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