November 19-21 | Boston, MA, USA

Workshop A: 1 place remaining!

Register by Friday, September 20 to save up to $900!

What’s On › Pre-Conference Workshops

Workshop A Tuesday, November 19

8:00 am - 11:00 am
Enhancing Analytical Comparability Strategies to Support Every Stage of Development

Whatever stage of development you’re currently at, progressing to the next phase and adapting your analytical strategy is a key challenge you will need to navigate. This is all in the context of increasing regulatory scrutiny and uncertainty over the analytical and comparability strategies required to satisfy the regulators. Attend this workshop to discuss these topics in more detail:
  • Dissecting the transitions between early and late stages
  • Developing effective bridging studies
  • Dispelling uncertainties around the changes that can be made to processes while maintaining analytical comparability to satisfy regulatory agencies
  • Understanding how analytical methods need to evolve and improve as development reaches later stages
Workshop Leader: David Malliaros, Senior Director, Quality Control, Ultragenyx

Workshop B Tuesday, November 19

11:30 am - 2:30 pm
Discussing How to Develop Accurate Assays to Measure Residual Impurities

Analyzing both DNA and protein impurities is a key aspect of gene therapy analytical investigation. It’s clear that there are numerous challenges involved in this analysis, that limit the potential to establish methods that capture the extent and diversity of impurities present.

This workshop represents an opportunity to discuss these challenges and learn about:

  • Insights into the use of an HSV platform and the assays utilized
  • Understanding approaches to measure DNA and plasmid residuals and also impurities from the HSV helper virus system
  • Investigating transferable, cross-platform insights
  • Discussing standardization and how data and results can be shared across organizations in the field

Workshop Leader: Nathalie Clement, Associate Director & Associate Professor, Powell Gene Therapy Center, University of Florida

Workshop C Tuesday, November 19

3:00 pm - 6:00 pm
Investigating Outsourcing Strategies to Utilize Internal and External Resources Effectively

Establishing mutually beneficial collaborations with external organizations is a key factor in long-term success. Given the complexity of gene therapy analytics, establishing these relationships is a complex task and decisions around when as well as what to outsource are key. This workshop will provide an opportunity for in-depth discussions from those who have been intimately involved in this aspect of this field.

Attend this workshop to discuss these topics in more detail:

  • Internal vs External? Understanding the factors influencing decisions to outsource of invest in improving internal capabilities and how this situation is evolving in the field
  • Highlighting the key criteria to assess in selecting an external partner organization
  • Improving the tech transfer process: how to transfer key information successfully to maintain efficiency and safety
  • Describing differences in the requirements for outsourcing small-scale upstream processes to running GMP testing

Workshop Leader: Lauren Drouin, Associate Director, Analytical Development, Logic Bio