Biomarkers Come of Age - Pharmaceutical Executive

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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


Other indications Many diseases with long onset and long time to progression require clinical trials that take years and large numbers of patients to determine the benefit of biomarkers or new treatments. For such indications, establishing the value of biomarkers will be longer term.

However, Edmonds suggests that biomarkers might have a positive impact on metabolic diseases, such as diabetes, relatively soon—after all, a diabetes trial using biomarkers can show effects in patients on a timeline that is shorter than using traditional clinical measurements. On the other hand, immunology and asthma are considered two therapeutic areas in which biomarkers are not expected to have an impact in the near future.

Expectations

It is difficult to predict a timeline for future biomarker impact, and estimates vary widely. Vonderscher, for instance, estimates that 20 percent of pharmaceutical R&D is currently improved by post-genomic biomarkers and that this number will increase to 70 percent by 2008. Dracopoli, on the other hand, estimates that 10 percent of R&D is currently affected and that this number will increase to 50 percent by 2008. "This will happen drug by drug," he says.

"The number of trials using biomarkers will increase over three years," says Edmonds. "In principle, at Eli Lilly, all trials will have biomarkers included in the protocol by then, since every compound must have a biomarker strategy in place for management approval for compounds to advance. Some aspect of biomarkers will be there, principally to identify responders to maximize patient enrollment."

Roberts estimates that biomarkers could be in widespread clinical use in oncology in five to 10 years. Regarding co-development of a diagnostic test with a pharmaceutical product, the challenge, she says, is to create novel assays in parallel with a clinical development plan, without delaying the clinical development plan—which will require very early partnership.

Full panels of tests (for example, a group of tests to evaluate response for various drugs in the same therapeutic area) are further off. They will depend a great deal on companies' business models, desired market position, capitalization, and other factors—which will probably mean development will be slower than anyone currently thinks. "I would say 10 years, but I would not be surprised if it is less or longer," Edmonds says.

It is possible that the impetus to create such panels of tests may even come from others than pharma companies themselves. For example, a diagnostic company may develop such a panel, which may be supported by payers who desire to control/rationalize expenditures.

Carney estimates that a panel of tests to predict outcomes is about five to 10 years away from being available and another seven to 10 years away in terms of physician adoption. He projects that angiogenesis will be the next area where a combination drug and diagnostic test become available, because of the large number of new drugs in the pipeline.

What's Next?

The use of biomarker-based tests in the clinic clearly fits with what physicians are looking for—a way to better treat patients. However, the timing for the appearance of new biomarker tests is expected to be slower than most people outside the industry expect, and the timing of biomarker impact within various therapeutic areas will certainly differ. Short-term challenges include the education of clinical study sites on how to use biomarkers, and education of practicing physicians in relevant early-adopter clinical areas.

To truly gain the value of personalized medicine, though, a larger market-development process will be required, one that encourages collaboration among patients, prescribers, diagnostic and pharmaceutical manufacturers, academic groups, payers, and regulatory institutions. That process will be ongoing for a long time, but the investments, initial returns, and acceptance along the typical technology-adoption curve are underway in leading companies and in the marketplace.

Today's investments in biomarkers for R&D will lead naturally to the arrival of new drug/biomarker test combinations in the market. And there is reason to hope that as diseases and patient subgroups are redefined based on the continuing use of biomarkers, these tests may become even more of a solution, not an added effort.


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