Pre-Conference Workshops

Monday, November 29 2021 | 09.00AM - 2.00PM EST

Morning Workshops

Workshop A:  09.00am-11.00am EST

Mastering Potency Assays: Your Blueprint to Tackle the Field’s Greatest Analytical Challenge

Your one stop shop for all things potency. Potency assay development strategies & common challenges

Join this workshop to discuss:

  • Assessing Best Practice for Selection of Parameters for Assay Validation With Potency Assays
  • Long Term Program Management for Potency Assays
  • Developing In Vitro Mechanism of Action Potency Assays & Demonstrating Choice of Cell Line
  • Understanding & Characterizing the Impact of Deamidation on Potency

Workshop Leader:

1

Connie Tsai
Principle Scientist Analytical Development Bioassay
Novartis Gene Therapies

tushar

Tushar Patel
Associate Director Analytical
Vedere Bio

elena

Elena Peletskaya
Senior Director
BMS

andrea 2

Andrea Sobjak
Senior Scientist
JnJ

David Dobnik

David Dobnik
Associate Scientist
National Institute of Biology

jim

James Richardson
Sr. Director Analytical Development
Interius Biotherapeutics

Workshop B: 9.00am-11.00am EST

Reference Standard Materials 101

Join to discuss the “What, Why & How” for Reference Standards in the gene therapy field. Including types, uses and when they have to be changed.

Join this workshop to discuss:

  • What are the different types of reference standards and what are their uses?
  • When do I need a product reference standard and how and when are these changed?
  • How should in-house reference materials be tested and controlled?
  • Dossier requirements for approval

Workshop Leader:

Christopher Bravery

Christopher Bravery
Consultant

Workshop C: 09.00am-11.00am EST

AAV Full-Empty Characterization

Empty full characterizations stands as one of the greatest challenges in gene therapy analytics. Join to discuss analytical approaches for empty full characterization and understand how common hurdles can be overcome

Join this workshop to discuss:

  • Best Practice Analytical Methods for Empty Full Characterization
  • Alternative Methods to AUC for Empty-Full Characterization
  • Strategies to Validate Empty-Full Characterization Without 100% empty and Full Capsid Samples

Workshop Leaders:

3
4
2

Darren Bedgley
Principal Scientist Analytical Development
Resilience

Nicholas Larson
Scientist
Biogen

Benjamin Draper
Research Scientist
Indiana University

Afternoon Workshops

Workshop D:  12.00pm-2.00pm EST

Transferring a Complex Analytical Method to Quality Control

As new analytical methodologies continue to come to the forefront it is hugely important they can be moved into the QC environment. Join to understand how such hurdles can be overcome.

Join this workshop to discuss:

  • How to bring New Technologies & Analytical Approaches into a QC Environment
  • Challenges of moving new and complex analytical methodologies into a QC environment
  • What makes an analytical assay QC friendly?

Workshop Leader:

Dwayne Neal

Dwayne Neal
Senior Director Analytical Validation
AVROBIO

Workshop E: 12.00pm-2.00pm EST

Process Control & Process Analytics

Discuss how analytical and process development can marry together to reduce variability in results. Learn how choose the optimum process analytical strategy

Join this workshop to discuss:

  • The greatest challenges with the use of analytics in the context of process development
  • Best practice and strategy development to deduce variability in analytics
  • How to chose optimum process analytics

Workshop Leader:

Bill Janssen

Bill Janssen
Consultant

Workshop F: 12.00pm-2.00pm EST

Stability-Indicating Assays for AAV-Based Vectors

  • AAV-based vectors used in Gene Therapy are new and complex modalities both in terms of structure and function.
  • The mechanism of action of viral vectors is multifaceted, which requires matrixed approach for assessment of biological activity


Join this workshop to discuss:

  • Stability-indicating methods for AAV-based vectors
  • Challenges and opportunities for structure-activity relationship studies in the context of developing stability indicating assays

 

Workshop Leader:

Michael Tovey

Michael Tovey
Chief Scientific Advisor
Svar Life Science AB