Dr. Joanna Grudzinska-Goebel

Company: Bayer

Job title: Immunogenicity Risk Assessment Expert / Senior DMPK Project Lead

Bio:

Joanna Grudzinska-Goebel works as a Senior DMPK Project Lead at Bayer focusing on Biotherapeutics and New Modalities including mRNA/LNP-based therapies. She is the leader of the global Immunogenicity Team at Bayer which established the Immunogenicity Risk Assessment Process for Biotherapeutics and New Modalities. As Immunogenicity Risk Assessment Expert, she supports project teams in conducting the risk assessment. In addition, she is facilitating cross-industry alignment on Immunogenicity Risk Assessment of different modalities by leading and contributing to working groups within various industry consortia.

Seminars:

Immunogenicity Risk Assessment of LNP-Delivered Nucleic Acid Modalities in Therapeutic Applications 9:25 am

Discussing how these therapies can trigger unwanted innate and adaptive immune responses, potentially impacting treatment efficacy and patient safety Describing strategies for product design adaptations during early development stages to minimize immunogenicity Outlining recommendations for defining an Immunogenicity Risk Assessment based clinical testing strategy driven by immunogenicity consequences, including streamlined monitoring for minimal impact scenarios…Read more

day: Conference Agenda

Q&A Session 9:50 am

Join our speakers for an interactive Q&A session, where they’ll come together to answer your questions, share further insights, and expand on key themes from their presentations.Read more

day: Conference Agenda