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10 Biomarkers to Watch in Oncology

We decided to mine the biomarkers being used in clinical trials for interesting test development opportunities, and we began with Oncology as the first therapeutic area to explore.

Biomarkers In Clinical Trials: 80% Are Used In Two Or More Therapeutic Areas

We have been mining BiomarkerBase a bit more deeply to understand biomarker use across different therapeutic areas, and are frankly a bit surprised by how many biomarkers cross multiple TAs.

Clinical Trials Are Increasingly Using Multi-Biomarker Approaches

While multi-biomarker approaches are certainly going to become more common (key quote: "We really are moving away from this one drug, one biomarker, one companion diagnostic," Dr Richard Pazdur, FDA's oncology chief), this article identifies one key challenge, and that is sample scarcity. ...

Industry Report: Using Biomarkers To Accelerate Clinical Development

PPD has published a very nice white paper that provides an overview of the ways in which biomarkers are used in the clinical stages of drug development.

Genetic Testing Is Becoming More Routine At Cancer Hospitals

This article provides a nice summary of progress in using biomarkers to help treat cancer. One of the key takeaways is how much potential there is to understand the precise differences in tumors, and how different drugs will affect each of them. The article references "matrix style" trials as a way ...

Companies That Entered The Biomarker-Based IVD Market For The First Time During 2013

Six companies had their first biomarker-based tests cleared by FDA in 2013, and while they (and the tests they released) were quite diverse in many respects, company size is not one of them. Philips Healthcare is the one large company represented, and the remaining five have less than 300 employees ...

NanoString Inks $45 million CDx Collaboration With Celgene

NanoString will utilize IP from a 20-gene expression assay developed by the Lymphoma/Leukemia Molecular Profiling Project (LLMP) to develop a companion diagnostic test to support clinical validation of Celgene's REVLIMID®. NanoString could receive up to $45 million in payments under the deal.

   

March

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Pharmacovigilance and Safety Biomarkers

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