Biomarkers Come of Age - Pharmaceutical Executive


Biomarkers Come of Age
In the past five years, biomarkers have become an essential part of pharmaceutical R&D. Seven industry experts explain how it happened—and what comes next.

Pharmaceutical Executive

Nicholas Dracopoli
Pfizer is continuing to change its internal processes to further support broad use of biomarkers and other technology, within the context of desired commercial impact on its products. At its New York headquarters, the clinical platforms group is applying business plans to advance biomarkers as part of Pfizer's diagnostic agenda.

"In the past year, the situation went from one of 'Why biomarkers?' within parts of the organization to one of solid support from management," says David Lester, PhD, Pfizer's New York site head for global clinical technology platforms, who regularly interacts with the commercial groups in CNS, cardiovascular, allergy/ophthalmic, and oncology.

One commercial expectation is that the use of biomarkers and other technology may support or revitalize products that are already on the market, gaining better patient loyalty, higher response to treatment, and more patient subpopulations for drug treatment.

Bayer's new chairman of healthcare, Arthur Higgins, views personalized medicine as a way to differentiate its products from other companies'. Bayer has focused on biomarker programs in both oncology and cardiovascular at an early stage, says Walter Carney, PhD. (Carney heads OncogeneScience, a division of Bayer HealthCare, whose serum HER2/neu test is marketed as a microtiter test by DakoCytomation in an automated format available on the ADVIA Centaur immunoassay system by Bayer Diagnostics.)

Brian Edmonds
The company's oncology effort was linked closely to a new drug, and the cardiovascular effort was brought forward by the availability of BNP (B-type natriuretic peptide) for acute coronary syndrome about two years ago. This latter test, in conjunction with other known risk factors, can be used to predict survival, as well as the likelihood of future heart failure.

One of Bayer's compounds, a kinase inhibitor called sorafenib (BAY 43-9006), is moving through the approval process for renal cancer and is also in Phase III with other cancers as new indications. This drug received a major biomarker focus prior to the initiation of clinical trials for new indications.

"This was a good example of the OncogeneScience and therapeutic groups at Bayer working together to ensure that biomarkers were available for drug trials," Carney says. OncogeneScience is also working closely with GlaxoSmithKline on its new drug lapatinib, a dual tyrosine kinase inhibitor that targets HER2/neu and epidermal growth factor receptor (EGFR).

Example of Imaging Biomakers
These companies are clearly taking the initiative to apply biomarker technology by discovering and advancing the biomarkers and associated information to develop and deploy offense and defense strategies (see "Offense or Defense"); companies that are not taking this initiative or that view biomarkers as an "added effort" will have to deal with the consequences. Having strategies for both offense and defense may be advantageous, especially when addressing scenarios and possible outcomes for clinical decisions and patient stratification for clinical trials (which later affects commercial and portfolio decisions).

Varying Technical Approaches

In developing biomarkers, says Novartis' Vonderscher, "One type of biomarker or one technology is not enough in many cases." For example, if only a cellular focus is investigated, the physiological aspects are often lacking, and cellular response may not reflect the larger biological system. "Growth hormone would not have been discovered if discovery had been done only at the cellular level," Vonderscher says. Multiple approaches are required to get the answer, and more than one type of biomarker (DNA, RNA, protein, biochemical) can be essential to detection.


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