Troels Jordansen

Company: Glycostem

Job title: Chief Executive Officer

Seminars:

From Europe to the US: Sharing an Expert’s Guide to Regulatory Success in Europe, & Differences Identified in FDA Processes 5:10 pm

Discussing the regulatory interactions and expectations experienced in Europe, from trial design to safety expectations and IND processes Highlighting the key priorities when working with European regulators, and discussing the differences in experience with early US preparations Sharing which data to focus on to maximize interactions with EMA and MHRA bodies, and how this might…Read more

day: Day One

Panel Discussion: Optimizing Innate Therapy in the Clinic 2:30 pm

Discussing the pros and cons of monotherapy vs. combination therapy Strategies to target on tumor effects and characterize good clinical targets Considering which edits, combinations, and cell types make sense clinically Discussing the need for preconditioning and CRS treatment for innate immune cells in comparison to T cell therapiesRead more

day: Day One Track B PM

Driving GMP Readiness with Scalable Manufacturing Platforms & Second Sourcing Strategies with GMP Materials 3:15 pm

Sharing development of a GMP-ready manufacturing process, and key features to easily reach GMP grade Evaluating second sources in CMC and qualifying materials to meet supply demand Carrying out risk assessments and comparability testing on new materials on IND submissions and related dossiersRead more

day: Day One Track C PM