Keynote: Navigating the Biomarker Spectrum: From Pharmacokinetics to Companion Diagnostics in a Complex Regulatory World

Tuesday, November 11, 2025

1:30 PM - 2:30 PM CT

Location:221 AB

Keynote Speaker(s)

Sarah Hersey, MS, MBA, RAC (she/her/hers)

Vice President, Head of Precision Medicine, Bioanalytical and Translational Sciences
Bristol Myers Squibb
Madison, New Jersey

Moderator(s)

Lina Luo, MS (she/her/hers)

Director
Bristol-Myers Squibb Company
Princeton, New Jersey

Join us for an insightful keynote exploring the evolving landscape of biomarkers in drug development and patient care. From understanding pharmacokinetic measures to advancing companion diagnostics, this session will illuminate the scientific, clinical, and regulatory challenges shaping the biomarker spectrum. Attendees will gain a deeper perspective on how to translate biomarker innovation into meaningful patient outcomes while navigating today’s complex regulatory environment.

Learning Objectives:

Understand the biomarker continuum Explore the role of biomarkers across the drug development spectrum, from pharmacokinetic assessments to the design and implementation of companion diagnostics.
Navigate regulatory complexities Identify key regulatory challenges and frameworks that influence biomarker development, validation, and approval in global markets.
Translate biomarker science into patient impact Examine strategies to integrate biomarkers into clinical and commercial decision-making, ultimately improving therapeutic precision and patient outcomes.