What are some of the encouraging recent developments in clinical validation of immunology biomarkers?

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.

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This week Dr. Brodmerkel answers this question:

Could you give us your own take on what you think to have been the most encouraging recent developments in clinical validation of immunology biomarkers?

Dr. Brodmerkel: There have been very exciting findings in the last year or two. We are excited about the possibility of predicting response in autoimmune disease. We’ve published data from our studies in ulcers and colitis and we are very active in rheumatoid arthritis, both testing published signatures for replication and deriving level biomarkers in-house in respiratory. Just very recently, we have Genentech’s anti-IL 13, a clinical antibody where they’ve shown they view stratification in the development utilizing PH2 signature and periostin status to stratify their patient. That is something that I think we’ll see more and more of, particularly in respiratory. Similar approaches will have to be used for COPD because it’s such a broad population, but driven by multiple molecular pathways.

These diseases are complex and difficult, but from the data that we’re seeing really in the last year or two, we can now see personalized medicine as something that is going to be a reality.

From both a space of personalized medicine and also your work in particular, what are some of the greatest challenges to progress that you’ve faced?

Dr. Brodmerkel: Top challenge continues to be access to disease tissue. It’s very difficult to ask patients with various diseases for repeat biopsy samples from tissues or to undergo difficult procedures. Really, the only way that you’re going to understand the disease better and find the underlying pathway information that you need is to have enough patient samples to do so. This is true in all disease areas. It’s not unique to immunology. We are looking into ways of pulling resources. How can we cooperate across pharma and academia to accelerate the science? We are also working on new paradigms for data sharing. IP issues are always paramount for industry, but there’s an evolving recognition that cooperation will produce results for everyone.

We are also at a time where data generation can outstrip our capability to analyze and understand the data. So, pooled resources really would help that. An improvement in informatics and data handling technologies are also needed to help push us to that next level of understanding.