Katia Karalis

Company: Regeneron Pharmaceuticals

Job title: Executive Director - Research & Development

Seminars:

Panel Discussion: Defining Biomarker Context of Use in Early on to Ensure Valuable Insights from Clinical Implementation into Neurology Trials 3:45 pm

Critically evaluating correct and valuable applications of biomarkers for meaningful and actionable insights: target engagement, patient stratification, diagnosis, prognosis and predicting patient outcome • Addressing regulatory requirements and validation processes necessary for biomarkers in clinical trials and discuss strategies for robust biomarker validation to ensure reliability and reproducibility of results across different patient populations and…Read more

day: Conference Day One

How Much Can we Rely on Human Cell-Based Immune Systems to Support & Implement Caveats of New Therapeutic Approaches? 3:15 pm

Reviewing a case study for in vitro systems to apply, move on and stratify patients to optimize drug development Exploring design for discovery, first in human and early clinical studies to meet expectations and requirements from the regulators following the FDA modernization act for IND and BLA approvals Exploring alignment of phenotypic changes, secretory and…Read more

day: Conference Day One