Lara Nascimento Brooks

Company: GlaxoSmithKline

Job title: Strategic Technology and Collaborations Manager

Seminars:

Roundtable Discussion: Overcoming Tech Transfer Hurdles to Maintain Product Quality, Consistency & Regulatory Compliance 11:20 am

Discuss best practices for transferring manufacturing processes between teams or sites to ensure consistency, quality, and regulatory compliance without delaying timelines Explore the key challenges of scaling up gene therapy production and strategies for minimising bottlenecks to maintain efficient timelines Highlight the importance of collaboration across R&D, manufacturing, and quality control teams to ensure smooth…Read more

day: Day Two

From Bench to Bedside: Mastering QC & CMC Alignment to Meet Evolving Regulatory Standards 1:00 pm

Ensuring QC readiness and CMC alignment is critical to the successful development and regulatory approval of gene therapies. As regulatory standards evolve, especially with the complexities of viral vector production, maintaining consistency and meeting compliance requirements at each stage—from early development to clinical trials-is essential. Timing & Implementation of QC Assays: Identifying the optimal stages…Read more

day: Pre-Conference QC Readiness Track B - PM