Speakers
Akash Bhattacharya
Senior Application Engineer
Beckman Coulter Life Sciences
Day One
Wednesday, 2nd September 2020
4:00 pm | Session Reserved for Beckman Coulter
4:50 pm | Live Q&A & Panel Discussion
Ales Strancar
Chief Executive Officer
BIA Separations
Day One
Wednesday, 2nd September 2020
4:50 pm | Live Q&A & Panel Discussion
3:30 pm | Session Reserved for BIA Separations
Christopher Bravery
Founder
Consulting on Advanced Biologicals Ltd
Clare Blue
Director of Analytical Development
Biogen
Day One
Wednesday, 2nd September 2020
9:10 am | Panel Discussion: Addressing the Current Challenges of Analytical Development Between Phases
8:50 am | Analytical Comparability Requirements During the Development & Commercialisation of Gene Therapy Products
Daniel Gall
Scientist
BridgeBio
David Dobnik
Scientific Associate, Head of Laboratory for Therapeutic Viruses
National Institute of Biology
Day One
Wednesday, 2nd September 2020
12:30 pm | Analytical Technologies Interactive Discussion
Day Two
Thursday, 3rd September 2020
10:00 am | Live Q&A & Panel Discussion
8:50 am | Accurate & Sensitive Identification of Nucleic Acid Impurities in AAV Vector Samples by High-Throughput Sequencing
Dianna Maar
Product Manager, Digital Biology Group
Bio-Rad Laboratories
Day One
Wednesday, 2nd September 2020
2:40 pm | Live Q&A & Panel Discussion
1:50 pm | Exploring Droplet Precision for Analytical Development & AAV Quantification
Doyoung Lee
Senior Scientist, Lead UK DRI Vector Core
King’s College London
Day One
Wednesday, 2nd September 2020
12:30 pm | Analytical Technologies Interactive Discussion
Edina Ljubovic-Couteau
Director, Drug Product Development
UniQure
Day Two
Thursday, 3rd September 2020
1:40 pm | Panel Q&A & Panel Discussion
1:20 pm | Formulation & Manufacturing Process Optimization to Prevent Aggregation in Final Drug Product
Eduard Ayuso
Team Leader, Innovative Vectorology, Scientific Director Translational Vector Core (CPV)
INSERM
Day Two
Thursday, 3rd September 2020
10:00 am | Live Q&A & Panel Discussion
8:30 am | Characterisation of AAV Stocks by High-throughput Sequencing
Elina Hessels
Senior Scientist, Lead Assay Development
UniQure
Day One
Wednesday, 2nd September 2020
12:00 pm | Live Q&A & Panel Discussion
11:00 am | Case Study: Developing a Functional Potency Assay to Demonstrate a Link to Effectiveness
Eric Yearley
Principal Scientist, Analytical Development
BridgeBio
Day One
Wednesday, 2nd September 2020
12:00 pm | Live Q&A & Panel Discussion
11:20 am | Phase-Appropriate Analytical Control Strategies for Recombinant AAV-Based Gene Therapy Products: Case Studies in the Characterization of a Process-Related Impurity and Development of an In-Vitro Potency Assay
Fabien Dorange
Head of Analytical Development
Genethon
Day One
Wednesday, 2nd September 2020
2:40 pm | Live Q&A & Panel Discussion
2:20 pm | Applications of ddPCR for the Characterisation of AAV Vectors
Felix Gloge
Analytical Service
Wyatt Technology
Day One
Wednesday, 2nd September 2020
5:50 pm | Panel Q&A & Discussion Session
5:00 pm | Quantify Viral Vector Attributes with Light Scattering
Franz Schnetzinger
Director, Quality Control & Chemical Manufacturing Control Analytical Development
Gyroscope
Day Two
Thursday, 3rd September 2020
1:40 pm | Panel Q&A & Panel Discussion
12:30 pm | Characterising Aggregates: Exploring Methods for Transfer into QC
Greg Saia
Senior Scientist
bluebird bio
Day Two
Thursday, 3rd September 2020
11:25 am | Regulatory Panel Discussion: Expected Regulatory Requirements for Analytics Depending on the Product’s Stage in Clinical Development
Ian Anderson
