Three Visuals to Explain the Impact of Pharmacogenomic and Epigenetic Biomarkers in Oncology

This post was authored by Mike Madarasz of the Institute for International Research.  You can follow him on Twitter at @MikeMadarasz

In an effort to increase efficiency and streamline development of effective cancer therapies as well hold down costs associated with conducting clinical trials, drug developers have increased their investment in clinical biomarker research.  Specifically, there has been an increase in the use of pharmagenomic (PGX) biomarkers to either select or stratify patients.  Citeline recently published a white paper outlining some of the major impacts in oncology—some of which are explained in the charts below.

The increase in oncology trials selecting or stratifying by PGBX Biomarkers

The percentage of trials in this category has more than doubled since 2002

Breakdown of countries in PGX trials

The U.S. accounts for nearly 30% of these trials with Japan being the next closest at almost 15%.

Top sponsors using PGX biomarkers to select/stratify patients

The National Cancer Institute comes out as the top sponsor both in the relative     sense and in number of PGX trials.

To check out more from Citeline, download the white paper here.

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An Exclusive Interview about Immunogenicity from Dr. Martin Lechmann of Merck Serono

The 13th annual Immunogenicity for Biotherapeutics conferenceis devoted to offering you the most pressing and timely knowledge about designing safer biologics.

As part of this ongoing commitment to our audience, we are pleased to announce an exclusive interview with Dr. Martin Lechmann, Associate Director for Bioanalytics, Immunogenicity, and DMPK, Non-Clinical Development, at Merck Serono.

Dr. Lechmann’s interview addresses potential pharmacokinetic and pharmacodynamic biomarkers for immunogenicity, mechanisms for improving drug tolerability, immunoassay reliability, and other major concerns now facing the industry. Please click here to download the interview.

Download Dr. Lechmann’s podcast here.

Here's an excerpt from the article:

Now, can we delve into that a little bit? What are some of the challenges that are involved in using PD activity as a biomarker for immunogenicity? If they can be overcome, what are the specific benefits?

Dr. Lechmann's response: Yes, of course. First of all, you have to have an appropriate biomarker in your hands. In many cases, it is very difficult to achieve this. Of course, then if you have the biomarker, you have to have a very good understanding of the biology of the biomarker and to see if it is an early biomarker or late biomarker. And furthermore, it’s very crucial, also, to see how you determine what the kind of assay is to determine the concentration of the biomarkers. So, the capability of the biomarker. I think these are the challenges that you face with PD markers.

Immunogenicity for Biotherapeutics can help you find more answers about designing worthwhile assays and safer molecular configurations. To find out more about the event, download the brochure.

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Covance Partners with RBM to Extend Biomarker Offering

According to this article in outsourcing-pharma.com Covance will outsource biomarker activities to Rules Based Medicine, which is a US based laboratory group. Demand for biomarker services and the use of biomarker analysis in clinical trials has increased dramatically, and so this couldn't come at a better time.

Before the deal took place Covance had also begun building biomarker capacity. Under the deal RBM will apply its multi-analyte profile (MAP) technologies to projects being carried out by Covance's customers.

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