In the evolving landscape of drug development, biomarkers are increasingly vital in driving decisions across preclinical and clinical studies. From patient stratification and efficacy monitoring to safety assessments and pharmacodynamic evaluations, biomarkers are critical tools for reducing development timelines and increasing the likelihood of regulatory success. But with so many roles for biomarkers come equally complex questions: When is qualification sufficient? When is validation necessary? And how do global regulatory expectations align, or diverge?
Watch our latest webinar, “To Validate or Qualify your Biomarker Assay? That is the Question!”, where we will explore the differences between qualification and validation, explain how these terms are applied (and sometimes misused), and examine how to build a fit-for-purpose approach that meets the scientific goals of your program while satisfying regulatory expectations
Learning Objectives:
- The critical distinctions between biomarker qualification and validation, and when each is required.
- How to design a fit-for-purpose biomarker strategy tailored to clinical phase and regulatory needs.
- Global regulatory perspectives and how to align biomarker approaches across regions.
About the Expert Speaker:
- Dr. Dominic Warrino, Senior Director of Scientific Services at KCAS Bio: Dominic leads a team of scientific advisors for both clients and internal teams for development, validation, and sample analysis for support of PK, immunogenicity, and biomarker methods for a wide range of therapeutics. Dominic has 30 years of experience developing and validating assays for support of drug development.
Who Should Watch:
Attendees will gain practical insights into biomarker characterization, from selecting relevant assays and technologies to interpreting performance metrics like sensitivity, specificity, and reproducibility. In addition, we’ll provide a global perspective, comparing approaches from the FDA, EMA, and other international health authorities, highlighting both consistencies and key differences that may affect your strategy.
Whether you’re working with exploratory biomarkers in early-phase research or seeking qualification for a biomarker intended to support clinical decision-making, this talk will equip you with the knowledge to move forward with clarity and confidence.