Biomarker Podcast Exclusive: Carrier Brodmerkel, Director of Immunology Biomarkers at Centocor

Carrie Brodmerkel, Director of Immunology Biomarkers at Centocor, discusses her experiences in using immunology biomarkers to improve clinical trial results--not just for predicting patient health outcomes but also for patient stratification. Most clinical biomarker applications relate to oncology, so these insights from an immunology perspective will be both novel and highly valuable. Her talk is a direct lead-in to the at-show presentation by Brandon Higgs, Bioinformatics Lead at Medimmune, who will likewise be talking about biomarkers for autoimmune diseases that can be used in clinical trials.  This podcast is presetned to you by the Biomarker Applications For Improved Clinical Trial Outcomes Event, taking place November 15-16 in Boston.  For more on the event, visit the homepage.

Download the podcast here.

During the podcast, Carrie was asked:
Could you walk us through how your experiences have been used to modifiy the pipeline of drugs for autoimmune diseases? You mentioned some of the respiratory diseases before, such as asthma and COPD. From a pipeline perspective, what effect has it had?

Dr. Brodmerkel: One area that we focus on quite a bit is molecular profiling. We are utilizing that in several ways. In certain indications, we’ve created molecular phenotypes using molecular profiling to augment traditional clinical implantsand complement what we would normally do to understand mechanism of action of a drug. We anticipate that these molecular phenotypes may be more precise than some of the composite clinical end points that have softer patient-recorded or clinician-report outcome. While these are not currently accepted as surrogates, the data systems with internal decision making allowing us to make a better understanding of the activity of our drug in the disease of interest.

We also use molecular profiling to better understand the disease and what our treatments do and may not do. For example, in works that we’ve done in psoriasis, we’ve identified key pathways which are regulated in response to therapy. But, we’ve also identified genes and pathways which remain disregulated and are not corrected by existing drugs. In this way, understanding what’s not corrected by a clinically efficacious therapy, we want to get novel insights into how the disease develops. Hopefully, that will provide us with new targets and perhaps someday a means to really affect true disease cure.

Finally, we use molecular profiling in other types of information that we develop from patients from clinical trials to understand differentiation early in development. So, if a new product that we have in the pipeline has activity, but it is not superior on a molecular level from existing treatments (either from our pipeline or other products that are on the market), we can use that information to make concrete go/no go decisions for early pipeline products.