Scott Burger
Company: Advanced Cell & Gene Therapy
Job title: Principal
Seminars:
The Sponsor-Regulator Relationship to Facilitate Mutual Education on Gene Therapies 1:30 pm
Scaling up manufacturing from conventional cell stacks to bioreactors in non-AAV vectors Adapting technology to suspension-based bioreactors Debating manufacturing requirements between rare and non-rare genetic disease indicationsRead more
day: Regulatory Focus Day PM
Setting the Context on the Current Regulatory Landscape of Gene Therapy Analytics 10:00 am
Overviewing changes and updates in regulatory attitude in 2023 Outlining the current mismatches between industry and regulatory bodies on necessary assay information to provide (e.g., TCID 50 beyond early phase development) Explaining the regulatory expectations for control strategies • How has regulatory language evolved with science and technology advancements?Read more
day: Regulatory Focus Day AM
Applying Biologics Development Practices to Gene Therapy Products: Platform Methods & Quality by Design 9:05 am
Outlining lessons from biologics to generate platform methods for gene therapy analytics How well do QbD principles fit when applied to gene therapy analytical development? Breaking down practices to adapt to the realities of gene therapy – adjusting a round hole to fit a square pegRead more
day: Pre-Conf Quality & Process Development Track AM