The Summit sessions take place in two concurrent tracks. Track 1 talks cover a range of topics in both Cell Line Development and Gene Therapy, while Track 2 is focused on Bioanalysis techniques. Times in bold are shown as Greenwich Mean Time (GMT).
| 11:30 12:30 (CET) 06:30 (EST) 03:30 (PST) |
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Opening address & Poster session |
| 12:00 13:00 (CET) 07:00 (EST) 04:00 (PST) |
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Analysis of critical quality attributes of adeno-associated viruses (AAVs) Dr. Farihah Haque, Product Specialist for GPC/SEC, Tosoh Bioscience |
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Pharma compliance David Grant, Global Product Manager, ELGA LabWater |
| 12:45 13:45 (CET) 07:45 (EST) 04:45 (PST) |
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Applying a matrix approach for potency assay development for in vivo and ex vivo gene therapies Dominic Hildebrand, Head of Laboratory / QC & Analytical Development, BayerShihua Lin, Pharmaceutical R&D Scientist, AstraZeneca Sarah Currie, Account Manager, BioPhorum |
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Biolayer interferometry as an alternative to surface plasmon resonance in a biopharma regulated environment Dr. Arnaud Delobel, R&D and Innovation Director, Strategy & Innovation, Quality Assistance S.A. |
| 13:15 14:15 (CET) 08:15 (EST) 05:15 (PST) |
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Semi-targeted spent media LC-MS assay: Assuring product quality during cell line development for biologics Keynote: Dr. Andrew Mahan, Associate Director, Janssen: Pharmaceutical Companies of Johnson & Johnson |
| 14:00 15:00 (CET) 09:00 (EST) 06:00 (PST) |
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Go beyond titer and select top producers with favorable quality attributes within 5 days of cloning Dr. Aurora Fabry-Wood, Product Manager, Cell Line Development, Berkeley Lights |
| 15:00 16:00 (CET) 10:00 (EST) 07:00 (PST) |
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Single cell antibody discovery using ‘Islands of automation' Keynote: Paul Anderson, Director - Biologics Discovery Automation at Eli Lilly |
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Recent advances in oligo purity and sequence determination by LCMS: Maximizing throughput, confidence, and coverage Dr. Peter Rye, Application Engineer, Agilent Technologies |
| 15:45 16:45 (CET) 10:45 (EST) 07:45 (PST) |
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Virtual coffee break - Connect with fellow attendees |
| 16:05 17:05 (CET) 11:05 (EST) 08:05 (PST) |
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User stories for IT to support cell and gene therapies David Wallace, Facilitator, BioPhorumDoan Chau, Global Industry Technical Consultant, Rockwell Automation Sean Buckley, Chief Information Officer, Immunocore Fred Dardy, IT Portfolio Architect - Architecture & Emerging Technologies Chapter – PTIX, Roche Christian Hoferer, Team Head MES & Serialization, Roche Kim Wilson, Life Sciences Business Consultant, Dassault Systèmes |
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Developing methods for biosimilarty studies of therapeutic monoclonal antibodies Dr. Kalhari Silva, Head of Scientific Innovation and Research, Custom Biologics |
| 16:50 17:50 (CET) 11:50 (EST) 08:50 (PST) |
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A mid-down strategy for the mass spectrometric sequencing of progressively larger nucleic acids Dr. Dan Fabris, Harold S. Schwenk Sr. Distinguished Chair in Chemistry, University of Connecticut |
| 17:05 18:05 (CET) 12:05 (EST) 09:05 (PST) |
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Release specifications for plasmids and master cell banks used in gene therapy Dr. Basak Clements, Associate Director, Janssen: Pharmaceutical Companies of Johnson & Johnson |
| 17:35 18:35 (CET) 12:35 (EST) 09:35 (PST) |
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Ligand binding assay validation requirements and strategies Mark Dysinger, Associate Director, Alexion Pharmaceuticals |
| 17:50 18:50 (CET) 12:50 (EST) 09:50 (PST) |
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Cell and gene therapy validation challenges Dr. Sharif Ahmed, Director, Process Validation - Global MSAT-Biotech, Bayer |
| 18:35 19:35 (CET) 13:35 (EST) 10:35 (PST) |
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Poster session |
