Prologue: Practical Considerations for Implementing Biomarkers in Clinical Trials, Challenges and Opportunities

Tuesday, October 18, 2022

8:30 AM – 9:00 AM ET

Location:253 B

Prologue Speaker(s)

Lakshmi Amaravadi, PhD

SVP, Head of Preclinical Development & Translational Medicine
Dewpoint Therapeutics
Boston, Massachusetts

Biomarkers are powerful tools that can enable patient selection to assessment of drug's action, to determine the right dose, assess patient response and even as key endpoints. Protein biomarkers in blood are often utilized during clinical development and as diagnostic markers, as they are simplest to implement. However, more informative biomarkers are found elsewhere in the body such as in cells, at tissue level or tissue specific exosomes or in the form of DNA shed from the tumors etc. The presentation will address implementation of various types biomarkers in clinical development based on context, why, when and how?

Learning Objectives:

Understand the various types of biomarker categories based on body compartment they come from. What type of matrix should be chosen for what biomarker/disease type etc
Explore the unique objectives that can be achieved by evaluating biomarkers at the cellular, tissue or unique compartment level that can be achieve by measuring biomarkers in blood. Understand why context of biomarker is importnat.
Discuss the opportunities, challenges and some evolving solutions in the implementation complex biomarkers to enable obtaining rich information can't be obtained by analyzing blood samples.