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MDS Pharma VP Claudio Carini explains what’s driving the field.
Big Pharma is facing many problems, but the core issue is that pipelines are running dry. Translational medicine may offer answers. By using biomarkers, perhaps we can reduce the pain of going to Phase III, by lowering costs, and we can also make drugs safer at the same time.
Of course, biomarkers are already extremely useful, and traditional markers like blood cholesterol and CD4 have been used for many years. Now scientists have access to an even wider range of markers including genetic, biochemical, and immunological markers as well as imaging.
In the future, we will get even more use out of markers. In the HIV field, biomarkers already monitor a patient’s status, drug efficacy, and prognosis. Future biomarkers may tell in advance which individual is prone to which side effects to further guide treatment. Biomarkers might also be used to monitor safety and efficacy in drugs, as well as distinguish between responders and non-responders.
But who is going to find all these biomarkers, and how? Though there has been a lot of thought about biomarkers in Big Pharma, there is not much investment, and upper management has not always seen the need for implementing biomarker development and a translational medicine-based strategy. They don’t have the people, and they have been reluctant to invest the money.
As a result, this is a great service for a CRO to offer, and at MDS, we have The Biomarker Alliance, which covers genetics, genomics, proteomics, and imaging. We can provide the technologies that groups, especially small companies, want.
We have not reached the era of personalized medicine yet, and we have a way to go, but certainly there are many more things we can do with technology now, and many studies are much more predictable thanks to biomarkers.
Claudio Carini is vice president of Translational Medicine at MDS Pharma Services.
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