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

One thing is certain: There will be an increase in the use of panels consisting of multiple biomarkers. The next advance—using different types of biomarkers together (e.g., DNA plus protein, RNA plus protein, etc.)—is already surfacing, and it will be facilitated by new instrumentation that allows two types of molecules to be detected simultaneously.

This April, Edmonds, working with an outside vendor, received new data showing that a technology platform could simultaneously test RNA and protein. And in late May, Olympus and Cangen Biotechnologies announced their plan to co-develop hybrid DNA- and protein-based diagnostic tests that can detect early stage lung cancer using microarray technology.

Today, smaller companies are coming into play, working with pharmaceutical companies to discover, develop, and implement biomarkers, as well as to independently create new diagnostic tests. These companies will push innovation as large pharmaceutical companies turn to them for technology, biomarkers/biomarker approaches, and in some cases, as diagnostic partners. Companies that have taken an offensive approach with biomarkers will lead and are already seeing benefits.

But given the timeline for the development, validation, and deployment of new biomarker tests, it will take considerable time for a company to catch up if doesn't already have biomarkers in place. A purely defensive strategy will be costly, in terms of market share, addressable product potential, and product usage.

Commercialization and Portfolio

Today, research and development organizations seem to be the principle drivers for implementation of biomarkers. But if patient stratification is to succeed at the product level (that is, in the hands of physicians), the marketing and sales functions must fully participate to ensure success. This is already happening at some companies.

At Novartis, for example, Phase IV oncology trials must include the use of innovative biomarker tests, and the trials are supported by marketing dollars. But in other pharma companies, it will take a concerted effort to turn around these more customer-facing areas. It may even be necessary to replace current personnel in order to achieve the necessary level of change.

The question is: When will companies change sufficiently to allow all relevant functions to work in concert to implement biomarkers throughout the commercialization process? Obviously, multiple areas of the pharmaceutical organization that regularly interact with physicians and patients will need to change practice in order to fully support the use of biomarkers by physicians. Key areas of change will include:

  • physician education
  • programs to support point-of-care decision making
  • allocation of personnel and assets to support therapeutic decision-making that is increasingly biologically determined
  • biomarker expertise within customer facingmedical, regulatory, marketing, and sales organizations.

The specifics of how and when these areas are expected to be affected may be the subject of a future article in Pharmaceutical Executive.

Offense or Defense?

Biomarker-induced market changes are due to arrive over the next five to 10 years. But they are already creating a competitive advantage today, as companies pursue offense and defense strategies.

Offense attacks are expected to come in many different forms, such as (1) biomarker-enhanced products seeking to displace older products through superiority in safety, efficacy, or patient preference; (2) payers, providers, or governmental bodies seeking to limit prescribing volume for a therapeutic class; and (3) innovation on the part of diagnostic companies that restructure prescribing volumes for a disease category.

Defense strategies require preparation now: It will be difficult to mount a defense once the attack has already been launched, given the number of years it takes to conclude relevant biomarker studies—and the limited lifecycle of profitability for patented products.

Every company should have a joint biomarker technology development and licensing/acquisition strategy to monitor biomarker evolution, engage potential biomarker co-development partners, and to license or acquire biomarker technologies.

Senior executives in every major pharmaceutical and biotechnology company can soon expect to be faced with a major biomarker "difficulty" dealing with portfolio allocation of major assets against late-stage opportunities. Based on five- to 10-year projections of future markets, the portfolio analysis and relevant marketing organizations need biomarker-related data and skills to help senior management make informed competitive decisions today.


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