and innovative solutions to a targeted audience of senior scientists and engineers looking to solve hurdles in their production processes.
To learn more about sponsoring this session, contact us at Partners@informaconnectls.com
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Break
1:00pm - 2:10pm
Lunch in the Exhibit Hall
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Development of Emerging Cell & Gene Therapies
Cell Therapy Manufacturing & Analytics
Gene Therapy Manufacturing & Analytics
2:10pm - 2:15pm
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
2:15pm - 2:45pm
Harnessing AI and Machine Learning for the Future of Cell & Gene Therapy Development
2:45pm - 3:15pm
Leveraging Platform-Based, Multi-Attribute LC Assays to Characterize Multi-components Prime Editing (PE) RNA-LNP
- Minjia Wang - Analytical Development Scientist II, Prime Medicine
2:10pm - 2:15pm
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
2:15pm - 2:45pm
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
2:45pm - 3:15pm
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
3:15pm - 3:45pm
Sponsored Scientific Track Presentation
Spotlight Presentation – Calling all Technology Thought Leaders!
This session is your platform to demonstrate leadership and technical expertise. Present your data, case studies, and innovative solutions to a targeted audience of senior scientists and engineers looking to solve hurdles in their production processes.
To learn more about sponsoring this session, contact us at Partners@informaconnectls.com
2:10pm - 2:15pm
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
2:15pm - 2:45pm
Process Intensification for Affinity Capture of AAV Gene Therapies
- Lukas Maloney - Process Development Engineer I, Regeneron
2:45pm - 3:15pm
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 - 3:45pm
Sponsored Scientific Track Presentation:
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Break
3:45pm - 4:30pm
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
4:30pm - 5:30pm
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 - 5:00pm
Case Study: Harnessing AI & Digitalization for Cell Therapy Manufacturing Optimization and Process Control
- Rashed Harun - Scientist, Genentech
5:00pm - 5:30pm
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
4:30pm - 5:00pm
Effective Tech Transfer of Manufacturing Processes to CDMO Partners
- Hunter Reese - Senior Scientist, AskBio
5:00pm - 5:30pm
Analytical Control Strategy for Successful Method Transfer to Commercial Testing Lab
- Rajeev Boregowda - Associate Director, Bioassay & Molecular Analytical Development, Genomic Medicine CMC, Sanofi
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Break
5:30pm - 7:30pm
Close Of Day Agenda – Biotech Week Boston Party
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