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
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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Gene Therapy Manufacturing & Analytics
8:50am - 9:00am
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
- Santosh Yadav - Senior Director, Drug Product Development, Ocugen, Inc.
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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Gene Therapy Manufacturing & Analytics
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
Cell Bank Characterization and Qualification Strategy for AAV PCLs
- Wei Xue - Associate Director, Ultragenyx Pharmaceutical Inc.
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Gene Therapy Manufacturing & Analytics
2:10pm - 2:15pm
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
- Gurinderpal Singh - Director, Quality Operations R & D, GSK
2:15pm - 2:45pm
Process Intensification for Affinity Capture of AAV Gene Therapies
- Lukas Maloney - Process Development Engineer I, Regeneron
2:45pm - 3:15pm
Effective Tech Transfer of Manufacturing Processes to CDMO Partners
- Hunter Reese - Senior Scientist, AskBio
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Gene Therapy Manufacturing & Analytics
4:30pm - 5:00pm
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
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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