Speakers

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Ales Strancar
Chief Executive Officer
BIA Separations

Day One

Wednesday, 2nd September 2020

4:15 pm | AAV Manufacturing In-Process Control

Christopher Bravery
Founder
Consulting on Advanced Biologicals Ltd

Clare Blue
Director of Analytical Development
Biogen

Day One

Wednesday, 2nd September 2020

10:00 am | Panel Discussion: Addressing the Current Challenges of Analytical Development Between Phases

9:00 am | Analytical Comparability Requirements During the Development & Commercialisation of Gene Therapy Products

David Dobnik
Scientific Associate, Head of Laboratory for Therapeutic Viruses
National Institute of Biology

Day One

Wednesday, 2nd September 2020

2:00 pm | Accurate & Sensitive Identification of Nucleic Acid Impurities in AAV Vector Samples by High-Throughput Sequencing

1:00 pm | Lunch & Analytical Technologies Roundtable Discussion

Doyoung Lee
Senior Scientist, Lead UK DRI Vector Core
King’s College London

Day One

Wednesday, 2nd September 2020

1:00 pm | Lunch & Analytical Technologies Roundtable Discussion

Edina Ljubovic-Couteau
Director, Drug Product Development
UniQure

Day Two

Thursday, 3rd September 2020

9:30 am | 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

4:15 pm | Characterisation of AAV Stocks by High-throughput Sequencing

Elina Hessels
Senior Scientist, Lead Assay Development
UniQure

Day One

Wednesday, 2nd September 2020

11:10 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

12:10 pm | 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 Two

Thursday, 3rd September 2020

12:00 pm | Applications of ddPCR for the Characterisation of AAV Vectors

Franz Schnetzinger
Director, Quality Control & Chemical Manufacturing Control Analytical Development
Gyroscope

Day Two

Thursday, 3rd September 2020

8:30 am | Characterising Aggregates: Exploring Methods for Transfer into QC

Greg Saia
Senior Scientist
bluebird bio

Day Two

Thursday, 3rd September 2020

2:30 pm | 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

5:15 pm | Assessing Analytical Tools for the Characterisation of Empty, Partial & Full AAV Particles

1:00 pm | Lunch & Analytical Technologies Roundtable Discussion

Jaap Twisk
Senior Director, Analytical Development
UniQure

Day Two

Thursday, 3rd September 2020

2:30 pm | 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

2:30 pm | Regulatory Panel Discussion: Expected Regulatory Requirements for Analytics Depending on the Product’s Stage in Clinical Development

Katharina Hammer
Director, Quality Control
PROGEN

Day One

Wednesday, 2nd September 2020

11:40 am | AAV Titration ELISAs: a Robust & Reliable Tool for AAV Quantification

Louise Bisset
Senior Biopharmaceutical Quality Assessor
Medicines & Healthcare Products Regulatory Agency

Day Two

Thursday, 3rd September 2020

2:30 pm | 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 Two

Thursday, 3rd September 2020

11:30 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

10:00 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

Renee Tobias
Director of Marketing
Halo Labs

Day Two

Thursday, 3rd September 2020

9:00 am | Automated, Low-Volume Subvisible Particle Aggregate Analysis with the HORIZON System

Robert Pletzenauer
Head of Process Analytics
Takeda

Day One

Wednesday, 2nd September 2020

3:45 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

10:00 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 One

Wednesday, 2nd 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

4:45 pm | Mass Spectrophotometry Based Analytical Methods for AAV Protein Characterisation & Residual Protein Determination

10:00 am | Panel Discussion: Addressing the Current Challenges of Analytical Development Between Phases

Vesselin Mitaksov
Senior Principal Scientist
Pfizer

Day Two

Thursday, 3rd September 2020

2:00 pm | Development & Validation of Analytical Methods for Gene Therapy Commercialization

Vinay Kondeti
Scientist II, CMC Analytical
BridgeBio