Tuesday, November 22

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 techniquesTimes in bold are shown as Greenwich Mean Time (GMT).

 12:30 (CET) 
 06:30 (EST)
 03:30 (PST)

Opening address & Poster session

 13:00 (CET) 
 07:00 (EST)
 04:00 (PST)

Analysis of critical quality attributes of adeno-associated viruses (AAVs)

Dr. Farihah Haque, Product Specialist for GPC/SEC, Tosoh Bioscience

Pharma compliance

David Grant, Global Product Manager, ELGA LabWater
 13:45 (CET) 
 07:45 (EST)
 04:45 (PST) 

Applying a matrix approach for potency assay development for in vivo and ex vivo gene therapies

Dominic Hildebrand, Head of Laboratory / QC & Analytical Development, Bayer
Shihua Lin, Pharmaceutical R&D Scientist, AstraZeneca
Sarah Currie, Account Manager, BioPhorum

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.
 14:15 (CET) 
 08:15 (EST)
 05:15 (PST)

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
 15:00 (CET) 
 09:00 (EST)
 06:00 (PST)

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
 16:00 (CET) 
 10:00 (EST)
 07:00 (PST)

Single cell antibody discovery using ‘Islands of automation'

Keynote: Paul Anderson, Director - Biologics Discovery Automation at Eli Lilly

Recent advances in oligo purity and sequence determination by LCMS: Maximizing throughput, confidence, and coverage

Dr. Peter Rye, Application Engineer, Agilent Technologies

 16:45 (CET) 
 10:45 (EST)
 07:45 (PST)

Virtual coffee break - Connect with fellow attendees

 17:05 (CET) 
 11:05 (EST)
 08:05 (PST)

User stories for IT to support cell and gene therapies

David Wallace, Facilitator, BioPhorum
Doan 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

Developing methods for biosimilarty studies of therapeutic monoclonal antibodies 

Dr. Kalhari Silva, Head of Scientific Innovation and Research, Custom Biologics
 17:50 (CET) 
 11:50 (EST)
 08:50 (PST)

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
 18:05 (CET) 
 12:05 (EST)
 09:05 (PST)

Release specifications for plasmids and master cell banks used in gene therapy

Dr. Basak Clements, Associate Director, Janssen: Pharmaceutical Companies of Johnson & Johnson
 18:35 (CET) 
 12:35 (EST)
 09:35 (PST)

Ligand binding assay validation requirements and strategies 

Mark Dysinger, Associate Director, Alexion Pharmaceuticals
 18:50 (CET) 
 12:50 (EST)
 09:50 (PST)

Cell and gene therapy validation challenges 

Dr. Sharif Ahmed, Director, Process Validation - Global MSAT-Biotech, Bayer
 19:35 (CET) 
 13:35 (EST)
 10:35 (PST)

Poster session