Pre-Conference Workshops

Morning Workshops

Workshop A:  9:00am - 12:00pm

A Deep Dive into Potency Assays

Navigating the challenges of developing clinically relevant potency assays for gene therapy products

Workshop Leader:

Marina Feschenko, Principal Scientist, Analytical Development - Gene Therapy & Biologics, Biogen

 

Workshop B:  9:00am - 12:00pm

The Switch to Digital PCR

Discussing the challenges of switching from qPCR to digital PCR, whilst exploring the advantages and limitations of each technology

Workshop Leader:

Clare Blue, Director, Analytical Development, Biogen

 

Workshop C:  9:00am - 12:00pm

The Effort for QC-Friendly Empty-Full & Partial Characterisation

Exploring the analytical technologies used for empty-full characterisation and how these can be incorporated into a suitable QC environment

Workshop Leader:

John Little, Director, Quality Control, Freeline Therapeutics

Afternoon Workshops

Workshop D:  1:00pm - 4:00pm

Clinical Bridging: Bioanalytical Assays in the Biological Context – Immune Response, PKPD & Vector Shedding

Discussing analytical challenges with different matrices, safety concerns or issues when moving beyond analyzing the compound itself

Workshop Leader:

Scott Burger, Principal, Advanced Cell & Gene Therapy, LLC

Workshop E:  1:00pm - 4:00pm

High Throughput: Next Generation Sequencing Technology

Discovering the potential of characterization of AAV stocks by high-throughput sequencing: residual DNA, genome identity and integrity, sequencing biases

Workshop Leader:

Magalie Penaud-Budloo, Postdoctoral Research Scientist, Translational Gene Therapy for Genetic Diseases, INSERM

Workshop F:  1:00pm - 4:00pm

Characterizing Aggregates

Developing orthogonal methods for rAAV vector aggregate characterization and exploring the advantages and disadvantages of DLS, SEC-HPLC, nsTEM and other methods

Workshop Leaders:

Franz Schnetzinger, Director, Quality Control & CMC Analytical Development, Gyroscope Therapeutics

Andrea Hamilton, QC Senior Scientist, Freeline Therapeutics