Senior Manager, Analytical Sciences
Allergan
Day One
Wednesday, 2nd September 2020
4:50 pm | Live Q&A & Panel Discussion
12:30 pm | Analytical Technologies Interactive Discussion
4:30 pm | Assessing Analytical Tools for the Characterisation of Empty, Partial & Full AAV Particles
Jaap Twisk
Senior Director, Analytical Development
UniQure
Day Two
Thursday, 3rd September 2020
11:25 am | Regulatory Panel Discussion: Expected Regulatory Requirements for Analytics Depending on the Product’s Stage in Clinical Development
Jennifer Lin
Senior Scientist
Orchard Therapeutics
Joseph Lee
Executive Director, Analytical Development
PTC Therapeutics
Day Two
Thursday, 3rd September 2020
11:25 am | Regulatory Panel Discussion: Expected Regulatory Requirements for Analytics Depending on the Product’s Stage in Clinical Development
Katharina Hammer
Director, Quality Control
PROGEN
Day Two
Thursday, 3rd September 2020
10:00 am | Live Q&A & Panel Discussion
9:10 am | AAV Titration ELISAs: a AAV ELISAs: a Robust & Reliable Tool for Capsid Quantification & Reliable Tool for AAV Quantification
Koen De Gelas
Regional Sales Specialist ddPCR (BeNeLux & UK)
Bio-Rad Laboratories
Day One
Wednesday, 2nd September 2020
2:40 pm | Live Q&A & Panel Discussion
1:50 pm | Exploring Droplet Precision for Analytical Development & AAV Quantification
Louise Bisset
Senior Biopharmaceutical Quality Assessor
Medicines & Healthcare Products Regulatory Agency
Day Two
Thursday, 3rd September 2020
2:00 pm | Coffee Q&A Session
11:25 am | Regulatory Panel Discussion: Expected Regulatory Requirements for Analytics Depending on the Product’s Stage in Clinical Development
Marina Feschenko
Director, Analytical Development- Gene Therapy/Biologics
Biogen
Day One
Wednesday, 2nd September 2020
12:00 pm | Live Q&A & Panel Discussion
11:40 am | Using Infectivity Assays as a Surrogate for Potency Assessment of Viral Vectors
Mark Plavsic
Chief Technology Officer
Lysogene
Day One
Wednesday, 2nd September 2020
9:10 am | Panel Discussion: Addressing the Current Challenges of Analytical Development Between Phases
Marthi Pretorius
Analytical Project Lead
Novartis
Day Two
Thursday, 3rd September 2020
11:00 am | Validation of Safety Assays Required for Regulatory Submission
Rick Gordon
Vice President of Sales
Halo Labs
Day Two
Thursday, 3rd September 2020
1:40 pm | Panel Q&A & Panel Discussion
12:50 pm | Protein or Not? Advanced High Throughput Aggregate Analysis with the Aura
Robert Pletzenauer
Head of Process Analytics
Takeda
Day One
Wednesday, 2nd September 2020
2:40 pm | Live Q&A & Panel Discussion
1:30 pm | Digital PCR – State of the Art Vector Genome Titering Or Even More?
Sonya Schermann
Director, Analytics
Freeline Therapeutics
Day One
Wednesday, 2nd September 2020
9:10 am | Panel Discussion: Addressing the Current Challenges of Analytical Development Between Phases
8:30 am | Defining, Developing & Managing a Functionally Relevant Set of Assays for AAV Vectors
Sushmita ‘Mimi’ Roy
Executive Director, Analytical Sciences
BioMarin
Day Two
Thursday, 3rd September 2020
Tushar Patel
Scientist I, Vector Characterization
bluebird bio
Uditha deAlwis
Executive Director Analytical Sciences (AD/QC)
Sarepta Therapeutics
Day One
Wednesday, 2nd September 2020
5:50 pm | Panel Q&A & Discussion Session
5:30 pm | Mass Spectrophotometry Based Analytical Methods for AAV Protein Characterisation & Residual Protein Determination
9:10 am | Panel Discussion: Addressing the Current Challenges of Analytical Development Between Phases
Vesselin Mitaksov
Senior Principal Scientist
Pfizer
Vinay Kondeti
Scientist II, CMC Analytical
BridgeBio